Capsid inhibitors for the prevention of HIV

Abstract

Abstract Provided herein are methods for preventing, or reducing the risk of acquiring, HIV using compounds of Formula Ia or Formula Ib.

Description

2024205867   19 Aug 2024 This application is a divisional application of Australian Application No. 2020391466 the specification of which as originally filed is incorporated herein in its entirety by reference. FIELD

[0001] The present disclosure provides methods of preventing HIV in a subject comprising administering to the subject a therapeutically effective amount of an HIV capsid inhibitor, or a pharmaceutically acceptable salt thereof, optionally in combination with one or more additional therapeutic agents. SEQUENCE LISTING

[0002] This disclosure contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on November 16, 2020, is named 1329.P2PC_PF Sequence Listing.txt and is 854 bytes in size. BACKGROUND

[0003] The HIV / AIDS pandemic has claimed the lives of millions of people, and millions more are currently infected. Antiretroviral therapy has turned HIV infection into a chronic, manageable disease; however, no cure yet exists for HIV. Reduction in the number of new HIV infections is a global goal. To this end, prevention regimens relating to both preexposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are being explored. Truvada (emtricitabine-tenofovir disoproxil fumarate) and Descovy (emtricitabine-tenofovir alafenamide) are currently the only medications approved for PrEP. Accordingly, new and effective means for preventing HIV infection are needed and the methods described herein are developed to help meet this need. SUMMARY

[0004] The present disclosure provides a method of preventing an HIV infection in a subject, or a method of reducing the risk of acquiring HIV in a subject, comprising administering to the subject a therapeutically effective amount of an HIV capsid inhibitor, or a pharmaceutically acceptable salt thereof, optionally in combination with one or more additional therapeutic agents.

[0005] The present disclosure further provides an HIV capsid inhibitor, or a pharmaceutically acceptable salt thereof, for use in any of the methods described herein. 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221

[0006] The present disclosure further provides use of an HIV capsid inhibitor, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for use in any of the methods described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 shows a representative scheme illustrating the PrEP study design of Example 1.

[0008] FIG. 2 shows a representative scheme illustrating the PrEP study design of Example 2.

[0009] FIG. 3 shows a representative scheme illustrating the PrEP study design of Example 3.

[0010] FIG. 4 shows a graph of the pharmacokinetic profile for a compound of Formula (lb) (“Compound lb”) in the male / female rhesus animals challenged with SHIV, where study week is on the x-axis and plasma concentration (nM) of the compound of Formula (lb) (“Compound lb”) is on the y-axis.

[0011] FIG. 5 shows a graph of the infection rate over time in male / female rhesus monkeys after a single subcutaneous administration of vehicle or a compound of Formula (lb) (“Compound lb”) followed by challenges with SHIV, where study week is on the x-axis and percent aviremic is on the y-axis.

[0012] FIG. 6A shows the plasma SHIV viral loads over time in individual male / female rhesus monkeys after having received a single subcutaneous administration of vehicle, followed by repeated weekly intrarectal challenges with escalating SHIV doses, where study week is on the x-axis and plasma SHIV in copies per mL is on the y-axis.

[0013] FIG. 6B shows the plasma SHIV viral loads over time in individual male / female rhesus monkeys after having received a single subcutaneous administration of 150 mg / kg of a compound of Formula (lb) (“Compound lb”), followed by repeated weekly intrarectal challenges with escalating SHIV doses, where study week is on the x-axis and plasma SHIV in copies per mL is on the y-axis.

[0014] FIG. 6C shows the plasma SHIV viral loads over time in individual male / female rhesus monkeys after having received a single subcutaneous administration of 300 mg / kg of a compound of Formula (lb) (“Compound lb”), followed by repeated weekly intrarectal challenges with escalating SHIV doses, where study week is on the x-axis and plasma SHIV in copies per mL is on the y-axis. DETAILED DESCRIPTION 2024205867   19 Aug 2024

[0015] The present disclosure relates to a method of preventing an HIV infection (e.g., HIV-1 and / or HIV-2) in a subject (e.g., a human) by administering to the subject a therapeutically effective amount of an HIV capsid inhibitor, or a pharmaceutically acceptable salt thereof.

[0016] In some embodiments, the HIV capsid inhibitor (e.g., a compound of Formula (la) or (lb)), or a pharmaceutically acceptable salt thereof, is administered as a monotherapy (i.e., in the absence of an additional therapeutic agent). In some embodiments, the HIV capsid inhibitor (e.g., a compound of Formula (la) or (lb)), or a pharmaceutically acceptable salt thereof, is administered in combination with one or more additional therapeutic agents, such as anti-HIV agents.

[0017] In some embodiments, the HIV capsid inhibitor is a compound of Formula (la) or Formula (lb): or a pharmaceutically acceptable salt thereof.

[0018] In some embodiments, the method comprises administering the compound of Formula (la), or a pharmaceutically acceptable salt thereof. In some embodiments, the method comprises administering the compound of Formula (lb), or a pharmaceutically acceptable salt thereof.

[0019] The present disclosure includes methods of using a compound of Formula (la), N-((S)-l-(3-(4-chloro-3-(methylsulfonamido)-l-(2,2,2-trifluoroethyl)-lH-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-l-yn-l-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bS,4aR)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-lH-cyclopropa[3,4]cyclopenta[l,2-c]pyrazol-l-yl)acetamide, having the following structure: 2024205867   19 Aug 2024 or a pharmaceutically acceptable salt thereof, for the prevention of an HIV infection.

[0020] The present disclosure also includes methods of using a compound of Formula (lb), N-((S)-l-(3-(4-chloro-3-(cyclopropanesulfonamido)-l-(2,2-difluoroethyl)-lH-indazol-7-yl)-6-(3 -methyl-3 -(methyl sulfonyl)but-1 -yn-1 -yl)pyri din-2-yl)-2-(3,5 -difluorophenyl)ethyl)-2-((3bS,4aR)-3-(difluoromethyl)-5,5-difluoro-3b,4,4a,5-tetrahydro-lH- cyclopropa[3,4]cyclopenta[l,2-c]pyrazol-l-yl)acetamide, having the following structure: (lb) or a pharmaceutically acceptable salt thereof, for the prevention of an HIV infection.

[0021] Synthesis and characterization of the compounds of Formula (la) and Formula (lb), and salts thereof are described in WO 2018 / 035359 (see also US 20180051005) and WO 2019 / 161280, the contents of which are hereby incorporated by reference in their entirety. Various forms of the compounds of Formula (la) are disclosed in WO 2019 / 035973 (see also US 20190083478) and WO / 2019 / 03 5904 (see also US 20190084963), the contents of which are hereby incorporated by reference in their entirety. 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221

[0022] In some embodiments, the HIV capsid inhibitor is a pharmaceutically acceptable salt of the compound of Formula (la) or Formula (lb). Non-limiting examples of pharmaceutically acceptable salts of the compound of Formula (la) and Formula (lb) include sodium salts. In some embodiments, the compound of Formula (la) is a sodium salt.

[0023] In the absence of a specific reference to a particular pharmaceutically acceptable salt and / or solvate of the above provided compound of Formula (la) or Formula (lb), any dosages, whether expressed in milligrams or as % by weight, should be understood as referring to the amount of the free acid, i.e., the compound of Formula (la) or Formula (lb). For example, a reference to “50 mg” of Formula (la), or a pharmaceutically acceptable salt thereof, refers to an amount of the compound of Formula (la), or a pharmaceutically acceptable salt thereof, which provides the same amount of the compound of Formula (la) as 50 mg of the compound of Formula (la) free acid. In some embodiments, a dosage referring to 50 mg of Formula (la) contains about 51.1 mg of Formula (la) monosodium salt.

[0024] In some embodiments of the methods disclosed herein, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 10 mg to about 2000 mg. In some embodiments of the methods disclosed herein, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 10 mg to about 3000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, about 1000 mg, about 1050 mg, about 1100 mg, about 1150 mg, about 1200 mg, about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, about 1500 mg, about 1550 mg, about 1600 mg, about 1650 mg, about 1700 mg, about 1750 mg, about 1800 mg, about 1850 mg, about 1900 mg, about 1950 mg, or about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 2050 mg, about 2100 mg, about 2150 mg, about 2200 mg, about 2250 mg, about 2300 mg, about 2350 mg, about 2400 mg, about 2450 mg, about 2500 mg, about 2550 mg, about 2600 mg, about 2650 mg, about 2700 mg, about 2750 mg, about 2800 mg, about 2850 mg, about 2900 mg, about 2950 mg, or about 3000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 900 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in 2024205867   19 Aug 2024 a dosage of about 500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 50 mg.

[0025] In some embodiments, the subject may have or be at risk of contracting an HIV infection. In some embodiments, the subject has been identified as an individual who is at risk of sexual transmission of HIV. In some embodiments, the individual has been identified as a man (e.g., who has sexual intercourse with a man or a woman), transgender man, transgender woman, a woman (e.g., who has sexual intercourse with a man or a woman), and / or a sex worker. In some embodiments, the individual has been identified as: • having anal sex with at least two different sexual partners and no consistent condom use over the last 6 months; and / or • having history of sexually transmitted diseases (STDs) during the last 12 months (e.g., syphilis, gonorrhea, chlamydiae, HBV or HCV infection); and / or • using psycho-active drugs during sexual intercourses (e.g., cocaine, gammahydroxybutyric acid (GHB), methylenedioxymethamphetamine (MDMA), mephedrone); and / or • having sexual intercourse with one or more partners originating from a region with high prevalence of HIV infection (> 1%) (e.g., South America, Sub-Saharan Africa, South-East Asia, Eastern Europe, French Guyana) and no consistent condom use; and / or • a sex worker; and / or • having a sexual partner who is an intravenous drug user sharing injection material; and / or • having an HIV-infected sexual partner with a detectable plasma viral load (e.g., >50 copies (cp) / milliliter (mL)).

[0026] In some embodiments, the subject is HIV-negative. In some embodiments, the HIV is HIV-1. In some embodiments, the HIV is HIV-2. In some embodiments, the HIV is HIV-1 and HIV-2.

[0027] As used herein, the terms “prevention” or “preventing” refers to the administration of a compound, pharmaceutically acceptable salt thereof, or composition comprising the compound or the pharmaceutically acceptable salt thereof according to the present disclosure pre- or post- 2024205867   19 Aug 2024 exposure of the subject to the virus but before the appearance of symptoms of the disease, and / or prior to the detection of the virus in the blood. The terms also refer to prevention of the appearance of symptoms of the disease and / or to prevent the virus from reaching detectable levels in the blood. The terms include both pre-exposure prophylaxis (PrEP), as well as postexposure prophylaxis (PEP) and event driven or “on demand” prophylaxis. The terms also refer to prevention of perinatal transmission of HIV from mother to baby by administration of a compound, pharmaceutically acceptable salt thereof, or composition comprising the compound or the pharmaceutically acceptable salt thereof according to the present disclosure to the mother before giving birth and to the child within the first days of life. The term also refers to prevention of transmission of HIV through blood transfusion.

[0028] As used herein, the term “period of exposure” refers to a period of time, ranging from a single event or to multiple events over an extended period of time, in which a subject is exposed to HIV. For example, a subject who engages in one sexual intercourse event with a partner who is HIV-positive has a period of exposure that is limited to the time and duration of that one sexual intercourse event with that partner. As another example, a subject who has sexual intercourse with a partner who is HIV-positive on multiple occasions over an extended period of time (e.g., days, weeks, months, or years) has a period of exposure that ranges from the first instance to the last instance of sexual intercourse with that partner.

[0029] As used herein, the term “inhibitory quotient” (IQ) refers to the EC95 value of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, that is adjusted for serum protein binding.

[0030] In some embodiments, the compound of Formula (la) or Formula (lb) as disclosed herein, or a pharmaceutically acceptable salt thereof, is administered daily. In some embodiments, the methods disclosed herein involve repeated administrations at intervals less than once daily. For example, in certain embodiments, the methods disclosed herein involve administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, every other day, five times per week, four times per week, three times per week, two times per week, one time per week, one time every two weeks, one time every three weeks, one time every four weeks, one time every five weeks, one time every six weeks, one time every seven weeks, or one time every eight weeks. In some embodiments of the methods disclosed herein, the methods involve administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, once every month, once every two months, once every three months, once every four months, once every five months, once every six months, or once every year. 2024205867   19 Aug 2024

[0031] In some embodiments, the methods disclosed herein comprise event driven administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, to the subject. As used herein, the terms “event driven” or “event driven administration” refer to administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, (1) prior to an event (e.g., 2 hours, 1 day, 2 days, 5 days, 7 days, 10 days, 14 days, 28 days (i.e., one month), or more days prior to the event) that would expose the subject to HIV (or that would otherwise increase the subject’s risk of acquiring HIV); and / or (2) during an event (or more than one recurring event) that would expose the subject to HIV (or that would otherwise increase the subject’s risk of acquiring HIV); and / or (3) after an event (or after the final event in a series of recurring events) that would expose the subject to HIV (or that would otherwise increase the subject’s risk of acquiring HIV). In some embodiments, the event driven administration is performed pre-exposure of the subject to the HIV. In some embodiments, the event driven administration is performed during exposure of the subject to the HIV. In some embodiments, the event driven administration is performed post-exposure of the subject to the HIV.

[0032] In some embodiments, the event driven administration is performed pre-exposure of the subject to the HIV and during exposure of the subject to the HIV

[0033] In some embodiments, the event driven administration is performed pre-exposure of the subject to the HIV and post-exposure of the subject to the HIV.

[0034] In some embodiments, the event driven administration is performed during exposure of the subject to the HIV and post-exposure of the subject to the HIV.

[0035] In certain embodiments, the methods disclosed herein involve administration prior to and / or after an event that would expose the subject to HIV or that would otherwise increase the subject’s risk of acquiring HIV, e.g., as pre-exposure prophylaxis (PrEP) and / or as postexposure prophylaxis (PEP). Examples of events that could increase a subject’s risk of acquiring HIV include, without limitation, no condom use during anal intercourse with an HIV positive partner or a partner of unknown HIV status; anal intercourse with more than 3 sex partners; exchange of money, gifts, shelter or drugs for anal sex; sex with male partner and diagnosis of sexually transmitted infection; and no consistent use of condoms with sex partner known to be HIV positive. In some embodiments, the methods disclosed herein comprise preexposure prophylaxis (PrEP). In some embodiments, methods disclosed herein comprise postexposure prophylaxis (PEP). In some embodiments, the methods disclosed herein comprise preexposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). 2024205867   19 Aug 2024

[0036] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before exposure of the subject to the HIV.

[0037] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered during exposure of the subject to the HIV.

[0038] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered after exposure of the subject to the HIV.

[0039] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before and during exposure of the subject to the HIV.

[0040] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before and after exposure of the subject to the HIV.

[0041] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered during and after exposure of the subject to the HIV.

[0042] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before, during, and after exposure of the subject to the HIV.

[0043] In some embodiments, the dose of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered during each period (i.e., before, during, and after exposure) may be different, i.e, independently selected from any of the doses disclosed herein.

[0044] An example of event driven dosing regimen includes administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at or within 5 to 10 days (e.g., about 7 days or one week) prior to HIV exposure (e.g., first sexual activity with sex partner known to be HIV positive, including sexual intercourse), followed by administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt, once every 1 to 12 weeks during the period of exposure (e.g., sexual activity with sex partner known to be HIV positive). Such a dosing regimen can be followed by a further administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, after the last exposure (e.g., sexual activity with sex partner known to be HIV positive). 2024205867   19 Aug 2024

[0045] In certain embodiments, e.g., when administered as PrEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered 1 hour to 240 hours (i.e., within 10 days), 1 hour to 216 hours, 1 hour to 192 hours, 1 hour to 168 hours, 1 hour to 144 hours, 1 hour to 120 hours, 1 hour to 96 hours, 1 hour to 72 hours, 1 hour to 48 hours, 1 hour to 24 hours, or 1 hour to 12 hours prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual activity) prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual intercourse or other exposure to the HIV). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered within 14 days, 13 days, 12 days, 11 days, 10 days, 9 days, 8 days, 7 days, 6 days, 5 days, 4 days, 3 days, 2 days, or 1 day prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual intercourse or other exposure to the HIV). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered within 72 hours, 60 hours, 48 hours, 24 hours, 12 hours, 9 hours, 6 hours, 4 hours, 3 hours, 2 hours, or 1 hour prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual intercourse or other exposure to the HIV). In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered prior to an event that would increase the subject’ risk of acquiring HIV, it is administered daily prior to the event (e.g., sexual activity). In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered prior to an event that would increase the subject’s risk of acquiring HIV, it is administered one to three times prior to the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered prior to an event that would increase the subject’s risk of acquiring HIV, it is administered one time (i.e., once) prior to the event.

[0046] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 14 days to about one day before exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 14 days to about one day before exposure of the subject to the HIV.

[0047] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 10 days to about 5 days before exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 10 days to about 5 days before exposure of the subject to the HIV. 2024205867   19 Aug 2024

[0048] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 8 days to about 6 days before exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 8 days to about 6 days before exposure of the subject to the HIV.

[0049] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered about 7 days before exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about 7 days before exposure of the subject to the HIV.

[0050] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 72 hours to about 1 hour before exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 72 hours to about 1 hour before exposure of the subject to the HIV.

[0051] In some embodiments of the methods provided herein, the pre-exposure prophylaxis (PrEP) comprises continuous PrEP. In some embodiments, the continuous PrEP comprises daily administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, from about 14 days to about 1 hour before the exposure of the subject to the HIV.

