High-Potency Single-Unit Dose Formulations and Methods of Use

Abstract

Described herein, in part, are single-unit dosage forms, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl), wherein the composition is bioequivalent to a reference composition of the same dosage strength administered as multiple small, round tablets. The present invention further comprises methods useful for treating a disease or condition relating to aberrant function or activity of a T-type calcium channel, such as tremor (e.g., essential tremor).

Description

High-Potency Single-Unit Dose Formulations and Methods of Use RELATED ORDERS

[001] This request claims priority over the Provisional Request of U.S. No. 63 / 449.529, filed on March 2, 2023, the full content of which is incorporated by reference herein. BACKGROUND

[002] Essential tremor (ET) is the most common adult movement disorder, affecting up to 2% of the United States population (approximately 7 million Americans). ET is characterized by postural and kinetic tremor of 5 to 12 Hz (i.e., tremor during voluntary movement) in the upper extremities. The most characteristic clinical feature is kinetic tremor of the arms and hands, but tremor can also occur in the head and voice and, less commonly, in the face, legs, and trunk. The diagnosis of ET is based on medical history and neurological examination, as described in the International Parkinson and Movement Disorders Society Consensus Statement on the Classification of Tremors.

[003] There is a range of severity in ET; some patients do not require treatment, while others have severe disability with impairment in activities of daily living such as dressing and eating. ET, by definition, is generally not associated with other neurological signs, although there is growing recognition that ET may also be associated with additional motor features such as postural instability, dystonia, mild to moderate gait ataxia, and eye movement abnormalities. ET is also associated with a high prevalence of comorbid psychiatric disorders, including anxiety and depression. ET often worsens over time, with more severe tremor over years to decades and a corresponding worsening of disability. Petition 870250101458, dated 05 / 11 / 2025, p. 7 / 254 2 / 211

[004] ET can be sporadic, but a family history of an autosomal dominant inheritance pattern is commonly found and, most importantly, variants in the alpha1G calcium voltage-gated channel subunit gene (CACNA1G), which encodes the Cav3.1 T-type Ca2+ channel isoform, have been identified as the cause of ET in at least three families. The importance of the CACNA1G gene for cerebellar development and function is further highlighted by the observation that variants in this gene can also cause cerebellar atrophy in childhood and spinocerebellar ataxia type 42. The functional consequences of these genetic variants are consistent with the expression of T-type Ca2+ channels in the cerebellum and the cerebellar-thalamo-distal cortical (CTC) circuit and their physiological contribution to oscillatory firing in the thalamus that is synchronized with and likely drives clinically observable tremor.

[005] Propranolol is the only orally administered treatment approved by the U.S. Food and Drug Administration (FDA) for the treatment of ET. Propranolol was originally developed for hypertension and, in the treatment of ET, has limited efficacy with side effects (e.g., bradycardia) that frequently lead to discontinuation. The unmet medical need in ET has resulted in the off-label use of medications in various drug classes, including anticonvulsants, barbiturates, benzodiazepines, antipsychotics, and others, with limited appreciable therapeutic benefit for patients with ET. A recent evidence-based review concluded that only propranolol, primidone, and topiramate had sufficient evidence to support efficacy among 28 drugs studied for ET.Surgical interventions that interrupt cerebellar-thalamo-cortical (CTC) disruption activity, such as deep brain stimulation or focused ultrasound, are effective treatments for ET, but carry risks, such as sensory disturbances, etc. Petition 870250101458, dated 05 / 11 / 2025, page 8 / 254 3 / 211 myparesis, dysarthria, ataxia, gait disturbances, delirium, cognitive decline, tissue damage, venous thromboembolic events, and intracerebral hemorrhage.

[006] Voltage-gated ion channels play a critical role in maintaining the delicate balance between neuronal excitation and inhibition within neuronal networks. Alterations in voltage-gated ion channels, particularly T-type Ca2+ channels, have been implicated in ET. Comprising three isoforms (CaV3.1, CaV3.2, and CaV3.3), T-type Ca2+ channels are widely expressed throughout the brain, especially in the CTC circuit. This class of calcium channels has been shown to play a critical role in modulating neuronal firing patterns, controlling the switch between a tonic and stable firing pattern to one consisting of brief bursts of high-frequency activity in wild-type rodents and in rodent tremor models.It is important to emphasize that aberrant bursts in the CTC circuit occur at the same frequency as upper limb tremor in ET, suggesting that reducing T-type calcium channel-mediated burst firing may have a therapeutic benefit in reducing tremor-related burst firing in the CTC circuit.

[007] PRAX-944 (N-((1-(2-( tert-butylamino)-2-oxoethyl)piperidin-4-yl)methyl)-3-chloro-5-fluorobenzamide hydrochloride) is a selective, state-dependent, high-affinity inhibitor of T-type Ca2+ channels being developed for the treatment of ET. In vitro electrophysiology studies have demonstrated that PRAX-944 has nanomolar specificity and potency for T-type Ca2+ channels (CaV3.1 and CaV3.3).

[008] By blocking T-type Ca2+ channels, PRAX-944 can reduce disruption activity in the CTC circuit and, in turn, reduce tremor and associated disability. PRAX-944 has shown robust activity in an animal model of ET. To date, the PRAX-944 program con Petition 870250101458, dated 05 / 11 / 2025, page 9 / 254 4 / 211 included 5 phase 1 studies in healthy participants using dose levels from 2.5 mg to 120 mg. Recent clinical studies with PRAX-944 used the MR7 formulation and introduced a titration regimen to achieve higher dose levels. Together, these developments contributed to improved safety and tolerability, as well as a wider therapeutic window compared to the immediate-release (IR) formulation. The MR7 formulation, which was designed to delay tmax and reduce Cmax and have minimal effects on AUC, was associated with a reduction in the frequency of CNS, psychiatric, and general adverse events compared to the IR formulation in 2 studies, Z944103 and Z944-104. Furthermore, the PRAX-944-105 study established that doses above 40 mg are well tolerated when administered in a 28-day titration regimen. No maximum tolerated dose was observed for the MR7 formulation administered in this way, and dosages up to 120 mg are well tolerated.The program also collected preliminary efficacy data in an initial phase 2 study in participants with ET.

[009] With a modified-release (MR) formulation that supports once-daily (1x / day) administration over a well-tolerated dose range of 24 times that exhibits robust pharmacodynamic effects, combined with preliminary efficacy data, there is a clear clinical rationale to support further study of the safety and efficacy of PRAX-944 to address the unmet need in ET.

[0010] However, certain challenges associated with the use of currently available PRAX-944 MR formulations (i.e., placebo, 5 mg, and 20 mg tablets) were identified during clinical studies. For example, for clinically blinded purposes, different dose potencies of PRAX-944 are supplied in multiple tablet combinations (e.g., including one or more placebo, 5 mg, and 20 mg tablets) packaged in blisters. It was found Petition 870250101458, dated 05 / 11 / 2025, page 10 / 254 5 / 211 Opening blister packs, handling small, round tablets, and taking many pills is especially challenging for patients struggling with movement disorders such as essential tremor (ET). Consequently, there is a need to develop new single-unit dose tablets of appropriate strengths to improve usability for patients, reduce the total number of dosage units (e.g., tablets) needed to deliver a specific dosage strength to a patient, and reduce or eliminate the risk of dosing errors. SUMMARY

[0011] The present invention provides compositions, including single-unit dosage forms and pharmaceutical compositions, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCI). In certain embodiments, the compositions described herein are bioequivalent to currently available oral dosage forms, such as the current dosage form of PRAX-944 which is a modified-release (MR) formulation available as 5 mg and 20 mg tablets that are round and small in size (e.g., about 6 mm in diameter). The present invention further comprises useful methods for treating a disease or condition related to aberrant function or activity of a T-type calcium channel, such as tremor (e.g., essential tremor).The present invention further comprises useful methods for preventing and / or treating a disease or condition related to the aberrant function or activity of a T-type calcium channel, such as tremor, including essential tremor.

[0012] In one aspect, the present invention provides a single-unit dosage form comprising: the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the Petition 870250101458, dated 05 / 11 / 2025, p. 11 / 254 6 / 211 compound of Formula (II), for example, PRAX-944 HCl), wherein the single unit dosage form is bioequivalent to a reference composition of the same dosage potency administered as one or more dosage forms, such as multiple small round 20 mg tablets of PRAX-944.

[0013] In some embodiments, the single-unit dosage form and the reference composition have: (i) a different size; (ii) a different shape; (iii) a different size and a different shape; (iv) the same shape but different sizes; or (v) the same size but different shapes. In certain embodiments, the single-unit dosage form is larger than the reference composition. In some embodiments, the reference composition comprises smaller, round 20 mg PRAX-944 tablets.

[0014] In some embodiments, the single-unit dosage form is a larger tablet that exhibits bioequivalence after administration to a fed and / or fasted individual compared with administration of a reference composition of the same dosage potency administered as one or more smaller dosage forms, optionally one or more small, round, 20 mg PRAX-944 tablets, to a fed and / or fasted individual;wherein bioequivalence is established by: (a) a 90% Confidence Interval for AUC that is between approximately 80% and approximately 125% (e.g., approximately 80%, approximately 81%, approximately 82%, approximately 83%, approximately 84%, approximately 85%, approximately 86%, approximately 87%, approximately 88%, approximately 89%, approximately 90%, approximately 91%, approximately 92%, approximately 93%, approximately 94%, approximately 95%, approximately 96%, approximately 97%, approximately 98%, approximately 99%, approximately 100%, approximately 101%, approximately 102%, approximately 103%, approximately 104%, approximately 105%, approximately 106%, approximately; 107%, about 108%, about 109%, about 110%, about Petition 870250101458, dated 05 / 11 / 2025, page 12 / 254 7 / 211 111%, about 112%, about 113%, about 114%, about 115%, about 116%, about 117%, about 118%, about 119%, about 120%, about 121%, about 122%, about (a) a 123%, approximately 124%, or approximately 125%) and (b) a 90% Confidence Interval for Cmax, which is between approximately 80% and approximately 125% (for example, approximately 80%, approximately 81%, approximately 82%, approximately 83%, approximately 84%, approximately 85%, approximately 86%, approximately 87%, approximately 88%, approximately 89%, approximately 90%, approximately 91%, approximately 92%, approximately 93%, approximately 94%, approximately 95%, approximately 96%, approximately 97%, approximately 98%, approximately 99%, approximately 100%, approximately 101%, approximately 102%, approximately 103%, approximately 104%, approximately 105%, about 106%, about 107%, about 108%, about 109%, about 110%, about 111%, about 112%, about 113%, about 114%, about 115%, about 116%, about 117%, about 118%, about 119%, about 120%, about 121%, approximately 122%, approximately 123%, approximately 124% or approximately 125%). In some applications, the 90% confidence interval for AUC and / or Cmax may be contained within tighter confidence limits, for example, approximately 90% to approximately 120%, approximately 90% to approximately 115%, approximately 90% to approximately 110%, or approximately 90% to approximately 100%.

[0015] In some embodiments, the single-unit dosage form (i) reduces the total number of dosage units (e.g., tablets) required to deliver a specific dosage potency to an individual; (ii) is characterized by a physical size and shape (e.g., tablet size and shape) that makes it easier and more convenient for individuals with a movement disorder, such as essential tremor (ET), to grasp; (iii) may be formulated as single-unit dose potencies of 5 mg, 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg; and / or (iv) does not require Petition 870250101458, dated 05 / 11 / 2025, p. 13 / 254 8 / 211 Titration to achieve doses >40 mg. In certain embodiments, titration may reduce and / or eliminate adverse events. In some embodiments, titration may comprise the administration of one or more single-unit dosage forms described in this document. In some embodiments, at least about 50% (e.g., at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100%) of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within a predetermined time period after administration to an individual.In certain modalities, the predetermined time period can vary from about 1 hour to about 12 hours (for example, about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours, about 11 hours or about 12 hours).

[0016] In some embodiments, at least about 50% (e.g., at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100%) of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours, about 11 hours, or about 12 hours) after administration Petition 870250101458, dated 05 / 11 / 2025, p. 14 / 254 9 / 211 traction to an individual.

[0017] In some embodiments, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours). hours, approximately 7 hours, approximately 8 hours, approximately 9 hours, approximately 10 hours, approximately 11 hours, or approximately 12 hours) after administration to an individual.

[0018] In some embodiments, about 5% to about 25% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is released within about 1 to about 2 hours after administration to an individual.

[0019] In some embodiments, about 25% to about 50% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is released within about 2 hours to about 4 hours after administration to an individual.

[0020] In some embodiments, about 50% to about 75% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is released within about 3 hours to about 7 hours after administration to an individual.

[0021] In some embodiments, about 75% to about 100% of the compound of Formula (I) or a pharmaceutically acceptable salt of Petition 870250101458, dated 05 / 11 / 2025, p. 15 / 254 10 / 211 same (for example, the compound of Formula (II), for example, PRAX-944 HCl) is released within about 6 hours to about 10 hours after administration to an individual.

[0022] In some forms, approximately 80% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within approximately 7 hours after administration to an individual.

[0023] In some forms, approximately 90% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 9 hours to about 12 hours after administration to an individual.

[0024] In some embodiments, at least about 50% (for example, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100%) of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is released within a predetermined time period using the USP type I apparatus, medium containing 900 mL of 0.1 M HCl, and a paddle speed of 100 rpm. In certain embodiments, the predetermined period of time may range from about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours, about 11 hours, or about 12 hours).

[0025] In some forms, at least about 50% (for example, at least about 50%, at least about 55%, at least Petition 870250101458, dated 05 / 11 / 2025, p. 16 / 254 11 / 211 less about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100%) of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released in about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours, about 11 hours, or about 12 hours) using the USP type I apparatus, medium containing 900 mL of 0.1 M of HCl, and a blade speed of 100 rpm.In some embodiments, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released in about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours). hours, approximately 8 hours, approximately 9 hours, approximately 10 hours, approximately 11 hours, or approximately 12 hours) using a USP type I apparatus, a medium containing 900 mL of 0.1 M HCl, and a paddle speed of 100 rpm.

[0026] In some embodiments, the single-unit dosage form comprises from about 1 mg to about 200 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (I), for example, PRAX-944 HCl). In some embodiments, the single-unit dosage form Petition 870250101458, dated 05 / 11 / 2025, p. 17 / 254 12 / 211 comprises from about 1% by weight to about 70% by weight of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (I), for example, PRAX944 HCl).

[0027] In some embodiments, the single-unit dosage form further comprises a modified-release polymer. In some embodiments, the modified-release polymer comprises a matrix polymer, optionally selected from the group consisting of a hydrophilic matrix polymer, a hydrophobic matrix polymer, a polyacrylate polymer, and combinations thereof.In some embodiments, the modified-release polymer comprises (i) a hydrophilic matrix polymer, optionally selected from the group consisting of hypromellose, HPMC (hydroxypropylmethylcellulose) and combinations thereof, optionally wherein the HPMC (hydroxypropylmethylcellulose) is selected from the group consisting of Methocel K4M, Methocel K100LV, Methocel E50LV and combinations thereof; (ii) a hydrophobic matrix polymer, optionally selected from the group consisting of ethylcellulose, etocel and combinations thereof; and / or (iii) a polyacrylate polymer, optionally selected from the group consisting of Eudragit RL100, Eudragit RS100 and combinations thereof. In some embodiments, the single-unit dosage form comprises from about 5 mg to 300 mg of a modified-release polymer. In some embodiments, the single-unit dosage form comprises from about 10% by weight to about 70% by weight of the modified-release polymer.In some embodiments, the modified-release polymer is hypromellose.

[0028] In some embodiments, the single-unit dosage form further comprises a diluent, optionally a soluble diluent. In some embodiments, the diluent comprises: (i) a cellulose derivative, optionally a microcrystalline cellulose, optionally Petition 870250101458, dated 05 / 11 / 2025, page 18 / 254 13 / 211 contains a silicified microcrystalline cellulose; (ii) a starch, optionally selected from the group consisting of hydrolyzed starch, pregelatinized starch and combinations thereof; (iii) anhydrous lactose; (iv) lactose monohydrate; (v) dicalcium phosphate (DCP); and / or (vi) a sugar alcohol, optionally selected from the group consisting of sorbitol, xylitol, mannitol and combinations thereof. In some embodiments, the single-unit dosage form comprises from about 5 mg to about 300 mg of diluent. In some embodiments, the single-unit dosage form comprises from about 5% by weight to about 50% by weight of diluent. In some embodiments, the diluent is microcrystalline cellulose, optionally silicified microcrystalline cellulose. In some embodiments, the diluent is a sugar alcohol, optionally mannitol.

[0029] In some embodiments, the single-unit dosage form further comprises a glidant. In some embodiments, the glidant is selected from the group consisting of fumed silica, optionally colloidal silicon dioxide, talc, magnesium carbonate, and combinations thereof. In some embodiments, the single-unit dosage form comprises from about 1 mg to about 10 mg of glidant. In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 10% by weight of glidant. In some embodiments, the glidant is fumed silica, optionally colloidal silicon dioxide.

[0030] In some embodiments, the single-unit dosage form further comprises a lubricant. In some embodiments, the lubricant is selected from the group consisting of magnesium stearate, calcium stearate, stearic acid, talc, silica, a fat, optionally vegetable stearin, and combinations thereof. In some embodiments, the single-unit dosage form comprises from about 1 mg to about 10 mg of lubricant. In Petition 870250101458, dated 05 / 11 / 2025, p. 19 / 254 14 / 211 In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 10% by weight of lubricant. In some embodiments, the lubricant comprises magnesium stearate.

[0031] In some embodiments, the single-unit dosage form further comprises a coating. In some embodiments, the coating comprises a film coating agent. In some embodiments, the coating comprises compendial grade polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350 and / or talc. In some embodiments, the single-unit dosage form comprises from about 1 mg to about 20 mg of coating. In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 10% by weight of coating. In some embodiments, the coating comprises Opadry® II white 85F18422.

[0032] In some embodiments, the single-unit dosage form comprises a tablet, optionally formulated for oral administration. In some embodiments, the single-unit dosage form comprises an oblong tablet, an oval tablet, or a capsule-shaped tablet, optionally wherein the tablet is not a round tablet. In some embodiments, opening blister packs of oblong, oval, or capsule-shaped tablets, handling oblong, oval, or capsule-shaped tablets, and taking one or more oblong, oval, or capsule-shaped tablets is less challenging and more convenient for patients struggling with movement disorders, such as essential tremor (ET), for example, compared to a small, round tablet (e.g., about 6 mm in diameter).

[0033] In some embodiments, the single-unit dosage form comprises a total weight of approximately 200 mg to approximately 600 mg. Petition 870250101458, dated 05 / 11 / 2025, p. 20 / 254 15 / 211 mg per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 1% to about 100% by weight of PRAX-944 HCl, optionally, wherein the total weight of the dosage unit (e.g., per tablet) is from about 200 mg to about 600 mg (e.g., about 200 mg, about 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, about 250 mg, about 255 mg, about 260 mg, about 265 mg, about 270 mg, about 275 mg, about 280 mg, about 285 mg, about 290 mg, about 295 mg, about 300 mg). mg, about 305 mg, about 310 mg, about 315 mg, about 320 mg, about 325 mg, about 330 mg, about 335 mg, about 340 mg, about 345 mg, about 350 mg, about 355 mg, about 360 mg, about 365 mg, about 370 mg, about 375 mg, about 380 mg, about 385 mg, about 390 mg,about 395 mg, about 400 mg, about 405 mg, about 410 mg, about 415 mg, about 420 mg, about 425 mg, about 430 mg, about 435 mg, about 440 mg, about 445 mg, about 450 mg, about 455 mg, about 460 mg, about 465 mg, about 470 mg, about 475 mg, about 480 mg, about 485 mg, about 490 mg, about 495 mg, about 500 mg, about 505 mg, about 510 mg, about 515 mg, about 520 mg, about 525 mg, about 530 mg, about 535 mg, about 540 mg, about 545 mg, about 550 mg, about 555 mg, about 560 mg, about 565 mg, about 570 mg, about 575 mg, about 580 mg, about 585 mg, about 590 mg, about 595 mg, or about 600 mg).

[0034] In some embodiments, the single unit dosage form comprises a length of about 1 mm to about 30 mm (for example, a length of about 1 mm, about 1.5 mm). Petition 870250101458, dated 05 / 11 / 2025, page 21 / 254 16 / 211 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 3.5 mm, approximately 4 mm, approximately 4.5 mm, approximately 5 mm, approximately 5.5 mm, approximately 6 mm, approximately 6.5 mm, approximately 7 mm, approximately 7.5 mm, approximately 8 mm, approximately 8.5 mm, approximately 9 mm, approximately 9.5 mm, approximately 10 mm, approximately 10.5 mm, approximately 11 mm, approximately 11.5 mm, approximately 12 mm, approximately 12.5 mm, approximately 13 mm, approximately 13.5 mm, approximately 14 mm, approximately 14.5 mm, approximately 15 mm, approximately 15.5 mm, approximately 16 mm, approximately 16.5 mm, approximately 17 mm, approximately 17.5 mm, approximately of 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, about 20 mm, about 20.5 mm, about 21 mm, about 21.5 mm, about 22 mm, about 22.5 mm, about 23 mm, about 23.5 mm, about 24 mm, about 24.5 mm, about 25 mm, about 25.5 mm, about 26 mm, about 26.5 mm, about 27 mm, about 27.5 mm, about 28 mm, about 28.5 mm, about 29 mm, about 29.5 mm, or about 30 mm).

[0035] In some embodiments, the single unit dosage form comprises a width of about 1 mm to about 30 mm (for example, a width of about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm). mm, about 15 mm, about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17.5 mm, about 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, about 20 mm, about 20.5 mm, about 21 mm, about 21.5 mm, about 22mm, about 22.5mm, about 23mm, about 23.5mm, about 24mm, about 24.5mm, about 25. Petition 870250101458, dated 05 / 11 / 2025, page 22 / 254 17 / 211 mm, about 25.5 mm, about 26 mm, about 26.5 mm, about 27 mm, about 27.5 mm, about 28 mm, about 28.5 mm, about 29 mm, about 29.5 mm, or about 30 mm).

[0036] In some embodiments, the single unit dosage form comprises a width of about 1 mm to about 10 mm (for example, a width of about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6mm, about 3.7mm, about 3.8mm, about 3.9mm, about 4mm, about 4.1mm, about 4.2mm, about 4.3mm, about 4.4mm, about 4.5mm, about 4.6mm, about 4.7mm, about 4.8mm, about 4.9mm, about 5mm, about 5.1mm, about 5.2mm, about 5.3mm, about 5.4mm, about 5.5mm, about 5.6mm, about 5.7mm, about 5.8mm, about 5.9mm,about 6mm, about 6.1mm, about 6.2mm, about 6.3mm, about 6.4mm, about 6.5mm, about 6.6mm, about 6.7mm, about 6.8mm, about 6.9mm, about 7mm, about 7.1mm, about 7.2mm, about 7.3mm, about 7.4mm, about 7.5mm, about 7.6mm, about 7.7mm, about 7.8mm, about 7.9mm, about 8mm, about 8.1mm, about 8.2mm, about 8.3mm, about 8.4mm, about 8.5mm, about 8.6mm, about 8.7mm, about 8.8mm, about 8.9mm, about 9mm, about 9.1 mm, about 9.2 mm, about 9.3 mm, about 9.4 mm, about 9.5 mm, about 9.6 mm, about 9.7 mm, about 9.8 mm, about 9.9 mm or about 10 mm).

[0037] In some embodiments, the unit dosage form, Petition 870250101458, dated 05 / 11 / 2025, page 23 / 254 18 / 211 unique comprises a length of about 14 to about 16 mm (for example, a length of about 14 mm, about 14.1 mm, about 14.2 mm, about 14.3 mm, about 14.4 mm, about 14.5 mm, about 14.6 mm, about 14.7 mm, about 14.8 mm, about 14.9 mm, about 15 mm, about 15.1 mm, about 15.2 mm, about 15.3 mm, about 15.4 mm, about 15.5 mm, about 15.6 mm, about 15.7 mm, about 15.8 mm, about 15.9 mm, or about 16 mm), and a width of about 5 mm to about 7 mm (for example, a width of about 5 mm, about 5.1mm, about 5.2mm, about 5.3mm, about 5.4mm, about 5.5mm, about 5.6mm, about 5.7mm, about 5.8mm, about 5.9mm, about 6mm, about 6.1mm, about 6.2mm, about 6.3mm, about 6.4mm, about 6.5mm, about 6.6mm, about 6.7mm, about 6.8mm, about 6.9mm, or about 7mm).

[0038] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 5 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 1 mg to about 10 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0039] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 10 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 5 mg to about 15 mg of PRAX-944 HCl per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, page 24 / 254 19 / 211

[0040] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 15 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 10 mg to about 20 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0041] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 20 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 15 mg to about 25 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0042] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 25 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 20 mg to about 30 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0043] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 30 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 25 mg to Petition 870250101458, dated 05 / 11 / 2025, page 25 / 254 20 / 211 approximately 35 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0044] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 35 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 30 mg to about 40 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0045] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 40 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 35 mg to about 45 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0046] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 45 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 40 mg to about 50 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0047] In some embodiments, the single unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to Petition 870250101458, dated 05 / 11 / 2025, page 26 / 254 21 / 211 approximately 50 mg of PRAX-944 free base per dosage unit (e.g., per tablet), optionally from approximately 45 mg to approximately 55 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0048] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 55 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 50 mg to about 60 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0049] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 60 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 55 mg to about 65 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0050] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 65 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 60 mg to about 70 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0051] In some embodiments, the single unit dosage form comprises the compound of Formula (I) or a pharmaceutical salt Petition 870250101458, dated 05 / 11 / 2025, p. 27 / 254 22 / 211 acceptable amount thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 70 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 65 mg to about 75 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0052] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 75 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 70 mg to about 80 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0053] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 80 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 75 mg to about 85 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0054] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 85 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 80 mg to about 90 mg of PRAX-944 HCl per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, page 28 / 254 23 / 211

[0055] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 90 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 85 mg to about 95 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0056] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 95 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 90 mg to about 100 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0057] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 100 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 95 mg to about 105 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0058] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 105 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 100 mg to Petition 870250101458, dated 05 / 11 / 2025, page 29 / 254 24 / 211 approximately 110 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0059] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 110 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 105 mg to about 115 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0060] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 115 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 110 mg to about 120 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0061] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 120 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 115 mg to about 125 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0062] In some embodiments, the single unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to Petition 870250101458, dated 05 / 11 / 2025, p. 30 / 254 25 / 211 approximately 125 mg of PRAX-944 free base per dosage unit (e.g., per tablet), optionally from approximately 120 mg to approximately 130 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0063] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 130 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 125 mg to about 135 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0064] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 135 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 130 mg to about 140 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0065] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 140 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 135 mg to about 145 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0066] In some embodiments, the single unit dosage form comprises the compound of Formula (I) or a pharmaceutical salt Petition 870250101458, dated 05 / 11 / 2025, p. 31 / 254 26 / 211 acceptable amount thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 145 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 140 mg to about 150 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0067] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 150 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 145 mg to about 155 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0068] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 155 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 150 mg to about 160 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[0069] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 160 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 155 mg to about 165 mg of PRAX-944 HCl per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, page 32 / 254 27 / 211

[0070] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 1.0 mg to about 200 mg (for example, 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,or approximately 200 mg) of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 50% (e.g., about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45% or about 50%) by weight of PRAX-944 HCl, optionally wherein the weight of the total dosage unit (e.g., tablet) is from about 50 mg to about 500 mg (e.g., 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 160 mg, about 170 mg, about 180 mg, about 190 mg, about 200 mg, about 210 mg, about 220 mg, about 230 mg, about 240 mg, about 250 mg, about 260 mg, about 270 mg, about 280 mg, about 290 mg, about 300 mg, about 310 mg, Petition 870250101458, dated 05 / 11 / 2025, page 33 / 254 28 / 211 about 320 mg, about 330 mg, about 340 mg, about 350 mg, about 360 mg, about 370 mg, about 380 mg, about 390 mg, about 400 mg, about 410 mg, about 420 mg, about 430 mg, about 440 mg, about 450 mg, about 460 mg, about 470 mg, about 480 mg, about 490 mg or about 500 mg).

[0071] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 5.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 5% by weight of PRAX-944 HCl, optionally from about 1 mg to about 10 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0072] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 10.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 10% by weight of PRAX-944 HCl, optionally from about 5 mg to about 15 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0073] In some embodiments, the single unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to Petition 870250101458, dated 05 / 11 / 2025, p. 34 / 254 29 / 211 approximately 20.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from approximately 1% by weight to approximately 10% by weight of PRAX-944 HCl, optionally from approximately 15 mg to approximately 25 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0074] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 40.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 5% by weight to about 15% by weight of PRAX-944 HCl, optionally from about 25 mg to about 50 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0075] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 60.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 5% by weight to about 20% by weight of PRAX-944 HCl, optionally from about 50 mg to about 75 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0076] In some embodiments, the single unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to Petition 870250101458, dated 05 / 11 / 2025, p. 35 / 254 30 / 211 approximately 80.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from approximately 15% by weight to approximately 25% by weight of PRAX-944 HCl, optionally from approximately 75 mg to approximately 100 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0077] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 100.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 20% by weight to about 25% by weight of PRAX-944 HCl, optionally from about 75 mg to about 125 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0078] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 120.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 25% by weight to about 35% by weight of PRAX-944 HCl, optionally from about 110 mg to about 135 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[0079] In some embodiments, the single-unit dosage form further comprises one or more of (i) a modified-release polymer, optionally from about 35% by weight to about 45% by weight of modified-release polymer, optionally of Petition 870250101458, dated 05 / 11 / 2025, page 36 / 254 31 / 211 approximately 175 mg to approximately 185 mg of modified-release polymer per dosage unit (e.g., per tablet); (i) a soluble diluent, optionally from approximately 6% by weight to approximately 10% by weight of soluble diluent, optionally from approximately 34 mg to approximately 38 mg of soluble diluent per dosage unit (e.g., per tablet); (iii) a glide, optionally from approximately 1% by weight to approximately 3% by weight of glide, optionally from approximately 6 mg to approximately 8 mg of glide per dosage unit (e.g., per tablet); (iv) a lubricant, optionally from approximately 0.5% by weight to approximately 2% by weight of lubricant, optionally from approximately 3 mg to approximately 6 mg of lubricant per dosage unit (e.g., per tablet);and (v) a coating, optionally of about 12% by weight to about 15% by weight of coating, optionally of about 1 mg to about 5 mg of coating per dosage unit (e.g., per tablet).

[0080] In some embodiments, the single unit dosage form comprises: (i) large tablet prototype 01 (58% K4M Round) (DC); (ii) large tablet prototype 01 (58% K4M (Drágea) (DC); (iii) prototype of large tablet 04 (58% K4M) (DG); (iv) prototype of large tablet 23 (50% K4M); (v) prototype of large tablet 28 (58% K100LV); (vi) prototype of large tablet 34 (50% K100LV, 8% Mannitol EG); (vii) prototype of large tablet 36 (50% K100LV, 8% Mannitol IG); (viii) prototype of large tablet 52 (28% K100LV, 30% E50LV); (ix) prototype of large tablet 53 (40% K100LV, 8% Mannitol IG); or (x) prototype of large tablet 54 (46% K100LV, 12% Mannitol IG). In some embodiments, the single-unit dosage form comprises: (i) prototype large tablet 04 (58% K4M) (DG); (ii) prototype large tablet 28 (58% K100LV); or (iii) prototype tablet Petition 870250101458, dated 05 / 11 / 2025, page 37 / 254 32 / 211 large 53 (40% K100LV, 8% Mannitol IG).

[0081] In one aspect, the present invention provides a pharmaceutical composition comprising the single-unit dosage form of any of the preceding claims and at least one pharmaceutically acceptable vehicle or excipient.

[0082] In one aspect, the present invention provides a method for treating a disease or condition related to aberrant function or activity of a T-type calcium channel in an individual in need, comprising administering to the individual a therapeutically effective amount of the single-unit dosage or pharmaceutical composition described in this document.

[0083] In one aspect, the present invention provides a method of treating a tremor in an individual in need, comprising administering to the individual a therapeutically effective amount of the single-unit dosage or pharmaceutical composition described in this document.

[0084] In one aspect, the present invention provides a method of treating an essential tremor in an individual in need, comprising administering to the individual a therapeutically effective amount of the single-unit dosage or pharmaceutical composition described in this document.

[0085] In some modalities, the method results in a reduction of essential tremor as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) score. In some modalities, the reduction of essential tremor is assessed by the upper limb score of The Essential Tremor Rating Assessment Scale (TETRAS). In some modalities, the reduction of essential tremor is assessed by TETRAS-ADL (activities of daily living). In some modalities, the reduction of essential tremor is assessed by the TETRAS performance subscale score or individual items of Petition 870250101458, dated 05 / 11 / 2025, page 38 / 254 33 / 211 performance TETRAS. In some modalities, the method results in a reduction of essential tremor, as assessed by accelerometer-based upper limb scoring. In some modalities, the method results in a reduction of the sigma frequency band. In some modalities, essential tremor is upper limb tremor.

[0086] Other objects and advantages will become apparent to those skilled in the art based on consideration of the Brief Description of the Figures, Detailed Description, Examples, and subsequent Claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] FIG. 1 represents the composition and characteristics of the active pharmaceutical ingredient, PRAX-944 (also referred to in this document as PRAX-944 HCl).

[0088] FIG. 2A shows tablets of various shapes and sizes.

[0089] FIG. 2B represents a comparison between the currently available dosage form of PRAX-944, which is a modified-release (MR) formulation available as small (6 mm diameter) 5 mg and 20 mg round tablets, and an exemplary bioequivalent single-unit dosage form described in this document.

[0090] FIG. 3A describes the design of the PRAX-944-107 study. N = number of participants planned for the total population; n = number of participants planned per group. Fasting: each dose of the study drug will be taken with 240 mL of water after an overnight fast. No food or drink, except water, will be allowed for at least 10 hours before administration of the dose. Participants must remain fasting for 4 hours after the dose. Participants may not drink water for 2 hours before and for 1 hour after. Petition 870250101458, dated 05 / 11 / 2025, page 39 / 254 34 / 211 per dose. Post-prandial: Study drug co-administered with a high-fat, high-calorie meal.

[0091] FIG. 3B depicts the drugs under study administered in PRAX-944-107.

[0092] FIG. 3C depicts exemplary formulations of high-dose potency PRAX-944 tablets tested in study 944107.

[0093] FIG. 3D represents a schematic of an exemplary phase 3 clinical study design to evaluate the efficacy of large, single-dose unit tablets of PRAX-944 (20 mg, 40 mg, 80 mg and 120 mg) compared with the same dose levels delivered with small, round 20 mg tablets of PRAX-944 (1, 2, 4 and 6 tablets, respectively).

[0094] FIGS. 4A-4B represent in vitro (FIG. 4A) and in vivo (FIG. 4B) release profiles for the 20 mg potency modified-release (MR) tablet of PRAX-944 and immediate-release (IR) capsule. For improved tolerability, PRAX-944 is formulated as a modified-release (MR) tablet to extend drug release and absorption and therefore Cmax and prolong the plasma concentration-time profile compared to an immediate-release (IR) dosage form. As shown in FIG. 4A, approximately 100% of PRAX-944 is released within approximately 1 hour for the immediate-release (IR) dosage form; and approximately 80% of PRAX-944 is released within approximately 7 hours for the modified-release (MR) dosage form.

[0095] As shown in FIG. 4B, the IR formulation reached a Cmax (ng / mL) (CV%) of 131 (25.6) and an AUC (ng.hr / mL) (CV%) of 1090 (24.4); and the MR formulation achieved Cmax (ng / ml) (CV%) of 47.1 (34.3) and AUC (ng.hr / mL) (CV%) of 1010 (34.2).

[0096] FIG. 5A represents in vitro release profiles for protons Petition 870250101458, dated 05 / 11 / 2025, p. 40 / 254 35 / 211 types of large PRAX-944 tablets (i.e., prototype large tablet 01 (58% K4M Round) (DC), prototype large tablet 01 (58% K4M dragee) (DC), prototype large tablet 04 (58% K4M) (DG), prototype large tablet 23 (50% K4M), prototype large tablet 28 (58% K100LV), prototype large tablet 34 (50% K100LV, 8% Mannitol EG), prototype large tablet 36 (50% K100LV, 8% Mannitol IG), prototype large tablet 52 (28% K100LV, 30% E50LV), prototype large tablet 53 (40% K100LV, 8% Mannitol IG), and prototype large tablet 54 (46% K100LV, 12% Mannitol IG)) compared to the reference tablet (i.e., 20 mg small, round clinical tablet). DC and DG designate direct compression and dry granulation, respectively.

[0097] FIG. 5B represents in vitro release profiles for large tablet prototypes of PRAX-944 (i.e., large tablet prototype 04, large tablet prototype 28 and large tablet prototype 53) compared with the reference tablet (i.e., small round clinical tablet of 20 mg).

[0098] FIG. 5C represents in vitro release profiles for PRAX-944 MR tablets (i.e., 20 mg large tablet, 40 mg large tablet, 80 mg large tablet and 120 mg large tablet) compared with the reference tablet (i.e., 20 mg small round clinical tablet).

[0099] FIGS. 6A-6B represent the relative bioavailability of large 120 mg tablets (test) compared with small round tablets (reference) by cross-analysis. By cross-analysis, both large and small round 120 mg tablets meet the bioequivalence criteria (90% CI within 80-125%) for AUCultima and Cmx (FIG. 6B). Outliers excluded Petition 870250101458, dated 05 / 11 / 2025, page 41 / 254 36 / 211 of the analysis.

[00100] FIG. 7 represents dose proportionality with small, round tablets or large tablets. Atypical participants excluded from the analysis.

[00101] FIGS. 8A-8B represent the lack of food effect with 120 mg of PRAX-944. Co-administration of the 120 mg large tablet with a high-fat, high-calorie meal results in a 3-hour delay in tmax and a slight increase in AUC and Cmax, but within the no-effect range (90% CI 80-125%). Outliers excluded from the analysis.

[00102] FIGS. 9A-9C represent relative bioavailability by parallel analysis with small, round, or large tablets. Although the large tablets appear to have increased exposure compared to the small and round tablets, this is likely an artifact of the parallel study design. When the relative bioavailability of the 120 mg tablets is assessed by cross-analysis, the bioequivalence (BE) criteria are met, whereas when assessed by parallel analysis, the large tablet has greater exposure than the small and round tablets, by a magnitude similar to the tablets at lower strengths. Outliers excluded from the analysis.

[00103] FIG. 10A represents an exemplary scheme of a crossover bioequivalence study. DETAILED DESCRIPTION

[00104] The present invention provides compositions designed to provide a larger and more convenient dosage form of PRAX-944 compared to the currently available dosage form of PRAX-944, which is a modified-release (MR) formulation available as 5 mg and 20 mg tablets that are round and small in size (6 mm in diameter). For example, the compositions Petition 870250101458, dated 05 / 11 / 2025, page 42 / 254 37 / 211 pharmaceutical components of the present invention are designed to minimize the number of tablets required to deliver specific dose levels of PRAX-944 (FIG. 1) and to increase the physical size of the tablet and make it into a capsule form for easier comprehension and greater convenience, including more usability, for patients, especially those with essential tremor (ET). FIG. 2A shows tablets of various shapes and sizes, and FIG. 2B shows a comparison between the currently available dosage form of PRAX-944, which is a modified-release (MR) formulation available as 5 mg and 20 mg tablets that are round and small in size (6 mm in diameter), and an exemplary bioequivalent single-unit dosage form described in this document.Furthermore, the pharmaceutical compositions of the present invention comprising larger capsule-shaped tablets have substantially the same bioavailability, for example, with respect to the rate (maximum plasma drug concentration; Cmax) and extent (area under the plasma concentration-time curve; AUC) of absorption of PRAX-944 compared with various small, round 20 mg tablets. Definitions

[00105] In general, the effective amount of a compound refers to an amount sufficient to elicit the desired biological response. As will be appreciated by those skilled in the art, the effective amount of a compound may vary depending on factors such as the desired biological outcome, the pharmacokinetics of the compound, the disease being treated, the route of administration, and the age, weight, health, and condition of the individual. An effective amount encompasses both therapeutic and prophylactic treatment.

[00106] As used in this document, and unless otherwise specified, a therapeutically effective amount of a compound Petition 870250101458, dated 05 / 11 / 2025, page 43 / 254 38 / 211 is a sufficient amount to provide a therapeutic benefit in the treatment of a disease, disorder, or condition, or to slow, reduce, or eliminate one or more symptoms associated with the disease, disorder, or condition. A therapeutically effective amount of a compound means an amount of therapeutic agent, alone or in combination with other therapies, that provides a therapeutic benefit in the treatment of the disease, disorder, or condition. The term therapeutically effective amount may encompass an amount that improves overall therapy, reduces or prevents symptoms or causes of the disease or condition, or increases the therapeutic effectiveness of another therapeutic agent.

[00107] As used in this document, the term refractory refers to a disease, disorder, or condition that does not readily produce or respond to therapy or treatment, or that is not controlled by therapy or treatment. In some modalities, a disease, disorder, or condition described in this document is refractory (e.g., refractory epilepsy or refractory absence seizures or essential tremor that is refractory) and does not respond to standard therapy or treatment.

[00108] As used in this document, an individual to whom administration is contemplated includes, but is not limited to, human beings (i.e., a man or woman of any age range, for example, a pediatric individual (e.g., infant, child, adolescent) or an adult individual (e.g., young adult, middle-aged adult, or elderly adult)) and / or a non-human animal, for example, a mammal such as primates (e.g., cynomolgus monkeys, rhesus monkeys), cattle, pigs, horses, sheep, goats, rodents, cats, and / or dogs. In certain embodiments, the individual is a human. In certain embodiments, the individual is a non-human animal. In certain embodiments, the terms patient and individual are used interchangeably. Petition 870250101458, dated 05 / 11 / 2025, page 44 / 254 39 / 211 interchangeable in this document. In some modalities, individuals are selected for treatment with the compound of formula (I) due to a clinical diagnosis of essential tremor. In some modalities, individuals selected for treatment with the compound of formula (I) have essential tremor but do not exhibit intention tremor.

[00109] The terms disease, disorder, and condition are used interchangeably in this document.

[00110] As used in this document, and unless otherwise specified, the terms treat, treating, and treatment encompass an action that occurs while an individual suffers from the specified disease, disorder, or condition, that reduces the severity of the disease, disorder, or condition, or slows or diminishes the progression of the disease, disorder, or condition (therapeutic treatment), and also encompass an action that occurs before an individual begins to suffer from a disease, disorder, or condition (prophylactic treatment).

[00111] As used in this document, the term pharmaceutically acceptable salt refers to those salts which are, within the scope of good medical judgment, suitable for use in contact with the tissues of humans and lower animals without undue toxicity, irritation, allergic response and the like, and are proportionate to a reasonable risk / benefit ratio. Pharmaceutically acceptable salts are well known in the art; for example, Berge et al., describes pharmaceutically acceptable salts in detail in J. Pharmaceutical Sciences (1977) 66:1-19. Pharmaceutically acceptable salts of the compounds of this invention include those derived from suitable inorganic and organic acids and bases. Examples of non-toxic and pharmaceutically acceptable acid addition salts are salts of an amino group formed with inorganic acids, such as hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid and perchloric acid, or Petition 870250101458, dated 05 / 11 / 2025, page 45 / 25440 / 211 with organic acids, such as acetic acid, oxalic acid, maleic acid, tartaric acid, citric acid, succinic acid or malonic acid, or using other methods used in the technique, such as ion exchange. Other pharmaceutically acceptable salts include acetate, adipate, alginate, ascorbate, aspartate, benzenesulfonate, benzoate, besylate, bisulfate, borate, butyrate, camphorate, camphorsulfonate, citrate, cyclopentanepropionate, cyclamate, digluconate, dodecylsulfate, edisilate, ethanesulfonate, esilate, formate, fumarate, gentisate, glucoheptonate, glycerophosphate, gluconate, glucuronate, glutamate, glutarate, glycolate, hemisulfate, heptanoate, hexanoate, hippurate, iodide-hydroxy, 2-hydroxyethanesulfonate, isethionate, ketoglutarate, lactobionate, lactate, laurate, lauryl sulfate, malate, maleate, malonate, mesylate, methanesulfonate, napadisilate, napsylate, 2-naphthalenesulfonate, nicotinate, nitrate, oleate, oxalate, oroate, palmitate, pamoate, pectinate, persulfate,3-phenylpropionate, phosphate, picrate, pivalate, propionate, sebacate, stearate, succinate, sulfate, tartrate, thiocyanate, p-toluenesulfonate, undecanoate, valerate salts, stereoisomers thereof (e.g., enantiomers, diastereomers) and the like.

[00112] Other pharmaceutically acceptable salts include, where appropriate, non-toxic ammonium, quaternary ammonium, and amine cations formed using counter-ions, such as halide, hydroxide, carboxylate, sulfate, phosphate, nitrate, lower alkyl sulfonate, and aryl sulfonate. In certain embodiments, a compound of Formula (I) is a hydrochloric acid salt.

[00113] The term modified-release polymer or matrix polymer refers to a polymer that is used in a formulation (e.g., tablets and capsules) to modify the rate of drug release after administration to an individual. For example, a modified-release polymer is used to dissolve a drug over time in order to be released more slowly and more stably. Petition 870250101458, dated 05 / 11 / 2025, page 46 / 254 41 / 211 in the bloodstream. For example, a modified-release polymer is a controlled-release polymer. For example, a modified-release polymer or a controlled-release polymer is an HPMC polymer. In some embodiments, a modified-release polymer may include hydrophilic matrix polymers (e.g., hypromellose, HPMC (hydroxyl-propylmethylcellulose)), hydrophobic matrix polymers (e.g., ethyl cellulose, etocel), or polyacrylate polymers (e.g., Eudragit RL100, Eudragit RS100).

[00114] The term diluent or bulking agent, as used in this document, refers to an excipient used to increase the weight and improve the uniformity of the contents.For example, diluents include cellulose derivatives (e.g., microcrystalline cellulose), starches (e.g., hydrolyzed starches and partially pregelatinized starches), anhydrous lactose, lactose monohydrate, dicalcium phosphate (DCP), sugar alcohols (e.g., sorbitol, xylitol, and mannitol).

[00115] The term slip agent, as used in this document, refers to an excipient used to promote powder flow by reducing friction and cohesion between particles. For example, slip agents include fumed silica (e.g., colloidal silicon dioxide), talc, and magnesium carbonate.

[00116] The term lubricant, as used in this document, refers to an excipient used to prevent ingredients from clumping together and sticking to tablet punches or the capsule filling machine. Lubricants are also used to ensure that tablet formation and ejection can occur with low friction between the solid and the mold wall. For example, lubricants include magnesium stearate, calcium stearate, stearic acid, talc, silica, and fats (e.g., vegetable stearin).

[00117] The term coating, as used in this document, Petition 870250101458, dated 05 / 11 / 2025, page 47 / 254 42 / 211 refers to an excipient to protect the tablet ingredients from deterioration by moisture in the air and to make large or unpleasant tablets easier to swallow. For example, coatings may include Opadry® II White 85F18422, which is composed of compendial grade polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, and talc.

[00118] The term bioavailability refers to the extent to which an active portion (e.g., a drug and / or a metabolite) is absorbed into the general circulation and becomes available at the drug's site of action in the body.

[00119] The term bioequivalence or bioequivalent means that two pharmaceutical products do not differ significantly when the two products are administered at the same dose under similar conditions. A product (e.g., a single-unit dosage form or a pharmaceutical composition, as described in this document) may be considered bioequivalent to a second product (e.g., a reference composition) if there is no significant difference in the rate and extent to which the active ingredient or active moiety becomes available at the drug's site of action when the product is administered at the same molar dose as the second product under similar conditions in a suitably designed study.Two products with different absorption rates may be considered equivalent if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and reflected in the proposed labeling, is not essential for achieving effective body drug concentrations in chronic use, and is considered clinically insignificant for the drug. In some embodiments, bioequivalence may be based on no more than a difference of about 20% between the AUC and Cmax of one product versus a second product. In some embodiments, bioequivalence... Petition 870250101458, dated 05 / 11 / 2025, page 48 / 254 43 / 211 The validity may be based on no more than about 0.5%, about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, about 4.5%, about 5%, about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%, about 10.5%, about 11%, about 11.5%, about 12%, about 12.5%, about 13%, about 13.5%, about 14%, about 14.5%, about 15%, about 15.5%, approximately 16%, approximately 16.5%, approximately 17%, approximately 17.5%, approximately 18%, approximately 18.5%, approximately 19%, approximately 19.5%, or approximately 20% difference between the AUC and Cmax of one product versus a second product.

[00120] In some embodiments, bioequivalence can be assumed when, for example, the 90% confidence interval varies between about 80% and about 125% (for example, about 80%, about 81%, about 82%, about 83%, about 84%, about 85%, about 86%, about 87%, about 88%, about 89%, about 90%, about 91%, about 92%, about 93%, about 94%, close to 95%, close to 96%, close to 97%, close to 98%, close to 99%, close to 100%, close to 101%, close to 102%, close to 103%, close to 104%, close to 105%, close to 106%, close 107%, close to 108%, close to 109%, close to 110%, close 111%, close to 112%, close to 113%, close to 114%, close 115%, close to 116%, close to 117%, close to 118%, close 119%, close to 120%, close to 121%, close to 122%, close 123%, approximately 124%, or approximately 125%) for the target parameters (e.g., Cmax and AUC). In some embodiments, the 90% confidence interval for AUC and / or Cmax may be contained within tighter confidence limits, for example, approximately 90% to approximately 120%, approximately 90% to approximately 115%, approximately 90% to approximately 110%, or approximately 90% to approximately 100%. In some embodiments Petition 870250101458, dated 05 / 11 / 2025, p. 49 / 254 44 / 211 des, bioequivalence can be determined based on steady-state studies and / or single-dose studies. In some modalities, bioequivalence studies can be conducted in fasting and / or postprandial states.

[00121] In certain embodiments, the compositions described in this document are bioequivalent to currently available oral dosage forms, such as the current dosage form of PRAX-944 which is a modified-release (MR) formulation available as 5 mg and 20 mg tablets that are round and small in size (e.g., about 6 mm in diameter).

[00122] Consequently, a test composition, such as a single-unit dosage form or a pharmaceutical composition, as described in this document, can be said to be bioequivalent to a reference composition if the 90% confidence interval of the mean value for the area under the curve (AUC) (AUCt or AUCinf) of plasma blood levels of the test composition is within about 80% to about 125% (e.g., about 80%, about 81%, about 82%, about 83%, about 84%, about 85%, about 86%, about 87%, about 88%, about 89%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, about 100%, about 101%, about 102%, about 103%, about 104%, about 105%, about 106%, about 107%, about 108%, about 109%, about 110%, about 111%, approximately 115%, approximately 119%, approximately 112%, approximately 113%, 116%, approximately 117%, 120%, approximately 121%, approximately 114%, approximately approximately 118%, approximately approximately 122%, approximately 123%, approximately 124%, or approximately 125% of the corresponding mean value of the reference composition, and if the 90% confidence interval of the mean value for the maximum concentration (Cmax) of the levels Petition 870250101458, dated 05 / 11 / 2025, page 50 / 254 45 / 211 plasma composition of the test is within approximately 80% to approximately 125% (e.g., approximately 80%, approximately 81%, approximately 82%, approximately 83%, approximately 84%, approximately 85%, approximately 86%, approximately 87%, approximately 88%, approximately 89%, approximately 90%, approximately 91%, approximately 92%, approximately 93%, approximately 94%, approximately 95%, approximately 96%, approximately 97%, approximately 98%, approximately 99%, approximately 100%, approximately 104%, approximately 108%, approximately 112%, approximately 116%, approximately 120%, approximately 101%, approximately 105%, approximately 109%, approximately 113%, approximately 117%, approximately 121%, approximately 102%, approximately 106%, approximately 110%, approximately 114%, approximately 118%, approximately 122%, approximately 103%, approximately 107%, approximately 111%, approximately 115%, approximately 119%, approximately 123%, approximately 124%, or approximately 125%) of the corresponding average value of the reference composition. In some embodiments, the reference composition comprises the pharmaceutical product PRAX-944 supplied as 5 mg and 20 mg white, round MR film-coated tablets. Each reference tablet may contain PRAX-944 HCl DS equivalent to 5 mg or 20 mg of PRAX-944 free base and, optionally, the following inactive ingredients: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate, triacetin, titanium dioxide and talc.

[00123] The terms dose potency and dose level are used interchangeably in this document and may refer to the amount of an active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), measured in concentration units. In certain embodiments, the terms dose potency and dose level may refer to the amount of the active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula Petition 870250101458, dated 05 / 11 / 2025, p. 51 / 254 46 / 211 (II), for example, PRAX-944 HCl), as a free base and not to the amount of salts or derivatives of the active agent that is included in the compositions, formulations and dosage forms described in this document.