[0052] In certain embodiments where the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before exposure of the subject to the HIV, the methods disclosed herein further comprise administering one or more additional doses of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, during, and / or after exposure of the subject to the HIV.

[0053] In some embodiments, e.g., when administered as part of a PrEP regimen or as part of a PEP regimen, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered during the period of exposure of the subject to the HIV. In certain embodiments wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before HIV exposure, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered about every 7 days, about every 14 days, about every 21 days, about every 28 days, about every 35 days, or about every 42 days (e.g., as a single dose) during the time of HIV exposure (e.g., during the time period of sexual activity with sex partner known to be HIV positive). In some 2024205867   19 Aug 2024 embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 7 days, about every 14 days, about every 21 days, about every 28 days, about every 35 days, or about every 42 days during the period of exposure of the subject to the HIV.

[0054] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once (e.g., at about 7 days, 14 days, 21 days, or 28 days) after final exposure to the HIV (e.g., after a period of sexual activity with sex partner known to be HIV positive).

[0055] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered prior to exposure to the HIV is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered during and / or after exposure to the HIV. For example, in some embodiments, the dose of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is increased, e.g., as a double dose, as a triple dose, and the like as compared to an earlier administered dose (e.g., a dose prior to exposure to the HIV). In some embodiments, the increased dose of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is a double dose. In some embodiments, the dose of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is decreased, e.g, a half dose as compared to an earlier administered dose (e.g., a dose prior to exposure to the HIV).

[0056] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered as a single dose from about 1 hour to about 10 days before exposure of the subject to the HIV.

[0057] Additional examples of PrEP and / or PEP can be found, for example, at the clinical trial summary titled “On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men” (Clinical Trial # NCT01473472); the clinical trial summary titled “Prevention of HIV in ile-de-France” (Clinical Trials # NCT03113123), and at Molina et al, N. Engl. J. Med. 2015, 353:2237-2246, the disclosure of each of which is incorporated herein by reference in its entirety.

[0058] In some embodiments, e.g., when administered as part of a PrEP regimen or as part of a PEP regimen, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered 1 hour to 10 days, 1 hour to 7 days, 1 hour to 5 days, 1 to 72 hours, 1 to 48 hours, 1 to 36 hours, 1 to 24 hours, or 1 to 12 hours following an event that 2024205867   19 Aug 2024 would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV).

[0059] In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered for 7 days, 14 days, 21 days, 28 days, 30 days, or 45 days following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered for 30 days following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered less than 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 12 hours, 18 hours, 24 hours, 36 hours, or 48 hours following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV virus). In certain embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered for 1 day, 2 days, 3 days, 4 days, or 5 days following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered daily following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to three times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered once following the event.

[0060] In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every month, once about every 2 months, once about every 3 months, once about every 4 months, once about every 5 months, once about every 6 months, or once about every 12 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every month following an event that would 2024205867   19 Aug 2024 increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 2 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 3 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 4 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 5 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 6 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV). In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 12 months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV).

[0061] In certain embodiments, e.g., when administered as PEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered for one month, two months, three months, four months, five months, six months, or twelve months following an event that would increase the subject’s risk of acquiring HIV (e.g., following sexual intercourse or other exposure to the HIV).

[0062] In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to fifty times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to forty times following the event. In 2024205867   19 Aug 2024 certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to thirty times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to twenty times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to fifteen times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to ten times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered one to five times following the event.

[0063] In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered two times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered three times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered four times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered five times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered six times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered seven times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase 2024205867   19 Aug 2024 the subject’s risk of acquiring HIV, it is administered eight times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered nine times following the event. In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered ten times following the event.

[0064] In certain embodiments, when the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered following an event that would increase the subject’s risk of acquiring HIV, it is administered twice following the event.

[0065] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered during exposure of the subject to the HIV (e.g., during a period of sexual activity with sex partner known to be HIV positive).

[0066] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered after exposure (e.g., after final exposure) of the subject to the HIV (e.g., after a period of sexual activity with sex partner known to be HIV positive). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 1 hour to about 14 days after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 1 hour to about 14 days after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 1 hour to about 7 days after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 1 hour to about 7 days after exposure (c.g, after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 1 hour to about 72 hours after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 1 hour to about 72 hours after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 1 hour to about 24 hours after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, 2024205867   19 Aug 2024 the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 1 hour to about 24 hours after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered from about 24 hours to about 72 hours after exposure (e.g., after final exposure) of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 24 hours to about 72 hours after exposure (e.g., after final exposure) of the subject to the HIV.

[0067] In some embodiments, e.g., when administered as PrEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual activity), and following the event. For example, in certain embodiments, when administered as PrEP, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered 1 to 240 hours (i.e., within 10 days), 1 hour to 216 hours, 1 hour to 192 hours, 1 hour to 168 hours, 1 hour to 144 hours, 1 hour to 120 hours, 1 hour to 96 hours, 1 hour to 72 hours, 1 hour to 48 hours, 1 hour to 24 hours, or 1 hour to 12 hours prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual activity) and 1 hour to 240 hours (i.e., within 10 days), 1 hour to 216 hours, 1 hour to 192 hours, 1 hour to 168 hours, 1 hour to 144 hours, 1 hour to 120 hours, 1 hour to 96 hours, 1 hour to 72, 1 hour to 48 hours, 1 hour to 36 hours, 1 hour to 24 hours, or 1 hour to 12 hours following the event. For example, in some embodiments, one or more (e.g., one, two, or three) dosages of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, are administered one to ten days (e.g., seven days) prior to an event that would increase the subject’s risk of acquiring HIV (e.g., prior to sexual intercourse) and once during a period of one to ten days following the event. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once per week, twice per week, three times per week, four times per week, or five times per week and one or more times (e.g, one, two, or three times) beginning 1 to 48 hours following an event that would increase the subject’s risk of acquiring HIV (e.g, following sexual intercourse).

[0068] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a 2024205867   19 Aug 2024 pharmaceutically acceptable salt thereof, once every 7 days during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0069] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 14 days during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0070] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 21 days during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0071] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 28 days during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0072] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 35 days during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0073] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 42 days during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0074] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 1 month during the period of exposure to the HIV.

[0075] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 2 months during the period of exposure to the HIV.

[0076] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 3 months during the period of exposure to the HIV.

[0077] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 6 months during the period of exposure to the HIV.

[0078] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 12 months during the period of exposure to the HIV.

[0079] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 1 month during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii). 2024205867   19 Aug 2024

[0080] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 2 months during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0081] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 3 months during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0082] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 6 months during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0083] In some embodiments, the methods comprise: (i) administering the compound of Formula (la) or Formula (lb), or a 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and (ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 12 months during the period of exposure to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

[0084] In some embodiments, the administrations of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof (as in steps (i) or (ii)), further comprise administration of: (a) bictegravir, or a pharmaceutically acceptable salt thereof; (b) tenofovir alafenamide, or a pharmaceutically acceptable salt thereof; or (c) bictegravir, or a pharmaceutically acceptable salt thereof and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof.

[0085] In some embodiments, the administrations of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof (as in steps (i) or (ii)), further comprise administration of bictegravir, or a pharmaceutically acceptable salt thereof, in a dosage of from about 10 mg to about 600 mg and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, in a dosage of from about 10 mg to about 50 mg.

[0086] In some embodiments, the administrations of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof (as in steps (i) or (ii)), further comprise administration of bictegravir, or a pharmaceutically acceptable salt thereof, in a dosage of from about 10 mg to about 200 mg and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, in a dosage of from about 10 mg to about 50 mg.

[0087] Also provided herein is a method of reducing the risk of acquiring HIV in a subject, comprising administering to the subject a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[0088] In some embodiments, methods for reducing the risk of acquiring HIV (e.g., HIV-1 and / or HIV-2) comprise administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, to a subject in combination with safer sexual intercourse practices. In certain embodiments, methods for reducing the risk of acquiring HIV (e.g., HIV-1 and / or HIV-2) comprise administration of the compound of Formula (la) or 2024205867   19 Aug 2024 Formula (lb), or a pharmaceutically acceptable salt thereof, to a subject at risk of acquiring HIV. Examples of subjects at high risk for acquiring HIV include, without limitation, a subject who is at risk of sexual transmission of HIV.

[0089] In some embodiments, the reduction in risk of acquiring HIV is at least about 40%, 50%, 60%, 70%, 80%, 90%, or 95% (compared to a subject having not been administered the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof according to any of the methods provided herein). In some embodiments, the reduction in risk of acquiring HIV is about 80%, 85%, or 90%. In some embodiments, the reduction in risk of acquiring HIV is at least about 75%. In some embodiments, the reduction in risk of acquiring HIV is at least about 80%. In some embodiments, the reduction in risk of acquiring HIV is at least about 85%. In some embodiments, the reduction in risk of acquiring HIV is at least about 90%. Dosing Regimens

[0090] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered to a subject (e.g., a human patient) in accordance with an effective dosing regimen for a desired period of time or duration. In some embodiments, the dosing regimen includes administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, for at least about 1 week, about 2 weeks, about 4 weeks, about 8 weeks, about 12 weeks, about 16 weeks, about 20 weeks, about 24 weeks, about 28 weeks, about 32 weeks, about 36 weeks, about 40 weeks, about 44 weeks, about 48 weeks, about 52 weeks, or longer.

[0091] In some embodiments, the dosing regimen includes administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, for at least about 1 year, 2 years, 3 years, 4 years, 5 years, 10 years, or longer. In some embodiments, the dosing regimen includes continuous administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, during the life of the subject.

[0092] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered on a daily or intermittent schedule. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once daily. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered on a monthly schedule. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 1 week, about every 2 2024205867   19 Aug 2024 weeks, about every 4 weeks, about every 8 weeks, about every 12 weeks, about every 16 weeks, about every 20 weeks, about every 24 weeks, or once about every 48 weeks. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once every 4 weeks (or monthly). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once every 8 weeks (or 2 months). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once every 12 weeks (or three months). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once every 16 weeks (or four months). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once every 20 weeks (or five months). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every 24 weeks (or 6 months). In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every 52 weeks (or yearly).

[0093] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every month, about every 2 months, about every 3 months, about every 4 months, about every 5 months, about every 6 months, or about every 12 months during the period of exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every month during the period of exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 2 months during the period of exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 3 months during the period of exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 4 months during the period of exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 5 months during the period of exposure of the subject to the HIV. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 6 months during the period of exposure of the subject to the HIV. In some embodiments, the compound of 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 12 months during the period of exposure of the subject to the HIV.

[0094] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously administered to a subject (e.g., a human patient) for at least about one month. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously or intramuscularly administered to a subject for at least about 2 months, at least about 3 months, at least about 4 months, or at least about 6 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously administered to a subject once about every month. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously or intramuscularly administered to a subject once about every 3 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously or intramuscularly administered to a subject once about every 6 months.

[0095] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously or intramuscularly administered to a subject once about every 12 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously administered to a subject once about every 12 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is intramuscularly administered to a subject once about every 12 months.

[0096] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is intramuscularly administered to a subject once about every month. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously administered to a subject once about every 3 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is intramuscularly administered to a subject once about every 3 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously administered to a subject once about every 6 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is intramuscularly administered to a subject once about every 6 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is subcutaneously administered to a subject once about every year. In some embodiments, the compound of Formula (la) or Formula (lb), or a 2024205867   19 Aug 2024 pharmaceutically acceptable salt thereof, is intramuscularly administered to a subject once about every year.

[0097] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once daily. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once about every 1 week, about every 2 weeks, about every 4 weeks, about every 8 weeks, about every 12 weeks, about every 16 weeks, about every 20 weeks, about every 24 weeks, about every 48 weeks, or about every year. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once about every 1 week. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once about every month. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once about every 3 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once about every 6 months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is orally administered to a subject once about every year.

[0098] The dosage or dosing frequency of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, can be adjusted over the course of the treatment, based on the judgment of the administering physician.

[0099] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered to a subject (for example, a human) in a therapeutically effective amount. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once daily. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every two months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every three months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every four months. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every six months. 2024205867   19 Aug 2024 In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered yearly.

[00100] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage amount that is effective. In some embodiments, the dosage is from about 1 mg to about 1000 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In certain embodiments, the dosage amount is about 1 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 120 mg, about 130 mg, about 140 mg, or about 150 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In certain embodiments, the dosage amount is about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, or about 1000 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[00101] In certain embodiments, the dosage amount is about 1 mg, about 5 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 100 mg, about 110 mg, about 120 mg, about 130 mg, about 140 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, about 1000 mg, about 1050 mg, about 1100 mg, about 1150 mg, about 1200 mg, about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, about 1500 mg, about 1550 mg, about 2000 mg, about 2050 mg, or about 3000 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[00102] In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 1 mg to about 2500 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 2400 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 2000 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 1500 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a 2024205867   19 Aug 2024 pharmaceutically acceptable salt thereof, is about 5 mg to about 1200 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 1000 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 500 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 300 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 200 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 100 mg. In some embodiments, the dosage amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is about 5 mg to about 50 mg.

[00103] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1 mg to about 1500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 5 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 100 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 200 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 300 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 500 mg to about 1200 mg.

[00104] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1 mg to about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 5 mg to about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 10 mg to about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 50 mg to 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 100 mg to about 200 mg.

[00105] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, about 120 mg, about 125 mg, about 130 mg, about 135 mg, about 140 mg, about 145 mg, about 150 mg, about 155 mg, about 160 mg, about 165 mg, about 170 mg, about 175 mg, about 180 mg, about 185 mg, about 190 mg, about 195 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, about 1000 mg, about 1050 mg, about 1100 mg, about 1150 mg, about 1200 mg, about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, or about 1500 mg.

[00106] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1 mg.

[00107] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 5 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 10 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 15 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 20 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 25 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 50 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 75 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable 2024205867   19 Aug 2024 salt thereof, is administered in a once daily dose of about 125 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 150 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 175 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 600 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 700 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 800 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 900 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a once daily dose of about 1500 mg.

[00108] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 100 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 100 mg to 2024205867   19 Aug 2024 about 2400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 100 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 300 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 500 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 800 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1000 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 100 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 150 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 200 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 300 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 500 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 600 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 800 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1000 mg to about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 2024205867   19 Aug 2024 mg, about 1075 mg, about 1100 mg, about 1125 mg, about 1150 mg, about 1175 mg, about 1200 mg, about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, about 1500 mg, about 1550 mg, about 1600 mg, about 1650 mg, about 1700 mg, about 1750 mg, about 1800 mg, about 1850 mg, about 1900 mg, about 1950 mg, about 2000 mg, about 2050 mg, about 2100 mg, about 2150 mg, about 2200 mg, about 2250 mg, about 2300 mg, about 2350 mg, about 2400 mg, about 2450 mg, or about 2500 mg.

[00109] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 150 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 175 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 300 mg.

[00110] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 600 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 700 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 800 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 900 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is 2024205867   19 Aug 2024 administered weekly at a dose of about 1300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1600 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1700 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1800 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 1900 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 2100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 2200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 2300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 2400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered weekly at a dose of about 2500 mg.

[00111] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 100 mg to about 3000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 100 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 100 mg to about 2400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 100 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 300 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a 2024205867   19 Aug 2024 pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 500 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 800 mg to about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1000 mg to about 2500 mg.

[00112] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 200 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 300 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 400 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 500 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 800 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1000 mg to about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1125 mg, about 1150 mg, about 1175 mg, about 1200 mg, about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, about 1500 mg, about 1550 mg, about 1600 mg, about 1650 mg, about 1700 mg, about 1750 mg, about 1800 mg, about 1850 mg, about 1900 mg, about 1950 mg, about 2000 mg, about 2050 mg, about 2100 mg, about 2150 mg, about 2200 mg, about 2250 mg, about 2300 mg, about 2350 mg, about 2400 mg, about 2450 mg, about 2500 mg, about 2550 mg, about 2600 mg, about 2650 mg, about 2700 mg, about 2750 mg, about 2800 mg, about 2850 mg, about 2900 mg, about 2950 mg, or about 3000 mg. 2024205867   19 Aug 2024

[00113] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 150 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 800 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 1800 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2000 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2100 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2200 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2300 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2400 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2500 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a 2024205867   19 Aug 2024 pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2600 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2700 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2800 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 2900 mg. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered monthly at a dose of about 3000 mg.

[00114] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered every 6 months at a dose of about 600 mg. Salts and Compositions

[00115] The present methods comprise administration of salts of the compound of Formula (la) or Formula (lb), such as pharmaceutically acceptable salts. A salt generally refers to a derivative of a disclosed compound wherein the parent compound is modified by converting an existing acid or base moiety to its salt form. A pharmaceutically acceptable salt is one that, within the scope of sound medical judgment, is suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines; alkali or organic salts of acidic residues such as carboxylic acids; and the like. The pharmaceutically acceptable salts of the present disclosure include the conventional non-toxic salts of the parent compound formed, for example, from non-toxic inorganic or organic acids. The pharmaceutically acceptable salts of the present disclosure can be synthesized from the parent compound which contains a basic or acidic moiety by conventional chemical methods. Generally, such salts can be prepared by reacting the free acid or base forms of these compounds with a stoichiometric amount of the appropriate base or acid. Lists of suitable salts are found in Remington’s Pharmaceutical Sciences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418 and Journal of Pharmaceutical Science, 66, 2 (1977), each of which is incorporated herein by reference in its entirety. In some embodiments, the salt is a sodium salt. 2024205867   19 Aug 2024

[00116] The compound of Formula (la) or Formula (lb), or its salt, can be present in a composition (such as a pharmaceutical composition or formulation) where the composition includes at least one compound other than the compound of Formula (la) or Formula (lb) or salt of the disclosure.