[00124] The terms dosage form and dosage unit are used interchangeably in this document and may refer to the physical form of a dose of an active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), intended for administration or consumption. In some embodiments, the dosage form comprises a physically discrete unit suitable for dosing an individual, for example, each unit containing a predetermined amount and / or dose strength of an active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), calculated to produce a desired therapeutic effect alone or in combination with one or more additional dosage units.The route of administration (ROA) for the delivery of an active agent may depend, for example, on the dosage form of the active agent. In certain embodiments, the compositions, formulations, and dosage forms described in this document may be formulated and intended for oral administration to an individual. In some embodiments, the compositions, formulations, and dosage forms described in this document, when formulated and intended for oral administration to an individual, may include capsules, tablets, pills, powders, lozenges, aqueous or oily suspensions, granules, emulsions, syrups, elixirs, and the like. In such dosage forms, the active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), may be mixed with an excipient or vehicle. Petition 870250101458, dated 05 / 11 / 2025, page 52 / 254 47 / 211 pharmaceutically acceptable.

[00125] The terms single unit dosage and single unit dosage form are used interchangeably in this document and may refer to compositions and formulations comprising an active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), comprising a discrete dosage unit, for example, a tablet. In some embodiments, the dosage forms, for example, single unit dosage forms, described in this document are bioequivalent to currently available PRAX-944 dosage forms, for example, comprising a modified-release (MR) formulation available as 5 mg and 20 mg round tablets with a small size (approximately 6 mm in diameter).

[00126] The terms multi-unit dosage and multi-unit dosage form are used interchangeably in this document and may refer to compositions and formulations comprising an active agent, for example, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), comprising a plurality of dosage units, for example, a plurality of tablets. In some embodiments, the currently available dosage forms of PRAX-944 comprise multiple unit dosage forms, for example, comprising a modified-release (MR) formulation available as 5 mg and 20 mg round tablets with a small size (approximately 6 mm in diameter). Petition 870250101458, dated 05 / 11 / 2025, page 53 / 254 48 / 211 Table 1. Abbreviations Term or abbreviation Definition ABC adenosine triphosphate-binding cassette ADLs activities of daily living AE adverse event AESI adverse event of special interest ALT alanine aminotransferase AST aspartate aminotransferase AIVR accelerated idioventricular rhythm APD duration of action potential AUC area under the concentration-time curve AUC- area under the plasma concentration-time curve from time zero to infinity AUCultima area under the curve up to the last measurable concentration AUCt area under the plasma concentration-time curve during a dosing interval BCRP breast cancer resistance protein BDC cannulated bile duct BID twice daily BLQ below the lower limit of quantification BMI body mass index bpm beats per minute BUN blood urea nitrogen Cmax maximum plasma drug concentration CRF case report form Petition 870250101458, dated 05 / 11 / 2025, page 54 / 254 49 / 211 C-SSRS Columbia Suicide Severity Rating Scale Ca2+ calcium ion CaV voltage-dependent calcium channels CaV1.2 L-type voltage-dependent calcium channel, alpha 1C subunit CaV2.2 N-type voltage-dependent calcium channel, alpha 1B subunit CaV3.1 L-type voltage-dependent calcium channel, alpha 1G subunit CaV3.2 L-type voltage-dependent calcium channel, alpha 1H subunit CaV3.3 L-type voltage-dependent calcium channel, alpha 1I subunit CD-1 cluster of differentiation 1 Cmax maximum plasma drug concentration (peak) CNS central nervous system CPN progressive chronic nephropathy CTC cerebellum-thalamus-cortical CV% coefficient of variation CYP cytochrome P450 CYP1A2 cytochrome P450 1A2 CYP2B6 cytochrome P450 2B6 CYP2C8 cytochrome P450 2C8 CYP2C9 cytochrome P450 2C9 CYP2C19 cytochrome P450 2C19 CYP2D6 cytochrome P450 2D6 CYP3A4 cytochrome P450 3A4 Petition 870250101458, dated 05 / 11 / 2025, page 55 / 254 50 / 211 DBS deep brain stimulation DMSO dimethyl sulfoxide DRG dorsal root ganglion DS pharmacological substance ECG electrocardiogram EOS End of study EOT End of treatment EEG electroencephalogram ET essential tremor FDA Food and Drug Administration FSH follicle-stimulating hormone FOB functional observation battery GCP Good Clinical Practice GI gastrointestinal GLP Good Laboratory Practice HBsAg hepatitis B surface antigen hCaV human L-type voltage-dependent calcium channel hCaV3.1 human L-type voltage-dependent calcium channel, alpha 1G subunit hCaV3.2 human L-type voltage-dependent calcium channel, alpha 1H subunit hCaV3.3 human L-type voltage-dependent calcium channel, alpha 1I subunit HCl hydrochloride hERG human ether-a-go-go IB Investigator's Brochure IC50 half the maximum inhibitory concentration Intestine intestinal luminal concentration Petition 870250101458, dated 05 / 11 / 2025, page 56 / 254 51 / 211 Intraperitoneal IP (IP) Immediate-release IR (IR) Intravenous IV (IV) KIM-1 Kidney Injury Molecule-1 (KIM-1) MATE Multidrug and Toxin Extrusion Protein 1 (MDR1) Multidrug Resistance Protein 1 (MDS) International Parkinson and Movement Disorders Society (MDS) Modified-release mRNA Messenger Ribonucleic Acid (MR) MTD Maximum Tolerated Dose (MTD) NaV Voltage-Dependent Sodium Channel (NaV1.5) Sodium Channel Protein Type 5 Alpha Subunit (NOAEL) No Observed Adverse Effect Level (NREM) Non-Rapid Eye Movement (NSVT) Non-Sustained Ventricular Tachycardia (NSVT) Organic Anion Transporter (OAT) Organic Anion Transporting Polypeptides (OATP) Organic Anion Transporting Polypeptides (OCT) Organic Cation Transporter (PBPK) Physiologically Based Pharmacokinetics (P-gp) P-Glycoprotein (PD) Parkinson's Disease (PK) Pharmacokinetics (PO) Oral Administration (PS) Performance Subscale (PSG) Polysomnography Petition 870250101458, dated 05 / 11 / 2025, page 57 / 254 52 / 211 QD once daily QID four times daily RBD REM sleep behavior disorder rCaV rat N-type voltage-dependent calcium channel rCaV1.2 rat N-type voltage-dependent calcium channel, alpha 1C subunit rCaV2.2 rat N-type voltage-dependent calcium channel, alpha 1B subunit rCYP recombinant CYP REM rapid eye movement SAE serious adverse event SLC vehicle solute sLMA spontaneous locomotor activity SNc substantia nigra pars compacta STN subthalamic nucleus tV elimination half-life TEAE treatment-emergent adverse event TETRAS Essential Tremor Assessment Scale TETRAS-PS TETRAS performance subscale TETRAS-UL Upper limb TETRAS TK toxicokinetics tmax time to peak plasma concentration after drug administration USA United States Dosage forms of PRAX-944 and modified-release compositions

[00127] PRAX-944 (FIG. 1) is a selective, state-dependent inhibitor of T-type calcium channels (Ca2+). The family of channels Petition 870250101458, dated 05 / 11 / 2025, page 58 / 254 53 / 211 T-type calcium channels are composed of three different isoforms, CaV3.1, CaV3.2, and CaV3.3, which are widely but differentially expressed in the thalmocortical and cerebellar circuits, critical pathways implicated in the development of, for example, essential tremor (ET). PRAX-944 is being developed for the treatment of various diseases or conditions related to aberrant function or activity of a T-type calcium channel, including, for example, essential tremor (ET). For evaluation in clinical studies, PRAX-944 is currently produced as 5 mg and 20 mg modified-release (MR) film-coated tablets and a corresponding placebo for once-daily (QD) oral administration. The MR mechanism is achieved through the inclusion of a hydrophilic polymer that hydrates and gels in an aqueous medium to form a matrix that controls the release of the pharmacological substance (DS) from the tablet.Each active tablet contains, for example, PRAX-944 hydrochloride (HCl) DS equivalent to 5 mg or 20 mg of PRAX-944 free base and the following inactive ingredients: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate, triacetin, titanium dioxide, and talc. PRAX-944 was previously produced as immediate-release (IR) tablets, as described, for example, in the first clinical study, Z944-B01. The current 5 mg and 20 mg MR formulations were developed following the observation in the first clinical study, Z944-B01, that the central nervous system (CNS) and psychiatric adverse events (AEs) observed with a single daily dose of the IR formulation could be reduced by dividing it into multiple administrations over several hours, as described, for example, in the clinical study, Z944104, evaluating the safety and tolerability of the PRAX944 MR7 formulation.

[00128] The PRAX-944 MR7 formulation currently being used in clinical studies was designed to release 80% of the active drug in Petition 870250101458, dated 05 / 11 / 2025, page 59 / 254 54 / 211 solution in vitro after 7 hours. This formulation was selected for further development after comparing the formulation with other MR formulations with faster dissolution. In general, previously studied MR formulations, produced as 5 mg and 20 mg MR, film-coated tablets, blinded Cmax and tmax, are slower compared to the IR formulation, but have minimal effects on AUC. Furthermore, the frequency of CNS, psychiatric, and general adverse events is reduced with MR formulations, with greater reductions in AE frequency corresponding to the reduction in Cmax, resulting in the selection of the MR7 formulation for ongoing clinical studies. Additionally, titration has been shown to improve the tolerability profile of PRAX-944 MR7. However, during clinical studies, certain challenges associated with the use of currently available PRAX-944 MR formulations (i.e., placebo tablets, 5 mg and 20 mg MR) were identified.For example, for clinically blinded purposes, different dose potencies of PRAX-944 are provided in multiple tablet combinations (e.g., including one or more placebo tablets, 5 mg and 20 mg) packaged in blisters. Handling small, round tablets, blister packs, and multiple pills has been found to be particularly challenging for patients struggling with movement disorders such as essential tremor (ET). As such, there is a need to develop new, larger-sized, high-dose-potency single-unit tablets with a suitable shape to improve patient comfort and convenience and reduce or eliminate the chances of dosing errors.

[00129] Consequently, in one aspect, the present invention provides compositions, including single-unit dosage forms, comprising a compound of Formula (I): Petition 870250101458, dated 05 / 11 / 2025, page 60 / 254 55 / 211 or a pharmaceutically acceptable salt thereof.

[00130] In some embodiments, the compound is the HCl salt of the compound of Formula (I), represented below as Formula (II):

[00131] In some embodiments, the compound is the acetate salt, adipate salt, alginate salt, ascorbate salt, aspartate salt, besylate salt, benzoate salt, citrate salt, cyclamate salt, edisylate salt, esylate salt, isethionate salt, fumarate salt, gentisate salt, gluconate salt, glucuronate salt, glutamate salt, glutarate salt, ketoglutarate salt, glycolate salt, hippurate salt, lactobionate salt, maleate salt, malate salt, malonate salt, mesylate salt, napadisylate salt, napsylate salt, oleate salt, oroate salt, oxalate salt, pamoate salt, phosphate salt, sebacate salt, succinate salt, or tartrate salt of the compound of Formula (I).

[00132] A compound of Formula (I) is described, for example, in PCT Publication WO2009 / 146540, incorporated by reference herein. Crystalline salts of a compound of Formula (I) are described, for example, in PCT Publication WO2021 / 007487, incorporated by reference herein. Deuterated analogues of a compound of Formula (I) are described, for example, in PCT Publication WO2022 / 099207, incorporated by reference herein. The safety, efficacy, tolerability and pharmacokinetic profile of a compound of Formula (I) in modified-release formulations with and without titration were evaluated, as described in PCT Publication Petition 870250101458, dated 05 / 11 / 2025, page 61 / 254 56 / 211 WO2021 / 222342, incorporated by reference in this document.

[00133] In some embodiments, the compound of formula (I) is in a crystalline form. In certain embodiments, the crystalline form is a previously or contemporaneously described crystalline form, such as Crystalline Pattern B, Crystalline Pattern C, or Crystalline Pattern D. Crystalline Pattern B and Crystalline Pattern C are described, for example, in WO 2021 / 007487, the full content of which is incorporated herein by reference. Crystalline Pattern D is characterized by an X-ray powder diffraction pattern (XRPD) comprising at least one peak at the diffraction angle (o 2θ) selected from the group consisting of: a peak at approximately 12.0°; a peak at approximately 15.6°; a peak at approximately 16.7°; a peak at approximately 19.8°; a peak at approximately 21.2°; a peak at approximately 24.1°; a peak at approximately 25.2°; a peak at approximately 27.3°; and a peak at approximately 30.2°.

[00134] In some embodiments, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) is PRAX-944 HCl hydrochloride (N-((1-(2-( tert-butylamino)-2-oxoethyl)piperidin-4-yl)methyl)-3-chloro-5-fluorobenzamide).

[00135] In some embodiments, the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), may be in a dosage form, such as a single-unit dosage form or in a pharmaceutical composition.

[00136] In one aspect, the present invention provides compositions, Petition 870250101458, dated 05 / 11 / 2025, p. 62 / 254 57 / 211 including single unit dosage forms, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl).

[00137] In one aspect, the present invention provides modified-release dosage forms, including single-unit dosage forms, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl).

[00138] In one aspect, the present invention provides compositions, including single-unit dosage forms, comprising: the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl), wherein the composition is bioequivalent to a reference composition of the same dosage potency administered as multiple small, round 20 mg tablets of PRAX-944. In some embodiments, the compositions exhibit bioequivalence after administration to a human subject, for example, in a fed and / or fasting state, compared with administration of a reference composition of the same dosage potency administered as multiple small, round 20 mg tablets of PRAX-944 to a human subject, for example, in a fed and / or fasting state.In some modalities, bioequivalence is established by: (i) a 90% confidence interval for AUC that is between approximately 80% and approximately 125% (e.g., approximately 80%, approximately 81%, approximately 82%, approximately 83%, approximately 84%, approximately 85%, approximately 86%, approximately 87%, approximately 88%, approximately 89%, approximately 90%, approximately 91%, approximately 92%, approximately 93%, approximately 94%, approximately 95%, approximately 96%, approximately 97%, approximately 98%, approximately 99%, approximately 100%,). Petition 870250101458, dated 05 / 11 / 2025, page 63 / 254 58 / 211 about 101%, about 102%, about 103%, about 104%, about 105%, about 106%, about 107%, about 108%, about 109%, approximately 113%, approximately 117%, approximately 110%, approximately 114%, approximately 118%, approximately 111%, approximately 115%, approximately 119%, approximately 112%, approximately 116%, approximately 120%, approximately 121%, about 122%, about 123%, about 124%, or about (ii) a 90% confidence interval for Cmax, which is between approximately 80% and approximately 125% (for example, approximately 80%, approximately 81%, approximately 82%, approximately 83%, approximately 84%, approximately 85%, approximately 86%, approximately 87%, approximately 88%, approximately 89%, approximately 90%, approximately 91%, approximately 92%, approximately 93%, approximately 94%, approximately 95%, approximately 96%, approximately 97%, approximately 98%, approximately 99%, approximately 100%, approximately 101%, approximately 102%, approximately 103%, approximately 104%, approximately 105%, approximately 106%, close 107%, close to 108%, close to 109%, close to 110%, close 111%, close to 112%, close to 113%, close to 114%, close 115%, close to 116%, close to 117%, close to 118%, close 119%, close to 120%, close to 121%, close to 122%, close 123%, approximately 124%, or approximately 125%). In some embodiments, the 90% confidence interval for AUC and / or Cmax may be contained within tighter confidence limits, for example, approximately 90% to approximately 120%, approximately 90% to approximately 115%, approximately 90% to approximately 110%, or approximately 90% to approximately 100%.

[00139] Certain embodiments of the present invention provide larger single-unit dose strength MR tablets (e.g., about 15 mm in length and about 6.5 mm in width) that are bioequivalent to smaller, round 20 mg tablets, for example, at each of the dose levels used in the current titration regimen: 20 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg.

[00140] In some modalities, at least around 50% (per Petition 870250101458, dated 05 / 11 / 2025, p. 64 / 254 59 / 211 example, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100%) of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within a predetermined time period after administration to an individual. In certain embodiments, the predetermined period of time may range from about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours, about 11 hours, or about 12 hours).

[00141] In some embodiments, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 1 hour to about 12 hours (e.g., about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, approximately 7 hours, approximately 8 hours, approximately 9 hours, approximately 10 hours, approximately 11 hours, or approximately 12 hours) after administration to an individual.In some embodiments, approximately 5% to approximately 25% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) is released within approximately 1 to approximately 2 hours after administration to an individual. In some embodiments, approximately 25% to approximately... Petition 870250101458, dated 05 / 11 / 2025, p. 65 / 254 60 / 211 50% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 2 to about 4 hours after administration to an individual. In some embodiments, about 50% to about 75% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 3 to about 7 hours after administration to an individual. In some embodiments, about 75% to about 100% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 6 to about 10 hours after administration to an individual.In some embodiments, approximately 80% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) is released within approximately 7 hours after administration to an individual. In some embodiments, approximately 90% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) is released within approximately 9 hours after administration to an individual.

[00142] In some embodiments, the dosage form comprises from about 1 mg to about 200 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) (for example, from about 1 mg to about 5 mg, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about Petition 870250101458, dated 05 / 11 / 2025, p. 66 / 254 61 / 211 from 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about 60 mg to about 65 mg, from about 65 mg to about 70 mg, from about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about 85 mg, from about 85 mg to about 90 mg, from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about 110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg, from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, from about 135 mg to about 140 mg, from about 140 mg to about 145 mg, from about 145 mg to about 150 mg, from about 150 mg to about 155 mg, from about 155 mg to about 160 mg, from about 160 mg to about 165 mg, from about 165 mg to about 170 mg, from about 170 mg to about 175 mg,from about 175 mg to about 180 mg, from about 180 mg to about 185 mg, from about 185 mg to about 190 mg, from about 190 mg to about 195 mg, or from about 195 mg to about 200 mg).

[00143] In some embodiments, the dosage form comprises from about 1 mg to about 200 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) (for example, 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 Petition 870250101458, dated 05 / 11 / 2025, page 67 / 254 62 / 211 of 160 mg, about 165 mg, about 170 mg, about 175 mg, about 180 mg, about 185 mg, about 190 mg, about 195 mg, or about 200 mg).

[00144] In some embodiments, the compositions, formulations and dosage forms comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) described in this document have a dose potency ranging from about 1 mg to about 200 mg (for example, from about 1 mg to about 5 mg, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about 60 mg to about 65 mg, from about 65 mg to about 70 mg, from about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about 85 mg, from about 85 mg to about 90 mg,from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about 110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg, from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, from about 135 mg to about 140 mg, from about 140 mg to about 145 mg, from about 145 mg to about 150 mg, from about 150 mg to about 155 mg, from about 155 mg to about 160 mg, from about 160 mg to about 165 mg, from about 165 mg to about 170 mg, from about 170 mg to about 175 mg, from about 175 mg to about 180 mg, from about 180 mg to about 185 mg, from about 185 mg to about 190 mg, from about 190 mg to about, Petition 870250101458, dated 05 / 11 / 2025, page 68 / 254 63 / 211 195 mg or from about 195 mg to about 200 mg).

[00145] In some embodiments, the compositions, formulations, and dosage forms comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) described in this document have a dose potency ranging from about 1 mg to about 200 mg (e.g., 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, or about 200 mg).

[00146] In some embodiments, the compositions, formulations, and dosage forms described in this document comprise an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) equivalent to about 1 mg to about 200 mg (for example, 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 Petition 870250101458, dated 05 / 11 / 2025, page 69 / 254 64 / 211 of 155 mg, approximately 160 mg, approximately 165 mg, approximately 170 mg, approximately 175 mg, approximately 180 mg, approximately 185 mg, approximately 190 mg, approximately 195 mg, or approximately 200 mg) of PRAX-944 free base per dosage unit (e.g., per tablet).

[00147] In some embodiments, the single-unit dosage form comprises the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 1.0 mg to about 200 mg (e.g., 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). 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,or approximately 200 mg) of PRAX-944 free base per dosage unit (e.g., per tablet). In some embodiments, the single-unit dosage form comprises from about 1% by weight to about 50% (e.g., about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45% or about 50%) by weight of PRAX-944 HCl, optionally wherein the total dosage unit weight (e.g., tablet) is from about 50 mg to about 500 mg (e.g., 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 160 mg, Petition 870250101458, dated 05 / 11 / 2025, page 70 / 254 65 / 211 mg, approximately 170 mg, approximately 180 mg, approximately 190 mg, approximately 200 mg, approximately 210 mg, approximately 220 mg, approximately 230 mg, approximately 240 mg, approximately 250 mg, approximately 260 mg, approximately 270 mg, approximately 280 mg, approximately 290 mg, approximately 300 mg, approximately 310 mg, approximately 320 mg, approximately 330 mg, approximately 340 mg, approximately 350 mg, approximately 360 mg, approximately 370 mg, approximately 380 mg, approximately 390 mg, approximately 400 mg, approximately 410 mg, approximately 420 mg, approximately 430 mg, approximately 440 mg, approximately 450 mg, approximately 460 mg, approximately 470 mg, approximately 480 mg, approximately 490 mg or approximately 500 mg).

[00148] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 5 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 1 mg to about 10 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00149] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 10 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 5 mg to about 15 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00150] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 Petition 870250101458, dated 05 / 11 / 2025, p. 71 / 254 66 / 211 (HCl) in an amount equivalent to approximately 15 mg of PRAX-944 free base per dosage unit (e.g., per tablet), optionally from approximately 10 mg to approximately 20 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[00151] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 20 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 15 mg to about 25 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00152] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 25 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 20 mg to about 30 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00153] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 30 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 25 mg to about 35 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00154] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the com Petition 870250101458, dated 05 / 11 / 2025, p. 72 / 254 67 / 211 of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 35 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 30 mg to about 40 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00155] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 40 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 35 mg to about 45 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00156] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 45 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 40 mg to about 50 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00157] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 50 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 45 mg to about 55 mg of PRAX-944 HCl per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, p. 73 / 254 68 / 211

[00158] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 55 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 50 mg to about 60 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00159] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 60 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 55 mg to about 65 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00160] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 65 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 60 mg to about 70 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00161] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 70 mg of free base of PRAX-944 per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, p. 74 / 254 69 / 211), optionally from about 65 mg to about 75 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[00162] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 75 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 70 mg to about 80 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00163] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 80 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 75 mg to about 85 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00164] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 85 mg of free base of PRAX-944 per dosage unit (for example, per tablet), optionally from about 80 mg to about 90 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00165] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 Petition 870250101458, dated 05 / 11 / 2025, p. 75 / 254 70 / 211 (HCl) in an amount equivalent to approximately 90 mg of PRAX-944 free base per dosage unit (e.g., per tablet), optionally from approximately 85 mg to approximately 95 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[00166] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 95 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 90 mg to about 100 mg of PRAX944 HCl per dosage unit (for example, per tablet).

[00167] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 100 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 95 mg to about 105 mg of PRAX944 HCl per dosage unit (for example, per tablet).

[00168] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 105 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 100 mg to about 110 mg of PRAX944 HCl per dosage unit (for example, per tablet).

[00169] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the com Petition 870250101458, dated 05 / 11 / 2025, p. 76 / 254 71 / 211 of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 110 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 105 mg to about 115 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00170] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 115 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 110 mg to about 120 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00171] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 120 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 115 mg to about 125 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00172] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 125 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 120 mg to about 130 mg of PRAX-944 HCl per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, p. 77 / 254 72 / 211

[00173] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 130 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 125 mg to about 135 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00174] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 135 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 130 mg to about 140 mg of PRAX944 HCl per dosage unit (for example, per tablet).

[00175] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 140 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 135 mg to about 145 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00176] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 145 mg of PRAX-944 free base per dosage unit (for example, per tablet), Petition 870250101458, dated 05 / 11 / 2025, p. 78 / 254 73 / 211 optionally from about 140 mg to about 150 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

[00177] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 150 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 145 mg to about 155 mg of PRAX944 HCl per dosage unit (for example, per tablet).

[00178] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 155 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 150 mg to about 160 mg of PRAX944 HCl per dosage unit (for example, per tablet).

[00179] In some embodiments, the compositions, formulations and dosage forms described in this document comprise the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) in an amount equivalent to about 160 mg of PRAX-944 free base per dosage unit (for example, per tablet), optionally from about 155 mg to about 165 mg of PRAX-944 HCl per dosage unit (for example, per tablet).

[00180] In some embodiments, the dosage form comprises from about 1% by weight to about 70% by weight of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) Petition 870250101458, dated 05 / 11 / 2025, p. 79 / 254 74 / 211 (for example, from about 1% to about 5%, from about 5% to about 10%, from about 10% to about 15%, from about 15% to about 20%, from about 20% to about 25%, from about 25% to about 30%, from about 30% to about 35%, from about 35% to about 40%, from about 40% to about 45%, from about 45% to about 50%, from about 50% to about 55%, from about 55% to about 60%, from about 60% to about 65%, or from about 65% to about 70% by weight of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), e.g. PRAX-944 HCl).

[00181] In some embodiments, the dosage form comprises from about 1% by weight to about 70% by weight of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) (for example, about 5% by weight, about 10% by weight, about 15% by weight, about 20% by weight, about 25% by weight, about 30% by weight, about 35% by weight, about 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, about 60% by weight, about 65% by weight, about 70% by weight of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl).

[00182] Exemplary dosage forms comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) as an active agent are provided in Tables 616. Modified-release polymer

[00183] In some embodiments, the dosage form comprises a modified-release polymer. Petition 870250101458, dated 05 / 11 / 2025, page 80 / 254 75 / 211

[00184] In some embodiments, the modified-release polymer is used in a formulation (e.g., tablets and capsules) to modify the release rate of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) after administration to an individual. In some embodiments, the modified-release polymer is used to dissolve the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) over time to be released more slowly, more steadily, or both more slowly and more steadily into the bloodstream.

[00185] In some embodiments, the modified-release polymer is a controlled-release polymer. In some embodiments, the modified-release polymer or the controlled-release polymer is a cellulose ether. In some embodiments, the modified-release polymer or a controlled-release polymer is an HPMC (hydroxypropyl methylcellulose). In some embodiments, the modified-release polymer or the controlled-release polymer is selected from the group consisting of METHOCEL® E50LV, K100LV, K100LV CR, K4M, K15M, K100M, E4M, E10M, K4MCR, K15MCR, K100MCR, E4MCR, E10MCR and their combinations. In some embodiments, the modified-release polymer or controlled-release polymer is HPMC K100 LV Premium CR. In some embodiments, the modified-release polymer or controlled-release polymer is an HPMC (hydroxypropylmethylcellulose) selected from the group consisting of Methocel K4M, Methocel K100LV, Methocel E50LV and their combinations. In some embodiments, the modified-release polymer may comprise a matrix polymer (e.g., a hydrophilic matrix polymer, a hydrophobic matrix polymer, a polyacrylate polymer and their combinations). Petition 870250101458, dated 05 / 11 / 2025, page 81 / 254 76 / 211 In some embodiments, the modified-release polymer comprises a hydrophilic matrix polymer (e.g., hypromellose, HPMC (hydroxypropyl methylcellulose)), a hydrophobic matrix polymer (e.g., ethyl cellulose, etocel), or a polyacrylate polymer (e.g., Eudragit RL100, Eudragit RS100). In some embodiments, the modified-release polymer is a hydrophilic matrix polymer. In some embodiments, the modified-release polymer is hypromellose. In some embodiments, the modified-release polymer is HPMC (hydroxypropyl methylcellulose). In some embodiments, the modified-release polymer is a hydrophobic matrix polymer. In some embodiments, the modified-release polymer is ethylcellulose. In some embodiments, the modified-release polymer is etocel. In some embodiments, the modified-release polymer is a polyacrylate polymer. In some embodiments, the modified-release polymer is Eudragit RL100.In some embodiments, the modified-release polymer is Eudragit RS100.

[00186] In some embodiments, the dosage form comprises from about 5 mg to 300 mg of a modified-release polymer (for example, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about 60 mg to about 65 mg, from about 65 mg to about 70 mg, from about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about 85 mg, from about 85 mg to about 90 mg, from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about of Petition 870250101458, dated 05 / 11 / 2025, page 82 / 254 77 / 211110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg, from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, from about 135 mg to about 140 mg, from about 140 mg to about 145 mg, from about 145 mg to about 150 mg, from about 150 mg to about 155 mg, from about 155 mg to about 160 mg, from about 160 mg to about 165 mg, from about 165 mg to about 170 mg, from about 170 mg to about 175 mg, from about 175 mg to about 180 mg, from about 180 mg to about 185 mg, from about 185 mg to about 190 mg, from about 190 mg to about 195 mg, from about 195 mg to about 200 mg, from about 200 mg to about 205 mg, from about 205 mg to about 210 mg, from about 210 mg to about 215 mg, from about 215 mg to about 220 mg, from about 220 mg to about 225 mg, from about 225 mg to about 230 mg, from about 230 mg to about 235 mg, from about 235 mg to about 240 mg,from about 240 mg to about 245 mg, from about 245 mg to about 250 mg, from about 250 mg to about 255 mg, from about 255 mg to about 260 mg, from about 260 mg to about 265 mg, from about 265 mg to about 270 mg, from about 270 mg to about 275 mg, from about 275 mg to about 280 mg, from about 280 mg to about 285 mg, from about 285 mg to about 290 mg, from about 290 mg to about 295 mg, or from about 295 mg to about 300 mg of a modified-release polymer).

[00187] In some embodiments, the dosage form comprises from about 5 mg to 300 mg of a modified-release polymer (for example, 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 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). Petition 870250101458, dated 05 / 11 / 2025, page 83 / 254 78 / 211 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 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, about 250 mg, approximately 255 mg, approximately 260 mg, approximately 265 mg, approximately 270 mg, approximately 275 mg, approximately 280 mg, approximately 285 mg, approximately 290 mg, approximately 295 mg, or approximately 300 mg of a modified-release polymer).

[00188] In some embodiments, the dosage form comprises from about 10% by weight to about 70% by weight of the modified-release polymer (for example, from about 10% to about 15%, from about 15% to about 20%, from about 20% to about 25%, from about 25% to about 30%, from about 30% to about 35%, from about 35% to about 40%, from about 40% to about 45%, from about 45% to about 50%, from about 50% to about 55%, from about 55% to about 60%, from about 60% to about 65%, or from about 65% to about 70% by weight of the modified-release polymer).

[00189] In some embodiments, the dosage form comprises from about 10% by weight to about 70% by weight of the modified-release polymer (for example, about 10% by weight, about 15% by weight, about 20% by weight, about 25% by weight, about 30% by weight, about 35% by weight, about 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, about 60% by weight, about 65% by weight or about 70% by weight of the modified-release polymer). Petition 870250101458, dated 05 / 11 / 2025, page 84 / 254 79 / 211

[00190] In some embodiments, a dosage form comprises from about 5 mg to about 300 mg of hypromelose (for example, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about 60 mg to about 65 mg, from about 65 mg to about 70 mg, about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about 85 mg, from about 85 mg to about 90 mg, from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about 110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg,from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, from about 135 mg to about 140 mg, from about 140 mg to about 145 mg, from about 145 mg to about 150 mg, from about 150 mg to about 155 mg, from about 155 mg to about 160 mg, from about 160 mg to about 165 mg, from about 165 mg to about 170 mg, from about 170 mg to about 175 mg, from about 175 mg to about 180 mg, from about 180 mg to about 185 mg, from about 185 mg to about 190 mg, from about 190 mg to about 195 mg, about 195 mg to about 200 mg, from about 200 mg to about 205 mg, from about 205 mg to about 210 mg, from about 210 mg to about 215 mg, from about 215 mg to about 220 mg, from about 220 mg to about 225 mg, from about 225 mg to about 230 mg, from about 230 mg to about 235 mg, from about 235 mg to about 240 mg, from about 240 mg to about 245 mg, from about 245 mg to about 250 mg, from about 250 mg to about 255 mg, of, Petition 870250101458, dated 05 / 11 / 2025, page. 85 / 254 80 / 211 approximately 255 mg to approximately 260 mg, approximately 260 mg to approximately 265 mg, approximately 265 mg to approximately 270 mg, approximately 270 mg to approximately 275 mg, approximately 275 mg to approximately 280 mg, approximately 280 mg to approximately 285 mg, approximately 285 mg to approximately 290 mg, approximately 290 mg to approximately 295 mg, or approximately 295 mg to approximately 300 mg of hypromellose).

[00191] In some embodiments, the dosage form comprises from about 5 mg to 300 mg of hypromellose (for example, about 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 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, about 250 mg, about 255 mg, about 260 mg, about 265 mg,about 270 mg, about 275 mg, about 280 mg, about 285 mg, about 290 mg, about 295 mg, or about 300 mg of hypromellose).

[00192] In some embodiments, the dosage form comprises from about 10% by weight to about 70% by weight of hypromellose (for example, from about 10% to about 15%, from about 15% to about 20%, from about 20% to about 25%, from about 25% to about 30%, from about 30% to about 35%, from about 35% to about 40%, from about 40% to about 45%, from about 45% to Petition 870250101458, dated 05 / 11 / 2025, page 86 / 254 81 / 211 about 50%, from about 50% to about 55%, from about 55% to about 60%, from about 60% to about 65%, or from 65% to about 70% by weight of hypromellose).

[00193] In some embodiments, the dosage form comprises from about 10% by weight to about 70% by weight of hypromellose (for example, about 10% by weight, about 15% by weight, about 20% by weight, about 25% by weight, about 30% by weight, about 35% by weight, about 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, about 60% by weight, about 65% by weight or about 70% by weight of hypromellose). Diluent

[00194] In some embodiments, the dosage form comprises a diluent.

[00195] In some embodiments, the dosage form comprises a soluble diluent.

[00196] In some embodiments, the diluent is used in a formulation (e.g., tablets and capsules) as a bulking agent.

[00197] In some embodiments, the term diluent includes an excipient, for example, used to increase weight and improve content uniformity. In some embodiments, the diluent may comprise a cellulose derivative (for example, a microcrystalline cellulose, for example, a silicified microcrystalline cellulose), a starch (for example, a hydrolyzed starch and partially a pregelatinized starch), an anhydrous lactose, a lactose monohydrate, a dicalcium phosphate (DCP), a sugar alcohol (for example, a sorbitol, a xylitol and mannitol) and combinations thereof.

[00198] In some embodiments, the diluent may comprise PEARLITOL® Mannitol.

[00199] In some embodiments, the diluent may comprise Petition 870250101458, dated 05 / 11 / 2025, page 87 / 254 82 / 211 mannitol, optionally in a grade selected from the group consisting of MQ, 100SD, 200SD, EZ, XL, M100, M200, 300DC, 400DC, 500DC, 2080, AG, GF, GS, GR and combinations thereof.

[00200] In some embodiments, the dosage form comprises from about 5 mg to about 300 mg of diluent (for example, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about 60 mg to about 65 mg, from about 65 mg to about 70 mg, from about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about 85 mg, from about 85 mg to about 90 mg, from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about 110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg,from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, from about 135 mg to about 140 mg, from about 140 mg to about 145 mg, from about 145 mg to about 150 mg, from about 150 mg to about 155 mg, from about 155 mg to about 160 mg, from about 160 mg to about 165 mg, from about 165 mg to about 170 mg, from about 170 mg to about 175 mg, from about 175 mg to about 180 mg, from about 180 mg to about 185 mg, from about 185 mg to about 190 mg, from about 190 mg to about 195 mg, from about 195 mg to about 200 mg, from about 200 mg to about 205 mg, from about 205 mg to about 210 mg, from about 210 mg to about 215 mg, from about 215 mg to about 220 mg, from about 220 mg to about 225 mg, from about 225 mg to about, Petition 870250101458, dated 05 / 11 / 2025, page 88 / 254 83 / 211 230 mg, from about 230 mg to about 235 mg, from about 235 mg to about 240 mg, from about 240 mg to about 245 mg, from about 245 mg to about 250 mg, from about 250 mg to about 255 mg, from about 255 mg to about 260 mg, from about 260 mg to about 265 mg, from about 265 mg to about 270 mg, from about 270 mg to about 275 mg, from about 275 mg to about 280 mg, from about 280 mg to about 285 mg, from about 285 mg to about 290 mg, from about 290 mg to about 295 mg, or from about 295 mg to about 300 mg of diluent).

[00201] In some embodiments, the dosage form comprises from about 5 mg to about 300 mg of diluent (for example, 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 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, about 250 mg, about 255 mg, about 260 mg,about 265 mg, about 270 mg, about 275 mg, about 280 mg, about 285 mg, about 290 mg, about 295 mg or about 300 mg of diluent).

[00202] In some embodiments, the dosage form comprises from about 5% by weight to about 50% by weight of diluent (for example, from about 5% to about 10%, from about 10% to about Petition 870250101458, dated 05 / 11 / 2025, page 89 / 254 84 / 211 15%, from about 15% to about 20%, from about 20% to about 25%, from about 25% to about 30%, from about 30% to about 35%, from about 35% to about 40%, from about 40% to about 45%, or from about 45% to about 50% by weight of diluent).

[00203] In some embodiments, the dosage form comprises from about 5% by weight to about 50% by weight of diluent (for example, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight, about 20% by weight, about 21% by weight, about 22% by weight, about 23% by weight, about 24% by weight, about 25% by weight, about 26% by weight, about 27% by weight, about 28% by weight, approximately 29% by weight, approximately 30% by weight, approximately 31% by weight, approximately 32% by weight, approximately 33% by weight, approximately 34% by weight, approximately 35% by weight, approximately 36% by weight, approximately 37% by weight, approximately 38% by weight, approximately 39% by weight, approximately 40% by weight, approximately 41% by weight, approximately 42% by weight, approximately 43% by weight,approximately 44% by weight, approximately 45% by weight, approximately 46% by weight, approximately 47% by weight, approximately 48% by weight, approximately 49% by weight, or approximately 50% by weight of diluent).

[00204] In some embodiments, the dosage form comprises microcrystalline cellulose (MCC), for example, silicified microcrystalline cellulose (SMCC). MCC and SMCC are commercially available under various trade names (e.g., AVICEL®; EMCOCEL®; MICROCEL®; COMPRECEL®; E460; COELUS KG®; PHARMACEL®; FIBROCEL® and PROSOLV®) and in different particle sizes, densities and moisture content. Petition 870250101458, dated 05 / 11 / 2025, page 90 / 254 85 / 211

[00205] In some embodiments, the dosage form may comprise a microcrystalline cellulose (MCC) selected from the group consisting of PH 101, PH 102, PH 103, PH 105, PH 112, PH 200, PH 113, PH 301, PH 302, PH 200LM and combinations thereof.

[00206] In some embodiments, the dosage form may comprise a silicified microcrystalline cellulose (SMCC) comprising a microcrystalline cellulose (MCC) and a colloidal silicon dioxide (CSD). In some embodiments, the silicified microcrystalline cellulose comprises from about 90% to about 99% (e.g., about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98% or about 99%) of microcrystalline cellulose (MCC) by weight and from about 1% to about 10% (e.g., 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9% or about 10%) of colloidal silicon dioxide (CSD) by weight. In some embodiments, the dosage form may comprise a PROSOLV® SMCC.In some embodiments, the dosage form may comprise a silicified microcrystalline cellulose (SMCC) selected from the group consisting of PROSOLV® SMCC 50, 50LD, 90, HD 90, 90 LM and combinations thereof.

[00207] In some embodiments, the dosage form may comprise a microcrystalline cellulose (MCC), for example, a silicified microcrystalline cellulose (SMCC), with a particle size of less than about 50 μm. In some embodiments, the dosage form may comprise a microcrystalline cellulose (MCC), for example, a silicified microcrystalline cellulose (SMCC), with a particle size greater than about 50 μm. In some embodiments, the dosage form may comprise a microcrystalline cellulose (MCC), for example, a silicified microcrystalline cellulose (SMCC), having an average particle size of about 50 μm to Petition 870250101458, dated 05 / 11 / 2025, page 91 / 254 86 / 211 about 200 μm (for example, about 50 μm, about 55 μm, about 60 pm, about 65 pm, about 70 μm, about 75 μm, about 80 pm, about 85 pm, about 90 pm, about 95 pm, about 100 pm, about 105 pm, about 110 pm, about 115 pm, about 120 pm, about 125 pm, about 130 pm, about 135 pm, about 140 pm, about 145 pm, about 150 pm, about 155 pm, about 160 pm, about 165 pm, about 170 pm, about 175 pm, about 180 pm, about 185 pm, approximately 190 pm, approximately 195 pm, or approximately 200 pm). In some embodiments, the dosage form may comprise microcrystalline cellulose (MCC), for example, silicified microcrystalline cellulose (SMCC), with a moisture content of approximately 0.1% to approximately 5% (for example, approximately 0.1%, approximately 0.5%, approximately 1%, approximately 1.5%, approximately 2%, approximately 2.5%, approximately 3%, approximately 3.5%, approximately 4%, approximately 4.5%, or approximately 5%).In some embodiments, the dosage form may comprise microcrystalline cellulose (MCC), for example, silicified microcrystalline cellulose (SMCC), with a moisture content of less than about 0.5%, less than about 1%, less than about 1.5%, less than about 2%, less than about 2.5%, less than about 3%, less than about 3.5%, less than about 4%, less than about 4.5%, less than about 5%.

[00208] In some embodiments, the dosage form comprises from about 5 mg to about 300 mg of microcrystalline cellulose, for example, silicified microcrystalline cellulose (for example, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about Petition 870250101458, dated 05 / 11 / 2025, page 92 / 254 87 / 211 from 60 mg to about 65 mg, from about 65 mg to about 70 mg, from about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about 85 mg, from about 85 mg to about 90 mg, from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about 110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg, from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, of approximately 135 mg to approximately 140 mg, approximately 140 mg to approximately 145 mg, approximately 145 mg to approximately 150 mg, approximately 150 mg to approximately 155 mg, approximately 155 mg to approximately 160 mg, approximately 160 mg to approximately 165 mg, approximately 165 mg to approximately 170 mg, approximately 170 mg to approximately 175 mg, approximately 175 mg to approximately 180 mg, approximately 180 mg to approximately 185 mg, approximately 185 mg to approximately 190 mgfrom about 190 mg to about 195 mg, from about 195 mg to about 200 mg, from about 200 mg to about 205 mg, from about 205 mg to about 210 mg, from about 210 mg to about 215 mg, from about 215 mg to about 220 mg, from about 220 mg to about 225 mg, from about 225 mg to about 230 mg, from about 230 mg to about 235 mg, from about 235 mg to about 240 mg, from about 240 mg to about 245 mg, from about 245 mg to about 250 mg, from about 250 mg to about 255 mg, from about 255 mg to about 260 mg, from about 260 mg approximately 265 mg, from approximately 265 mg to approximately 270 mg, from approximately 270 mg to approximately 275 mg, from approximately 275 mg to approximately 280 mg, from approximately 280 mg to approximately 285 mg, from approximately 285 mg to approximately 290 mg, from approximately 290 mg to approximately 295 mg, or from approximately 295 mg to approximately 300 mg of microcrystalline cellulose, for example, silicified microcrystalline cellulose.

[00209] In some modalities, the dosage form comprises Petition 870250101458, dated 05 / 11 / 2025, p. 93 / 254 88 / 211 of about 5 mg to about 300 mg of microcrystalline cellulose, for example, silicified microcrystalline cellulose (for example, 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 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, about 250 mg, about 255 mg,approximately 260 mg, approximately 265 mg, approximately 270 mg, approximately 275 mg, approximately 280 mg, approximately 285 mg, approximately 290 mg, approximately 295 mg, or approximately 300 mg of microcrystalline cellulose, for example, silicified microcrystalline cellulose.

[00210] In some embodiments, the dosage form comprises from about 5% by weight to about 50% by weight of microcrystalline cellulose, for example, silicified microcrystalline cellulose (for example, from about 5% to about 10%, from about 10% to about 15%, from about 15% to about 20%, from about 20% to about 25%, from about 25% to about 30%, from about 30% to about 35%, from about 35% to about 40%, from about 40% to about 45%, or from about 45% to about 50% by weight of microcrystalline cellulose, for example, silicified microcrystalline cellulose).

[00211] In some embodiments, the dosage form comprises from about 5% by weight to about 50% by weight of microcellulose. Petition 870250101458, dated 05 / 11 / 2025, page 94 / 254 89 / 211 Crocristalina, for example, silicified microcrystalline cellulose (for example, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight, about 20% by weight, about 21% by weight, about 22% by weight, about 23% by weight, about 24% by weight, about 25% by weight, about 26% by weight, about 27% by weight, about 28% by weight, about 29% by weight weight, approximately 30% by weight, approximately 31% by weight, approximately 32% by weight, approximately 33% by weight, approximately 34% by weight, approximately 35% by weight, approximately 36% by weight, approximately 37% by weight, approximately 38% by weight, approximately 39% by weight, approximately 40% by weight, approximately 41% by weight, approximately 42% by weight, approximately 43% by weight, approximately 44% by weight, approximately 45% by weight,approximately 46% by weight, approximately 47% by weight, approximately 48% by weight, approximately 49% by weight, or approximately 50% by weight of microcrystalline cellulose, for example, silicified microcrystalline cellulose.

[00212] In some embodiments, the dosage form comprises from about 5 mg to about 300 mg of sugar alcohol, for example, mannitol (for example, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, from about 20 mg to about 25 mg, from about 25 mg to about 30 mg, from about 30 mg to about 35 mg, from about 35 mg to about 40 mg, from about 40 mg to about 45 mg, from about 45 mg to about 50 mg, from about 50 mg to about 55 mg, from about 55 mg to about 60 mg, from about 60 mg to about 65 mg, from about 65 mg to about 70 mg, from about 70 mg to about 75 mg, from about 75 mg to about 80 mg, from about 80 mg to about Petition 870250101458, dated 05 / 11 / 2025, page 95 / 254 90 / 211 of 85 mg, from about 85 mg to about 90 mg, from about 90 mg to about 95 mg, from about 95 mg to about 100 mg, from about 100 mg to about 105 mg, from about 105 mg to about 110 mg, from about 110 mg to about 115 mg, from about 115 mg to about 120 mg, from about 120 mg to about 125 mg, from about 125 mg to about 130 mg, from about 130 mg to about 135 mg, from about 135 mg to about 140 mg, from about 140 mg to about 145 mg, from about 145 mg to about 150 mg, from about 150 mg to about 155 mg, from approximately 155 mg to approximately 160 mg, from approximately 160 mg to approximately 165 mg, from approximately 165 mg to approximately 170 mg, from approximately 170 mg to approximately 175 mg, from approximately 175 mg to approximately 180 mg, from approximately 180 mg to approximately 185 mg, from approximately 185 mg to approximately 190 mg, from approximately 190 mg to approximately 195 mg, from approximately 195 mg to approximately 200 mg, from approximately 200 mg to approximately 205 mg, from approximately 205 mg to approximately 210 mg, from approximately 210 mg to approximately 215 mg,from about 215 mg to about 220 mg, from about 220 mg to about 225 mg, from about 225 mg to about 230 mg, from about 230 mg to about 235 mg, from about 235 mg to about 240 mg, from about 240 mg to about 245 mg, from about 245 mg to about 250 mg, from about 250 mg to about 255 mg, from about 255 mg to about 260 mg, from about 260 mg to about 265 mg, from about 265 mg to about 270 mg, from about 270 mg to about 275 mg, from about 275 mg to about 280 mg, from about 280 mg to about 285 mg, from about 285 mg to approximately 290 mg, from approximately 290 mg to approximately 295 mg, or from approximately 295 mg to approximately 300 mg of sugar alcohol, for example, mannitol).

[00213] In some embodiments, the dosage form comprises from about 5 mg to about 300 mg of sugar alcohol, for example, mannitol (e.g., about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about Petition 870250101458, dated 05 / 11 / 2025, p. 96 / 254 91 / 211 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 of approximately 195 mg, approximately 200 mg, approximately 205 mg, approximately 210 mg, approximately 215 mg, approximately 220 mg, approximately 225 mg, approximately 230 mg, approximately 235 mg, approximately 240 mg, approximately 245 mg, approximately 250 mg, approximately 255 mg, approximately 260 mg, approximately 265 mg, approximately 270 mg, approximately 275 mg, approximately 280 mg, approximately 285 mg, approximately 290 mg, approximately 295 mg, or approximately 300 mg of sugar alcohol, for example, mannitol).

[00214] In some embodiments, the dosage form comprises from about 5% by weight to about 50% by weight of sugar alcohol, for example, mannitol (for example, from about 5% to about 10%, from about 10% to about 15%, from about 15% to about 20%, from about 20% to about 25%, from about 25% to about 30%, from about 30% to about 35%, from about 35% to about 40%, from about 40% to about 45%, or from about 45% to about 50% by weight of sugar alcohol, for example, mannitol).

[00215] In some embodiments, the dosage form comprises from about 5% by weight to about 50% by weight of sugar alcohol, for example, mannitol (for example, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight). Petition 870250101458, dated 05 / 11 / 2025, page 97 / 254 92 / 211 weight, approximately 18% by weight, approximately 19% by weight, approximately 20% by weight, approximately 21% by weight, approximately 22% by weight, approximately 23% by weight, approximately 24% by weight, approximately 25% by weight, approximately 26% by weight, approximately 27% by weight, approximately 28% by weight, approximately 29% by weight, approximately 30% by weight, approximately 31% by weight, approximately 32% by weight, approximately 33% by weight, approximately 34% by weight, approximately 35% by weight, approximately 36% by weight, approximately 37% by weight, approximately 38% by weight, approximately 39% by weight, approximately 40% by weight, approximately 41% by weight, approximately 42% by weight, approximately 43% by weight, approximately 44% by weight, approximately 45% by weight, approximately 46% by weight, approximately 47% by weight, approximately 48% by weight, approximately 49% by weight, or approximately 50% by weight of sugar alcohol, for example, mannitol). Sliding

[00216] In some forms, the dosage form comprises a slider.

[00217] In some embodiments, the slider comprises an excipient, for example, used to promote powder flow by reducing friction and interparticle cohesion. In some embodiments, the slider comprises fumed silica (e.g., colloidal silicon dioxide), talc, and magnesium carbonate. In some embodiments, the slider comprises colloidal silicon dioxide. In some embodiments, the colloidal silicon dioxide may comprise AEROSIL® 200 Pharma, also referred to as colloidal silicon dioxide (Aerosil 200).

[00218] In some embodiments, the dosage form comprises from about 1 mg to about 10 mg of slider (for example, from about 1 mg to about 2 mg, from about 2 mg to about 3 mg, from about 3 mg to about 4 mg, from about 4 mg to about 5 mg, from about 5 mg to about 6 mg, from about 6 mg to about 7 mg, of Petition 870250101458, dated 05 / 11 / 2025, p. 98 / 254 93 / 211 about 7 mg to about 8 mg, from about 8 mg to about 9 mg or from about 9 mg to about 10 mg of slider).

[00219] In some embodiments, the dosage form comprises from about 1 mg to about 10 mg of slider (for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg or about 10 mg of slider).

[00220] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of glide (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, or from about 9% to about 10% by weight of glide).

[00221] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of glidant (for example, about 1% by weight, about 2% by weight, about 3% by weight, approximately 4% by weight, approximately 5% by weight, approximately 6% by weight, approximately 7% by weight, approximately 8% by weight, approximately 9% by weight or about 10% by weight of the sliding material).

[00222] In some embodiments, the dosage form comprises from about 1 mg to about 10 mg of pyrogenic silica, for example, colloidal silicon dioxide (for example, from about 1 mg to about 2 mg, from about 2 mg to about 3 mg, from about 3 mg to about 4 mg, from about 4 mg to about 5 mg, from about 5 mg to about 6 mg, from about 6 mg to about 7 mg, from about 7 mg to about 8 mg, from about 8 mg to about 9 mg or from about 9 mg to about 10 mg of pyrogenic silica, for example, colloidal silicon dioxide).

[00223] In some forms, the dosage form comprises Petition 870250101458, dated 05 / 11 / 2025, page 99 / 254 94 / 211 of about 1 mg to about 10 mg of pyrogenic silica, for example, colloidal silicon dioxide (for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg or about 10 mg of pyrogenic silica, for example, colloidal silicon dioxide).

[00224] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of fumed silica, for example, colloidal silicon dioxide (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, or from about 9% to about 10% by weight of fumed silica, for example, colloidal silicon dioxide).

[00225] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of fumed silica, for example, colloidal silicon dioxide (for example, about 1% by weight, approximately 2% by weight, approximately 3% by weight, approximately 4% by weight, approximately 5% by weight, approximately 6% by weight, approximately 7% by weight, approximately 8% by weight, approximately 9% by weight, or approximately 10% by weight of pyrogenic silica, for example, colloidal silicon dioxide). Lubricant

[00226] In some embodiments, the composition comprises a lubricant.

[00227] In some embodiments, the lubricant comprises an excipient, for example, used to prevent ingredients from clumping together and sticking to tablet punches or capsule filling machines. In some embodiments, lubricants are also used to ensure that tablet formation and ejection can occur with low friction between the solid and the tablet wall. Petition 870250101458, dated 05 / 11 / 2025, pages 100 / 254 95 / 211 mold. In some embodiments, the lubricants comprise magnesium stearate, calcium stearate, stearic acid, talc, silica, and fats (e.g., vegetable stearin). In some embodiments, the lubricant comprises magnesium stearate.