[00117] In some embodiments, the composition comprises the compound of Formula (la) or Formula (lb), or a salt thereof, and one or more additional compounds (e.g., one or more additional therapeutic compounds), or salts thereof. In some embodiments, the composition comprises the compound of Formula (la) or Formula (lb), or a salt thereof; bictegravir, or a salt thereof; and one or more additional compounds (e.g., one or more additional therapeutic compounds such as tenofovir alafenamide, or a pharmaceutically acceptable salt thereof), or salts thereof.

[00118] Compositions can include mixtures containing the compound of Formula (la) or Formula (lb), or salt thereof, and one or more solvents, substrates, carriers, etc. In some embodiments, the composition comprises the compound of Formula (la) or Formula (lb), or salt thereof, in an amount greater than about 25% by weight, for example, greater than about 25% by weight, greater than about 50% by weight, greater than about 75% by weight, greater than about 80% by weight, greater than about 90% by weight, or greater than about 95% by weight.

[00119] The present disclosure further includes pharmaceutical compositions comprising the compound of Formula (la) or Formula (lb), or pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier. As used herein, “pharmaceutically acceptable carrier” is meant to refer to any adjuvant, carrier, excipient, glidant, sweetening agent, diluent, preservative, dye / colorant, flavor enhancer, surfactant, wetting agent, dispersing agent, suspending agent, stabilizer, isotonic agent, solvent, or emulsifier which has been approved by the United States Food and Drug Administration as being acceptable for use in humans or domestic animals.

[00120] Administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, can be carried out via any of the accepted modes of administration of agents for serving similar utilities. The pharmaceutical compositions of the disclosure can be prepared by combining the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, with an appropriate pharmaceutically acceptable carrier and, in specific embodiments, are formulated into preparations in solid, semi solid, liquid or gaseous forms, such as tablets, capsules, powders, granules, ointments, solutions, suppositories, injections, inhalants, gels, microspheres, and aerosols. Exemplary routes of administering such pharmaceutical compositions include, without limitation, oral, topical, 2024205867   19 Aug 2024 transdermal, inhalation, parenteral, sublingual, buccal, rectal, vaginal, and intranasal. In some embodiments, pharmaceutical compositions of the disclosure are tablets. In some embodiments, pharmaceutical compositions of the disclosure are injection (e.g., intramuscular (IM) or intraperitoneal (IP)). Pharmaceutical compositions of the disclosure are formulated so as to allow the active ingredients contained therein to be bioavailable upon administration of the composition to a subject. Compositions that will be administered to a subject take the form of one or more dosage units, where for example, a tablet may be a single dosage unit, and a container of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in aerosol form may hold a plurality of dosage units. Actual methods of preparing such dosage forms are known, or will be apparent, to those skilled in this art; for example, see Remington: The Science and Practice of Pharmacy, 20th Edition (Philadelphia College of Pharmacy and Science, 2000). The composition to be administered will, in any event, contain a therapeutically effective amount of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, for prevention of an HIV infection or reducing the risk of acquiring HIV, as described herein.

[00121] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally, subcutaneously, intramuscularly, or intravenously.

[00122] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 20 mg / mL to about 300 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 300 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 200 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 20 mg / mL to about 100 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 30 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 50 mg / mL.

[00123] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is formulated as a hard gelatin capsule. 2024205867   19 Aug 2024

[00124] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is formulated as a soft gelatin capsule.

[00125] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is formulated as a tablet. In some embodiments, the tablet comprises from about 5 mg to about 500 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 50 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the tablet comprises about 300 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[00126] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered parenterally. Parenteral administration includes, but is not limited to, intravenous, intraarterial, subcutaneous, intraperitoneal, intramuscular, intracranial, transdermal, and vaginal administration. Parenteral administration can be administered, for example, in the form of a single bolus dose or by a continuous perfusion pump. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered to the subject through a medical device. Exemplary medical devices include, but are not limited to, a patch (e.g., a transdermal patch), an implantable device (e.g., an implantable device for metered or sustained release of an active agent; a subdermal device), a syringe, a contraceptive device (e.g., a vaginal ring, an intrauterine device), and the like.

[00127] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 10 mg / mL to about 500 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 50 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 100 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 150 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 300 mg / mL. 2024205867   19 Aug 2024

[00128] In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 125 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 309 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 400 mg / mL. In some embodiments, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 500 mg / mL.

[00129] In some embodiments of the methods provided herein, the compound of Formula (la) or Formula (lb) is administered to the subject as a solution (e.g., for subcutaneous administration or for oral administration via, e.g., a capsule). In some embodiments, the solution comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, and water. In some embodiments, the solution comprises a compound of Formula (la) or a pharmaceutically acceptable salt thereof, PEG 300, and water. In some embodiments, the solution comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, and water. In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, and water. In some embodiments, the solution comprises a compound of Formula (lb), PEG 300, and water.

[00130] In some embodiments, the solution comprises a compound of Formula (la), PEG 300, and water. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 50 mg / ml to about 500 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 50 mg / ml to about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 50 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 75 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 50 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 75 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 100 mg / ml. In some embodiments, the 2024205867   19 Aug 2024 concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 125 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 150 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 175 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 200 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 225 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 250 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 275 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 325 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 350 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 375 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 425 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 450 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 475 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 500 mg / ml.

[00131] In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 5 w / w% to about 15 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 5 w / w% to about 10 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 8 w / w% to 2024205867   19 Aug 2024 about 12 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 9 w / w% to about 10 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 8.0 w / w%, about 8.1 w / w%, about 8.2 w / w%, about 8.3 w / w%, about 8.4 w / w%, about 8.5 w / w%, about 8.6 w / w%, about 8.7 w / w%, about 8.8 w / w%, about 8.9 w / w%, about 9.0 w / w%, about 9.1 w / w%, about 9.2 w / w%, about 9.3 w / w%, about 9.4 w / w%, about 9.5 w / w%, about 9.6 w / w%, about 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, about 10.0 w / w%, about 10.1 w / w%, about 10.2 w / w%, about 10.3 w / w%, about 10.4 w / w%, about 10.5 w / w%, about 10.6 w / w%, about 10.7 w / w%, about 10.8 w / w%, about 10.9 w / w%, about 11.0 w / w%, about 11.1 w / w%, about 11.2 w / w%, about 11.3 w / w%, about 11.4 w / w%, about 11.5 w / w%, about 11.6 w / w%, about 11.7 w / w%, about 11.8 w / w%, about 11.9 w / w%, or about 12.0 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 9.0 w / w%, about 9.1 w / w%, about 9.2 w / w%, about 9.3 w / w%, about 9.4 w / w%, about 9.5 w / w%, about 9.6 w / w%, about 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, or about 10.0 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 9.5 w / w%, about 9.6 w / w%, about 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, or about 10.0 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 9.8 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, and water is about 10 w / w%.

[00132] In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, and water is about 50 w / w% to about 85 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, and water is about 60 w / w% to about 80 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, and water is about 60 w / w% to about 70 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, and water is about 50 w / w%, about 55 w / w%, about 60 w / w%, about 65 w / w%, about 70 w / w%, about 75 w / w%, about 80 w / w%, or about 85 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, and water is about 65 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, and water is about 65.0 w / w%.

[00133] In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 15 w / w% to about 35 2024205867   19 Aug 2024 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 20 w / w% to about 35 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 24 w / w% to about 26 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, or about 25.5 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 25 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, and water is about 25.2 w / w%.

[00134] In some embodiments, the solution comprises about 5 w / w% to about 15 w / w% water, about 50 w / w% to about 85 w / w% PEG 300, and about 15 w / w% to about 35 w / w% of a compound of Formula (la). In some embodiments, the solution comprises about 5 w / w% to about 10 w / w% water, about 60 w / w% to about 80 w / w% PEG 300, and about 20 w / w% to about 35 w / w% of a compound of Formula (la). In some embodiments, the solution comprises about 8 w / w% to about 12 w / w% water, about 60 w / w% to about 70 w / w% PEG 300, and about 15 w / w% to about 35 w / w% of a compound of Formula (la). In some embodiments, the solution comprises about 9 w / w% to about 10 w / w% water, about 60 w / w% to about 70 w / w% PEG 300, and about 24 w / w% to about 26 w / w% of a compound of Formula (la). In some embodiments, the solution comprises about 9.8 w / w% water, about 65.0 w / w% PEG 300, and about 25.2 w / w% of a compound of Formula (la). In some embodiments, the solution comprises about 10 w / w% water, about 65.0 w / w% PEG 300, and about 25 w / w% of a compound of Formula (la).

[00135] In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, and water. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50 mg / ml to about 500 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 75 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the 2024205867   19 Aug 2024 solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 75 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 100 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 125 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 150 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 175 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 200 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 225 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 250 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 275 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 325 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 350 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 375 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 425 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 450 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in 2024205867   19 Aug 2024 the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 475 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 500 mg / ml.

[00136] In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 309 mg / ml.

[00137] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 10 w / w% to about 40 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 20 w / w% to about 30 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 21 w / w% to about 29 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 23.4 w / w% to about 27.5 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 23.41 w / w% to about 27.47 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or 2024205867   19 Aug 2024 about 29.0 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 23.4 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 23.41 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 27.47 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 27.5 w / w%.

[00138] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 21.1 w / w% to about 27.5 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 21.13 w / w% to about 27.47 w / w%.

[00139] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 21.1 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 21.13 w / w%.

[00140] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 45 w / w% to about 65 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 48 w / w% to about 60 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50 w / w% to about 59 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50.1 w / w% to about 58.8 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50.13 w / w% to about 58.84 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 45 w / w%, about 46 w / w%, about 47 w / w%, about 48 w / w%, about 49 w / w%, about 50 w / w%, about 51 w / w%, about 52 w / w%, about 53 w / w%, about 54 w / w%, about 55 w / w%, about 56 w / w%, about 57 w / w%, about 58 w / w%, about 59 w / w%, about 60 w / w%, about 61 w / w%, about 62 w / w%, about 63 w / w%, about 64 w / w%, or about 65 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a 2024205867   19 Aug 2024 sodium salt of the compound of Formula (la), PEG 300, and water is about 50.1 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 50.13 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 58.8 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 58.84 w / w%.

[00141] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 45.3 w / w% to about 58.8 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 45.25 w / w% to about 58.84 w / w%.

[00142] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 45.25 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 45.3 w / w%.

[00143] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 5 w / w% to about 35 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 10 w / w% to about 30 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 11 w / w% to about 28 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13 w / w% to about 27 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.69 w / w% to about 26.46 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.7 w / w% to about 26.5 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.0 w / w%, about 13.1 w / w%, about 13.2 w / w%, about 13.3 w / w%, about 13.4 w / w%, about 13.5 w / w%, about 13.6 w / w%, about 13.7 w / w%, about 13.8 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 w / w%, about 13.9 w / w%, about 14.0 w / w%, about 14.1 w / w%, about 14.2 w / w%, about 14.3 w / w%, about 14.4 w / w%, about 14.5 w / w%, about 14.6 w / w%, about 14.7 w / w%, about 14.8 w / w%, about 14.9 w / w%, about 15.0 w / w%, about 15.1 w / w%, about 15.2 w / w%, about 15.3 w / w%, about 15.4 w / w%, about 15.5 w / w%, about 15.6 w / w%, about 15.7 w / w%, about 15.8 w / w%, about 15.9 w / w%, about 16.0 w / w%, about 16.1 w / w%, about 16.2 w / w%, about 16.3 w / w%, about 16.4 w / w%, about 16.5 w / w%, about 16.6 w / w%, about 16.7 w / w%, about 16.8 w / w%, about 16.9 w / w%, about 17.0 w / w%, about 17.1 w / w%, about 17.2 w / w%, about 17.3 w / w%, about 17.4 w / w%, about 17.5 w / w%, about 17.6 w / w%, about 17.7 w / w%, about 17.8 w / w%, about 17.9 w / w%, about 18.0 w / w%, about 18.1 w / w%, about 18.2 w / w%, about 18.3 w / w%, about 18.4 w / w%, about 18.5 w / w%, about 18.6 w / w%, about 18.7 w / w%, about 18.8 w / w%, about 18.9 w / w%, about 19.0 w / w%, about 19.1 w / w%, about 19.2 w / w%, about 19.3 w / w%, about 19.4 w / w%, about 19.5 w / w%, about 19.6 w / w%, about 19.7 w / w%, about 19.8 w / w%, about 19.9 w / w%, about 20.0 w / w%, about 21.1 w / w%, about 21.2 w / w%, about 21.3 w / w%, about 21.4 w / w%, about 21.5 w / w%, about 21.6 w / w%, about 21.7 w / w%, about 21.8 w / w%, about 21.9 w / w%, about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or about 29.0 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.69 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.7 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 26.46 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 26.5 w / w%.

[00144] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.69 w / w% to about 33.61 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 13.7 w / w% to about 33.6 w / w%.

[00145] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 33.61 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and water is about 33.6 w / w%.

[00146] In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 35 w / w% to about 75 w / w% PEG 300, and about 5 w / w% to about 35 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 15 w / w% to about 35 w / w% water, about 45 w / w% to about 65 w / w% PEG 300, and about 10 w / w% to about 30 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 20 w / w% to about 30 w / w% water, about 48 w / w% to about 60 w / w% PEG 300, and about 11 w / w% to about 28 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 21 w / w% to about 29 w / w% water, about 50 w / w% to about 59 w / w% PEG 300, and about 13 w / w% to about 27 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 23.4 w / w% to about 27.5 w / w% water, about 50.1 w / w% to about 58.8 w / w% PEG 300, and about 13.7 w / w% to about 26.5 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 23.41 w / w% to about 27.47 w / w% water, about 50.13 w / w% to about 58.84 w / w% PEG 300, and about 13.69 w / w% to about 26.46 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 27.5 w / w% water, about 58.8 w / w% PEG 300, and about 13.7 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 27.47 w / w% water, about 58.84 w / w% PEG 300, and about 13.69 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 23.4 w / w% water, about 50.1 w / w% PEG 300, and about 26.5 w / w% of a sodium salt of 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 the compound of Formula (la). In some embodiments, the solution comprises about 23.41 w / w% water, about 50.13 w / w% PEG 300, and about 26.46 w / w% of a sodium salt of the compound of Formula (la).

[00147] In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 35 w / w% to about 75 w / w% PEG 300, and about 5 w / w% to about 45 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 10 w / w% to about 30 w / w% water, about 35 w / w% to about 65 w / w% PEG 300, and about 5 w / w% to about 45 w / w% of a sodium salt of the compound of Formula (la).

[00148] In some embodiments, the solution comprises about 21.1 w / w% to about 27.5 w / w% water, about 45.3 w / w% to about 58.8 w / w% PEG 300, and about 13.7 w / w% to about 33.6 w / w% of a sodium salt of the compound of Formula (la). In some embodiments, the solution comprises about 21.13 w / w% to about 27.47 w / w% water, about 45.25 w / w% to about 58.84 w / w% PEG 300, and about 13.69 w / w% to about 33.61 w / w% of a sodium salt of the compound of Formula (la).

[00149] In some embodiments, the solution comprises about 21.1 w / w% water, about 45.3 w / w% PEG 300, and about 33.6 w / w% of a sodium salt of a compound of Formula (la). In some embodiments, the solution comprises about 21.13 w / w% water, about 45.25 w / w% PEG 300, and about 33.61 w / w% of a sodium salt of a compound of Formula (la).

[00150] In some embodiments, the solution comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, water, and ethanol. In some embodiments, the solution comprises a compound of Formula (la), or a pharmaceutically acceptable salt thereof, PEG 300, water, and ethanol. In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol. In some embodiments, the solution comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, water, and ethanol.

[00151] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 10 w / w% to about 20 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 12 w / w% to about 20 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 16.93 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 16.9 w / w%. 2024205867   19 Aug 2024

[00152] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 30 w / w% to about 40 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 32 w / w% to about 40 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 36.22 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 36.2 w / w%.

[00153] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 35 w / w% to about 45 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 37 w / w% to about 45 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 41.85 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 41.9 w / w%.

[00154] In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 1 w / w% to about 9 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 3 w / w% to about 8 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 5.00 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, and ethanol is about 5.0 w / w%.

[00155] In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 20 w / w% to about 75 w / w% PEG 300, about 10 w / w% to about 70 w / w% of a sodium salt of the compound of Formula (la), and about 1 w / w% to about 9 w / w% of ethanol. In some embodiments, the solution comprises about 10 w / w% to about 20 w / w% water, about 30 w / w% to about 40 w / w% PEG 300, about 37 w / w% to about 45 w / w% of a sodium salt of the compound of Formula (la), and about 3 w / w% to about 8 w / w% of ethanol. 2024205867   19 Aug 2024

[00156] In some embodiments, the solution comprises about 16.93 w / w% water, about 36.22 w / w% PEG 300, about 41.85 w / w% of a sodium salt of the compound of Formula (la), and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 16.9 w / w% water, about 36.2 w / w% PEG 300, about 41.9 w / w% of a sodium salt of the compound of Formula (la), and about 5.0 w / w% ethanol.

[00157] In some embodiments, the solution comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, poloxamer 188, and water. In some embodiments, the solution comprises a compound of Formula (la) or a pharmaceutically acceptable salt thereof, PEG 300, poloxamer 188, and water. In some embodiments, the solution comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, poloxamer 188, and water. In some embodiments, the solution comprises a compound of Formula (la), PEG 300, poloxamer 188, and water. In some embodiments, the solution comprises a compound of Formula (lb), PEG 300, poloxamer 188, and water.

[00158] In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 50 mg / ml to about 500 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 50 mg / ml to about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 50 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 75 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 50 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 75 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 100 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water 2024205867   19 Aug 2024 is about 125 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 150 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 175 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 200 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 225 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 250 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 275 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 325 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 350 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 375 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 425 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 450 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 475 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 500 mg / ml. 2024205867   19 Aug 2024

[00159] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 10 w / w% to about 45 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 20 w / w% to about 35 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 20 w / w% to about 31 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 21.9 w / w% to about 30.1 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 21.87 w / w% to about 30.07 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 19.0 w / w%, about 19.1 w / w%, about 19.2 w / w%, about 19.3 w / w%, about 19.4 w / w%, about 19.5 w / w%, about 19.6 w / w%, about 19.7 w / w%, about 19.8 w / w%, about 19.9 w / w%, about 20.0 w / w%, about 20.1 w / w%, about 20.2 w / w%, about 20.3 w / w%, about 20.4 w / w%, about 20.5 w / w%, about 20.6 w / w%, about 20.7 w / w%, about 20.8 w / w%, about 20.9 w / w%, about 21.0 w / w%, about 21.1 w / w%, about 21.2 w / w%, about 21.3 w / w%, about 21.4 w / w%, about 21.5 w / w%, about 21.6 w / w%, about 21.7 w / w%, about 21.8 w / w%, about 21.9 w / w%, about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, 2024205867   19 Aug 2024 about 28.8 w / w%, about 28.9 w / w%, about 29.0 w / w%, about 29.1 w / w%, about 29.2 w / w%, about 29.3 w / w%, about 29.4 w / w%, about 29.5 w / w%, about 29.6 w / w%, about 29.7 w / w%, about 29.8 w / w%, about 29.9 w / w%, about 30.0 w / w%, about 30.1 w / w%, about 30.2 w / w%, about 30.3 w / w%, about 30.4 w / w%, about 30.5 w / w%, about 30.6 w / w%, about 30.7 w / w%, about 30.8 w / w%, about 30.9 w / w%, about 31.0 w / w%, about 31.1 w / w%, about 31.2 w / w%, about 31.3 w / w%, about 31.4 w / w%, about 31.5 w / w%, about 31.6 w / w%, about 31.7 w / w%, about 31.8 w / w%, about 31.9 w / w%, about 32.0 w / w%, about 32.1 w / w%, about 32.2 w / w%, about 32.3 w / w%, about 32.4 w / w%, about 32.5 w / w%, about 32.6 w / w%, about 32.7 w / w%, about 32.8 w / w%, about 32.9 w / w%, or about 33.0 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 21.87 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 21.9 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 26.68 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 26.7 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, and poloxamer 188, and water is about 27.5 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 27.51 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 28.36 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 28.4 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 29.2 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 29.21 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 30.07 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 30.1 w / w%.

[00160] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 19.18 w / w% to 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 about 30.07 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 19.2 w / w% to about 30.1 w / w%.

[00161] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 19.18 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 19.2 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 20.16 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 20.2 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 22.10 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 22.1 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 22.48 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 22.5 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 22.85 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 22.9 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 23.22 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 23.2 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 26.79 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 26.8 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 27.61 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 27.6 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of 2024205867   19 Aug 2024 the compound of Formula (la), PEG 300, poloxamer 188, and water is about 28.43 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 28.4 w / w%.

[00162] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 30 w / w% to about 85 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 40 w / w% to about 70 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 45 w / w% to about 68 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 46.8 w / w% to about 64.4 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 46.84 w / w% to about 64.40 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 40 w / w%, about 41 w / w%, about 42 w / w%, about 43 w / w%, about 44 w / w%, about 45 w / w%, about 46 w / w%, about 47 w / w%, about 48 w / w%, about 49 w / w%, about 50 w / w%, about 51 w / w%, about 52 w / w%, about 53 w / w%, about 54 w / w%, about 55 w / w%, about 56 w / w%, about 57 w / w%, about 58 w / w%, about 59 w / w%, about 60 w / w%, about 61 w / w%, about 62 w / w%, about 63 w / w%, about 64 w / w%, about 65 w / w%, about 66 w / w%, about 67 w / w%, about 68 w / w%, about 69 w / w%, or about 70 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 46.8 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 46.84 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 57.1 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 57.13 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 58.9 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound 2024205867   19 Aug 2024 of Formula (la), PEG 300, poloxamer 188, and water is about 58.92 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 60.7 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 60.73 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 62.55 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 62.6 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 64.4 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 64.40 w / w%.

[00163] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 41.09 w / w% to about 64.40 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 41.1 w / w% to about 64.4 w / w%.

[00164] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 41.09 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 41.1 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 43.17 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 43.2 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 47.33 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 47.3 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 48.13 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 48.1 w / w%. In some 2024205867   19 Aug 2024 embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 48.94 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 48.9 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 49.73 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 49.7 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 57.38 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 57.4 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 59.13 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 59.1 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 60.90 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 60.9 w / w%.

[00165] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.5 w / w% to about 40 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1 w / w% to about 35 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1 w / w% to about 30 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 3 w / w% to about 28 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4 w / w% to about 27 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium 2024205867   19 Aug 2024 salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.68 w / w% to about 26.47 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.7 w / w% to about 26.5 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 3.0 w / w%, about 3.1 w / w%, about 3.2 w / w%, about 3.3 w / w%, about 3.4 w / w%, about 3.5 w / w%, about 3.6 w / w%, about 3.7 w / w%, about 3.8 w / w%, about 3.9 w / w%, about 4.0 w / w%, about 4.1 w / w%, about 4.2 w / w%, about 4.3 w / w%, about 4.4 w / w%, about 4.5 w / w%, about 4.6 w / w%, about 4.7 w / w%, about 4.8 w / w%, about 4.9 w / w%, about 5.0 w / w%, about 5.1 w / w%, about 5.2 w / w%, about 5.3 w / w%, about 5.4 w / w%, about 5.5 w / w%, about 5.6 w / w%, about 5.7 w / w%, about 5.8 w / w%, about 5.9 w / w%, about 6.0 w / w%, about 6.1 w / w%, about 6.2 w / w%, about 6.3 w / w%, about 6.4 w / w%, about 6.5 w / w%, about 6.6 w / w%, about 6.7 w / w%, about 6.8 w / w%, about 6.9 w / w%, about 7.0 w / w%, about 7.1 w / w%, about 7.2 w / w%, about 7.3 w / w%, about 7.4 w / w%, about 7.5 w / w%, about 7.6 w / w%, about 7.7 w / w%, about 7.8 w / w%, about 7.9 w / w%, about 8.0 w / w%, about 8.1 w / w%, about 8.2 w / w%, about 8.3 w / w%, about 8.4 w / w%, about 8.5 w / w%, about 8.6 w / w%, about 8.7 w / w%, about 8.8 w / w%, about 8.9 w / w%, about 9.0 w / w%, about 9.1 w / w%, about 9.2 w / w%, about 9.3 w / w%, about 9.4 w / w%, about 9.5 w / w%, about 9.6 w / w%, about 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, about 10.0 w / w%, about 10.1 w / w%, about 10.2 w / w%, about 10.3 w / w%, about 10.4 w / w%, about 10.5 w / w%, about 10.6 w / w%, about 10.7 w / w%, about 10.8 w / w%, about 10.9 w / w%, about 11.0 w / w%, about 11.1 w / w%, about 11.2 w / w%, about 11.3 w / w%, about 11.4 w / w%, about 11.5 w / w%, about 11.6 w / w%, about 11.7 w / w%, about 11.8 w / w%, about 11.9 w / w%, about 12.0 w / w%, about 12.1 w / w%, about 12.2 w / w%, about 12.3 w / w%, about 12.4 w / w%, about 12.5 w / w%, about 12.6 w / w%, about 12.7 w / w%, about 12.8 w / w%, about 12.9 w / w%, about 13.0 w / w%, about 13.1 w / w%, about 13.2 w / w%, about 13.3 w / w%, about 13.4 w / w%, about 13.5 w / w%, about 13.6 w / w%, about 13.7 w / w%, about 13.8 w / w%, about 13.9 w / w%, about 14.0 w / w%, about 14.1 w / w%, about 14.2 w / w%, about 14.3 w / w%, about 14.4 w / w%, about 14.5 w / w%, about 14.6 w / w%, about 14.7 w / w%, about 14.8 w / w%, about 14.9 w / w%, about 15.0 w / w%, about 15.1 w / w%, about 15.2 w / w%, about 15.3 w / w%, about 15.4 w / w%, about 15.5 w / w%, about 15.6 w / w%, about 15.7 w / w%, about 15.8 w / w%, about 15.9 w / w%, about 16.0 w / w%, about 16.1 w / w%, about 16.2 w / w%, about 16.3 w / w%, about 16.4 w / w%, about 16.5 w / w%, about 16.6 w / w%, about 16.7 w / w%, about 16.8 w / w%, about 16.9 w / w%, about 17.0 w / w%, about 17.1 w / w%, about 17.2 w / w%, about 17.3 w / w%, about 17.4 w / w%, 2024205867   19 Aug 2024 about 17.5 w / w%, about 17.6 w / w%, about 17.7 w / w%, about 17.8 w / w%, about 17.9 w / w%, about 18.0 w / w%, about 18.1 w / w%, about 18.2 w / w%, about 18.3 w / w%, about 18.4 w / w%, about 18.5 w / w%, about 18.6 w / w%, about 18.7 w / w%, about 18.8 w / w%, about 18.9 w / w%, about 19.0 w / w%, about 19.1 w / w%, about 19.2 w / w%, about 19.3 w / w%, about 19.4 w / w%, about 19.5 w / w%, about 19.6 w / w%, about 19.7 w / w%, about 19.8 w / w%, about 19.9 w / w%, about 20.0 w / w%, about 20.1 w / w%, about 20.2 w / w%, about 20.3 w / w%, about 20.4 w / w%, about 20.5 w / w%, about 20.6 w / w%, about 20.7 w / w%, about 20.8 w / w%, about 20.9 w / w%, about 21.0 w / w%, about 21.1 w / w%, about 21.2 w / w%, about 21.3 w / w%, about 21.4 w / w%, about 21.5 w / w%, about 21.6 w / w%, about 21.7 w / w%, about 21.8 w / w%, about 21.9 w / w%, about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or about 29.0 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.68 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.7 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 6.97 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 7 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the 2024205867   19 Aug 2024 compound of Formula (la), PEG 300, poloxamer 188, and water is about 9.2 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 9.23 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 11.48 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 11.5 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 13.7 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 13.70 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 26.47 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 26.5 w / w%.

[00166] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.68 w / w% to about 33.61 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.7 w / w% to about 33.6 w / w%.

[00167] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 9.03 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 9.0 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 11.22 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 11.2 w / w%. In some embodiments, the amount of the 2024205867   19 Aug 2024 sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 13.39 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 13.4 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 25.85 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 25.87 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 25.9 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 33.61 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 33.6 w / w%.

[00168] In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.3 w / w% to about 8 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.5 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.6 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.85 w / w% to about 4.82 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.9 w / w% to about 4.8 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1.0 w / w%, about 1.1 w / w%, about 1.2 w / w%, about 1.3 w / w%, about 1.4 w / w%, about 1.5 w / w%, about 1.6 w / w%, about 1.7 w / w%, about 1.8 w / w%, about 1.9 w / w%, about 2.0 w / w%, about 2.1 2024205867   19 Aug 2024 w / w%, about 2.2 w / w%, about 2.3 w / w%, about 2.4 w / w%, about 2.5 w / w%, about 2.6 w / w%, about 2.7 w / w%, about 2.8 w / w%, about 2.9 w / w%, about 3.0 w / w%, about 3.1 w / w%, about 3.2 w / w%, about 3.3 w / w%, about 3.4 w / w%, about 3.5 w / w%, about 3.6 w / w%, about 3.7 w / w%, about 3.8 w / w%, about 3.9 w / w%, about 4.0 w / w%, about 4.1 w / w%, about 4.2 w / w%, about 4.3 w / w%, about 4.4 w / w%, about 4.5 w / w%, about 4.6 w / w%, about 4.7 w / w%, about 4.8 w / w%, about 4.9 w / w%, about 5.0 w / w%, about 5.1 w / w%, about 5.2 w / w%, about 5.3 w / w%, about 5.4 w / w%, about 5.5 w / w%, about 5.6 w / w%, about 5.7 w / w%, about 5.8 w / w%, about 5.9 w / w%, about 6.0 w / w%, about 6.1 w / w%, about 6.2 w / w%, about 6.3 w / w%, about 6.4 w / w%, about 6.5 w / w%, about 6.6 w / w%, about 6.7 w / w%, about 6.8 w / w%, about 6.9 w / w%, or about 7.0 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.85 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.9 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.27 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.3 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.68 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.09 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.1 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.49 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.5 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.8 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.82 w / w%. 2024205867   19 Aug 2024

[00169] In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.85 w / w% to about 6.12 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 0.9 w / w% to about 6.1 w / w%.

[00170] In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.18 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.2 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.64 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 1.6 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.04 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.0 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.36 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.44 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 2.4 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 3.06 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 3.1 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 3.54 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 3.5 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.72 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a 2024205867   19 Aug 2024 sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 4.7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 6.12 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, poloxamer 188, and water is about 6.1 w / w%.

[00171] In some embodiments, the solution comprises about 10 w / w% to about 45 w / w% water, about 30 w / w% to about 85 w / w% PEG 300, about 0.5 w / w% to about 40 w / w% of a sodium salt of a compound of Formula (la), and about 0.1 w / w% to about 10 w / w% of poloxamer 188. In some embodiments, the solution comprises about 15 w / w% to about 35 w / w% water, about 35 w / w% to about 75 w / w% PEG 300, about 1 w / w% to about 35 w / w% of a sodium salt of a compound of Formula (la), and about 0.3 w / w% to about 8 w / w% of poloxamer 188. In some embodiments, the solution comprises about 20 w / w% to about 35 w / w% water, about 40 w / w% to about 70 w / w% PEG 300, about 1 w / w% to about 30 w / w% of a sodium salt of a compound of Formula (la), and about 0.5 w / w% to about 7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 20 w / w% to about 31 w / w% water, about 45 w / w% to about 68 w / w% PEG 300, about 3 w / w% to about 28 w / w% of a sodium salt of a compound of Formula (la), and about 0.6 w / w% to about 7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 21.9 w / w% to about 30.1 w / w% water, about 46.8 w / w% to about 64.4 w / w% PEG 300, about 4.7 w / w% to about 26.5 w / w% of a sodium salt of a compound of Formula (la), and about 0.9 w / w% to about 4.8 w / w% of poloxamer 188. In some embodiments, the solution comprises about 21.87 w / w% to about 30.07 w / w% water, about 46.84 w / w% to about 64.40 w / w% PEG 300, about 4.68 w / w% to about 26.47 w / w% of a sodium salt of a compound of Formula (la), and about 0.85 w / w% to about 4.82 w / w% of poloxamer 188. In some embodiments, the solution comprises about 30.1 w / w% water, about 64.4 w / w% PEG 300, about 4.7 w / w% of a sodium salt of a compound of Formula (la), and about 0.9 w / w% of poloxamer 188. In some embodiments, the solution comprises about 30.07 w / w% water, about 64.40 w / w% PEG 300, about 4.68 w / w% of a sodium salt of a compound of Formula (la), and about 0.85 w / w% of poloxamer 188. In some embodiments, the solution comprises about 29.2 w / w% water, about 62.6 w / w% PEG 300, about 7 w / w% of a sodium salt of a compound of Formula (la), and about 1.3 w / w% of poloxamer 188. In some embodiments, the solution comprises about 29.21 w / w% water, about 62.55 w / w% PEG 300, about 6.97 w / w% of a sodium salt of a compound of Formula (la), and about 1.27 w / w% of poloxamer 188. In some embodiments, the solution comprises about 28.4 w / w% 2024205867   19 Aug 2024 water, about 60.7 w / w% PEG 300, about 9.2 w / w% of a sodium salt of a compound of Formula (la), and about 1.7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 28.36 w / w% water, about 60.73 w / w% PEG 300, about 9.23 w / w% of a sodium salt of a compound of Formula (la), and about 1.68 w / w% of poloxamer 188. In some embodiments, the solution comprises about 27.5 w / w% water, about 58.9 w / w% PEG 300, about 11.5 w / w% of a sodium salt of a compound of Formula (la), and about 2.1 w / w% of poloxamer 188. In some embodiments, the solution comprises about 27.51 w / w% water, about 58.92 w / w% PEG 300, about 11.48 w / w% of a sodium salt of a compound of Formula (la), and about 2.09 w / w% of poloxamer 188. In some embodiments, the solution comprises about 26.7 w / w% water, about 57.1 w / w% PEG 300, about 13.7 w / w% of a sodium salt of a compound of Formula (la), and about 2.5 w / w% of poloxamer 188. In some embodiments, the solution comprises about 26.68 w / w% water, about 57.13 w / w% PEG 300, about 13.70 w / w% of a sodium salt of a compound of Formula (la), and about 2.49 w / w% of poloxamer 188. In some embodiments, the solution comprises about 21.9 w / w% water, about 46.8 w / w% PEG 300, about 26.5 w / w% of a sodium salt of a compound of Formula (la), and about 4.8 w / w% of poloxamer 188. In some embodiments, the solution comprises about 21.87 w / w% water, about 46.84 w / w% PEG 300, about 26.47 w / w% of a sodium salt of a compound of Formula (la), and about 4.82 w / w% of poloxamer 188.