[00228] In some embodiments, the dosage form comprises from about 1 mg to about 10 mg of lubricant (for example, from about 1 mg to about 2 mg, from about 2 mg to about 3 mg, from about 3 mg to about 4 mg, from about 4 mg to about 5 mg, from about 5 mg to about 6 mg, from about 6 mg to about 7 mg, from about 7 mg to about 8 mg, from about 8 mg to about 9 mg or from about 9 mg to about 10 mg of lubricant).

[00229] In some embodiments, the dosage form comprises from about 1 mg to about 10 mg of lubricant (for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg or about 10 mg of lubricant).

[00230] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of lubricant (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, or from about 9% to about 10% by weight of lubricant).

[00231] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of lubricant (for example, about 1% by weight, about 2% by weight, about 3% by weight, approximately 4% by weight, approximately 5% by weight, approximately 6% by weight, approximately 7% by weight, approximately 8% by weight, approximately 9% by weight or about 10% by weight of lubricant).

[00232] In some forms, the dosage form comprises Petition 870250101458, dated 05 / 11 / 2025, pp. 101 / 254 96 / 211 of about 1 mg to about 10 mg of magnesium stearate (for example, from about 1 mg to about 2 mg, from about 2 mg to about 3 mg, from about 3 mg to about 4 mg, from about 4 mg to about 5 mg, from about 5 mg to about 6 mg, from about 6 mg to about 7 mg, from about 7 mg to about 8 mg, from about 8 mg to about 9 mg or from about 9 mg to about 10 mg of magnesium stearate).

[00233] In some embodiments, the dosage form comprises from about 1 mg to about 10 mg of magnesium stearate (for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg or about 10 mg of magnesium stearate).

[00234] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of magnesium stearate (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, or from about 9% to about 10% by weight of magnesium stearate).

[00235] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of magnesium stearate (for example, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight or about 10% by weight of magnesium stearate). Coating

[00236] In some forms, the composition includes a coating. Petition 870250101458, dated 05 / 11 / 2025, page 102 / 254 97 / 211

[00237] In some embodiments, the coating comprises an excipient, for example, to protect the tablet ingredients from deterioration by moisture in the air and to make large or unpleasant-tasting tablets easier to swallow. In some embodiments, the coating comprises a film coating agent. In some embodiments, the coating comprises Opadry® II white 85F18422, which is composed of compendial grade polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350 and talc.

[00238] In some embodiments, the dosage form comprises from about 1 mg to about 20 mg of coating, for example, film coating agent (for example, from about 1 mg to about 2 mg, from about 2 mg to about 3 mg, from about 3 mg to about 4 mg, from about 4 mg to about 5 mg, from about 5 mg to about 6 mg, from about 6 mg to about 7 mg, from about 7 mg to about 8 mg, from about 8 mg to about 9 mg, from about 9 mg to about 10 mg, from about 10 mg to about 11 mg, from about 11 mg to about 12 mg, from about 12 mg to about 13 mg, from about 13 mg to about 14 mg, from about 14 mg to about 15 mg, from about 15 mg to about 16 mg, from about 16 mg to about 17 mg, from about 17 mg to about 18 mg, from about 18 mg to about 19 mg, or from about 19 mg to about 20 mg of coating, e.g., film coating agent).

[00239] In some embodiments, the dosage form comprises from about 1 mg to about 20 mg of coating, for example, film coating agent (for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, about 10 mg, about 11 mg, about 12 mg, about 13 mg, about 14 mg, about 15 mg, about 16 mg, about 17 mg, about 18 mg, about 19 mg or about 20 mg of coating, for example, Petition 870250101458, dated 05 / 11 / 2025, page 103 / 254 98 / 211 film coating agent).

[00240] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of coating, for example, film coating agent (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, from about 9% to about 10% by weight of coating, for example, film coating agent).

[00241] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of coating, for example, film coating agent (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, from about 9% to about 10% (approximately 1% by weight, approximately 2% by weight, approximately 3% by weight, approximately 4% by weight, approximately 5% by weight, approximately 6% by weight, approximately 7% by weight, approximately 8% by weight, approximately 9% by weight, or approximately 10% by weight of coating, for example, film coating agent).

[00242] In some embodiments, the dosage form comprises from about 1 mg to about 20 mg of Opadry® II white 85F18422 (for example, from about 1 mg to about 2 mg, from about 2 mg to about 3 mg, from about 3 mg to about 4 mg, from about 4 mg to about 5 mg, from about 5 mg to about 6 mg, from about 6 mg to about 7 mg, from about 7 mg to about 8 mg, from about 8 mg to about 9 mg, from about 9 mg to about 10 mg, from about 10 mg to about 11 mg, from about 11 mg to about 12 mg, Petition 870250101458, dated 05 / 11 / 2025, page 104 / 254 99 / 211 of approximately 12 mg to approximately 13 mg, of approximately 13 mg to approximately 14 mg, of approximately 14 mg to approximately 15 mg, of approximately 15 mg to approximately 16 mg, of approximately 16 mg to approximately 17 mg, of approximately 17 mg to approximately 18 mg, of approximately 18 mg to approximately 19 mg, or of approximately 19 mg to approximately 20 mg of Opadry® II white 85F18422).

[00243] In some embodiments, a dosage comprises from about 1 mg to about 20 mg of Opadry® II white 85F18422 (for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, about 10 mg, about 11 mg, about 12 mg, about 13 mg, about 14 mg, about 15 mg, about 16 mg, about 17 mg, about 18 mg, about 19 mg or about 20 mg of Opadry® II white 85F18422).

[00244] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of Opadry® II white 85F18422 (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, from about 9% to about 10% by weight of Opadry® II white 85F18422).

[00245] In some embodiments, the dosage form comprises from about 1% by weight to about 10% by weight of Opadry® II white 85F18422 (for example, from about 1% to about 2%, from about 2% to about 3%, from about 3% to about 4%, from about 4% to about 5%, from about 5% to about 6%, from about 6% to about 7%, from about 7% to about 8%, from about 8% to about 9%, from about 9% to about 10%, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 1% by weight). Petition 870250101458, dated 05 / 11 / 2025, page 105 / 254 100 / 211 approximately 8% by weight, approximately 9% by weight, or approximately 10% by weight of Opadry® II white 85F18422). Form factor

[00246] The compositions, formulations, and dosage forms described in this document may be manufactured using any appropriate manufacturing method known in the art, including, but not limited to, direct compression, dry granulation (e.g., slugging or roller compression), wet granulation, and any combination thereof. The compositions, formulations, and dosage forms described in this document should advantageously be of a shape, size, and weight that can be easily taken, for example, orally. Consequently, in one aspect, the compositions, formulations, and dosage forms described in this document may be a suitable solid dosage form for oral administration. The dosage form may be selected from the group consisting of tablets, capsules, films, powders, granules, solutions, solids, suspensions, and other acceptable oral dosage forms. In some embodiments, the dosage form is a tablet, such as a dragee.In other dosage forms, the dosage is a capsule. In certain other dosage forms, the dosage is a suspension.

[00247] In some embodiments, the dosage form (e.g., tablet) may be compressed or molded during its manufacture and may be of almost any size, shape, weight, and color. In some embodiments, the dosage form (e.g., tablet) has the form of a capsule (also referred to as a dragee). Most tablets are intended to be swallowed whole, and consequently, preferred tablets are designed for oral administration. However, in some embodiments, tablets may be dissolved in the mouth, chewed, or dissolved in liquid before swallowing, and some may be placed in a cavity. Petition 870250101458, dated 05 / 11 / 2025, p. 106 / 254 101 / 211 body.

[00248] In some embodiments, the total weight of the dosage form (e.g., tablet), which is a function of the total size of the dosage form (e.g., tablet), may be adjusted in order to provide the best compromise between desired pharmacokinetics (PK) and patient compliance.

[00249] In some embodiments, the dosage form (e.g., tablet) has a total weight of about 50 mg to about 600 mg (e.g., about 50 mg to about 75 mg, about 75 mg to about 100 mg, about 100 mg to about 125 mg, about 125 mg to about 150 mg, about 150 mg to about 175 mg, about 175 mg to about 200 mg, about 200 mg to about 225 mg, about 225 mg to about 250 mg, about 250 mg to about 275 mg, about 275 mg to about 300 mg, about 300 mg to about 325 mg, about 325 mg to about 350 mg, from about 350 mg to about 375 mg, from about 375 mg to about 400 mg, from about 400 mg to about 425 mg, from about 425 mg to about 450 mg, from about 450 mg to about 475 mg, from about 475 mg to about 500 mg, from about 500 mg to about 525 mg, from about 525 mg to about 550 mg, from about 550 mg to about 575 mg, or from about 575 mg to about 600 mg).

[00250] In some embodiments, the dosage form (e.g., tablet) has a total weight of about 50 mg to about 600 mg (e.g., 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 ... Petition 870250101458, dated 05 / 11 / 2025, page 107 / 254 102 / 211 approximately 180 mg, approximately 185 mg, approximately 190 mg, approximately 195 mg, approximately 200 mg, approximately 205 mg, approximately 210 mg, approximately 215 mg, approximately 220 mg, approximately 225 mg, approximately 230 mg, approximately 235 mg, approximately 240 mg, approximately 245 mg, approximately 250 mg, approximately 255 mg, approximately 260 mg, approximately 265 mg, approximately 270 mg, approximately 275 mg, approximately 280 mg, approximately 285 mg, approximately 290 mg, approximately 295 mg, approximately 300 mg, approximately 305 mg, approximately 310 mg, approximately 315 mg, approximately 320 mg, approximately 325 mg, approximately 330 mg, approximately 335 mg, approximately 340 mg, approximately 345 mg, approximately 350 mg, approximately 355 mg, approximately 360 mg, approximately 365 mg, approximately 370 mg, approximately 375 mg, approximately 380 mg, approximately 385 mg, approximately 390 mg, approximately 395 mg, approximately 400 mg, approximately 405 mg, approximately 410 mg, approximately 415 mg, approximately 420 mg, approximately 425 mg, approximately 430 mg, approximately 435 mg, approximately 440 mg, approximately 445 mg, approximately 450 mg, approximately 455 mg, approximately 460 mg, approximately 465 mgabout 470 mg, about 475 mg, about 480 mg, about 485 mg, about 490 mg, about 495 mg, about 500 mg, about 505 mg, about 510 mg, about 515 mg, about 520 mg, about 525 mg, about 530 mg, about 535 mg, about 540 mg, about 545 mg, about 550 mg, about 555 mg, about 560 mg, about 565 mg, about 570 mg, about 575 mg, about 580 mg, about 585 mg, about 590 mg, about 595 mg, or about 600 mg).

[00251] In some embodiments, the dosage form is a round tablet. In some embodiments, the tablet may have a diameter in the range of about 1 mm to about 30 mm (for example, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm). Petition 870250101458, dated 05 / 11 / 2025, page 108 / 254 103 / 211 mm, approximately 18 mm, approximately 19 mm, approximately 20 mm, approximately 21 mm, approximately 22 mm, approximately 23 mm, approximately 24 mm, approximately 25 mm, approximately 26 mm, approximately 27 mm, approximately 28 mm, approximately 29 mm, or approximately 30 mm). In some embodiments, the tablet has no diameter in the range of approximately 1 mm to approximately 6 mm (for example, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm).

[00252] In some embodiments, the dosage form is an oblong tablet. In some embodiments, opening blister packs of oblong tablets, handling oblong tablets, and taking one or more oblong tablets is less challenging and convenient for patients struggling with movement disorders, such as essential tremor (ET), for example, compared with a small, round tablet (e.g., 6 mm in diameter).

[00253] In some embodiments, the dosage form is an oval tablet. In some embodiments, opening blister packs of oval tablets, handling oval tablets, and taking one or more oval tablets is less challenging and convenient for patients struggling with movement disorders, such as essential tremor (ET), for example, compared to a small, round tablet (e.g., 6 mm in diameter).

[00254] In some embodiments, the dosage form is a capsule-shaped tablet (e.g., a dragee). In some embodiments, opening blister packs of capsule-shaped tablets, handling capsule-shaped tablets, and taking one or more capsule-shaped tablets is less challenging and convenient for patients struggling with movement disorders, such as essential tremor (ET), for example, compared to a small, round tablet (e.g., 6 mm in diameter).

[00255] In some forms, the dosage form (e.g. Petition 870250101458, dated 05 / 11 / 2025, p. 109 / 254 104 / 211 plo, compressed) may have a length of about 1 mm to about 30 mm (for example, from about 1 mm to about 2 mm, from about 2 mm to about 3 mm, from about 3 mm to about 4 mm, from about 4 mm to about 5 mm, from about 5 mm to about 6 mm, from about 6 mm to about 7 mm, from about 7 mm to about 8 mm, from about 8 mm to about 9 mm, from about 9 mm to about 10 mm, from about 10 mm to about 11 mm, from about 11 mm to about 12 mm, from about 12 mm to about 13 mm, from about 13 mm to about 14 mm, from about 14 mm to about 15 mm, from about 15 mm to about 16 mm, from about 16mm to about 17mm, from about 17mm to about 18mm, from about 18mm to about 19mm, from about 19mm to about 20mm, from about 20mm to about 21mm, from about 21mm to about 22mm, from about 22mm to about 23mm, from about 23mm to about 24mm, from about 24mm to about 25mm, from about 25mm to about 26mm,from about 26 mm to about 27 mm, from about 27 mm to about 28 mm, from about 28 mm to about 29 mm, or from about 29 mm to about 30 mm).

[00256] In some embodiments, the dosage form (e.g., tablet) may have a length of about 1 mm to about 30 mm (e.g., about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5mm, about 15mm, about 15.5mm, about 16mm, about 16.5mm, about 17mm, about 17.5mm, about 18mm, about 18.5mm, about 19mm, about Petition 870250101458, dated 05 / 11 / 2025, page 110 / 254 105 / 211 19.5 mm, approximately 20 mm, approximately 20.5 mm, approximately 21 mm, approximately 21.5 mm, approximately 22 mm, approximately 22.5 mm, approximately 23 mm, approximately 23.5 mm, approximately 24 mm, approximately 24.5 mm, approximately 25 mm, approximately 25.5 mm, approximately 26 mm, approximately 26.5 mm, approximately 27 mm, approximately 27.5 mm, approximately 28 mm, approximately 28.5 mm, approximately 29 mm, approximately 29.5 mm, or approximately 30 mm).

[00257] In some embodiments, the dosage form (e.g., tablet) may have a width of about 1 mm to about 30 mm (e.g., from about 1 mm to about 2 mm, from about 2 mm to about 3 mm, from about 3 mm to about 4 mm, from about 4 mm to about 5 mm, from about 5 mm to about 6 mm, from about 6 mm to about 7 mm, from about 7 mm to about 8 mm, from about 8 mm to about 9 mm, from about 9 mm to about 10 mm, from about 10 mm to about 11 mm, from about 11 mm to about 12 mm, from about 12 mm to about 13 mm, from about 13 mm to about 14 mm, from about 14 mm to about 15 mm, from about 15 mm to about 16mm, from about 16mm to about 17mm, from about 17mm to about 18mm, from about 18mm to about 19mm, from about 19mm to about 20mm, from about 20mm to about 21mm, from about 21mm to about 22mm, from about 22mm to about 23mm, from about 23mm to about 24mm, from about 24mm to about 25mm,from about 25 mm to about 26 mm, from about 26 mm to about 27 mm, from about 27 mm to about 28 mm, from about 28 mm to about 29 mm, or from about 29 mm to about 30 mm).

[00258] In some embodiments, the dosage form (e.g., tablet) may have a width of about 1 mm to about 30 mm (e.g., about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, Petition 870250101458, dated 05 / 11 / 2025, p. 111 / 254 106 / 211 approximately 6.5 mm, approximately 7 mm, approximately 7.5 mm, approximately 8 mm, approximately 8.5 mm, approximately 9 mm, approximately 9.5 mm, approximately 10 mm, approximately 10.5 mm, approximately 11 mm, approximately 11.5 mm, approximately 12 mm, approximately 12.5 mm, approximately 13 mm, approximately 13.5 mm, approximately 14 mm, approximately 14.5 mm, approximately 15 mm, approximately 15.5 mm, approximately 16 mm, approximately 16.5 mm, approximately 17 mm, approximately 17.5 mm, approximately 18 mm, approximately 18.5 mm, approximately 19 mm, approximately 19.5 mm, approximately 20 mm, approximately 20.5 mm, approximately 21 mm, approximately 21.5 mm, approximately 22 mm, approximately 22.5 mm, approximately 23 mm, approximately 23.5 mm, approximately 24 mm, approximately 24.5 mm, approximately 25 mm, approximately 25.5 mm, approximately 26 mm, approximately 26.5 mm, approximately 27 mm, approximately 27.5 mm, approximately 28 mm, approximately 28.5 mm, approximately 29 mm, approximately 29.5 mm, or approximately 30 mm).

[00259] In some embodiments, the dosage form (e.g., tablet) may have a width of about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4 mm to about 5 mm, about 5 mm to about 6 mm, about 6 mm to about 7 mm, about 7 mm to about 8 mm, about 8 mm to about 9 mm, or about 9 mm to about 10 mm).

[00260] In some embodiments, the dosage form (e.g., tablet) comprises a width of about 1 mm to about 10 mm (e.g., a width of about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm). Petition 870250101458, dated 05 / 11 / 2025, page 112 / 254 107 / 211 mm, approximately 3.5 mm, approximately 3.6 mm, approximately 3.7 mm, approximately 3.8 mm, approximately 3.9 mm, approximately 4 mm, approximately 4.1 mm, approximately 4.2 mm, approximately 4.3 mm, approximately 4.4 mm, approximately 4.5 mm, approximately 4.6 mm, approximately 4.7 mm, approximately 4.8 mm, approximately 4.9 mm, approximately 5 mm, approximately 5.1 mm, approximately 5.2 mm, approximately 5.3 mm, approximately 5.4 mm, approximately 5.5 mm, approximately 5.6 mm, approximately 5.7 mm, approximately 5.8 mm, approximately 5.9 mm, approximately 6 mm, approximately 6.1 mm, approximately 6.2 mm, approximately 6.3 mm, approximately 6.4 mm, approximately 6.5 mm, approximately 6.6 mm, approximately 6.7 mm, approximately 6.8 mm, approximately 6.9 mm, approximately 7 mm, approximately 7.1 mm, approximately 7.2 mm, approximately 7.3 mm, approximately 7.4 mm, approximately 7.5 mm, approximately 7.6 mm, approximately 7.7 mm, approximately 7.8 mm, approximately 7.9 mm, approximately 8 mm, approximately 8.1 mm, approximately 8.2 mm, approximately 8.3 mm, approximately 8.4 mm, approximately 8.5 mm, approximately 8.6 mm, approximately 8.7 mm, approximately 8.8 mm, approximately 8.9 mm, approximately 9 mm, approximately 9.1 mm, approximately 9.2 mm, approximately 93mm, about 9.4mm, about 9.5mm, about 9.6mm, about 9.7mm, about 9.8mm, about 9.9mm, or about 10mm).

[00261] In some embodiments, the dosage form (e.g., tablet) may have a width of about 1 mm to about 10 mm (e.g., about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm or about 10 mm).

[00262] In some embodiments, the dosage form (e.g., tablet) may have a length of about 10 to about 20 mm (e.g., about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm). Petition 870250101458, dated 05 / 11 / 2025, p. 113 / 254 108 / 211 mm, approximately 4.5 mm, approximately 5 mm, approximately 5.5 mm, approximately 6 mm, approximately 6.5 mm, approximately 7 mm, approximately 7.5 mm, approximately 8 mm, approximately 8.5 mm, approximately 9 mm, approximately 9.5 mm, approximately 10 mm, approximately 10.5 mm, approximately 11 mm, approximately 11.5 mm, approximately mm, approximately 12.5 mm, approximately 13 mm, approximately 13.5 mm, approximately 14 mm, approximately 14.5 mm, approximately 15 mm, approximately 15.5 mm, approximately 16 mm, approximately 16.5 mm, approximately 17 mm, approximately 17.5 mm, approximately 18 mm, approximately 18.5 mm, approximately 19 mm, approximately 19.5 mm or about 20 mm) and a length of about 1 mm to about 10 mm (for example, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, or about 10 mm).

[00263] In some embodiments, the dosage form (e.g., tablet) may have a length of about 14 to about 16 mm (e.g., about 14 mm, about 14.1 mm, about 14.2 mm, about 14.3 mm, about 14.4 mm, about 14.5 mm, about 14.6 mm, about 14.7 mm, about 14.8 mm, about 14.9 mm, about 15 mm, about 15.1 mm, about 15.2 mm, about 15.3 mm, about 15.4 mm, about 15.5 mm, about 15.6 mm, about 15.7 mm, about 15.8 mm, about 15.9 mm, or about 16 mm) and a width of about 5 mm to about 7 mm (e.g., 5mm, about 5.1mm, about 5.2mm, about 5.3mm, about 5.4mm, about 5.5mm, about 5.6mm, about 5.7mm, about 5.8mm, about 5.9mm, about 6mm, about 6.1mm, about 6.2mm, about 6.3mm, about 6.4mm, about 6.5mm, about 6.6mm, about 6.7mm, about 6.8mm, about 6.9mm, about 7mm). Petition 870250101458, dated 05 / 11 / 2025, page 114 / 254 109 / 211

[00264] In some embodiments, the dosage form (e.g., tablet) may have a thickness of about 1 mm to about 10 mm (e.g., about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm or about mm).

[00265] Tablet hardness can be measured using any technique or apparatus known in the art for testing tablet hardness. For example, a force gauge can be used to determine the breaking strength, which is indicative of the tablet's toughness. Typical hardness measurement units include: kiloponds (kp), Strong Cobb Units (SCU), and Newtons (N). In some embodiments, the dosage form (e.g., tablet) may have a hardness of approximately 75 N, approximately 76 N, approximately 77 N, approximately 78 N, approximately 79 N, approximately 80 N, approximately 81 N, approximately 82 N, approximately 83 N, approximately 84 N, approximately 85 N, approximately 86 N, approximately 87 N, approximately 88 N, approximately 89 N, approximately 90 N, approximately 91 N, approximately 92 N, approximately 93 N, approximately 94 N, approximately 95 N, approximately 96 N, approximately 97 N, approximately 98 N, approximately 99 N, approximately 100 N, approximately 101 N, approximately 102 N, approximately 103 N, approximately 104 N, approximately 105 N, approximately 106 N, about 107 N, about 108 N,near 109 N, near 110 N, near 111 N, near 112 N, near 113 N, near 114 N, near 115 N, near 116 N, near 117 N, near 118 N, near 119 N, near 120 N, near 121 N, near 122 N, near 123 N, near 124 N, near 125 N, near 126 N, near 127 N, near 128 N, near 129 N, near 130 N, near 131 N, near 132 N, near 133 N, near 134 N, near 135 N, near 136 N, near 137 N, near 138 N, near, Petition 870250101458, dated 05 / 11 / 2025, page. 115 / 254 110 / 211 of 139 N, near 140 N, near 141 N, near 142 N, near 143 N, near 144 N, near 145 N, near 146 N, near 147 N, near 148 N, near 149 N, near 150 N, near 151 N, near 152 N, near 153 N, near 154 N, near 155 N, near 156 N, near 157 N, near 158 N, near 159 N, near 160 N, near 161 N, near 162 N, near 163 N, near 164 N, near 165 N, near 166 N, near 167 N, near 168 N, near 169 N, near 170 N, near 171 N, near 172 N, near 173 N, near 174 N, near 175 N, near 176 N, near 177 N, near 178 N, near 179 N, near 180 N, near 181 N, near 182 N, near 183 N, near 184 N, near 185 N, about 186 N, about 187 N, about 188 N, about 189 N, about 190 N, about 191 N, about 192 N, about 193 N, about 194 N, about 195 N, about 196 N, about 197 N, about 198 N, about 199 N, or about 200 N). In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 90 N to about 110 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 100 N to about 120 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 110 N to about 130 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 120 N to about 140 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 130 N to about 150 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 140 N to about 160 N.In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 150 N to about 170 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 160 N to about 170 N. Petition 870250101458, dated 05 / 11 / 2025, p. 116 / 254 111 / 211 of 180 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 170 N to about 190 N. In some embodiments, the dosage form (e.g., tablet) may have a hardness of about 180 N to about 200 N.

[00266] In some embodiments, the dosage form (e.g., tablet) may have a compression in observed hardness of about 5 N to about 35 N (e.g., about 5 N, about 6 N, about 7 N, about 8 N, about 9 N, about 10 N, about 11 N, about 12 N, about 13 N, about 14 N, about 15 N, about 16 N, about 17 N, about 18 N, about 19 N, about 20 N, about 21 N, about 22 N, about 23 N, about 24 N, about 25 N, about 26 N, about 27 N, about 28 N, about 29 N, about 30 N, about 31 N, about 32 N, about 33 N, about 34 N, or about 35 N). In some embodiments, the dosage form (e.g., tablet) may have a compression force at the observed hardness of about 5 N to about 15 N. In some embodiments, the dosage form (e.g., tablet) may have a compression force at the observed hardness of about 10 N to about 20 N.In some embodiments, the dosage form (e.g., tablet) may have a compressive strength at the observed hardness of about 15 N to about 25 N. In some embodiments, the dosage form (e.g., tablet) may have a compressive strength at the observed hardness of about 20 N to about 30 N. In some embodiments, the dosage form (e.g., tablet) may have a compressive strength at the observed hardness of about 25 N to about 35 N. In some embodiments, the dosage form (e.g., tablet) may have a compressive strength at the observed hardness of about 30 N to about 35 N. Petition 870250101458, dated 05 / 11 / 2025, p. 117 / 254 112 / 211

[00267] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 5.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00268] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 10.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00269] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 20.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00270] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 30.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00271] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 40.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00272] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 50.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, page 118 / 254 113 / 211

[00273] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 60.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00274] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 70.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00275] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 80.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00276] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 90.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00277] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 100.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet).

[00278] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 110.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet). Petition 870250101458, dated 05 / 11 / 2025, page 119 / 254 114 / 211

[00279] In some embodiments, the dosage form comprises an amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)) equivalent to about 120.0 mg of free base of PRAX-944 per dosage unit (for example, per tablet). Pharmaceutical compositions

[00280] The present invention encompasses the preparation and use of pharmaceutical compositions comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) as an active agent. Such a pharmaceutical composition may consist only of the active agent, as a combination of at least one active agent (e.g., an effective dose of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl)) in a form suitable for administration to an individual, or the pharmaceutical composition may comprise the active agent and one or more pharmaceutically acceptable vehicles, one or more additional ingredients (active and / or inactive), or some combination thereof.

[00281] In one aspect, the pharmaceutical compositions provided by the present invention include a single-unit dosage form comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)). In certain embodiments, the single-unit dosage form comprises up to 200 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof. In some embodiments, the single-unit dosage form comprises a length of up to 16 mm, for example, about 14 mm to about 16 mm and / or a width of up to 7 mm, for example, about 5 mm to about 7 mm. In some embodiments, the single-unit dosage form is bioequivalent Petition 870250101458, dated 05 / 11 / 2025, pp. 120 / 254 115 / 211 lens to a reference composition of the same dosage potency administered as multiple dosage forms, such as the modified-release (MR) formulation comprising the compound of Formula (I) available as 5 mg and 20 mg tablets that are round and small in size (e.g., about 6 mm in diameter). In some embodiments, bioequivalence can be established by: (a) a 90% confidence interval for AUC that is between about 80% and about 125% and (b) a 90% confidence interval for Cmax that is between about 80% and about 125%.

[00282] Exemplary pharmaceutical compositions comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) as an active agent are provided in Tables 616.

[00283] The pharmaceutical compositions of the invention may contain a therapeutically effective amount of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl). Those skilled in the art will recognize, however, that a pharmaceutical composition may contain more than a therapeutically effective amount, such as in bulk compositions, or less than a therapeutically effective amount, i.e., individual unit doses designed for multiple administration to achieve a therapeutically effective amount. Typically, the composition will contain from about 1 mg to about 200 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl), with the actual amount depending on the formulation itself, the route of administration, the frequency of dosing, and so forth.Depending on the dosage form, a composition suitable for an oral dosage form, for example. Petition 870250101458, dated 05 / 11 / 2025, pp. 121 / 254 116 / 211 may contain about 5 mg, about 10 mg, about 20 mg, about 40 mg, about 60 mg, about 80 mg, about 100 mg or about 120 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, compound of Formula (II), for example, PRAX-944 HCl).

[00284] The pharmaceutical compositions of the present invention are designed to provide a larger and more convenient dosage form of PRAX-944 compared to the currently available dosage form of PRAX-944, which is a modified-release (MR) formulation available as 5 mg and 20 mg tablets that are round and small in size (6 mm in diameter). For example, the pharmaceutical compositions of the present invention are designed to minimize the total number of dosage units (e.g., tablets) required to deliver specific dose levels of PRAX-944 and to increase the physical size of the tablet to facilitate understanding and be more convenient for patients, especially those with a movement disorder, such as, for example, essential tremor (ET).Furthermore, the pharmaceutical compositions of the present invention comprising larger tablets have substantially the same bioavailability, for example, with respect to the rate (maximum plasma drug concentration; Cmax) and extent (area under the plasma concentration-time curve; AUC) of absorption of PRAX-944 compared with several small, round, 20 mg tablets of the same total dosage.

[00285] The pharmaceutical compositions of the present invention can be administered in a manner appropriate to the condition, disease and / or disorder to be treated (or prevented). The amount and frequency of administration will be determined by factors such as the patient's condition and the type and severity of the condition, disease and / or disorder. Petition 870250101458, dated 05 / 11 / 2025, pp. 122 / 254 117 / 211 patient disturbance, although appropriate dosages may be determined by clinical studies. The administration of the pharmaceutical compositions may be carried out in any convenient manner, including, for example, by oral administration.

[00286] As used in this document, the term pharmaceutically acceptable vehicle means a chemical composition with which the active agent can be combined and which, after combination, can be used to deliver the active agent to an individual. Suitable vehicles are described in the most recent edition of Remington's Pharmaceutical Sciences, a standard reference text in the field, which is incorporated herein by reference.

[00287] The formulations of the pharmaceutical compositions described in this document may be prepared by any method known or subsequently developed in the art of pharmacology. In general, such preparatory methods include the step of combining the active agent with a vehicle or one or more other accessory ingredients and then, if necessary or desirable, shaping or packaging the product into a desired single or multiple dose unit. Kits

[00288] In one aspect, one or more dosage forms, as described in this document (for example, one or more 5 mg tablets, one or more 10 mg tablets, one or more 20 mg tablets, one or more 40 mg tablets, one or more 80 mg tablets and / or one or more 120 mg tablets) may be supplied, for example, in packages such as kits, blister packs, bundled packages or bottles. In one embodiment, a kit is supplied containing a plurality of oral dosage forms packaged together and instructions for use to administer the oral dosage forms according to the method described in this document. Petition 870250101458, dated 05 / 11 / 2025, pp. 123 / 254 118 / 211 document. The oral dosage form may be selected from the group consisting of tablets, capsules, films, powders, granules, solutions, solids and suspensions.

[00289] Packaged oral dosage forms may contain a refill supply of the medication normally prescribed for the intended therapy, for example, a titration regimen. A series of unit doses may be packaged together according to the prescribed regimen or treatment, for example, a 1-90 day supply, depending on the specific therapy. In some embodiments, a series of unit doses may comprise one or more 5 mg tablets, one or more 10 mg tablets, one or more 20 mg tablets, one or more 40 mg tablets, one or more 80 mg tablets and / or one or more 120 mg tablets, as described in this document.In some embodiments, a supply of up to about 90 days of each dosage quantity of about 5 mg to about 200 mg may be provided (for example, one or more 5 mg tablets, one or more 10 mg tablets, one or more 20 mg tablets, one or more 40 mg tablets, one or more 80 mg tablets and / or one or more 120 mg tablets, as described in this document), for example, in packs together.

[00290] In one embodiment, the oral dosage forms, for example, tablets, as described in this document, may be included in a blister pack with instructions for administering one or more tablets daily so that the dosage of the formulations described in this document is sufficiently administered. In another embodiment, the oral dosage forms, for example, tablets, as described in this document, may be included in a blister pack with instructions for administering two or more tablets daily so that the dosage Petition 870250101458, dated 05 / 11 / 2025, pages 124 / 254 119 / 211 of the formulations described in this document is sufficiently administered. In another embodiment, the oral dosage forms are included in a blister pack with instructions to administer one or more tablets on an alternate day so that the daily dosage is sufficiently administered. In another embodiment, the oral dosage forms, for example, tablets, as described in this document, may be included in a blister pack with instructions to administer one or more tablets weekly so that the dosage of the formulations described in this document is sufficiently administered. Treatment methods for a disease or condition related to the aberrant function or activity of a T-type calcium channel.

[00291] In one aspect, the present invention provides a method of treating a disease or condition related to aberrant function or activity of a T-type calcium channel, such as essential tremor (ET), in an individual in need, the method comprising administering (for example, once, twice, three times) daily to the individual a therapeutically effective amount of the compound of Formula (I): the NH ci F vel (e.g., cocrystal) position of Formula (II): OR, or a pharmaceutically acceptable salt solution of this, for example, a compound NH o • HCl Cl F

[00292] Formula (I) may also be called N-^-Z-^tert-butylamino)-2-oxoethyl)piperidin-4-yl)methyl)-3-chloro-5-fluorobenzamide, Petition 870250101458, dated 05 / 11 / 2025, pp. 125 / 254 120 / 211 while Formula (II) may be called N-((1-(2(tert-butylamino)-2-oxoethyl)piperidin-4-yl)methyl)-3-chloro-5-fluorobenzamide hydrochloride.

[00293] In some embodiments, the methods of the present invention comprise administering to an individual in need a single-unit dosage form comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)), wherein the composition is bioequivalent to a reference composition of the same dosage potency administered as multiple smaller round tablets.

[00294] In some embodiments, the methods of the present invention comprise administering to a needy individual a titrated dose of the compound of formula (I) or (II). In some embodiments, the maximum titrated dose is 60 mg per day or 100 mg per day. In one embodiment, the maximum titrated dose is 60 mg per day.

[00295] Methods of treatment for a disease or condition related to aberrant function or activity of a type T calcium channel are disclosed in this document, comprising administering a titrated dose such that the final or maintenance dose exceeds an initial dose or a dose at which adverse events are likely to be experienced without titration (a maximum tolerated dose achieved without titration). As used in this document, administering a titrated dose refers to the practice of starting with a low dose and escalating to one or more higher doses. For example, in certain embodiments, administering a titrated dose according to a method described in this document may comprise: (i) administering an initial dose, such as a dose of approximately 5 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual by a Petition 870250101458, dated 05 / 11 / 2025, pp. 126 / 254 121 / 211 first time period (e.g., the first week); (ii) administer a second dose, such as a dose of approximately 10 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for a second time period (e.g., the second week); (iii) administer a second dose, such as a dose of approximately 20 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for a third time period (e.g., the third week); (iv) administer a second dose, such as a dose of approximately 40 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for a fourth time period (e.g., the fourth week);(v) administer a second dose, such as a dose of approximately 60 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for a fifth time period (e.g., the fifth week); (vi) administer a second dose, such as a dose of approximately 80 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for a sixth time period (e.g., the sixth week); (vii) administer a second dose, such as a dose of approximately 100 mg daily of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for a seventh time period (e.g., the seventh week);and / or (ix) administer a second dose, such as a dose of approximately 120 mg daily of a compound from Formula (I) or a pharmaceutically acceptable salt thereof to the individual for an eighth time period (e.g., the eighth week). In some embodiments, the compositions, formulations, and dosage forms described herein make it possible to use a single tablet for each dose strength instead of needing to use multiple tablets. Petition 870250101458, dated 05 / 11 / 2025, pp. 127 / 254 122 / 211

[00296] For example, in certain embodiments, a method of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need is disclosed in this document comprising (a) administering a first dose, such as a dose of about 20 mg or about 40 mg, of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to the individual for the first period of time, wherein, after administration of the first dose of the compound for the first period of time, the individual has a maximum plasma concentration of the drug (Cmax) ranging from about 30 ng / ml to about 130 ng / ml and / or an area under the plasma concentration-time curve from the time of administration to 24 hours after administration (AUC24) ranging from about 490 ng*h / ml to about 2030 ng*h / ml;(b) increase the amount of the compound in the first dose and administer one or more increased doses of the compound to the individual to reach a maximum titrated dose; and (c) administer the maximum titrated dose of the compound to the individual to maintain in the individual a Cmax ranging from about 280 ng / mL to about 470 ng / mL and / or an AUC24 ranging from about 3480 ng*h / mL to about 5800 ng*h / mL. Normally, each dose is administered daily, preferably once daily; however, the frequency of administration may be altered provided the desired Cmax and / or AUC24 values ​​are achieved, as discussed in other sections of this application.

[00297] For example, in certain embodiments, step (b) comprises increasing the first dose to a second dose, such as, for example, a dose of about 40 mg to about 80 mg, and administering the second dose of the compound to the individual over a second period of time, wherein, after administration of the second dose of the compound over the second period of time, the individual has a Cmax varying Petition 870250101458, dated 05 / 11 / 2025, pages 128 / 254 123 / 211 ranging from about 80 ng / mL to about 300 ng / mL, such as from about 80 ng / mL to about 220 ng / mL, from about 80 ng / mL to about 130 ng / mL or from about 130 ng / mL to about 300 ng / mL and / or an AUC24 ranging from about 1220 ng*h / mL to about 4070 ng*h / mL, such as an AUC24 ranging from about 1220 ng*h / mL to about 3330 ng*h / mL or from about 1220 ng*h / mL to about 2030 ng*h / mL.

[00298] In certain embodiments, step (b) may further comprise increasing the second dose to a third dose, such as a dose ranging from about 60 mg to about 100 mg, and administering the third dose of the compound to the individual over a third period of time, wherein, after administration of the third dose, the individual has a Cmax ranging from about 130 ng / mL to about 380 ng / mL, such as from 130 ng / mL to about 220 ng / mL, from about 180 ng / mL to about 300 ng / mL, or from 230 ng / mL to about 380 ng / mL and / or an AUC24 ranging from about 2000 ng*h / mL to about 4700 ng*h / mL, such as from about 2000 ng*h / mL to about 3330 ng*h / mL, from about 2440 ng*h / mL to about 4070 ng*h / mL, or from about 2820 ng*h / mL to about 4700 ng*h / mL.

[00299] This document also discloses embodiments comprising further increasing the third dose to a fourth dose, such as a dose of approximately 80 mg to approximately 100 mg, and administering the fourth dose of the compound to the individual for the fourth time period, wherein, after administration of the fourth dose of the compound for the fourth time period, the individual has a Cmax ranging from approximately 180 ng / mL to approximately 380 ng / mL, such as approximately 180 ng / mL to approximately 300 ng / mL or approximately 230 to approximately 380 ng / mL and / or an AUC24 ranging from approximately 2440 ng*h / mL to approximately 4700 ng*h / mL, such as approximately 2440 ng*h / mL to approximately 4070 ng*h / mL or approximately 2820 ng*h / mL to approximately 4700 ng*h / mL. In certain aspects, the methods disclosed in this document may also include... Petition 870250101458, dated 05 / 11 / 2025, pp. 129 / 254 124 / 211 increase the fourth dose to a fifth dose, such as a dose of approximately 100 mg, and administer the fifth dose of the compound to the individual for a fifth time period, whereby, after administration of the fifth dose of the compound for the fifth time period, the individual has a Cmax ranging from approximately 230 ng / mL to approximately 380 ng / mL and an AUC24 ranging from approximately 2820 ng*h / mL to approximately 4700 ng*h / mL.

[00300] In certain modalities of the titrated dosing schedules disclosed in this document, it is possible to increase the maximum titrated dose to maintain in the individual a Cmax greater than 470 ng / mL and / or an AUC24 greater than 5800 ng*h / mL, provided that the individual is able to safely tolerate the higher dose. For example, in certain embodiments, the method comprises one or more additional titration steps to achieve a maximum titrated dose that is administered to the individual to maintain a Cmax ranging from about 450 ng / mL to about 750 ng / mL, including, for example, about 450 ng / mL to about 650 ng / mL, about 450 ng / mL to about 550 ng / mL, or about 450 ng / mL to about 500 ng / mL, and / or an AUC24 ranging from about 5500 ng*h / mL to about 9500 ng*h / mL, including, for example, about 5500 ng*h / mL to about 8500 ng*h / mL, 5500 ng*h / mL to about 7500 ng*h / mL, or approximately 5500 ng*h / mL to approximately 6500 ng*h / mL.

[00301] Also disclosed in this document is a method of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need of treatment comprising (a) administering to the individual for a first period about 5 mg to about 40 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period about 10 mg to about 100 mg per day of the compound of Formula (I) or a Petition 870250101458, dated 05 / 11 / 2025, pp. 130 / 254 125 / 211 pharmaceutically acceptable salt thereof; and (c) administer to the individual for a third period, approximately 20 mg to approximately 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof. Typically, each of the first, second, and third periods ranges from approximately 3 to approximately 9 days. However, shorter or longer periods of time may be used depending on the individual's tolerance, the clinician's judgment, and the like.

[00302] Also disclosed in this document is a method of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need of treatment comprising (a) administering to the individual for a first period about 5 mg to about 40 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period about 10 mg to about 100 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof; (c) administering to the individual for a third period about 20 mg to about 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof; (d) administering to the individual for a fourth period about 20 mg to about 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof;(e) administer to the individual for a fifth period, about 20 mg to about 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof; (f) administer to the individual for a sixth period, about 20 mg to about 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof; and (g) administer to the individual for a seventh period, about 0 mg to about 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof. Normally, each of the first period, second; Petition 870250101458, dated 05 / 11 / 2025, pp. 131 / 254 The 126 / 211 period, the third period, the fourth period, and the fifth period vary from about 3 to about 9 days, the sixth period varies from about 3 to about 16 days, and the seventh period extends beyond 14 days. However, shorter or longer periods of time may be used for each period, depending on the individual's tolerance, the doctor's judgment, and similar factors.

[00303] In certain embodiments, the individual does not experience adverse events at any of the dosage levels in the titrated dosing schedule. In certain embodiments, without administering a first dosage level during a first dosing period (e.g., about 5 mg to about 40 mg), the individual would experience adverse events at the second dosage level administered during the second dosing period (e.g., about 10 mg to about 100 mg, such as at least about 60 mg to about 100 mg). In certain embodiments, without administering the first and second dosage levels during the first and second dosing periods, an individual would experience adverse events at the third dosage level administered during the third dosing period (e.g., about 20 mg to about 120 mg, such as at least about 60 mg to about 120 mg).

[00304] In certain embodiments, where an individual would likely experience adverse events at the second dosage level administered during the second missed dosing period by administering the first dosage level during the first dosing period, the dosage may continue to be titrated to a dosage level that is higher than the second dosage level administered during the second dosing period, such as a dosage level that is at least about 25% higher, at least about 50% higher, at least about 75% higher, at least about 100% higher, at least about 125% higher, at least about 150% higher. Petition 870250101458, dated 05 / 11 / 2025, pp. 132 / 254 127 / 211 higher, at least about 175% higher, at least about 200% higher, at least about 250% higher, or at least about 300% higher than the dosage level at which adverse events are likely to occur without titration.

[00305] In certain aspects of all the modalities disclosed in this document, the administration time period, such as the first, second, third, fourth, or fifth time period, may vary from about 3 to about 9 days, for example, 3, 4, 5, 6, 7, 8, or 9 days. In certain aspects of the modalities disclosed in this document, the administration time period, such as the sixth time period, may vary from about 3 to about 16 days, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 days. In other aspects of the modalities disclosed in this document, the time periods, for example, the first, second, third, fourth, fifth, sixth, or seventh administration time period, may extend beyond 14 days.

[00306] In certain respects, the dose increase from the previous dose does not exceed 40 mg per day. For example, in certain embodiments, the second dose is increased by no more than 40 mg per day from the first dose, and in certain respects, the third dose is increased by no more than 40 mg per day from the second dose.

[00307] In another aspect, the present invention provides a method of treating a disease or condition related to aberrant function or activity of a T-type calcium channel in an individual in need, the method comprising administering (for example, once, twice, three times) daily to the individual a maximum of about 120 mg (for example, from about 5 mg to about 120 mg, from about 10 mg to about 120 mg, from about 15 mg to about 120 mg, from about 20 mg to about 120 mg, from about 40 mg to about Petition 870250101458, dated 05 / 11 / 2025, pp. 133 / 254 128 / 211 120 mg, from about 5 mg to about 100 mg, from about 10 mg to about 100 mg, from about 15 mg to about 100 mg, from about 20 mg to about 100 mg, from about 40 mg to about 100 mg, from about 5 mg to about 80 mg, from about 10 mg to about 80 mg, from about 15 mg to about 80 mg, from about 20 mg to about 80 mg, from about 40 mg to about 80 mg, from about 5 mg to about 60 mg, from about 10 mg to about 60 mg, from about 15 mg to about 60 mg, from about 20 mg to about 60 mg, or from about 40 mg to about 60 mg) of the compound of Formula (I) or a salt pharmaceutically acceptable of the same (for example, the compound of Formula (II)).

[00308] In another aspect, the present invention provides a method for treating a disease or condition related to aberrant function or activity of T-type calcium channels in an individual in need, the method comprising: (a) administer to the individual once daily for an initial period (e.g., 3, 4, 5, 6, 7, 8 or 9 days), 5 mg of the compound of formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II)); (b) administer to the individual once daily for a second period (for example, 3, 4, 5, 6, 7, 8 or 9 days), 10 mg of the compound of formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)); and (c) administer to the individual once daily for a third period (for example, 3, 4, 5, 6, 7, 8 or 9 days), 20 mg of the compound of formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)).

[00309] In another aspect, the present invention provides a method of treating a disorder in an individual in need, the method comprising: Petition 870250101458, dated 05 / 11 / 2025, pp. 134 / 254 129 / 211 (a) administer to the individual for an initial period (e.g., 3, 5, 6, 7, 8 or 9 days), 20-40 mg per day of the compound of formula (I) or a pharmaceutically acceptable salt thereof (e.g., compound of Formula (II)); (b) administer to the individual for a second period (for example, 3, 5, 6, 7, 8 or 9 days), 20-60 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)); and (c) administer to the individual for a third period (for example, 3, 4, 5, 6, 7, 8 or 9 days), 20-80 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)).

[00310] In some embodiments, the method further comprises (d) administering to the individual for a fourth period (for example, 3, 4, 5, 6, 7, 8 or 9 days), 20-100 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)).

[00311] In other embodiments, the method further comprises (e) administering to the individual for a fifth period (for example, 3, 4, 5, 6, 7, 8 or 9 days), 20-120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)).

[00312] In certain embodiments, the method further comprises (f) administering to the individual for the sixth period (for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 days), 20-120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)).

[00313] In certain modalities, the method further comprises (g) administering to the individual for the seventh period (for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or more days), 20-120 mg per day of the compound Petition 870250101458, dated 05 / 11 / 2025, pp. 135 / 254 130 / 211 to Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II)).

[00314] In certain aspects of these modalities, a physician may choose not to continue escalating the dose of the Formula (I) compound or a pharmaceutically acceptable salt thereof, so that the dosing periods may be less than the seven periods described above. For example, there may be only 1, 2, 3, 4, 5, or 6 periods of increasing doses needed to achieve a desired therapeutic effect. There may also be more than the seven dose escalation periods described above, as warranted by the individual's tolerance and the physician's judgment.

[00315] For example, in certain embodiments, a method of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need is disclosed comprising (a) administering to the individual for a first period ranging from about 3 to about 9 days, about 5 mg to about 40 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof, such as 20 mg or 40 mg per day; (b) administering to the individual for a second period ranging from about 3 to about 9 days, about 10 mg to about 100 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, such as 40 mg, 60 mg or 80 mg per day; and (c) administering to the individual for a third period ranging from about 3 to about 9 days, about 20 mg to about 120 mg per day of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, such as 60 mg, 80 mg, 100 mg or 120 mg per day.

[00316] In certain respects, a method of treatment for a disease or condition related to aberrant function or activity of T-type calcium channels in an individual in need is disclosed in this document, comprising (a) administering an initial dose of Petition 870250101458, dated 05 / 11 / 2025, pp. 136 / 254 131 / 211 about 20 mg to about 40 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof to an individual once daily for an initial period of time; (b) increasing the amount of the compound in the initial dose and administering one or more increased doses of the compound to the individual to reach a maximum titrated dose of about 80 mg to about 120 mg per day; and (c) administering the maximum titrated dose to the individual once daily as needed.

[00317] In related embodiments, the dosage of the Formula (I) compound may be adjusted up or down in increments of 1, 2, 3, 4, 5, 10, 15, 20 mg, as deemed necessary by a physician, depending on an individual's response to previous dosages of the Formula (I) compound.

[00318] In various embodiments of the invention, the methods disclosed in this document comprise (a) administering a first dose of 20 mg per day for a first period of 3 days, (b) administering a second dose of 40 mg per day for a second period of 3 days, (c) administering a third dose of 60 mg per day for a third period of 7 days; (d) administering a fourth dose of 80 mg per day for a fourth period of 7 days; (e) administering a fifth dose of 100 mg per day for a fifth period of 7 days; and (f) thereafter administering a sixth dose of 120 mg per day, as needed.In several other embodiments, the methods disclosed in this document comprise (a) administering a first dose of 20 mg per day for an initial period of 3 days, (b) administering a second dose of 40 mg per day for a second period of 3 days, (c) administering a third dose of 80 mg per day for a third period of 3 days; and (d) administering a fourth dose of 120 mg per day, as needed. Petition 870250101458, dated 05 / 11 / 2025, pp. 137 / 254 132 / 211

[00319] In certain embodiments, a method of treating a disease or condition related to aberrant function or activity of T-type calcium channels in an individual in need is disclosed comprising (a) administering to the individual for a first period of 3 days about 20 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period of about 3 days about 40 mg per day of the compound; (c) administering to the individual for a third period of about 3 days about 60 mg per day of the compound; (d) administering to the individual for a fourth period of about 3 days about 80 mg per day of the compound; (e) administering to the individual for a fifth period of about 3 days about 100 mg per day of the compound; and (f) administering to the individual for a sixth period of about 120 mg per day of the compound. Instead of every 3 days, doses can also be administered every 4, 5, or 6 days.

[00320] Also disclosed in this document is a method of treating a disease or condition related to aberrant function or activity of T-type calcium channels in an individual in need comprising (a) administering to the individual for a first period of 7 days about 20 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period of about 7 days about 40 mg per day of the compound; (c) administering to the individual for a third period of about 7 days about 60 mg per day of the compound; (d) administering to the individual for a fourth period of about 7 days about 80 mg per day of the compound; (e) administering to the individual for a fifth period of about 7 days about 100 mg per day of the compound; and (f) administering to the individual for a sixth period of about 120 mg per day of the compound.

[00321] In certain modalities, a treatment method is disclosed. Petition 870250101458, dated 05 / 11 / 2025, pp. 138 / 254 133 / 211 treatment of a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need comprising (a) administering to the individual for a first period of 3 days about 40 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period of about 3 days about 80 mg per day of the compound; and (c) administering to the individual for a third period about 120 mg per day of the compound. Instead of every 3 days, doses may also be administered every 4, 5 or 6 days.

[00322] Also disclosed in this document is a method of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need comprising (a) administering to the individual for a first period of 7 days about 40 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period of about 7 days about 80 mg per day of the compound; and (c) administering to the individual for a third period about 120 mg per day of the compound.

[00323] In certain embodiments, a method of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need is disclosed comprising (a) administering to the individual for a first period of 7 days about 20 mg per day of a compound of Formula (I) or a pharmaceutically acceptable salt thereof; (b) administering to the individual for a second period of about 7 days about 40 mg per day of the compound; (c) administering to the individual for a third period of about 7 days about 60 mg per day of the compound; (d) administering to the individual for a fourth period of about 7 days about 80 mg per day of the compound; (e) administering to the individual for a fifth period of about 7 days about 100 mg per day of the compound; (f) Petition 870250101458, dated 05 / 11 / 2025, pp. 139 / 254 134 / 211 administer to the individual for a sixth period of approximately 14 days approximately 120 mg per day of the compound; and (g) thereafter administer to the individual approximately 1-120 mg per day of the compound, as needed.

[00324] In certain modalities of the methods of treating a disease or condition related to aberrant function or activity of a type T calcium channel in an individual in need, a physician may choose to stop escalating the dose of the compound of Formula (I) or a pharmaceutically acceptable salt thereof once the individual has demonstrated the desired therapeutic effect. At this point, the physician may choose that the individual continue the dose that the individual has been taking to achieve the desired therapeutic effect or may choose that the individual decrease the dose of the compound of Formula (I) or a pharmaceutically acceptable salt thereof in order to maintain the desired therapeutic effect. Achieving the desired therapeutic effect may result from improvements in any therapeutic measure, for example, the individual's TETRA performance score, accelerometer performance score, or Archimedes spiral task test.

[00325] In some forms, the individual is a human being aged from birth to 100 years of age, such as 10 to 90 years, 20 to 70 years, 18 to 55 years or 55 to 75 years of age.