[00172] In some embodiments, the solution comprises about 19.2 w / w% to about 30.1 w / w% water, about 41.1 w / w% to about 64.4 w / w% PEG 300, about 4.7 w / w% to about 33.6 w / w% of a sodium salt of a compound of Formula (la), and about 0.9 w / w% to about 6.1 w / w% of poloxamer 188. In some embodiments, the solution comprises about 19.18 w / w% to about 30.07 w / w% water, about 41.09 w / w% to about 64.40 w / w% PEG 300, about 4.68 w / w% to about 33.61 w / w% of a sodium salt of a compound of Formula (la), and about 0.85 w / w% to about 6.12 w / w% of poloxamer 188.

[00173] In some embodiments, the solution comprises about 28.4 w / w% water, about 60.9 w / w% PEG 300, about 9.0 w / w% of a sodium salt of a compound of Formula (la), and about 1.6 w / w% of poloxamer 188. In some embodiments, the solution comprises about 28.43 w / w% water, about 60.90 w / w% PEG 300, about 9.03 w / w% of a sodium salt of a compound of Formula (la), and about 1.64 w / w% of poloxamer 188.

[00174] In some embodiments, the solution comprises about 27.6 w / w% water, about 59.1 w / w% PEG 300, about 11.2 w / w% of a sodium salt of a compound of Formula (la), and about 2.0 w / w% of poloxamer 188. In some embodiments, the solution comprises about 27.61 w / w% 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 water, about 59.13 w / w% PEG 300, about 11.22 w / w% of a sodium salt of a compound of Formula (la), and about 2.04 w / w% of poloxamer 188.

[00175] In some embodiments, the solution comprises about 26.8 w / w% water, about 57.4 w / w% PEG 300, about 13.4 w / w% of a sodium salt of a compound of Formula (la), and about 2.4 w / w% of poloxamer 188. In some embodiments, the solution comprises about 26.79 w / w% water, about 57.38 w / w% PEG 300, about 13.39 w / w% of a sodium salt of a compound of Formula (la), and about 2.44 w / w% of poloxamer 188.

[00176] In some embodiments, the solution comprises about 23.2 w / w% water, about 49.7 w / w% PEG 300, about 25.9 w / w% of a sodium salt of a compound of Formula (la), and about 1.2 w / w% of poloxamer 188. In some embodiments, the solution comprises about 23.22 w / w% water, about 49.73 w / w% PEG 300, about 25.87 w / w% of a sodium salt of a compound of Formula (la), and about 1.18 w / w% of poloxamer 188.

[00177] In some embodiments, the solution comprises about 22.9 w / w% water, about 48.9 w / w% PEG 300, about 25.9 w / w% of a sodium salt of a compound of Formula (la), and about 2.4 w / w% of poloxamer 188. In some embodiments, the solution comprises about 22.85 w / w% water, about 48.94 w / w% PEG 300, about 25.85 w / w% of a sodium salt of a compound of Formula (la), and about 2.36 w / w% of poloxamer 188.

[00178] In some embodiments, the solution comprises about 22.5 w / w% water, about 48.1 w / w% PEG 300, about 25.9 w / w% of a sodium salt of a compound of Formula (la), and about 3.5 w / w% of poloxamer 188. In some embodiments, the solution comprises about 22.48 w / w% water, about 48.13 w / w% PEG 300, about 25.85 w / w% of a sodium salt of a compound of Formula (la), and about 3.54 w / w% of poloxamer 188.

[00179] In some embodiments, the solution comprises about 22.1 w / w% water, about 47.3 w / w% PEG 300, about 25.9 w / w% of a sodium salt of a compound of Formula (la), and about 4.7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 22.10 w / w% water, about 47.33 w / w% PEG 300, about 25.85 w / w% of a sodium salt of a compound of Formula (la), and about 4.72 w / w% of poloxamer 188.

[00180] In some embodiments, the solution comprises about 20.2 w / w% water, about 43.2 w / w% PEG 300, about 33.6 w / w% of a sodium salt of a compound of Formula (la), and about 3.1 w / w% of poloxamer 188. In some embodiments, the solution comprises about 20.16 w / w% water, about 43.17 w / w% PEG 300, about 33.61 w / w% of a sodium salt of a compound of Formula (la), and about 3.06 w / w% of poloxamer 188.

[00181] In some embodiments, the solution comprises about 19.2 w / w% water, about 41.1 w / w% PEG 300, about 33.6 w / w% of a sodium salt of a compound of Formula (la), and about 2024205867   19 Aug 2024 6.1 w / w% of poloxamer 188. In some embodiments, the solution comprises about 19.18 w / w% water, about 41.09 w / w% PEG 300, about 33.61 w / w% of a sodium salt of a compound of Formula (la), and about 6.12 w / w% of poloxamer 188.

[00182] In some embodiments, the solution comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, water, poloxamer 188, and ethanol. In some embodiments, the solution comprises a compound of Formula (la), or a pharmaceutically acceptable salt thereof, PEG 300, water, poloxamer 188, and ethanol. In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol. In some embodiments, the solution comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, water, poloxamer 188, and ethanol.

[00183] In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 10 w / w% to about 20 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 10 w / w% to about 19 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 14.50 w / w% to about 15.71 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 14.5 w / w% to about 15.7 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 14.50 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 14.5 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 14.57 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 14.6 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 15.71 w / w%. In some embodiments, the amount of water in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 15.7 w / w%.

[00184] In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 25 2024205867   19 Aug 2024 w / w% to about 40 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 27 w / w% to about 37 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 31.04 w / w% to about 33.63 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 31.0 w / w% to about 33.6 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 31.04 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 31.0 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 31.21 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 31.2 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 33.63 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 33.6 w / w%.

[00185] In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 35 w / w% to about 45 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 37 w / w% to about 45 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 41.64 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 41.6 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 41.85 w / w%. In some embodiments, the amount of the sodium salt of the compound of Formula (la) in the solution comprising a sodium 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 41.9 w / w%.

[00186] In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 0.5 w / w% to about 12 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 1 w / w% to about 11 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 3.81 w / w% to about 7.61 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 3.8 w / w% to about 7.6 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 3.81 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 3.8 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 7.58 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 7.61 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 7.6 w / w%.

[00187] In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 1 w / w% to about 9 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 3 w / w% to about 8 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 5.00 w / w%. In some embodiments, the amount of ethanol in the solution comprising a sodium salt of the compound of Formula (la), PEG 300, water, poloxamer 188, and ethanol is about 5.0 w / w%. 2024205867   19 Aug 2024

[00188] In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 20 w / w% to about 75 w / w% PEG 300, about 10 w / w% to about 70 w / w% of a sodium salt of the compound of Formula (la), about 1 w / w% to about 20 w / w% poloxamer 188, and about 1 w / w% to about 10 w / w% of ethanol. In some embodiments, the solution comprises about 10 w / w% to about 20 w / w% water, about 25 w / w% to about 35 w / w% PEG 300, about 37 w / w% to about 45 w / w% of a sodium salt of the compound of Formula (la), and about 3 w / w% to about 8 w / w% of ethanol.

[00189] In some embodiments, the solution comprises about 15.71 w / w% water, about 33.63 w / w% PEG 300, about 41.85 w / w% of a sodium salt of the compound of Formula (la), about 3.81 w / w% poloxamer 188, and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 15.7 w / w% water, about 33.6 w / w% PEG 300, about 41.9 w / w% of a sodium salt of the compound of Formula (la), about 3.8 w / w% poloxamer 188, and about 5.0 w / w% ethanol.

[00190] In some embodiments, the solution comprises about 14.57 w / w% water, about 31.21 w / w% PEG 300, about 41.64 w / w% of a sodium salt of the compound of Formula (la), about 7.58 w / w% poloxamer 188, and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 14.6 w / w% water, about 31.2 w / w% PEG 300, about 41.6 w / w% of a sodium salt of the compound of Formula (la), about 7.6 w / w% poloxamer 188, and about 5.0 w / w% ethanol.

[00191] In some embodiments, the solution comprises about 14.50 w / w% water, about 31.04 w / w% PEG 300, about 41.85 w / w% of a sodium salt of the compound of Formula (la), about 7.61 w / w% poloxamer 188, and about 5.00 w / w% ethanol. In some embodiments, the solution comprises about 14.5 w / w% water, about 31.0 w / w% PEG 300, about 41.9 w / w% of a sodium salt of the compound of Formula (la), about 7.6 w / w% poloxamer 188, and about 5.0 w / w% ethanol.

[00192] In some embodiments of the methods herein, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof are administered as a parenteral formulation (for example, for SC or IM administration), which is an aqueous suspension. In some embodiments, the parenteral formulation (for example, an SC or IM formulation is an aqueous suspension that includes a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and saline. In some embodiments, the parenteral formulation (for example, an SC or IM formulation) is an aqueous suspension that comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, saline, and a suspending agent. In some embodiments, the parenteral formulation (for example, an SC 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 or IM formulation) is an aqueous suspension that comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, saline, and a poloxamer (such as poloxamer 338, 188, or 207).

[00193] In some embodiments, a suspension comprising a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in a poloxamer and saline is provided. In some embodiments, the concentration of poloxamer in saline is from about 0.1% to about 20%. In some embodiments, the concentration of poloxamer in saline is from about 0.1% to about 10%. In some embodiments, the concentration of poloxamer in saline is about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%. In certain embodiments, the concentration of poloxamer in saline is about 2%. In certain embodiments, the poloxamer is poloxamer 188. In certain embodiments, the compound is a compound of Formula (la), or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is a compound of Formula (la). In certain embodiments, the compound is a sodium salt of the compound of Formula (la). In certain embodiments, the compound is a compound of Formula (lb), or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is a compound of Formula (lb).

[00194] In some embodiments, a suspension comprising a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in a poloxamer and mannitol is provided. In some embodiments, the concentration of poloxamer in mannitol is from about 0.1% to about 20%. In some embodiments, the concentration of poloxamer in mannitol is from about 0.1% to about 10%. In some in embodiments, the concentration of poloxamer in mannitol is about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2,%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%. In certain embodiments, the concentration of poloxamer in mannitol is about 2%. In certain embodiments, the poloxamer is poloxamer 188. In certain embodiments, the compound is a compound of Formula (la), or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is a compound of Formula (la). In certain embodiments, the compound is a sodium salt of the compound of Formula (la). In certain embodiments, the compound is a compound of Formula (lb), or a pharmaceutically acceptable salt thereof. In certain embodiments, the compound is a compound of Formula (lb).

[00195] In certain embodiments, the composition is formulated as a solid dosage form. In some embodiments, the solid dosage form is a solid injectable dosage form, such as a solid depot form. 2024205867   19 Aug 2024

[00196] In certain embodiments, the active ingredient (for example, a compound of Formula (la) or Formula (lb)) is present as a free acid. In certain embodiments, the active ingredient (for example, a compound of Formula (la) or Formula (lb)) is present as a sodium salt. In some embodiments, the active ingredient is a compound of Formula (la). In some embodiments, the active ingredient is a compound of Formula (lb).

[00197] In certain embodiments, the pharmaceutical composition is a parenteral formulation. In certain embodiments, the formulation is administered subcutaneously to a subject (e.g., a human patient) in need thereof. In certain embodiments, the formulation is administered intramuscularly to a subject in need thereof.

[00198] In certain embodiments, the parenteral formulation comprises N-methyl-2-pyrrolidone (NMP). In certain embodiments, the parenteral formulation consists essentially of N-methyl-2-pyrrolidone. In certain embodiments, the parenteral formulation comprises dimethyl sulfoxide (DMSO). In some embodiments, the parenteral formulation comprises polyethylene glycol (PEG) or glycofurol. In some embodiments, the solution comprises PEG 200, ethanol, and water. In some embodiments, the solution comprises PEG 300 and water. In some embodiments, the solution comprises poloxamer in saline. In some embodiments, the solution comprises 2% poloxamer 188 in normal saline.

[00199] In certain embodiments, the parenteral formulation comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and water. In certain embodiments, the parenteral formulation comprises a compound of Formula (la), or a pharmaceutically acceptable salt thereof, and water. In certain embodiments, the parenteral formulation comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, and water. In certain embodiments, the parenteral formulation further contains an alcohol. In certain embodiments, the alcohol is ethanol. In certain embodiments, the parenteral formulation further contains polyethylene glycol. In certain embodiments, the polyethylene glycol has an average molecular weight of about 200 g / mol (for example, polyethylene glycol 200). In certain embodiments, the parenteral formulation further contains an inorganic base. In certain embodiments, the inorganic base is sodium hydroxide (NaOH). In certain embodiments, the inorganic base is sodium ethoxide (NaOEt). In certain embodiments, the formulation comprises from about 0.1 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises from about 0.5 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises from about 0.75 molar equivalents to about 1.2 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises about 1.0 molar equivalents inorganic 2024205867   19 Aug 2024 base. In certain embodiments, the formulation comprises about 1.2 molar equivalents inorganic base. In some embodiments, the inorganic base is NaOH or NaOEt.

[00200] In certain embodiments, the parenteral formulation comprises a compound of Formula (la), or a pharmaceutically acceptable salt thereof, water and polyethylene glycol PEG 300. In certain embodiments, the parenteral formulation comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, water, and polyethylene glycol PEG 300.

[00201] In certain embodiments, the parenteral formulation comprises a compound of Formula (la), or a pharmaceutically acceptable salt thereof, water, and polyethylene glycol PEG 300 (polyethylene glycol with an average molecular weight of 300 g / mol), and NaOH. In certain embodiments, the parenteral formulation comprises a compound of Formula (la), or a pharmaceutically acceptable salt thereof, water, and polyethylene glycol (PEG) 300, and NaOEt. In certain embodiments, the formulation includes from about 0.1 molar equivalents to about 1.5 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation includes from about 0.5 molar equivalents to about 1.5 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation includes from about 0.75 molar equivalents to about 1.2 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation comprises about 1.0 molar equivalents of NaOH or NaOEt. In certain embodiments, the formulation includes about 1.2 molar equivalents of NaOH or NaOEt.

[00202] In certain embodiments, the parenteral formulation is a solution formulation that includes a mixture of ethanol, water, and polyethylene glycol. In certain embodiments, the parenteral formulation is a solution formulation that includes a mixture of ethanol, water, and PEG 200. In certain embodiments, the solution formulation includes about 5% to about 20% ethanol, about 5% to about 20% water, and about 60% to about 90% PEG 200. In certain embodiments, the solution formulation comprises about 10% to about 15% ethanol, about 10% to about 15% water, and about 70% to about 80% PEG 200. In certain embodiments, the solution formulation includes about 10% ethanol, about 12% water, and about 78% PEG 200. In certain embodiments, the solution formulation further includes an inorganic base. In certain embodiments, the solution formulation includes about 10% ethanol, about 13% water, and about 77% PEG 200. In certain embodiments, the solution formulation further includes an inorganic base. In certain embodiments, the formulation includes from about 0.1 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises from about 0.5 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises from about 1.0 molar equivalents to about 1.2 molar equivalents of the inorganic base. In certain embodiments, the formulation 2024205867   19 Aug 2024 comprises about 1.2 molar equivalents inorganic base. In certain embodiments, the inorganic base is sodium hydroxide or sodium ethoxide. In certain embodiments, the inorganic base is sodium hydroxide.

[00203] In certain embodiments, the parenteral formulation is a solution formulation that includes a mixture of water and polyethylene glycol. In certain embodiments, the parenteral formulation is a solution formulation that includes a mixture of water and PEG 300. In certain embodiments, the solution formulation includes about 5% w / w to about 25% w / w water, and about 75% w / w to about 95% w / w PEG 300. In some embodiments, the solution formulation further includes an inorganic base. In certain embodiments, the formulation includes from about 0.1 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises from about 0.5 molar equivalents to about 1.5 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises from about 0.75 molar equivalents to about 1.2 molar equivalents of the inorganic base. In certain embodiments, the formulation comprises about 1.0 molar equivalents inorganic base. In certain embodiments, the formulation comprises about 1.2 molar equivalents inorganic base. In certain embodiments, the inorganic base is sodium hydroxide or sodium ethoxide. In certain embodiments, the inorganic base is sodium hydroxide.

[00204] In some embodiments, the solution comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, sodium hydroxide, and water. In some embodiments, the solution comprises a compound of Formula (la) or a pharmaceutically acceptable salt thereof, PEG 300, sodium hydroxide, and water. In some embodiments, the solution comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, sodium hydroxide, and water. In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, sodium hydroxide, and water. In some embodiments, the solution comprises a compound of Formula (lb), PEG 300, sodium hydroxide, and water.

[00205] In some embodiments, the solution comprises a compound of Formula (la), PEG 300, sodium hydroxide, and water. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50 mg / ml to about 500 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50 mg / ml to about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50 2024205867   19 Aug 2024 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 75 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 75 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 100 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 125 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 150 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 175 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 200 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 225 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 250 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 275 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 325 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 350 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 375 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in 2024205867   19 Aug 2024 the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 425 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 450 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 475 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 500 mg / ml.

[00206] In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 10 w / w% to about 40 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 20 w / w% to about 30 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 21 w / w% to about 29 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 23.2 w / w% to about 27.9 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 23.2 w / w% to about 27.92 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, 2024205867   19 Aug 2024 about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or about 29.0 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 23.2 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 27.9 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 27.92 w / w%.