[00326] In several respects, the methods disclosed in this document result in a reduction of the EEG sigma frequency band during NREM sleep in the individual, such as a reduction of the NREM sigma frequency band from an initial assessment of approximately 0.4 to 0.7, such as approximately 0.5 to approximately 0.6, or approximately 0.5. In certain modalities, the methods disclosed in this document result in a reduction of the EEG gamma frequency band during awakening in an EO condition or a condition Petition 870250101458, dated 05 / 11 / 2025, pp. 140 / 254 135 / 211 of the individual's EC, such as a reduction in the gamma frequency band compared to a reference gamma frequency band of at least about 25%, such as, for example, about a 50% reduction.

[00327] In certain embodiments, the methods disclosed in this document result in a reduction of the EEG sigma frequency during NREM sleep and / or a reduction of the EEG gamma frequency band during an EO or EC condition in the individual when the individual receives a dosage of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, resulting in a Cmax of about 30 ng / mL to about 470 ng / mL, such as a Cmax ranging from about 30 to about 50 ng / mL, from about 80 to about 130 ng / mL, from about 130 to about 222 ng / mL, from about 180 to about 300 ng / mL, from about 230 to 380 ng / mL or from about 280 to about 470 ng / mL.In certain embodiments, the methods disclosed in this document result in a reduction in EEG sigma frequency during NREM sleep and / or a reduction in EEG gamma frequency band during an EO or EC condition in the individual when the individual receives a dosage of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, resulting in an AUC24 ranging from about 490 ng*h / mL to about 5800 ng*h / mL, such as an AUC24 ranging from about 490 to 820 ng*h / mL, from about 1220 to 2030 ng*h / mL, from about 2000 to 3330 ng*h / mL, from about 2440 to 4070 ng*h / mL, from about 2820 to 4700 ng*h / mL, or from about 3480 to 5800 ng*h / mL.

[00328] In certain embodiments, the methods disclosed in this document result in a reduction in sigma frequency of NREM in the individual when the individual receives a dosage of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, resulting in a Cmax of about 5 ng / mL to about 470 ng / mL, such Petition 870250101458, dated 05 / 11 / 2025, pp. 141 / 254 136 / 211 as a Cmax of about 180 to about 300 ng / mL. In certain embodiments, the methods disclosed in this document result in a reduction in NREM sigma frequency in the individual when the individual receives a dosage of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, resulting in a mean plasma concentration (Cave) during EEG recording (i.e., over a period of about 24 hours) of about 10 ng / mL to about 200 ng / mL, such as a Cave of about 12 to about 150 ng / mL. In certain embodiments, the methods disclosed in this document result in a reduction of the gamma frequency band with EO or EC in the individual when the individual receives a dosage of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, resulting in a Cmax of the compound of approximately, such as a Cmax of approximately 280 to approximately 470 ng / mL.In certain embodiments, the methods disclosed in this document result in a reduction of the gamma frequency band with EO or EC in the individual when the individual receives a dosage of the compound of Formula (I) or a pharmaceutically acceptable salt thereof, resulting in a plasma concentration of about 75 ng / mL to about 310 ng / mL, such as a plasma concentration of about 90 to about 190 ng / mL.

[00329] In other embodiments, the disease or condition related to aberrant function or activity of a T-type calcium channel is selected from the group consisting of psychiatric disorders (e.g., mood disorder (e.g., major depressive disorder)), pain, tremor (e.g., essential tremor), seizures (e.g., absence seizures), and epilepsy or an epilepsy syndrome (e.g., juvenile myoclonic epilepsy).

[00330] In certain aspects of all the titrated dosing schedule modalities disclosed in this document, it is possible to increase the maximum titrated dose, including, for example, increasing the Petition 870250101458, dated 05 / 11 / 2025, pp. 142 / 254 137 / 211 maximum titrated dose above 120 mg in one or more additional titration steps, provided the individual is able to safely tolerate the higher dose.

[00331] In certain aspects of all embodiments of the titrated dosage schedules disclosed in this document, the maximum titrated dosage achieved is greater than 20 mg, greater than 40 mg, greater than 60 mg, such as approximately 80 mg, approximately 100 mg, approximately 120 mg, approximately 130 mg, approximately 140 mg, approximately 150 mg, approximately 160 mg, approximately 170 mg, approximately 180 mg, approximately 190 mg, approximately 200 mg, approximately 210 mg or approximately 220 mg. In certain aspects of the invention, the maximum dosage achieved for an individual is, for example, 40 mg, 60 mg or 80 mg if the individual has achieved a desired therapeutic outcome.

[00332] In certain aspects of all embodiments of the titrated dosing schedules disclosed in this document, the maximum titrated dosage is achieved in 42 days or less, such as 31 days or less, 28 days or less, 18 days or less, 10 days or less, or 7 days or less. In certain embodiments, the maximum titrated dosage is achieved in approximately 10 to approximately 42 days, such as, for example, approximately 36-42 days, approximately 22-28 days, approximately 16-18 days, or approximately 10-12 days. Administrations

[00333] In some modalities, the dosage form is administered to the individual more than once a day (for example, twice a day, three times a day, or four times a day).

[00334] In some embodiments, the dosage form is administered to the individual once daily (for example, one 5 mg tablet once daily, one 10 mg tablet once daily, one 20 mg tablet once daily, one 40 mg tablet once daily, one 80 mg tablet once daily or one tablet Petition 870250101458, dated 05 / 11 / 2025, pp. 143 / 254 138 / 211 of 120 mg once daily). In some embodiments, the dosage form is administered to the individual twice daily (e.g., one 5 mg tablet twice daily, one 10 mg tablet twice daily, one 20 mg tablet twice daily, one 40 mg tablet twice daily, one 80 mg tablet twice daily, or one 120 mg tablet twice daily).

[00335] In some embodiments, the dosage form is administered to the individual once daily (e.g., one 20 mg tablet daily, two 20 mg tablets daily, three 20 mg tablets daily, four 20 mg tablets daily, five 20 mg tablets daily, or six 20 mg tablets daily).In some formulations, the dosage form is administered to the individual twice daily (for example, one 10 mg tablet twice daily, one 20 mg tablet twice daily, two 20 mg tablets twice daily, three 20 mg tablets twice daily, four 20 mg tablets twice daily, five 20 mg tablets twice daily, or six 20 mg tablets twice daily).

[00336] In some modalities, the dosage form is administered to the individual on alternate days. In other modalities, the dosage form is administered to the individual once a week or twice a week.

[00337] In some embodiments, the methods of the present invention comprise administering to a needy individual a titrated dose of the compound of formula (I) or (II). In some embodiments, the maximum titrated dose is 60 mg per day or 100 mg per day. In one embodiment, the maximum titrated dose is 60 mg per day.

[00338] In certain embodiments, about 1 mg to 10 mg, such as 2 mg to 5 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), per Petition 870250101458, dated 05 / 11 / 2025, pp. 144 / 254 139 / 211 example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, about 1 mg to 20 mg, such as 5 mg to 10 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is administered to the individual daily. In certain embodiments, about 1 mg to 30 mg, such as 10 mg to 20 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is administered to the individual daily. In certain embodiments, approximately 1 mg to 40 mg, such as 20 mg to 30 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily.In certain embodiments, about 1 mg to 50 mg, such as 30 mg to 40 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, about 1 mg to 60 mg, such as 40 mg to 50 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, about 1 mg to 70 mg, such as 50 mg to 60 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, approximately 1 mg to 80 mg, such as 60 mg to 70 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily.In certain embodiments, about 1 mg to 90 mg, such as 70 mg to 80 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., Petition 870250101458, dated 05 / 11 / 2025, pp. 145 / 254 140 / 211 the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, about 1 mg to 100 mg, such as 80 mg to 90 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, about 1 mg to 110 mg, such as 90 mg to 100 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily. In certain embodiments, approximately 1 mg to 120 mg, such as 100 mg to 110 mg, of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl) is administered to the individual daily.

[00339] In some embodiments, the dosage form, when administered to the individual, has substantially the same bioavailability, for example, in relation to the rate (maximum plasma drug concentration; Cmax) and extent (area under the plasma concentration-time curve; AUC) of absorption of PRAX944 compared to several small, round 20 mg tablets.

[00340] In some embodiments, the dosage form, after administration to the individual, has a reduced Cmax value compared to a reference oral dosage form (e.g., a dosage form with any intended rate-release profile, e.g., modified rate-release profile, a dosage form that does not have a modified rate-release profile, a dosage form that does not have a modified-release polymer, e.g., an HPMC polymer). In some embodiments, the dosage form, after administration to the individual, has a higher tmax value than a reference oral dosage form (e.g., Petition 870250101458, dated 05 / 11 / 2025, pages 146 / 254 141 / 211 a dosage form with any intended release rate profile, for example, a modified release rate profile, a dosage form that does not have a modified release rate profile, a dosage form that does not have a modified release polymer, for example, an HPMC polymer). Tremor

[00341] The methods described in this document can be used to treat tremor, for example, a dosage or composition disclosed in this document can be used to treat cerebellar tremor or intention tremor, dystonic tremor, essential tremor, orthostatic tremor, parkinsonian tremor, physiological tremor or rubral tremor. Tremor includes hereditary, degenerative and idiopathic disorders, such as Wilson's disease (hereditary), Parkinson's disease (degenerative) and essential tremor (idiopathic); metabolic diseases; peripheral neuropathies (associated with complex regional pain syndrome, Charcot-Marie-Tooth, Roussy-Levy, diabetes mellitus); toxins (nicotine, mercury, lead, carbon monoxide, manganese, arsenic, toluene); Drug-induced (tricyclic neuroleptics, lithium, cocaine, alcohol, adrenaline, bronchodilators, theophylline, caffeine, steroids, valproate, amiodarone, thyroid hormones, vincristine); and psychogenic disorders.Clinical tremor can be neuropathic tremor, and can be classified into physiological tremor, potentiated physiological tremor, essential tremor syndromes (including classic essential tremor), primary orthostatic tremor, task- and position-specific tremor, dystonic tremor, parkinsonian tremor, cerebellar tremor, Holmes tremor (i.e., rubral tremor), palatal tremor, neuropathic tremor, drug-induced tremor, and psychogenic tremor. Tremor can be familial tremor.

[00342] Tremor is a rhythmic and involuntary oscillation of one or more parts of the body (for example, hands, arms, eyes, face, head, Petition 870250101458, dated 05 / 11 / 2025, pages 147 / 254 142 / 211 vocal folds, trunk and / or legs).

[00343] Cerebellar tremor or intention tremor is a slow, broad tremor of the extremities that occurs after an intentional movement. Cerebellar tremor is caused by lesions or damage to the cerebellum or pathways resulting, for example, from a tumor, stroke, or other focal lesion disease (e.g., multiple sclerosis) or a neurodegenerative disease.

[00344] Dystonic tremor occurs in individuals affected by dystonia, a movement disorder in which sustained involuntary muscle contractions cause twisting and repetitive movements and / or painful and abnormal postures or positions. Dystonic tremor can affect any muscle in the body. Dystonic tremors occur irregularly and can often be relieved by complete rest or certain sensory maneuvers.

[00345] Essential tremor, or benign essential tremor, is the most common type of tremor. Essential tremor can be mild and non-progressive in some, and it can be slowly progressive, starting on one side of the body but usually affecting both sides. The hands are most frequently affected, but the head, voice, tongue, legs, and trunk can also be involved. The frequency of tremors may decrease as a person ages, but the severity can also increase. Heightened emotion, stress, fever, physical exhaustion, or low blood sugar can trigger tremors and / or increase their severity. Symptoms usually develop over time and may be noticeable and persistent after onset. Tremors, including essential tremor, can interfere with any or all of a person's daily activities, such as personal hygiene, cooking, eating, dressing, doing home repairs, and interacting with others.Tremors, including essential tremor, can interfere with career choice or performance. Petition 870250101458, dated 05 / 11 / 2025, pages 148 / 254 143 / 211 of work (for example, typing on a computer or cell phone, using tools, sewing, working in a restaurant (cooking or serving), caring for others (medical or veterinary work), or any job that requires movement can be difficult). Tremors can also have profound emotional effects, such as fear of the tremor being discovered, fear of other people's reactions, or fear of rejection.

[00346] Orthostatic tremor is characterized by rapid rhythmic muscle contractions (e.g., greater than 12 Hz) that occur in the legs and trunk immediately after standing. Cramps are felt in the thighs and legs, and the patient may tremble uncontrollably when asked to stand in one place. Orthostatic tremor can occur in patients with essential tremor.

[00347] Parkinson's tremor is caused by damage to the structures within the brain that control movement. Parkinson's tremor is typically seen as a pill-rolling action of the hands that can also affect the chin, lips, legs, and trunk. The onset of Parkinsonian tremor typically begins after age 60. The movement dysfunction usually starts in one limb or on one side of the body and may progress to include the other side.

[00348] Rubral tremor is characterized by a coarse, slow tremor that may be present at rest, in posture, and with intention. The tremor is associated with conditions affecting the red nucleus in the midbrain, such as a stroke.

[00349] In some modalities, the tremor is selected from essential tremor, Parkinson's tremor, or cerebellar tremor. In some modalities, the tremor is essential tremor. Essential Tremor

[00350] The compositions described in this document are useful in the treatment of essential tremor (ET). ET is a movement disorder. Petition 870250101458, dated 05 / 11 / 2025, pages 149 / 254 144 / 211 of adults is the most common, affecting up to 2% of the United States population (approximately 7 million Americans) (Louis and Ottman 2014). ET is characterized by postural and kinetic tremor of 5 to 12 Hz (i.e., tremor during voluntary movement) in the upper limbs (Bhidayasiri 2005, Louis 2009). The most characteristic clinical feature is kinetic tremor of the arms and hands, but tremor can also occur in the head and voice and, less commonly, in the face, legs, and trunk. The diagnosis of ET is based on medical history and neurological examination, as described in the International Parkinson and Movement Disorders Society Consensus Statement on the Classification of Tremors (Bhatia et al 2018).

[00351] There is a range of severity in ET; some patients do not require treatment, while others have severe disability with impairment in activities of daily living, such as dressing and eating. ET, by definition, is generally not associated with other neurological signs (Deuschl et al 2011), although there is growing recognition that ET may also be associated with additional motor features such as postural instability, dystonia, mild to moderate gait ataxia, and eye movement abnormalities (Louis 2009). ET is also associated with a high prevalence of comorbid psychiatric disorders, including anxiety and depression (Dogu et al 2005, Miller et al 2007). ET often worsens over time, with more severe tremor over years to decades and a corresponding worsening of disability (Louis 2019).

[00352] ET can be sporadic, but a family history of an autosomal dominant inheritance pattern is commonly found (Clark and Louis 2018) and, more importantly, variants in the voltage-dependent calcium channel alpha1G subunit gene (CACNA1G), which encodes the Cav3.1 T-type Ca2+ channel isoform, have been identified as the cause of ET in at least 3 families (Od Petition 870250101458, dated 05 / 11 / 2025, pages 150 / 254 145 / 211 (Gerel et al 2019). The importance of the CACNA1G gene for cerebellar development and function is further highlighted by the observation that variants in this gene can also cause cerebellar atrophy in childhood (Chemin et al 2018) and spinocerebellar ataxia type 42 (Coutelier et al 2015). The functional consequences of these genetic variants are consistent with the expression of T-type Ca2+ channels in the cerebellum and distal CTC circuit and their physiological contribution to oscillatory firing in the thalamus that is synchronized with, and, according to sponsor hypotheses, leads to clinically observable tremor (Milosevic et al 2018).

[00353] Propranolol is the only orally administered treatment approved by the U.S. Food and Drug Administration (FDA) for the treatment of ET. Propranolol was originally developed for hypertension and, in the treatment of ET, has limited efficacy with side effects (e.g., bradycardia) that frequently lead to discontinuation (Hedera 2017, Louis 2015). The unmet medical need in ET has resulted in the off-label use of medications in various drug classes, including anticonvulsants, barbiturates, benzodiazepines, antipsychotics, and others, with limited appreciable therapeutic benefit for patients with ET. A recent evidence-based review concluded that only propranolol, primidone, and topiramate had sufficient evidence to support efficacy among 28 drugs studied for ET (Ferreira et al 2019).Surgical interventions that interrupt CTC disruption activity, such as deep brain stimulation or focused ultrasound, are effective treatments for ET, but carry risks such as sensory disturbances, hemiparesis, dysarthria, ataxia, gait disturbances, delirium, cognitive decline, tissue damage, venous thromboembolic events, and intracerebral hemorrhage (Dallapiazza et al 2019, Insightec, Inc. 2016). Petition 870250101458, dated 05 / 11 / 2025, pages 151 / 254 146 / 211

[00354] In some embodiments, the present invention also provides a method of treating essential tremor comprising administering to an individual in need a composition described in this document. In some embodiments, the method results in a reduction of essential tremor as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) score. The term Essential Tremor Rating Assessment Scale (TETRAS), as used in this document, refers to a scale developed to quantify the severity of essential tremor and its impact on daily activities. It has an Activities of Daily Living (ADL) section and a Performance section. The ADL section has 12 items rated between 0 and 4, and the Performance section has 9 items rated between 0 and 4.

[00355] In some modalities, the reduction of essential tremor is evaluated by the upper limb score of The Essential Tremor Rating Assessment Scale (TETRAS).

[00356] In some modalities, the reduction of essential tremor is assessed by the score on the TETRAs performance subscale or individual TETRAs performance items.

[00357] In some embodiments, individuals treated according to the methods provided by the present invention have moderate essential tremor (i.e., a TETRAS score of 10-15). In some embodiments, the individuals treated in this document have a TETRAS score of about 10 to about 15, or a TETRAS score of about 12, before treatment according to the methods of the present invention. Treatment using a composition described in this document can reduce the individual's TETRAS score. In some embodiments, individuals treated with a composition described in this document experience an average reduction in the TETRAS score of about 2 to 5, for example, about 3. In some Petition 870250101458, dated 05 / 11 / 2025, pp. 152 / 254 147 / 211 but modalities, individuals treated with a composition described in this document experience an average reduction in the TETRA score of about 30% to about 50%, for example, about 40%.

[00358] In some embodiments, the present invention also provides a method for treating essential tremor comprising administering to an individual in need a composition described in this document. In some embodiments, the method results in a reduction of essential tremor, as assessed by accelerometer-based scoring, for example, accelerometer-based upper limb scoring. In some embodiments, the method results in a reduction of essential tremor, as assessed by CGI scoring.

[00359] In some modalities, the essential tremor is the tremor of the upper limb.

[00360] In some modalities, individuals are selected for treatment with the compound of formula (I) due to a clinical diagnosis of essential tremor. In some modalities, individuals selected for treatment with the compound of formula (I) have essential tremor but do not exhibit intention tremor.

[00361] The efficacy of the compound or composition described in this document for treating essential tremor can be measured by the methods described in the technique, such as the methods described in the following references: Ferreira, JJ et al., MDS Evidence-Based Review of Treatments for Essential Tremor, Mov. Disord. July 2019; 34(7):950-958; Elble, R. et al., Task Force Report: Scales for Screening and Evaluating Tremor, Mov. Disord. November 2013; 28(13):179-3800; Deuschl G. et al., Treatment of patients with essential tremor, Lancet Neurol. 2011; 10:148-61; and Reich SG et al., Essential Tremor, Med. Clin. N. Am. 2019; 103:351-356. Disclosures of Petition 870250101458, dated 05 / 11 / 2025, pages 153 / 254 148 / 211 references are incorporated into this document in their entirety.

[00362] In some modalities, the methods described in this document result in at least a 25% reduction in upper limb tremor score, where tremor score can be converted to amplitude, compared to an initial assessment. For example, in certain modalities, the methods described in this document result in approximately a 40% average reduction in tremor amplitude, as measured by the upper limb score of the Essential Tremor Rating Assessment Scale (TETRAS), described, for example, in Elble, RJ, The Essential Tremor Rating Assessment Scale, J. Neurol. Neuromed. 2016; 1(4):34-38. In some modalities, the methods described in this document result in at least a 25% reduction in the TETRAS performance score compared to the initial assessment.In some modalities, the methods described in this document result in at least a 35% average reduction in symptom severity compared to the initial assessment, as measured by the TETRAS performance score. Parkinson's disease

[00363] The compositions described in this document are useful in the treatment of Parkinson's disease (PD). PD is a debilitating neurodegenerative disorder with approximately 1 million diagnosed patients in the United States (US) and approximately 10 million worldwide. Approximately 60,000 patients are diagnosed with PD each year in the US alone (Marras et al 2018). The diagnosis of PD is most often made based on medical history and neurological examination, as described in the Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al 2015) of the International Parkinson and Movement Disorders Society (MDS).

[00364] PD is characterized by slow movement (bradykinesia), in combination with resting tremor (4-6 Hz) and / or rigidity (postuma). Petition 870250101458, dated 05 / 11 / 2025, pages 154 / 254 149 / 211 et al 2015). Symptoms are typically unilateral at onset, mild, and non-disabling, but progress over time in severity and involve both sides of the body, often impairing activities of daily living (ADLs) such as dressing and eating. In addition to the cardinal symptoms above, patients with PD may develop abnormal posture (dystonia), severe forward flexion of the thoracolumbar spine (camptocormia), slurred speech (dysarthria), gait instability, and freezing of gait. Non-motor symptoms such as impaired smell, dream re-enactment behavior (sleep behavior disorder [RPD]), rapid eye movement [REM] sleep behavior disorder, constipation, depression, psychosis, and dementia also play a key role in the daily lives of patients with PD (Jankovic and Tan 2020).

[00365] Because the degeneration of dopaminergic neurons in the substantia nigra pars compacta (SNc) of PD patients results in the loss of dopaminergic output, the mainstay of treatment for PD is dopamine replacement therapy (Armstrong and Okun 2020). L-dopa or levodopa, a dopamine replacement formulation, is considered the gold standard treatment for PD. Levodopa is highly effective in improving the motor symptoms of bradykinesia and rigidity, particularly in the early stages of the disease, but has a variable impact on tremor. Most other common PD medications primarily reduce dopamine metabolism or are dopamine receptor agonists.

[00366] Although effective, the side effects of chronic dopaminergic therapy include motor complications (dyskinesias or involuntary choriform movements), impulse control disorders, and psychosis (Poewe et al 2017). These adverse effects themselves can be disabling, often requiring medication to counteract the adverse effects. Thus, symptom control using therapy Petition 870250101458, dated 05 / 11 / 2025, pages 155 / 254 150 / 211 as non-dopaminergic drugs have a better safety and tolerability profile and are necessary.

[00367] Adjunctive oral non-dopaminergic therapies that relieve PD symptoms could also reduce the need for dose escalation of dopaminergic therapies.

[00368] Surgical therapy, namely deep brain stimulation (DBS), can be very successful for uncontrolled tremors and motor complications and typically affects the function of the basal ganglia downstream of the nigrostriatal pathway (Fasano et al 2012). Depending on the patient's specific symptoms, DBS electrodes can be placed in the globulus pallidus internus, thalamic ventral intermediate nucleus, or subthalamic nucleus (STN) and can affect aberrant rupture burning in these areas (see below). DBS is typically reserved for patients who respond to but have maximized dopaminergic therapy and continue to present with troubling motor symptoms. Furthermore, DBS presents significant risks associated with brain surgery, including intracerebral hemorrhage, infection, hemiparesis, and cognitive decline (Pahwa et al 2006).The prospect of neuromyelitis in later years is often anxiety-inducing or contraindicated (e.g., due to the presence of cognitive impairment), and many patients are not treated with DBS. Thus, there is a clinical need for a pharmacological therapy that can mimic the effects of DBS. By modulating T-type Ca2+ channels, PRAX-944 may modulate continuous firing downstream of SNc degeneration.

[00369] Animal models and patient data from human PD demonstrate that degeneration of nigral dopaminergic neurons converts the downstream STN of a tonic firing pattern into an aberrant disruption phenotype (Ammari et al 2011, Tai et al 2011, Pan et al 2016). This disruption activity drives the symptoms of bradykinesia and rigidity. Petition 870250101458, dated 05 / 11 / 2025, pages 156 / 254 151 / 211 in animal models, and blocking T-type Ca2+ channels has been shown to reduce this phenotype (Tai et al 2011, Yang et al 2014, Pan et al 2016). T-type Ca2+ channels are widely expressed throughout the brain, including in the STN (Talley et al 1999, Weiss and Zamponi 2019). Eliminating this burst-burn through blocking T-type Ca2+ channels has been shown to improve motor function in a rat PD model with 6-hydroxydopamine (Pan et al 2016). Thus, a T-type Ca2+ channel inhibitor could offer a non-surgical and non-dopaminergic treatment option to alleviate motor symptoms in PD. Epilepsy and Epilepsy Syndromes

[00370] The compositions described in this document are useful in the treatment of epilepsy and epilepsy syndromes. Epilepsy is a disorder of the central nervous system in which the activity of nerve cells in the brain is disrupted, causing recurrent seizures that can manifest as abnormal movements, periods of unusual behavior, sensations, and sometimes loss of consciousness. Seizure symptoms vary widely, from a simple blank stare for a few seconds to repeated contractions of the arms or legs during a seizure.

[00371] Epilepsy can involve a generalized seizure, involving multiple areas of the brain, or a partial or focal seizure. All areas of the brain are involved in a generalized seizure. A person experiencing a generalized seizure may cry or make some sound, stiffen for several seconds to a minute, and then have rhythmic movements of their arms and legs. The eyes may remain open, and / or the person may appear not to be breathing and their suit may turn blue. Return to consciousness may be gradual, and the person may remain confused for minutes to hours. The following are the main types of generalized seizures: tonic seizures Petition 870250101458, dated 05 / 11 / 2025, pp. 157 / 254 152 / 211 clonic, tonic, clonic, myoclonic, myoclonic-tonic-clonic, myoclonic-atonic, atonic and absence seizures (atypical, atypical, myoclonic, myoclonic-clonic seizures) and epileptic spasms. In a partial or focal seizure, only part of the brain is involved, so only part of the body is affected. Depending on the part of the brain that shows abnormal electrical activity, the symptoms may vary.

[00372] Epilepsy, as described in this document, includes generalized partial, complex partial (e.g., seizures involving only part of the brain, but where consciousness is impaired), clonic tonic, clonic tonic, refractory seizures, status epilepticus, absence seizures, febrile seizures, or temporal lobe epilepsy.

[00373] The compositions described in this document may also be useful in the treatment of epilepsy syndromes. Severe syndromes caused by diffuse brain dysfunction, at least in part due to some aspect of epilepsy, are also called epileptic encephalopathies. They are associated with frequent seizures that are resistant to treatment and severe cognitive dysfunction, for example, West syndrome.