[00207] In some embodiments, the amount of PEG 300 in the solution comprising compound of Formula (la), PEG 300, sodium hydroxide, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 45 w / w% to about 65 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 48 w / w% to about 60 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 49 w / w% to about 59 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50.0 w / w% to about 58.0 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50.0 w / w% to about 58.04 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 45 w / w%, about 46 w / w%, about 47 w / w%, about 48 w / w%, about 49 w / w%, about 50 w / w%, about 51 w / w%, about 52 w / w%, about 53 w / w%, about 54 w / w%, about 55 w / w%, about 56 w / w%, about 57 w / w%, about 58 w / w%, about 59 w / w%, about 60 w / w%, about 61 w / w%, about 62 w / w%, about 63 w / w%, about 64 w / w%, or about 65 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 50.0 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 58.0 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 58.04 w / w%.

[00208] In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 5 w / w% to about 35 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water 2024205867   19 Aug 2024 is about 10 w / w% to about 30 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 11 w / w% to about 28 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 13 w / w% to about 27 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 13.5 w / w% to about 25.7 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 13.47 w / w% to about 25.7 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 13.0 w / w%, about 13.1 w / w%, about 13.2 w / w%, about 13.3 w / w%, about 13.4 w / w%, about 13.5 w / w%, about 13.6 w / w%, about 13.7 w / w%, about 13.8 w / w%, about 13.9 w / w%, about 14.0 w / w%, about 14.1 w / w%, about 14.2 w / w%, about 14.3 w / w%, about 14.4 w / w%, about 14.5 w / w%, about 14.6 w / w%, about 14.7 w / w%, about 14.8 w / w%, about 14.9 w / w%, about 15.0 w / w%, about 15.1 w / w%, about 15.2 w / w%, about 15.3 w / w%, about 15.4 w / w%, about 15.5 w / w%, about 15.6 w / w%, about 15.7 w / w%, about 15.8 w / w%, about 15.9 w / w%, about 16.0 w / w%, about 16.1 w / w%, about 16.2 w / w%, about 16.3 w / w%, about 16.4 w / w%, about 16.5 w / w%, about 16.6 w / w%, about 16.7 w / w%, about 16.8 w / w%, about 16.9 w / w%, about 17.0 w / w%, about 17.1 w / w%, about 17.2 w / w%, about 17.3 w / w%, about 17.4 w / w%, about 17.5 w / w%, about 17.6 w / w%, about 17.7 w / w%, about 17.8 w / w%, about 17.9 w / w%, about 18.0 w / w%, about 18.1 w / w%, about 18.2 w / w%, about 18.3 w / w%, about 18.4 w / w%, about 18.5 w / w%, about 18.6 w / w%, about 18.7 w / w%, about 18.8 w / w%, about 18.9 w / w%, about 19.0 w / w%, about 19.1 w / w%, about 19.2 w / w%, about 19.3 w / w%, about 19.4 w / w%, about 19.5 w / w%, about 19.6 w / w%, about 19.7 w / w%, about 19.8 w / w%, about 19.9 w / w%, about 20.0 w / w%, about 21.1 w / w%, about 21.2 w / w%, about 21.3 w / w%, about 21.4 w / w%, about 21.5 w / w%, about 21.6 w / w%, about 21.7 w / w%, about 21.8 w / w%, about 21.9 w / w%, about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, 2024205867   19 Aug 2024 about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or about 29.0 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 13.47 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 13.5 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 25.7 w / w%.

[00209] In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.05 w / w% to about 2 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.1 w / w% to about 1.5 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.3 w / w% to about 1.3 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.5 w / w% to about 1.2 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.6 w / w% to about 1.1 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.58 w / w% to about 1.1 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.1 w / w%, about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1.0 w / w%, about 1.1 w / w%, about 1.2 w / w%, about 1.3 w / w%, about 1.4 w / w%, about 1.5 w / w%, about 1.6 w / w%, about 1.7 w / w%, about 1.8 w / w%, about 1.9 w / w%, or about 2.0 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.58 w / w%. In some embodiments, the amount of sodium hydroxide in the 2024205867   19 Aug 2024 solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 0.6 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water is about 1.1 w / w%. In some embodiments, the solution comprises about 10 w / w% to about 40 w / w% water, about 35 w / w% to about 75 w / w% PEG 300, about 5 w / w% to about 35 w / w% of a compound of Formula (la), and about 0.05 w / w% to about 2 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 15 w / w% to about 35 w / w% water, about 45 w / w% to about 65 w / w% PEG 300, about 10 w / w% to about 30 w / w% of a compound of Formula (la), and about 0.1 w / w% to about 1.5 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 20 w / w% to about 30 w / w% water, about 48 w / w% to about 60 w / w% PEG 300, about 11 w / w% to about 28 w / w% of a compound of Formula (la), and about 0.3 w / w% to about 1.3 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 21 w / w% to about 29 w / w% water, about 49 w / w% to about 59 w / w% PEG 300, about 13 w / w% to about 27 w / w% of a compound of Formula (la), and about 0.5 w / w% to about 1.2 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 23.2 w / w% to about 27.9 w / w% water, about 50 w / w% to about 58 w / w% PEG 300, about 13.5 w / w% to about 25.7 w / w% of a compound of Formula (la), and about 0.6 w / w% to about 1.1 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 23.2 w / w% to about 27.92 w / w% water, about 50.0 w / w% to about 58.04 w / w% PEG 300, about 13.47 w / w% to about 25.7 w / w% of a compound of Formula (la), and about 0.58 w / w% to about 1.1 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 27.9 w / w% water, about 58 w / w% PEG 300, about 13.5 w / w% of a compound of Formula (la), and about 0.6 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 27.92 w / w% water, about 58.04 w / w% PEG 300, about 13.47 w / w% of a compound of Formula (la), and about 0.58 w / w% of sodium hydroxide. In some embodiments, the solution comprises about 23.2 w / w% water, about 50.0 w / w% PEG 300, about 25.7 w / w% of a compound of Formula (la), and about 1.1 w / w% of sodium hydroxide.

[00210] In some embodiments, the compound of Formula (la) becomes ionized in situ to a sodium salt of the compound of Formula (la) in the presence of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water. Thus, in some embodiments, the compound of Formula (la) is present as a sodium salt of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, and water. 2024205867   19 Aug 2024

[00211] In some embodiments, the pharmaceutical compositions comprise a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, a poloxamer, and a pharmaceutically acceptable excipient. In some embodiments, the pharmaceutical compositions comprise a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, poloxamer 188, and a pharmaceutically acceptable excipient. In some embodiments, the pharmaceutical compositions are solutions that comprise a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, a poloxamer, and a pharmaceutically acceptable excipient. In some embodiments, the pharmaceutical compositions are solutions that comprise a_compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, poloxamer 188, and a pharmaceutically acceptable excipient.

[00212] In some embodiments, the solution comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the solution comprises a compound of Formula (la) or a pharmaceutically acceptable salt thereof, PEG 300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the solution comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, PEG 300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the solution comprises a sodium salt of the compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water.

[00213] In some embodiments, the solution comprises a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 50 mg / ml to about 500 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 50 mg / ml to about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 50 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 75 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 50 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 75 mg / ml. In 2024205867   19 Aug 2024 some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 100 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 125 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 150 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 175 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 200 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 225 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 250 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 275 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 325 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 350 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 375 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 425 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of 2024205867   19 Aug 2024 Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 450 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 475 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 500 mg / ml.

[00214] In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 10 w / w% to about 45 w / w%. In some embodiments, the amount of water in the solution comprising a of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 15 w / w% to about 35 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 20 w / w% to about 35 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 20 w / w% to about 31 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 22 w / w% to about 30.1 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 21.97 w / w% to about 30.07 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 19.0 w / w%, about 19.1 w / w%, about 19.2 w / w%, about 19.3 w / w%, about 19.4 w / w%, about 19.5 w / w%, about 19.6 w / w%, about 19.7 w / w%, about 19.8 w / w%, about 19.9 w / w%, about 20.0 w / w%, about 20.1 w / w%, about 20.2 w / w%, about 20.3 w / w%, about 20.4 w / w%, about 20.5 w / w%, about 20.6 w / w%, about 20.7 w / w%, about 20.8 w / w%, about 20.9 w / w%, about 21.0 w / w%, about 21.1 w / w%, about 21.2 w / w%, about 21.3 w / w%, about 21.4 w / w%, about 21.5 w / w%, about 21.6 w / w%, about 21.7 w / w%, about 21.8 w / w%, about 21.9 w / w%, about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 2024205867   19 Aug 2024 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, about 29.0 w / w%, about 29.1 w / w%, about 29.2 w / w%, about 29.3 w / w%, about 29.4 w / w%, about 29.5 w / w%, about 29.6 w / w%, about 29.7 w / w%, about 29.8 w / w%, about 29.9 w / w%, about 30.0 w / w%, about 30.1 w / w%, about 30.2 w / w%, about 30.3 w / w%, about 30.4 w / w%, about 30.5 w / w%, about 30.6 w / w%, about 30.7 w / w%, about 30.8 w / w%, about 30.9 w / w%, about 31.0 w / w%, about 31.1 w / w%, about 31.2 w / w%, about 31.3 w / w%, about 31.4 w / w%, about 31.5 w / w%, about 31.6 w / w%, about 31.7 w / w%, about 31.8 w / w%, about 31.9 w / w%, about 32.0 w / w%, about 32.1 w / w%, about 32.2 w / w%, about 32.3 w / w%, about 32.4 w / w%, about 32.5 w / w%, about 32.6 w / w%, about 32.7 w / w%, about 32.8 w / w%, about 32.9 w / w%, or about 33.0 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 21.97 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 22 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 30.07 w / w%. In some embodiments, the amount of water in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 30.1 w / w%.

[00215] In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 30 w / w% to about 85 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 35 w / w% to about 75 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 40 w / w% to about 70 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 45 w / w% to about 68 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 47.1 w / w% to about 64.4 w / w%. In some 2024205867   19 Aug 2024 embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 47.05 w / w% to about 64.41 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 40 w / w%, about 41 w / w%, about 42 w / w%, about 43 w / w%, about 44 w / w%, about 45 w / w%, about 46 w / w%, about 47 w / w%, about 48 w / w%, about 49 w / w%, about 50 w / w%, about 51 w / w%, about 52 w / w%, about 53 w / w%, about 54 w / w%, about 55 w / w%, about 56 w / w%, about 57 w / w%, about 58 w / w%, about 59 w / w%, about 60 w / w%, about 61 w / w%, about 62 w / w%, about 63 w / w%, about 64 w / w%, about 65 w / w%, about 66 w / w%, about 67 w / w%, about 68 w / w%, about 69 w / w%, or about 70 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 47.05 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 47.1 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 64.4 w / w%. In some embodiments, the amount of PEG 300 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 64.41 w / w%.

[00216] In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.5 w / w% to about 40 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 1 w / w% to about 35 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 1 w / w% to about 30 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 3 w / w% to about 28 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 4 w / w% to about 26 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 4.6 w / w% to about 25.2 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, 2024205867   19 Aug 2024 sodium hydroxide, poloxamer 188, and water is about 4.57 w / w% to about 25.21 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 3.0 w / w%, about 3.1 w / w%, about 3.2 w / w%, about 3.3 w / w%, about 3.4 w / w%, about 3.5 w / w%, about 3.6 w / w%, about 3.7 w / w%, about 3.8 w / w%, about 3.9 w / w%, about 4.0 w / w%, about 4.1 w / w%, about 4.2 w / w%, about 4.3 w / w%, about 4.4 w / w%, about 4.5 w / w%, about 4.6 w / w%, about 4.7 w / w%, about 4.8 w / w%, about 4.9 w / w%, about 5.0 w / w%, about 5.1 w / w%, about 5.2 w / w%, about 5.3 w / w%, about 5.4 w / w%, about 5.5 w / w%, about 5.6 w / w%, about 5.7 w / w%, about 5.8 w / w%, about 5.9 w / w%, about 6.0 w / w%, about 6.1 w / w%, about 6.2 w / w%, about 6.3 w / w%, about 6.4 w / w%, about 6.5 w / w%, about 6.6 w / w%, about 6.7 w / w%, about 6.8 w / w%, about 6.9 w / w%, about 7.0 w / w%, about 7.1 w / w%, about 7.2 w / w%, about 7.3 w / w%, about 7.4 w / w%, about 7.5 w / w%, about 7.6 w / w%, about 7.7 w / w%, about 7.8 w / w%, about 7.9 w / w%, about 8.0 w / w%, about 8.1 w / w%, about 8.2 w / w%, about 8.3 w / w%, about 8.4 w / w%, about 8.5 w / w%, about 8.6 w / w%, about 8.7 w / w%, about 8.8 w / w%, about 8.9 w / w%, about 9.0 w / w%, about 9.1 w / w%, about 9.2 w / w%, about 9.3 w / w%, about 9.4 w / w%, about 9.5 w / w%, about 9.6 w / w%, about about 10.0 w / w%, about 10.1 w / w%, about 10.2 about 10.5 w / w%, about 10.6 w / w%, about 10.7 about 11.0 w / w%, about 11.1 w / w%, about 11.2 about 11.5 w / w%, about 11.6 w / w%, about 11.7 about 12.0 w / w%, about 12.1 w / w%, about 12.2 about 12.5 w / w%, about 12.6 w / w%, about 12.7 about 13.0 w / w%, about 13.1 w / w%, about 13.2 about 13.5 w / w%, about 13.6 w / w%, about 13.7 about 14.0 w / w%, about 14.1 w / w%, about 14.2 about 14.5 w / w%, about 14.6 w / w%, about 14.7 about 15.0 w / w%, about 15.1 w / w%, about 15.2 about 15.5 w / w%, about 15.6 w / w%, about 15.7 about 16.0 w / w%, about 16.1 w / w%, about 16.2 about 16.5 w / w%, about 16.6 w / w%, about 16.7 about 17.0 w / w%, about 17.1 w / w%, about 17.2 about 17.5 w / w%, about 17.6 w / w%, about 17.7 about 18.0 w / w%, about 18.1 w / w%, about 18.2 about 18.5 w / w%, about 18.6 w / w%, about 18.7 9.7 w / w%, about 9.8 w / w%, about 9.9 w / w%, w / w%, about 10.3 w / w%, about 10.4 w / w%, w / w%, about 10.8 w / w%, about 10.9 w / w%, w / w%, about 11.3 w / w%, about 11.4 w / w%, w / w%, about 11.8 w / w%, about 11.9 w / w%, w / w%, about 12.3 w / w%, about 12.4 w / w%, w / w%, about 12.8 w / w%, about 12.9 w / w%, w / w%, about 13.3 w / w%, about 13.4 w / w%, w / w%, about 13.8 w / w%, about 13.9 w / w%, w / w%, about 14.3 w / w%, about 14.4 w / w%, w / w%, about 14.8 w / w%, about 14.9 w / w%, w / w%, about 15.3 w / w%, about 15.4 w / w%, w / w%, about 15.8 w / w%, about 15.9 w / w%, w / w%, about 16.3 w / w%, about 16.4 w / w%, w / w%, about 16.8 w / w%, about 16.9 w / w%, w / w%, about 17.3 w / w%, about 17.4 w / w%, w / w%, about 17.8 w / w%, about 17.9 w / w%, w / w%, about 18.3 w / w%, about 18.4 w / w%, w / w%, about 18.8 w / w%, about 18.9 w / w%, 2024205867   19 Aug 2024 about 19.0 w / w%, about 19.1 w / w%, about 19.2 w / w%, about 19.3 w / w%, about 19.4 w / w%, about 19.5 w / w%, about 19.6 w / w%, about 19.7 w / w%, about 19.8 w / w%, about 19.9 w / w%, about 20.0 w / w%, about 21.1 w / w%, about 21.2 w / w%, about 21.3 w / w%, about 21.4 w / w%, about 21.5 w / w%, about 21.6 w / w%, about 21.7 w / w%, about 21.8 w / w%, about 21.9 w / w%, about 22.0 w / w%, about 22.1 w / w%, about 22.2 w / w%, about 22.3 w / w%, about 22.4 w / w%, about 22.5 w / w%, about 22.6 w / w%, about 22.7 w / w%, about 22.8 w / w%, about 22.9 w / w%, about 23.0 w / w%, about 23.1 w / w%, about 23.2 w / w%, about 23.3 w / w%, about 23.4 w / w%, about 23.5 w / w%, about 23.6 w / w%, about 23.7 w / w%, about 23.8 w / w%, about 23.9 w / w%, about 24.0 w / w%, about 24.1 w / w%, about 24.2 w / w%, about 24.3 w / w%, about 24.4 w / w%, about 24.5 w / w%, about 24.6 w / w%, about 24.7 w / w%, about 24.8 w / w%, about 24.9 w / w%, about 25.0 w / w%, about 25.1 w / w%, about 25.2 w / w%, about 25.3 w / w%, about 25.4 w / w%, about 25.5 w / w%, about 25.6 w / w%, about 25.7 w / w%, about 25.8 w / w%, about 25.9 w / w%, about 26.0 w / w%, about 26.1 w / w%, about 26.2 w / w%, about 26.3 w / w%, about 26.4 w / w%, about 26.5 w / w%, about 26.6 w / w%, about 26.7 w / w%, about 26.8 w / w%, about 26.9 w / w%, about 27.0 w / w%, about 27.1 w / w%, about 27.2 w / w%, about 27.3 w / w%, about 27.4 w / w%, about 27.5 w / w%, about 27.6 w / w%, about 27.7 w / w%, about 27.8 w / w%, about 27.9 w / w%, about 28.0 w / w%, about 28.1 w / w%, about 28.2 w / w%, about 28.3 w / w%, about 28.4 w / w%, about 28.5 w / w%, about 28.6 w / w%, about 28.7 w / w%, about 28.8 w / w%, about 28.9 w / w%, or about 29.0 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 4.57 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 4.6 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 25.2 w / w%. In some embodiments, the amount of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 25.21 w / w%.

[00217] In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.01 w / w% to about 3.0 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.01 w / w% to about 2.0 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.05 w / w% to about 1.5 w / w%. In some embodiments, the 2024205867   19 Aug 2024 amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.05 w / w% to about 1.2 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.1 w / w% to about 1.1 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.10 w / w% to about 1.08 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.01 w / w%, about 0.02 w / w%, about 0.03 w / w%, about 0.04 w / w%, about 0.05 w / w%, about 0.06 w / w%, about 0.07 w / w%, about 0.08 w / w%, about 0.09 w / w%, about 0.1 w / w%, about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1.0 w / w%, about 1.1 w / w%, about 1.2 w / w%, about 1.3 w / w%, about 1.4 w / w%, about 1.5 w / w%, about 1.6 w / w%, about 1.7 w / w%, about 1.8 w / w%, about 1.9 w / w%, or about 2.0 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.1 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.10 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 1.08 w / w%. In some embodiments, the amount of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 1.1 w / w%.

[00218] In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.1 w / w% to about 10 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.3 w / w% to about 8 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.5 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.6 w / w% to about 7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.85 w / w% to about 4.69 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a 2024205867   19 Aug 2024 compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.9 w / w% to about 4.7 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1.0 w / w%, about 1.1 w / w%, about 1.2 w / w%, about 1.3 w / w%, about 1.4 w / w%, about 1.5 w / w%, about 1.6 w / w%, about 1.7 w / w%, about 1.8 w / w%, about 1.9 w / w%, about 2.0 w / w%, about 2.1 w / w%, about 2.2 w / w%, about 2.3 w / w%, about 2.4 w / w%, about 2.5 w / w%, about 2.6 w / w%, about 2.7 w / w%, about 2.8 w / w%, about 2.9 w / w%, about 3.0 w / w%, about 3.1 w / w%, about 3.2 w / w%, about 3.3 w / w%, about 3.4 w / w%, about 3.5 w / w%, about 3.6 w / w%, about 3.7 w / w%, about 3.8 w / w%, about 3.9 w / w%, about 4.0 w / w%, about 4.1 w / w%, about 4.2 w / w%, about 4.3 w / w%, about 4.4 w / w%, about 4.5 w / w%, about 4.6 w / w%, about 4.7 w / w%, about 4.8 w / w%, about 4.9 w / w%, about 5.0 w / w%, about 5.1 w / w%, about 5.2 w / w%, about 5.3 w / w%, about 5.4 w / w%, about 5.5 w / w%, about 5.6 w / w%, about 5.7 w / w%, about 5.8 w / w%, about 5.9 w / w%, about 6.0 w / w%, about 6.1 w / w%, about 6.2 w / w%, about 6.3 w / w%, about 6.4 w / w%, about 6.5 w / w%, about 6.6 w / w%, about 6.7 w / w%, about 6.8 w / w%, about 6.9 w / w%, or about 7.0 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.85 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 0.9 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 4.69 w / w%. In some embodiments, the amount of poloxamer 188 in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water is about 4.7 w / w%.

[00219] In some embodiments, the solution comprises about 10 w / w% to about 45 w / w% water, about 30 w / w% to about 85 w / w% PEG 300, about 0.5 w / w% to about 40 w / w% of a compound of Formula (la), about 0.01 w / w% to about 3.0 w / w% of sodium hydroxide, and about 0.1 w / w% to about 10 w / w% of poloxamer 188. In some embodiments, the solution comprises about 15 w / w% to about 35 w / w% water, about 35 w / w% to about 75 w / w% PEG 300, about 1 w / w% to about 35 w / w% of a compound of Formula (la), about 0.01 w / w% to about 2.0 w / w% of sodium hydroxide, and about 0.3 w / w% to about 8 w / w% of poloxamer 188. In some embodiments, the solution comprises about 20 w / w% to about 35 w / w% water, about 40 w / w% to about 70 w / w% PEG 300, about 1 w / w% to about 30 w / w% of a compound of Formula (la), about 0.05 w / w% to about 1.5 w / w% of sodium hydroxide, and about 0.5 w / w% 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221 to about 7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 20 w / w% to about 31 w / w% water, about 45 w / w% to about 68 w / w% PEG 300, about 3 w / w% to about 28 w / w% of a compound of Formula (la), about 0.05 w / w% to about 1.2 w / w% of sodium hydroxide, and about 0.6 w / w% to about 7 w / w% of poloxamer 188.

[00220] In some embodiments, the solution comprises about 22 w / w% to about 30.1 w / w% water, about 47.1 w / w% to about 64.4 w / w% PEG 300, about 4.6 w / w% to about 25.2 w / w% of a compound of Formula (la), about 0.1 w / w% to about 1.1 w / w% of sodium hydroxide, and about 0.9 w / w% to about 4.7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 21.97 w / w% to about 30.07 w / w% water, about 47.05 w / w% to about 64.41 w / w% PEG 300, about 4.57 w / w% to about 25.21 w / w% of a compound of Formula (la), about 0.10 w / w% to about 1.08 w / w% of sodium hydroxide, and about 0.85 w / w% to about 4.69 w / w% of poloxamer 188. In some embodiments, the solution comprises about 30.1 w / w% water, about 64.4 w / w% PEG 300, about 4.6 w / w% of a compound of Formula (la), about 0.1 w / w% of sodium hydroxide, and about 0.9 w / w% of poloxamer 188. In some embodiments, the solution comprises about 30.07 w / w% water, about 64.41 w / w% PEG 300, about 4.57 w / w% of a compound of Formula (la), about 0.10 w / w% of sodium hydroxide, and about 0.85 w / w% of poloxamer 188. In some embodiments, the solution comprises about 22 w / w% water, about 47.1 w / w% PEG 300, about 25.2 w / w% of a compound of Formula (la), about 1.1 w / w% of sodium hydroxide, and about 4.7 w / w% of poloxamer 188. In some embodiments, the solution comprises about 21.97 w / w% water, about 47.05 w / w% PEG 300, about 25.21 w / w% of a compound of Formula (la), about 1.08 w / w% of sodium hydroxide, and about 4.69 w / w% of poloxamer 188.

[00221] In some embodiments, the compound of Formula (la) becomes ionized in situ to a sodium salt of the compound of Formula (la) in the presence of sodium hydroxide in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water. Thus, in some embodiments, the compound of Formula (la) is present as a sodium salt of the compound of Formula (la) in the solution comprising a compound of Formula (la), PEG 300, sodium hydroxide, poloxamer 188, and water.

[00222] In some embodiments, the solution formulation comprises about 50 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 75 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 125 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some 2024205867   19 Aug 2024 embodiments, the solution formulation comprises about 175 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 225 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 250 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 275 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 325 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 350 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 375 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[00223] In some embodiments, the solution formulation comprises about 100 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 150 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 200 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 300 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 400 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[00224] In some embodiments, the solution formulation comprises about 425 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 450 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 475 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof. In some embodiments, the solution formulation comprises about 500 mg / mL of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

[00225] In some embodiments, the PEG 300 of the solutions disclosed herein can be replaced with PEG 400 or PEG 600 in the same amount as the PEG 300. In some embodiments, the PEG 2024205867   19 Aug 2024 300 of the solutions disclosed herein can be replaced with PEG 400 in the same amount as the PEG 300. In some embodiments, the PEG 300 of the solutions disclosed herein can be replaced with PEG 600 in the same amount as the PEG 300.

[00226] In some embodiments, the molar ratio of sodium to a compound of Formula (la) or Formula (lb) is about 0:1 to about 1.5:1. In some embodiments, the molar ratio of sodium to a compound of Formula (la) is about 0:1 to about 1.5:1. In some embodiments, the molar ratio of sodium to a compound of Formula (la) is about 0:1 to about 1.2:1. In some embodiments, the molar ratio of sodium to a compound of Formula (la) is about 0:1. In some embodiments, the molar ratio of sodium to a compound of Formula (la) is about 0.5:1. In some embodiments, the molar ratio of sodium to a compound of Formula (la) is about 1:1. In some embodiments, the molar ratio of sodium to a compound of Formula (la) is about 1.2:1.

[00227] In some embodiments, the solutions are administered through subcutaneous injection. In some embodiments, the solutions are administered through intramuscular injection.

[00228] In some embodiments of the methods disclosed herein, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 309 mg / mL.

[00229] In some embodiments of the methods disclosed herein, a solution of the sodium salt of the compound of Formula (la) is administered subcutaneously, wherein the solution comprises about 20 w / w% to about 30 w / w% water, about 48 w / w% to about 60 w / w% PEG 300, and about 11 w / w% to about 28 w / w% of a sodium salt of the compound of Formula (la)

[00230] In some embodiments of the methods disclosed herein, a solution of the sodium salt of the compound of Formula (la) is administered subcutaneously, wherein the solution comprises about 23.41 w / w% water, about 50.13 w / w% PEG 300, and about 26.46 w / w% of the sodium salt of the compound of Formula (la).

[00231] In some embodiments of the methods disclosed herein, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered intramuscularly.

[00232] In some embodiments of the methods disclosed herein, the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered intramuscularly at a concentration of about 400 mg / mL to about 500 mg / mL.

[00233] In certain embodiments, an oral formulation of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and at least one excipient is provided. Excipients can include ethanol, medium chain triglycerides, vitamin E d-a-tocopheryl polyethylene glycol 1000 succinate (TPGS), glycerol monocaprylocaprate, glycerin, and / or 2024205867   19 Aug 2024 pharmaceutically acceptable oils. Examples of suitable medium chain triglycerides include, but are not limited to, MIGLYOL 810, MIGLYOL 821, and MIGLYOL 840. Examples of suitable pharmaceutically acceptable oils include, but are not limited to, sesame oil, castor oil, safflower oil, vegetable oil, and soybean oil. Oral formulations can include any combination of one or more suitable excipients. Excipients taken together can be present in greater than about 65% by weight of the total oral formulation, greater than about 70% by weight of the total oral formulation, greater than about 80% by weight of the total oral formulation, greater than about 90% by weight of the total oral formulation, or greater than about 95% by weight of the total oral formulation.

[00234] In some embodients, the oral formulation of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and at least one excipient as is prepared in hard or soft capsules. In some embodiments, the hard or soft capsules comprise a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and one or more excipients selected from the group consisting of ethanol, propylene glycol, glycerine, d-a-tocopheryl polyethylene glycol 1000 succinate (TPGS), polyoxyl 35 castor oil (e.g., Kolliphor® EL), glycerol monocapryolocaprate (e.g., Capmul® MCM), PEG 400 caprylic / capric glycerides (e.g., Labrasol®), PEG 400, di ethylene glycol monoethyl ether (e.g., Transcutol®), propylene glycol monocaprylate, Type II (e.g., Capryol® 90), glyceryl monooleate, Type 40 (e.g., Peceol™), medium chain triglycerides (e.g., Miglyol® 812N), glyceryl monolinoleate (e.g., Maisine®), and polysorbate 80. In some embodiments, the hard or soft capsules comprise a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and one or more excipients selected from the group consisting of ethanol, medium chain triglycerides (e.g., Miglyol® 812N), d-a-tocopheryl polyethylene glycol 1000 succinate (TPGS), glycerol monocapryolocaprate (e.g., Capmul® MCM), PEG 400 caprylic / capric glycerides (e.g., Labrasol®), and PEG 400.

[00235] In some embodiments, the hard or soft capsules further comprise a capsule shell. In some embodiments, the capsule shell comprises one or more pharmaceutically acceptable excipients. In some embodiments, the one or more pharmaceutically acceptable excipients of the capsule shell is selected from the group consisting of a gelatin shell, a plasticizer, an opacifier, and a colorant. Plasticizers, opacifiers, and colorants are well-known in the art. In some embodiments, the capsule shell comprises one or more pharmaceutically acceptable excipients selected from the group consisting of gelatin, glycerin, titanium dioxide, and iron oxide. In some embodiments, the iron oxide comprises iron oxide (yellow). 2024205867   19 Aug 2024

[00236] In some embodiments, an oral formulation of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is provided. In certain embodiments, the oral formulation comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and glycerol monocaprylocaprate. In certain embodiments, the oral formulation includes a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, about 5% to about 20% ethanol, about 10% to about 30% vitamin E TPGS, and about 50% to about 85% MIGLYOL 812. In some embodiments, the oral formulation includes a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, about 8% to about 15% ethanol, about 15% to about 25% vitamin E TPGS, and about 60% to about 77% MIGLYOL 812. In certain embodiments, the oral formulation includes a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in about 10% ethanol, about 20% vitamin E TPGS, and about 70% MIGLYOL 812. In certain embodiments, the oral formulation is prepared in hard gelatin capsules. In certain embodiments, the oral formulation is prepared in soft gelatin capsules.

[00237] In some embodiments, the hard gelatin or soft gelatin capsule comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient. In some embodiments, the hard gelatin or soft gelatin capsule comprises a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and glycerol monocaprylocaprate. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 10 mg / ml to about 500 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 10 mg / ml to about 400 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 50 mg / ml to about 300 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 50 mg / ml to about 200 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 50 mg / ml to about 100 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 10 mg / ml, about 15 mg / ml, about 20 mg / ml, about 25 mg / ml, about 30 mg / ml, about 30 mg / ml, about 40 mg / ml, about 45 mg / ml, about 50 mg / ml, about 55 mg / ml, 2024205867   19 Aug 2024 about 60 mg / ml, about 65 mg / ml, about 70 mg / ml, about 75 mg / ml, about 80 mg / ml, about 85 mg / ml, about 90 mg / ml, about 95 mg / ml, about 100 mg / ml, about 105 mg / ml, about 110 mg / ml, about 115 mg / ml, about 120 mg / ml, about 125 mg / ml, about 130 mg / ml, about 135 mg / ml, about 140 mg / ml, about 145 mg / ml, about 150 mg / ml, about 155 mg / ml, about 160 mg / ml, about 165 mg / ml, about 170 mg / ml, about 175 mg / ml, about 180 mg / ml, about 185 mg / ml, about 190 mg / ml, about 195 mg / ml, about 200 mg / ml, 205 mg / ml, about 210 mg / ml, about 215 mg / ml, about 220 mg / ml, about 225 mg / ml, about 230 mg / ml, about 235 mg / ml, about 240 mg / ml, about 245 mg / ml, about 250 mg / ml, about 255 mg / ml, about 260 mg / ml, about 265 mg / ml, about 270 mg / ml, about 275 mg / ml, about 280 mg / ml, about 285 mg / ml, about 290 mg / ml, about 295 mg / ml, about 300 mg / ml, about 305 mg / ml, about 310 mg / ml, about 315 mg / ml, about 320 mg / ml, about 325 mg / ml, about 330 mg / ml, about 335 mg / ml, about 340 mg / ml, about 345 mg / ml, about 350 mg / ml, about 355 mg / ml, about 360 mg / ml, about 365 mg / ml, about 370 mg / ml, about 375 mg / ml, about 380 mg / ml, about 385 mg / ml, about 390 mg / ml, about 395 mg / ml, about 400 mg / ml, about 405 mg / ml, about 410 mg / ml, about 415 mg / ml, about 420 mg / ml, about 425 mg / ml, about 430 mg / ml, about 435 mg / ml, about 440 mg / ml, about 445 mg / ml, about 450 mg / ml, about 455 mg / ml, about 460 mg / ml, about 465 mg / ml, about 470 mg / ml, about 475 mg / ml, about 480 mg / ml, about 485 mg / ml, about 490 mg / ml, about 495 mg / ml, or about 500 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 10 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 20 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 30 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 40 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 50 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 75 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 100 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin 2024205867   19 Aug 2024 or soft gelatin capsule is about 125 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 150 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 175 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 200 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 225 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 250 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 275 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 300 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 325 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 350 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 375 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 400 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 425 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 450 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 475 mg / ml. In some embodiments, the concentration of a compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, in the hard gelatin or soft gelatin capsule is about 500 mg / ml. 2024205867   19 Aug 2024 WO 2021 / 108544                                                 PCT / US2020 / 062221

[00238] In some embodiments, the hard gelatin or soft gelatin capsule comprises a compound of Formula (lb), or a pharmaceutically acceptable salt thereof, and glycerol monocaprylocaprate.

[00239] In some embodiments, the hard gelatin or soft gelatin capsule comprises a compound of Formula (la) and glycerol monocaprylocaprate. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 10 mg / ml to about 500 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 10 mg / ml to about 400 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 50 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 75 mg / ml to about 300 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 50 mg / ml to about 200 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 50 mg / ml to about 100 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 10 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 20 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 30 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 40 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 50 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 75 mg / ml. In some embodiments, the concentration of the compound of Formula (la) in the hard gelatin or 2024205867   19 Aug 2024 soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 100 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 125 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 150 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 175 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 200 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 225 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 250 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 275 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 300 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 325 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 350 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 375 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 400 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 425 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 450 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule 2024205867   19 Aug 2024 comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 475 mg / ml. In some embodiments, the concentration of a compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 500 mg / ml.

[00240] In some embodiments, the amount of glycerol monocaprylocaprate in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 30 w / w% to about 85 w / w%. In some embodiments, the amount of glycerol monocaprylocaprate in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 40 w / w% to about 80 w / w%. In some embodiments, the amount of glycerol monocaprylocaprate in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 50 w / w% to about 80 w / w%. In some embodiments, the amount of glycerol monocaprylocaprate in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 60 w / w% to about 70 w / w%. In some embodiments, the amount of glycerol monocaprylocaprate in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 65.9 w / w%. In some embodiments, the amount of glycerol monocaprylocaprate in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 65.94 w / w%.

[00241] In some embodiments, the amount of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 1 w / w% to about 40 w / w%. In some embodiments, the amount of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 1 w / w% to about 35 w / w%. In some embodiments, the amount of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 2 w / w% to about 30 w / w%. In some embodiments, the amount of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 3 w / w% to about 28 w / w%. In some embodiments, the amount of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 3.4 w / w%. In some embodiments, the amount of the compound of Formula (la) in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate is about 3.42 w / w%. 2024205867   19 Aug 2024

[00242] In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises a capsule shell. In some embodiments, the capsule shell comprises one or more pharmaceutically acceptable excipients. In some embodiments, the one or more pharmaceutically acceptable excipients of the capsule shell is selected from the group consisting of a gelatin shell, a plasticizer, an opacifier, and a colorant. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises one or more of a pharmaceutically acceptable excipient selected from the group consisting of gelatin, glycerin, titanium dioxide, and iron oxide. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises gelatin. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises glycerin. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises titanium dioxide. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises iron oxide. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises gelatin and glycerin. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises gelatin, glycerin, and titanium dioxide. In some embodiments, the hard gelatin or soft gelatin capsule comprising a compound of Formula (la) and glycerol monocaprylocaprate further comprises gelatin, glycerin, titanium dioxide, and iron oxide. In some embodiments, the iron oxide of the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide comprises iron oxide (yellow).

[00243] In some embodiments, the amount of gelatin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 10 w / w% to about 40 w / w%. In some embodiments, the amount of gelatin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 10 w / w% to about 30 w / w%. In some embodiments, the amount of gelatin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 15 w / w% to about 25 w / w%. In some embodiments, the amount of gelatin in the hard gelatin or 2024205867   19 Aug 2024 soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 18 w / w% to about 22 w / w%. In some embodiments, the amount of gelatin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 19.6 w / w%. In some embodiments, the amount of gelatin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 19.60 w / w%.

[00244] In some embodiments, the amount of glycerin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 3 w / w% to about 25 w / w%. In some embodiments, the amount of glycerin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 5 w / w% to about 20 w / w%. In some embodiments, the amount of glycerin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 5 w / w% to about 15 w / w%. In some embodiments, the amount of glycerin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 8 w / w% to about 12 w / w%. In some embodiments, the amount of glycerin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 10.8 w / w%. In some embodiments, the amount of glycerin in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 10.80 w / w%.

[00245] In some embodiments, the amount of titanium dioxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.01 w / w% to about 2 w / w%. In some embodiments, the amount of titanium dioxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.05 w / w% to about 1.5 w / w%. In some embodiments, the amount of titanium dioxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.1 w / w% to about 1.0 w / w%. In some embodiments, the amount of titanium dioxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 2024205867   19 Aug 2024 0.1 w / w% to about 0.5 w / w%. In some embodiments, the amount of titanium dioxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.2 w / w%. In some embodiments, the amount of titanium dioxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.22 w / w%.

[00246] In some embodiments, the amount of iron oxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.01 w / w% to about 1 w / w%. In some embodiments, the amount of iron oxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.01 w / w% to about 0.5 w / w%. In some embodiments, the amount of iron oxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.01 w / w% to about 0.15 w / w%. In some embodiments, the amount of iron oxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.01 w / w% to about 0.1 w / w%. In some embodiments, the amount of iron oxide in the hard gelatin or soft gelatin capsule comprising a compound of Formula (la), glycerol monocaprylocaprate, gelatin, glycerin, titanium dioxide, and iron oxide is about 0.02 w / w%.

[00247] In some embodiments, the hard gelatin or soft capsule comprises about 30 w / w% to about 85 w / w% of glycerol monocaprylocaprate and about 1 w / w% to about 40 w / w% of a compound of Formula (la). In some embodiments, the hard gelatin or soft capsule comprises about 40 w / w% to about 80 w / w% of glycerol monocaprylocaprate and about 1 w / w% to about 35 w / w% of a compound of Formula (la). In some embodiments, the hard gelatin or soft capsule comprises about 50 w / w% to about 80 w / w% of glycerol monocaprylocaprate and about 2 w / w% to about 30 w / w% of a compound of Formula (la). In some embodiments, the hard gelatin or soft capsule comprises about 60 w / w% to about 70 w / w% of glycerol monocaprylocaprate and about 3 w / w% to about 28 w / w% of a compound of Formula (la). In some embodiments, the hard gelatin or soft capsule comprises about 65.9 w / w% of glycerol monocaprylocaprate and about 3.4 w / w% of a compound of Formula (la). In some embodiments, the hard gelatin or soft capsule comprises about 65.94 w / w% of glycerol monocaprylocaprate and about 3.42 w / w% of a compound of Formula (la). 2024205867   19 Aug 2024

[00248] In some embodiments, the hard gelatin or soft capsule comprises about 30 w / w% to about 85 w / w% of glycerol monocaprylocaprate, about 1 w / w% to about 40 w / w% of a compound of Formula (la), about 10 w / w% to about 40 w / w% of gelatin, about 3 w / w% to about 25 w / w% of glycerin, about 0.01 w / w% to about 2 w / w% of titanium dioxide, and about 0.01 w / w% to about 1 w / w% of iron oxide. In some embodiments, the hard gelatin or soft capsule comprises about 40 w / w% to about 80 w / w% of glycerol monocaprylocaprate, about 1 w / w% to about 35 w / w% of a compound of Formula (la), about 10 w / w% to about 30 w / w% of gelatin, about 5 w / w% to about 20 w / w% of glycerin, about 0.05 w / w% to about 1.5 w / w% of titanium dioxide, and about 0.01 w / w% to about 0.5 w / w% of iron oxide. In some embodiments, the hard gelatin or soft capsule comprises about 50 w / w% to about 80 w / w% of glycerol monocaprylocaprate, about 2 w / w% to about 30 w / w% of a compound of Formula (la), about 15 w / w% to about 25 w / w% of gelatin, about 5 w / w% to about 15 w / w% of glycerin, about 0.1 w / w% to about 1.0 w / w% of titanium dioxide, and about 0.01 w / w% to ab...

Claims

1. A method of preventing an HIV infection in a subject, comprising administering to thesubject a compound of Formula (la) or Formula (lb):or a pharmaceutically acceptable salt thereof.

2. The method of claim 1, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally, subcutaneously, intramuscularly, or intravenously.

3. The method of any one of claims 1-2, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally.

4. The method of any one of claims 1-3, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 20 mg / mL to about 300 mg / mL.

5. The method of any one of claims 1-4, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 200 mg / mL.

6. The method of any one of claims 1-4, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 20 mg / mL to about 100 mg / mL.2024205867   19 Aug 20247. The method of any one of claims 1-4, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 30 mg / mL.

8. The method of any one of claims 1-4, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered orally at a concentration of about 50 mg / mL.

9. The method of any one of claims 1 to 8, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is formulated as a hard gelatin capsule.

10. The method of any one of claims 1 to 8, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is formulated as a soft gelatin capsule.

11. The method of any one of claims 1 to 3, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is formulated as a tablet.

12. The method of claim 11, wherein the tablet comprises from about 5 mg to about 500 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

13. The method of any one of claims 11-12, wherein the tablet comprises about 50 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

14. The method of any one of claims 11-12, wherein the tablet comprises about 300 mg of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

15. The method of any one of claims 1-2, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously.

16. The method of any one of claims 1-2 and 15, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a2024205867   19 Aug 2024concentration of about 10 mg / mL to about 500 mg / mL.

17. The method of any one of claims 1-2 and 15-16, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 50 mg / mL.

18. The method of any one of claims 1-2 and 15-16, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 100 mg / mL.

19. The method of any one of claims 1-2 and 15-16, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 150 mg / mL.

20. The method of any one of claims 1-2 and 15-16, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 300 mg / mL.

21. The method of any one of claims 1-2 and 15-16, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered subcutaneously at a concentration of about 309 mg / mL.

22. The method of any one of claims 1-2, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered intramuscularly.

23. The method of any one of claims 1-2 and 22, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered intramuscularly at a concentration of about 400 mg / mL to about 500 mg / mL.

24. The method of any one of claims 1 to 23, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 10 mg to about 2000 mg.

25. The method of any one of claims 1 to 24, wherein the compound of Formula (la) or2024205867   19 Aug 2024Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, or about1000 mg, about 1050 mg, about 1100 mg, about 1150 mg, about 1200 mg, about 1250 mg, about1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, about 1500 mg, about 1550 mg, about1600 mg, about 1650 mg, about 1700 mg, about 1750 mg, about 1800 mg, about 1850 mg, about1900 mg, about 1950 mg, or about 2000 mg.

26. The method of any one of claims 1 to 25, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 900 mg.

27. The method of any one of claims 1 to 25, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 500 mg.

28. The method of any one of claims 1 to 25, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 300 mg.

29. The method of any one of claims 1 to 25, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 100 mg.

30. The method of any one of claims 1 to 25, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 50 mg.

31. The method of any one of claims 1 to 30, further comprising administering one to three additional therapeutic agents to the subject.

32. The method of claim 31, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and the one to three additional therapeutic agents are2024205867   19 Aug 2024administered simultaneously.

33. The method of claim 31 or 32, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and the one to three additional therapeutic agents are administered as a unitary dosage form.

34. The method of any one of claims 31-33, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and the one to three additional therapeutic agents are administered as a fixed dose combination tablet.

35. The method of claim 31, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, and the one to three additional therapeutic agents are administered sequentially.

36. The method of any one of claims 31-35, wherein each of the additional therapeutic agents is independently selected from an HIV protease inhibiting compound, an HIV nonnucleoside inhibitor of reverse transcriptase, an HIV nucleoside inhibitor of reverse transcriptase, an HIV nucleotide inhibitor of reverse transcriptase, an HIV integrase inhibitor, a gp41 inhibitor, a CXCR4 inhibitor, a gpl20 inhibitor, a CCR5 inhibitor, a broadly neutralizing antibody against HIV, a bispecific antibody against HIV, an HIV vaccine, and an HIV capsid inhibitor, or any combination thereof.

37. The method of any one of claims 31-36, wherein one additional therapeutic agent is bictegravir, or a pharmaceutically acceptable salt thereof.

38. The method of claim 37, wherein the bictegravir, or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 10 mg to about 2000 mg.

39. The method of any one of claims 37-38, wherein the bictegravir, or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 10 mg to about 1000 mg.

40. The method of any one of claims 37-39, wherein the bictegravir, or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 400 mg,2024205867   19 Aug 2024about 450 mg, about 500 mg, about 550 mg, or about 600 mg.

41. The method of any one of claims 31-36, wherein one additional therapeutic agent is selected from tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, and tenofovir disoproxil, or a pharmaceutically acceptable salt thereof.

42. The method of any one of claims 31-36 and 41, wherein one additional therapeutic agent is tenofovir alafenamide, or a pharmaceutically acceptable salt thereof.

43. The method of claim 41 or 42, wherein the tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 10 mg to about 50 mg.

44. The method of any one of claims 41-43, wherein the tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, is administered in a dosage of from about 20 mg to about 30 mg.

45. The method of any one of claims 41-44, wherein the tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, is administered in a dosage of about 25 mg.

46. The method of any one of claims 41-45, wherein one additional therapeutic agent is tenofovir alafenamide hemifumarate.

47. The method of any one of claims 31-36, comprising administering a first additional therapeutic agent which is bictegravir, or a pharmaceutically acceptable salt thereof, and a second additional therapeutic agent which is tenofovir alafenamide, or a pharmaceutically acceptable salt thereof.

48. The method of any one of claims 31-36 and 47, comprising administering a first additional therapeutic agent which is bictegravir sodium salt and a second additional therapeutic agent which is tenofovir alafenamide hemifumarate.

49. The method of any one of claims 1-30, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered as a monotherapy.2024205867   19 Aug 2024WO 2021 / 108544                                                 PCT / US2020 / 06222150. The method of any one of claims 1 to 49, wherein the method comprises event driven administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, to the subject.

51. The method of any one of claims 1 to 49, wherein the method comprises pre-exposure prophylaxis (PrEP).

52. The method of any one of claims 1 to 49, wherein the method comprises post-exposure prophylaxis (PEP).

53. The method of any one of claims 1 to 49, wherein the method comprises pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

54. The method of any one of claims 1 to 53, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered before exposure of the subject to the HIV.

55. The method of any one of claims 1 to 54, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 14 days to about one day before exposure of the subject to the HIV.

56. The method of any one of claims 1 to 55, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 10 days to about 5 days before exposure of the subject to the HIV.

57. The method of any one of claims 1 to 56, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about 7 days before exposure of the subject to the HIV.

58. The method of any one of claims 1 to 54, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 72 hours to about 1 hour before exposure of the subject to the HIV.

59. The method of claim 51 or 53, wherein the pre-exposure prophylaxis (PrEP) comprisesWO 2021 / 108544continuous PrEP.2024205867   19 Aug 202460. The method of claim 59, wherein the continuous PrEP comprises daily administration of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, from about 14 days to about 1 hour before the exposure of the subject to the HIV.

61. The method of any one of claims 1 to 60, comprising administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, during the period of exposure of the subject to the HIV.

62. The method of claim 61, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every 7 days, about every 14 days, about every 21 days, about every 28 days, about every 35 days, or about every 42 days during the period of exposure of the subject to the HIV.

63. The method of claim 61, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once about every month, about every 2 months, about every 3 months, about every 6 months, or about every 12 months during the period of exposure of the subject to the HIV.

64. The method of any one of claims 1 to 63, comprising administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, after final exposure of the subject to the HIV.

65. The method of claim 64, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 1 hour to about 14 days after final exposure of the subject to the HIV.

66. The method of claim 64 or 65, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 1 hour to about 7 days after final exposure of the subject to the HIV.

67. The method of any one of claims 64-66, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, is administered once from about 12024205867   19 Aug 2024hour to about 72 hours after final exposure of the subject to the HIV.

68. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, once every 7 days during the period of exposure to the HIV.

69. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 14 days during the period of exposure to the HIV.

70. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 21 days during the period of exposure to the HIV.

71. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 28 days during the period of exposure to the HIV.

72. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 35 days during the period of exposure to the HIV.

73. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically2024205867   19 Aug 2024acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 42 days during the period of exposure to the HIV.

74. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 1 month during the period of exposure to the HIV.

75. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 2 months during the period of exposure to the HIV.

76. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 3 months during the period of exposure to the HIV.

77. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 6 months during the period of exposure to the HIV.

78. The method of any one of claims 1-25 and 50-51, wherein the method comprises:(i) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, at about 7 days prior to exposure of the subject to the HIV; and(ii) administering the compound of Formula (la) or Formula (lb), or a pharmaceutically salt thereof, once every 12 months during the period of exposure to the HIV.2024205867   19 Aug 202479. The method of any one of claims 68-78, wherein the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (i) is at a different dose than the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, administered in step (ii).

80. The method of any one of claims 68-79, wherein the administrations of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, further comprise administration of:(a) bictegravir, or a pharmaceutically acceptable salt thereof;(b) tenofovir alafenamide, or a pharmaceutically acceptable salt thereof; or(c) bictegravir, or a pharmaceutically acceptable salt thereof and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof.

81. The method of any one of claims 68-80, wherein the administrations of the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof, further comprise administration of bictegravir, or a pharmaceutically acceptable salt thereof, in a dosage of from about 10 mg to about 600 mg and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, in a dosage of from about 10 mg to about 50 mg.

82. A method of reducing the risk of acquiring HIV in a subject, comprising administering tothe subject a compound of Formula (la) or Formula (lb):

83. The method of claim 82, wherein the reduction in risk of acquiring HIV is at least about2024205867   19 Aug 2024WO 2021 / 108544                                                 PCT / US2020 / 06222175% compared to a subject having not been administered the compound of Formula (la) or Formula (lb), or a pharmaceutically acceptable salt thereof.

84. The method of any one of claims 1 to 83, wherein the subject has been identified as an individual who is at risk of sexual transmission of HIV.

85. The method of any one of claims 1 to 84, wherein the HIV is HIV-1.

86. The method of any one of claims 1 to 84, wherein the HIV is HIV-2.

87. The method of any one of claims 1 to 86, wherein the method comprises administeringthe compound of Formula (la), or a pharmaceutically acceptable salt thereof.

88. The method of claim 87, wherein the pharmaceutically acceptable salt of the compound of Formula (la) is a sodium salt.

89. The method of any one of claims 1-2, 15, 21, and 24-88, wherein a solution of the sodium salt of the compound of Formula (la) is administered subcutaneously and wherein the solution comprises about 20 w / w% to about 30 w / w% water, about 48 w / w% to about 60 w / w% PEG 300, and about 11 w / w% to about 28 w / w% of a sodium salt of the compound of Formula (la)90. The method claim 89, wherein a solution of the sodium salt of the compound of Formula (la) is administered subcutaneously and wherein the solution comprises about 23.41 w / w% water, about 50.13 w / w% PEG 300, and about 26.46 w / w% of the sodium salt of the compound of Formula (la)91. The method of any one of claims 1 to 86, wherein the method comprises administering the compound of Formula (lb), or a pharmaceutically acceptable salt thereof.

92. The method of any one of claims 1 to 91, wherein the subject is a human.

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