[00374] In some modalities, the epilepsy syndrome comprises epileptic encephalopathy, Dravet syndrome, Angelman syndrome, CDKL5 disorder, frontal lobe epilepsy, infantile spasms, West syndrome, juvenile myoclonic epilepsy, Landau-Kleffner syndrome, Lennox-Gastaut syndrome, Ohtahara syndrome, PCDH19 epilepsy, or Glut1 deficiency. In some modalities, the epilepsy syndrome is childhood absence epilepsy (CAE). In some modalities, the epilepsy syndrome is juvenile absence epilepsy (JAE). In some modalities, the epilepsy syndrome is Lennox-Gastaut syndrome. In some modalities, the Petition 870250101458, dated 05 / 11 / 2025, pages 158 / 254 153 / 211 epilepsy syndrome is SLC6A1 epileptic encephalopathy. In some forms, the epilepsy syndrome is associated with mutations in genes encoding T-type calcium channels (e.g., CACNA1G, EEF1A2, and GABRG2 for genetic generalized epilepsy (GGE) and LGI1, TRIM3, and GABRG2 for non-acquired focal epilepsy (NAFE)), as discussed, for example, in Feng, YCA, et al., Ultra-Rare Genetic Variation in the Epilepsies: A Whole-Exome Sequencing Study of 17,606 Individuals, Am. J. Human Gen. 2019; 105(2):267-282. In some forms, the epilepsy syndrome is Doose syndrome or myoclonic astatic epilepsy. In some forms, the epilepsy syndrome is continuous peak-wave sleep-disordered epileptic encephalopathy (CSWS). In some forms, the epilepsy syndrome is Landau-Kleffner syndrome (LKS). In some forms, the epilepsy syndrome is Jeavons syndrome. Absence Seizures

[00375] Absence seizures are one of the most common types of seizures in patients with idiopathic generalized epilepsy (IGE) (Berg et al., Epilepsy 2000). Absence seizures are relatively brief, non-convulsive seizures characterized by the abrupt onset of loss of consciousness and responsiveness, generally lasting between 10-30 seconds, with a rapid return to normal consciousness without postictal confusion. The seizures are characterized on an accompanying EEG recording by the abrupt onset and shift of generalized 1-6 Hz (e.g., 3 Hz) wave spikes and discharges. Absence seizures typically occur several times a day, disrupt learning and psychosocial functioning, and present a risk of injury due to frequent episodes of loss of consciousness. Typically, absence seizures begin in early childhood and remit in adolescence. However, in a minority of patients, they persist into adulthood. Petition 870250101458, dated 05 / 11 / 2025, pages 159 / 254 154 / 211 where they are generally drug-resistant and may be accompanied by other types of seizures, such as generalized tonic-clonic seizures. In these adult patients, absence seizures are usually highly disabling, particularly due to the disqualification of the sufferer from obtaining a driver's license or pursuing occupations and hobbies where the periods of loss of consciousness associated with seizures represent a safety risk and are associated with significant psychosocial impairments (Wirrell et al., 1997).

[00376] Although there is a common perception that absence seizures are relatively easy to treat, a randomized controlled clinical trial in patients with childhood absence epilepsy showed that even the most effective antiepileptic drugs, ethosuximide and valproate, only completely controlled seizures in 53% and 58% of patients, respectively, at 16 weeks, as assessed by video-EEG recordings (Glauser et al., 2010), and 45% and 44%, respectively, at 12 months (Glauser et al., 2013). Lamotrigine, the other commonly used AED to treat absence seizures, only controlled seizures in 29% of patients at 16 weeks and 21% of patients at 12 months. Furthermore, both ethosuximide and valproate are commonly associated with intolerable side effects (occurring in 24% of patients treated with either of these drugs) (Glauser et al.(2010), and the latter is now considered contraindicated in girls and women of childbearing potential. Other treatment options for absence seizures are limited, with only benzodiazepines having established efficacy, and these are generally poorly tolerated due to sedative and cognitive side effects. Persistent absence seizures into adulthood are particularly difficult to treat, with patients often being treated with... Petition 870250101458, dated 05 / 11 / 2025, pages 160 / 254 155 / 211 multiple drugs, resulting in significant side effects without having to control seizures.

[00377] There is abundant evidence that low-threshold (T-type) calcium channels play a critical role in the generation and maintenance of absence seizures, being a fundamental component of the oscillatory burst firing that occurs in thalamocortical neurons during absence seizures (Pinault and O'Brien, 1997). In some embodiments, the present invention is directed to a method for treating absence seizures with a composition described in this document. In some embodiments, the absence seizures are refractory to an antiepileptic drug (e.g., ethosuximide, valproic acid, or lamotrigine).

[00378] In some modalities, the individual has epilepsy. In some modalities, absence seizures are atypical absence seizures. In some modalities, absence seizures include adult absence seizures, juvenile absence seizures, or childhood absence seizures.

[00379] In some modalities, the methods described in this document also include the identification of an individual with absence seizures.

[00380] In some embodiments, the present invention provides a method of treating a generalized epileptic syndrome with absence seizures in an individual in need, the method comprising administering to the individual an effective amount of a composition described in this document. In some embodiments, the method results in a reduction in the number of seizures.

[00381] In some embodiments, the present invention provides a method of treating a generalized epileptic syndrome with Petition 870250101458, dated 05 / 11 / 2025, pages 161 / 254 156 / 211 absence seizures in an individual in need, the method comprising administering to the individual an effective amount of a composition described in this document.

[00382] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in the average or total duration of seizures.

[00383] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in the frequency, duration, or both of seizures, as measured by electroencephalography (EEG).

[00384] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in the average duration of seizures, as measured by EEG.

[00385] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in the cumulative duration of seizures, as measured by EEG.

[00386] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction of the total time with 2.5-4Hz spike wave discharges after hyperventilation challenges and photic stimulation, as measured by EEG.

[00387] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in overall severity as measured by the Clinical Global Impression-Severity (CGI-S) or Clinical Global Impression-Improvement (CGI-I) scores. The CGI-S is a 7-point scale test for classifying disease severity. Petition 870250101458, dated 05 / 11 / 2025, pages 162 / 254 157 / 211 of the patient at the time of assessment, in relation to the physician's past experience with patients with the same diagnosis. The CGI-I is a 7-point scale test to assess the patient's disease improvement relative to the initial assessment.

[00388] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in the number of seizures.

[00389] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in seizure density, as measured by electroencephalogram (EEG).

[00390] In some embodiments, the treatment method for a generalized epileptic syndrome with absence seizures provided by the present invention results in a reduction in the average duration of seizures, as measured by EEG. Genetic Epilepsies

[00391] In some modalities, epilepsy or epilepsy syndrome is genetic epilepsy or a genetic epilepsy syndrome. In some modalities, epilepsy or epilepsy syndrome is generalized genetic epilepsy. In some modalities, epilepsy or an epileptic syndrome comprises epileptic encephalopathy, epileptic encephalopathy with SCN1A, SCN2A, SCN8A mutations, early infantile epileptic encephalopathy, Dravet syndrome, Dravet syndrome with SCN1A mutation, generalized epilepsy with febrile seizures, intractable infantile epilepsy with generalized tonic-clonic seizures, infantile spasms, benign familial neonatal-infantile seizures, SCN2A epileptic encephalopathy, focal epilepsy with SCN3A mutation, cryptogenic pediatric partial epilepsy with SCN3A mutation, SCN8A epileptic encephalopathy, sudden unexpected death in Petition 870250101458, dated 05 / 11 / 2025, pp. 163 / 254 158 / 211 epilepsy (SUDEP), Rasmussen's encephalitis, malignant migratory partial seizures of childhood, autosomal dominant nocturnal frontal lobe epilepsy, KCNQ2 epileptic encephalopathy or KCNT1 epileptic encephalopathy.

[00392] In some embodiments, the methods described in this document further comprise the identification of an individual who has epilepsy or an epileptic syndrome (e.g., epileptic encephalopathy, epileptic encephalopathy with SCN1A, SCN2A, SCN8A mutations, early infantile epileptic encephalopathy, Dravet syndrome, Dravet syndrome with SCN1A mutation, generalized epilepsy with febrile seizures, intractable epilepsy in children with generalized tonic-clonic seizures, infantile spasms, benign familial neonatal-infantile seizures, SCN2A gene-associated epileptic encephalopathy, focal epilepsy with SCN3A mutation, pediatric cryptogenic partial epilepsy with SCN3A mutation, SCN8A epileptic encephalopathy, sudden unexpected death in epilepsy, Rasmussen encephalitis, malignant migratory partial seizures of childhood, autosomal dominant nocturnal frontal lobe epilepsy, sudden unexpected death in epilepsy (SUDEP),Epileptic encephalopathy KCNQ2 and epileptic encephalopathy KCNT1) before administration of a composition described in this document.

[00393] In one aspect, the present invention provides a method for treating epilepsy or epilepsy syndrome (for example, epileptic encephalopathy, epileptic encephalopathy with SCN1A, SCN2A, SCN8A mutations, early infantile epileptic encephalopathy, Dravet syndrome, Dravet syndrome with SCN1A mutation, generalized epilepsy with febrile seizures, intractable epilepsy in children with generalized tonic-clonic seizures, infantile spasms, benign familial neonatal-infantile seizures, SCN2A gene-associated epileptic encephalopathy, focal epilepsy with mutation in Petition 870250101458, dated 05 / 11 / 2025, pages 164 / 254 159 / 211 SCN3A, pediatric cryptogenic partial epilepsy with SCN3A mutation, SCN8A epileptic encephalopathy, sudden unexpected death in epilepsy, Rasmussen's encephalitis, childhood malignant migratory partial seizures, autosomal dominant nocturnal frontal lobe epilepsy, sudden unexpected death in epilepsy (SUDEP), KCNQ2 epileptic encephalopathy and KCNT1 epileptic encephalopathy) comprising administering to an individual in need a composition described in this document.

[00394] A composition of the present invention can also be used to treat epileptic encephalopathy, in which the individual has a mutation in one or more of the following: ALDH7A1, ALG13, ARHGEF9, ARX, ASAH1, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNB2, CLN8, CNTNAP2, CPA6, CSTB, DEPDC5, DNM1, EEF1A2, EPM2A, EPM2B, GABRA1, GABRB3, GABRG2, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HCN1, IER3IP1, KCNA2, KCNB1, KCNC1, KCNMA1, KCNQ2, KCNQ3, KCNT1, KCTD7, LGI1, MEF2C, NHLRC1, PCDH19, PLCB1, PNKP, PNPO, PRICKLE1, PRICKLE2, PRRT2, RELN, SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SCN9A, SIAT9, SIK1, SLC13A5, SLC25A22, SLC2A1, SLC35A2, SLC6A1, SNIP1, SPTAN1, SRPX2, ST3GAL3, STRADA, STX1B, STXBP1, SYN1, SYNGAP1, SZT2, TBC1D24 and WWOX.

[00395] In some embodiments, the methods described in this document further comprise identifying an individual with a mutation in one or more of the following: ALDH7A1, ALG13, ARHGEF9, ARX, ASAH1, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNB2, CLN8, CNTNAP2, CPA6, CSTB, DEPDC5, DNM1, EEF1A2, EPM2A, EPM2B, GABRA1, GABRB3, GABRG2, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HCN1, IER3IP1, KCNA2, KCNB1, KCNC1, KCNMA1, KCNQ2, KCNQ3, KCNT1, KCTD7, LGI1, MEF2C, NHLRC1, PCDH19, PLCB1, PNKP, PNPO, PRICKLE1, PRICKLE2, PRRT2, RELN, Petition 870250101458, dated 05 / 11 / 2025, pages 165 / 254 160 / 211 SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SCN9A, SIAT9, SIK1, SLC13A5, SLC25A22, SLC2A1, SLC35A2, SLC6A1, SNIP1, SPTAN1, SRPX2, ST3GAL3, STRADA, STX1B, STXBP1, SYN1, SYNGAP1, SZT2, TBC1D24, WWOXWWOX, CACNA1G, CACNA1H and CACNA1I before administration of a composition described in this document.

[00396] A composition of the present invention can also be used to treat epileptic encephalopathy, in which the individual has a mutation in one or more of the following: ADSL, ALDH5A1, ALDH7A1, ALG13, ARG1, ARHGEF9, ARX, ATP1A2, ATP1A3, ATRX, BRAT1, C12orf57, CACNA1A, CACNA2D2, CARS2, CASK, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNB2, CLCN4, CLN2 (TPP1), CLN3, CLN5, CLN6, CLN8, CNTNAP2, CSTB, CTSD, DDC, DEPDC5, DNAJC5, DNM1, DOCK7, DYRK1A, EEF1A2, EFHC1, EHMT1, EPM2A, FARS2, FOLR1, FOXG1, FRRS1L, GABBR2, GABRA1, GABRB2, GABRB3, GABRG2, GAMT, GATM, GLRA1, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HCN1, HNRNPU, IER3IP1, IQSEC2, ITPA, JMJD1C, KANSL1, KCNA2, KCNB1, KCNC1, KCNH2, KCNJ10, KCNMA1, KCNQ2, KCNQ3, KCNT1, KCTD7, LGI1, LIAS, MBD5, MECP2, MEF2C, MFSD8, MOCS1, MOCS2, MTOR, NEDD4L, NEXMIF, NGLY1, NHLRC1, NPRL3, NRXN1, PACS1, PCDH19, PIGA, PIGN, PIGO, PLCB1, PNKD, PNKP, PNPO, POLG, PPT1, PRICKLE1, PRIMA1, PRRT2, PURA, QARS, RELN, ROGDI, SATB2, SCARB2, SCN1A, SCN1B, SCN2A, SCN3A, SCN8A, SCN9A, SERPINI1, SGCE, SIK1, SLC12A5, SLC13A5, SLC19A3, SLC25A12, SLC25A22 SLC2A1, SLC35A2, SLC6A1, SLC6A8, SLC9A6, SMC1A, SNX27, SPATA5, SPTAN1, ST3GAL5, STRADA, STX1B, STXBP1, SUOX, SYN1, SYNGAP1, SYNJ1, SZT2, TBC1D24, TCF4, TPK1, TSC1, TSC2, UBE3A, WDR45, WWOX, ZDHHC9, ZEB2, ABAT, ARHGEF15, ATP6AP2, CACNA1H, CACNB4, CASR, CERS1, CNTN2, CPA6, DIAPH1, FASN, GABRD, GAL, GPHN, KCNA1, KCND2, KCNH5 Petition: 870250101458, on November 5, 2025, page. 166 / 254 161 / 211 KPNA7, LMNB2, NECAP1, PIGG, PIGQ, PIK3AP1, PRDM8, PRICKLE2, RBFOX1, RBFOX3, RYR3, SCN5A, SETD2, SLC35A3, SNAP25, SRPX2, ST3GAL3, TBL1XR1, AMT, GCSH, GLDC, FLNA, PTEN, e RANBP2.

[00397] In some embodiments, the methods described in this document further comprise the identification of an individual with a mutation in one or more of the following: ADSL, ALDH5A1, ALDH7A1, ALG13, ARG1, ARHGEF9, ARX, ATP1A2, ATP1A3, ATRX, BRAT1, C12orf57, CACNA1A, CACNA2D2, CARS2, CASK, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNB2, CLCN4, CLN2 (TPP1), CLN3, CLN5, CLN6, CLN8, CNTNAP2, CSTB, CTSD, DDC, DEPDC5, DNAJC5, DNM1, DOCK7, DYRK1A, EEF1A2, EFHC1, EHMT1, EPM2A, FARS2, FOLR1, FOXG1, FRRS1L, GABBR2, GABRA1, GABRB2, GABRB3, GABRG2, GAMT, GATM, GLRA1, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HCN1, HNRNPU, IER3IP1, IQSEC2, ITPA, JMJD1C, KANSL1, KCNA2, KCNB1, KCNC1, KCNH2, KCNJ10, KCNMA1, KCNQ2, KCNQ3, KCNT1, KCTD7, LGI1, LIAS, MBD5, MECP2, MEF2C, MFSD8, MOCS1, MOCS2, MTOR, NEDD4L, NEXMIF, NGLY1, NHLRC1, NPRL3, NRXN1, PACS1, PCDH19, PIGA, PIGN, PIGO, PLCB1, PNKD, PNKP, PNPO, POLG, PPT1, PRICKLE1, PRIMA1, PRRT2, PURA, QARS, RELN, ROGDI, SATB2, SCARB2, SCN1A, SCN1B, SCN2A, SCN3A, SCN8A, SCN9A, SERPINI1, SGCE, SIK1, SLC12A5, SLC13A5, SLC19A3, SLC25A12, SLC25A22 SLC2A1, SLC35A2, SLC6A1, SLC6A8, SLC9A6, SMC1A, SNX27, SPATA5, SPTAN1, ST3GAL5, STRADA, STX1B, STXBP1, SUOX, SYN1, SYNGAP1, SYNJ1, SZT2, TBC1D24, TCF4, TPK1, TSC1, TSC2, UBE3A, WDR45, WWOX, ZDHHC9, ZEB2, ABAT, ARHGEF15, ATP6AP2, CACNA1H, CACNB4, CASR, CERS1, CNTN2, CPA6, DIAPH1, FASN, GABRD, GAL, GPHN, KCNA1, KCND2, KCNH5, KPNA7, LMNB2, NECAP1, PIGG, PIGQ PIK3AP1, PRDM8, PRIC Petition: 870250101458, on November 5, 2025, page. 167 / 254 162 / 211 KLE2, RBFOX1, RBFOX3, RYR3, SCN5A, SETD2, SLC35A3, SNAP25, SRPX2, ST3GAL3, TBL1XR1, AMT, GCSH, GLDC, FLNA, PTEN, e RANBP2.

[00398] A composition of the present invention can also be used to treat epileptic encephalopathy, in which the individual has a mutation in one or more of the following: ADSL, ALDH5A1, ALDH7A1, ALG13, ARHGEF9, ARX, ASNS, ATP1A2, ATP1A3, ATP6AP2, ATRX, BRAT1, CACNA1A, CASK, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNA7, CHRNB2, CLCN4, CLN3, CLN5, CLN6, CLN8, CNTNAP2, CSTB, CTNNB1, CTSD (CLN10), CTSF, DDX3X, DEPDC5, DNAJC5 (CLN4B), DNM1, DYRK1A, EEF1A2, EHMT1, EPM2A, FLNA, FOLR1, FOXG1, FRRS1L, GABBR2, GABRA1, GABRB2, GABRB3, GABRG2, GAMT, GATM, GLDC, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HNRNPU, IQSEC2, KANSL1, KCNA2, KCNB1, KCNC1, KCNH1, KCNJ10, KCNMA1, KCNQ2, KCNQ3, KCNT1, KCTD7 (CLN14), KDM6A, KIAA2022, LGI1, MAGI2, MBD5, MECP2, MEF2C, MFSD8 (CLN7), NALCN, NGLY1, NHLRC1 (EPM2B), NPRL3.NR2F1, NRXN1, PACS1, PCDH19, PIGA PIGO, PIGV, PLCB1, PNKP, PNPO, POLG, PPP2R5D, PPT1 (CLN1), PRRT2, PURA, QARS, SATB2, SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SLC13A5, SLC19A3, SLC25A22, SLC2A1, SLC6A1, SLC6A8, SLC9A6, SMC1A, SPATA5, SPTAN1, STX1B, STXBP1, SYNGAP1, SZT2, TBC1D24, TBL1XR1, TCF4, TPP1 (CLN2), TSC1, TSC2, UBE3A, WDR45, WWOX and ZEB2.

[00399] In some embodiments, the methods described in this document further comprise the identification of an individual with a mutation in one or more of the following: ADSL, ALDH5A1, ALDH7A1, ALG13, ARHGEF9, ARX, ASNS, ATP1A2, ATP1A3, ATP6AP2, ATRX, BRAT1, CACNA1A, CASK, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNA7, CHRNB2, CLCN4, CLN3, CLN5, CLN6, CLN8, CNTNAP2, CSTB, CTNNB1, CTSD (CLN10), CTSF, DDX3X, DEPDC5, DNAJC5 Petition 870250101458, dated 05 / 11 / 2025, pp. 168 / 254 163 / 211 (CLN4B), DNM1, DYRK1A, EEF1A2, EHMT1, EPM2A, FLNA, FOLR1, FOXG1, FRRS1L, GABBR2, GABRA1, GABRB2, GABRB3, GABRG2, GAMT, GATM, GLDC, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, HNRNPU, IQSEC2, KANSL1, KCNA2, KCNB1, KCNC1, KCNH1, KCNJ10, KCNMA1, KCNQ2, KCNQ3, KCNT1, KCTD7 (CLN14), KDM6A, KIAA2022, LGI1, MAGI2, MBD5, MECP2, MEF2C, MFSD8 (CLN7), NALCN NGLY1, NHLRC1(EPM2B), NPRL3. NR2F1, NRXN1, PACS1, PCDH19, PIGA PIGO, PIGV, PLCB1, PNKP, PNPO, POLG, PPP2R5D, PPT1 (CLN1), PRRT2, PURA, QARS, SATB2, SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SLC13A5, SLC19A3, SLC25A22, SLC2A1, SLC6A1, SLC6A8, SLC9A6, SMC1A, SPATA5, SPTAN1, STX1B, STXBP1, SYNGAP1, SZT2, TBC1D24, TBL1XR1, TCF4, TPP1 (CLN2), TSC1, TSC2, UBE3A, WDR45, WWOX, e ZEB2.

[00400] A composition of the present invention can also be used to treat epileptic encephalopathy, in which the individual has a mutation in one or more of the following: ALDH7A1, ARHGEF9, ARX, ATP13A2, ATP1A2, CACNA1A, CASK, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNB2, CLN3, CLN5, CLN6, CLN8, CNTNAP2, CRH, CSTB, CTSD, CTSF, DCX, DEPDC5, DNAJC5, DNM1, DYNC1H1, DYRK1A, EEF1A2, EPM2A, FLNA, FOLR1, FOXG1, GABRA1, GABRB3, GABRG2, GAMT, GATM, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, GRN, HCN1, HNRNPU, IQSEC2, KCNA2, KCNC1, KCNJ10, KCNQ2, KCNQ3, KCNT1, KCTD7, KIAA2022, LGI1, MECP2, MEF2C, MFSD8, NHLRC1, NRXN1, PCDH19, PIGA, PLCB1, PNKP, PNPO, POLG, PPT1, PRICKLE1, PRRT2, PURA, SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SIK1, SLC13A5, SLC25A22, SLC2A1, SLC35A2, SLC6A1, SLC9A6, SMC1A, SNAP25, SPTAN1, ST3GAL3, STX1B, STXBP1, SYN1, SYNGAP1, SZT2, TBC1D24, TBL1XR1, TCF4, TPP1, TSC1, TSC2, UBE3A, WDR45 and ZEB2.

[00401] In some modalities, the methods described in this do Petition 870250101458, dated 05 / 11 / 2025, pp. 169 / 254 164 / 211 documents also include the identification of an individual with a mutation in one or more of the following: ALDH7A1, ARHGEF9, ARX, ATP13A2, ATP1A2, CACNA1A, CASK, CDKL5, CHD2, CHRNA2, CHRNA4, CHRNB2, CLN3, CLN5, CLN6, CLN8, CNTNAP2, CRH, CSTB, CTSD, CTSF, DCX, DEPDC5, DNAJC5, DNM1, DYNC1H1, DYRK1A, EEF1A2, EPM2A, FLNA, FOLR1, FOXG1, GABRA1, GABRB3, GABRG2, GAMT, GATM, GNAO1, GOSR2, GRIN1, GRIN2A, GRIN2B, GRN, HCN1, HNRNPU, IQSEC2, KCNA2, KCNC1, KCNJ10, KCNQ2, KCNQ3, KCNT1, KCTD7, KIAA2022, LGI1, MECP2, MEF2C, MFSD8, NHLRC1, NRXN1, PCDH19, PIGA, PLCB1, PNKP, PNPO, POLG, PPT1, PRICKLE1, PRRT2, PURA, SCARB2, SCN1A, SCN1B, SCN2A, SCN8A, SIK1, SLC13A5, SLC25A22, SLC2A1, SLC35A2, SLC6A1, SLC9A6, SMC1A, SNAP25, SPTAN1, ST3GAL3, STX1B, STXBP1, SYN1, SYNGAP1, SZT2, TBC1D24, TBL1XR1, TCF4, TPP1, TSC1, TSC2, UBE3A, WDR45, and ZEB2. Mood Disorders

[00402] This document also provides methods for treating a psychiatric disorder, such as a mood disorder, for example, clinical depression, postnatal or postpartum depression, perinatal depression, atypical depression, melancholic depression, psychotic major depression, catatonic depression, seasonal affective disorder, dysthymia, double depression, depressive personality disorder, recurrent brief depression, minor depressive disorder, bipolar or manic-depressive disorder, depression caused by chronic conditions, treatment-resistant depression, refractory depression, suicidal tendencies, suicidal ideation, or suicidal behavior. In some modalities, the method described in this document provides a therapeutic effect to an individual suffering from depression (e.g., moderate or severe depression). In some modalities, the mood disorder is associated with a disease or disorder described Petition 870250101458, dated 05 / 11 / 2025, pp. 170 / 254 165 / 211 in this document (for example, neuroendocrine diseases and disorders, neurodegenerative diseases and disorders (e.g., epilepsy), movement disorders, tremor (e.g., Parkinson's disease), women's health disorders or conditions).

[00403] Clinical depression is also known as major depression, major depressive disorder (MDD), severe depression, unipolar depression, unipolar disorder, and recurrent depression, and refers to a mental disorder characterized by widespread and persistent low mood that is accompanied by low self-esteem and loss of interest or pleasure in normally enjoyable activities. Some people with clinical depression have difficulty sleeping, lose weight, and generally feel agitated and irritable. Clinical depression affects how an individual feels, thinks, and behaves and can lead to a variety of emotional and physical problems. Individuals with clinical depression may have difficulty performing everyday activities and may feel as if life is not worth living.

[00404] Peripartum depression refers to depression during pregnancy. Symptoms include irritability, crying, restlessness, difficulty sleeping, extreme exhaustion (emotional and / or physical), changes in appetite, difficulty concentrating, increased anxiety and / or worry, feeling disconnected from the baby and / or fetus, and loss of interest in previously enjoyable activities.

[00405] Postnatal depression (PND) is also called postpartum depression (PPD) and refers to a type of clinical depression that affects women after childbirth. Symptoms may include sadness, fatigue, changes in sleep and eating habits, decreased sex drive, crying spells, anxiety, and irritability. In some forms, PND is treatment-resistant depression (e.g., treatment-resistant depression as described in this document). In some forms, PND is Petition 870250101458, dated 05 / 11 / 2025, pp. 171 / 254 166 / 211 refractory depression (for example, a refractory depression as described in this document).

[00406] In some forms, an individual with PND also experienced depression, or a symptom of depression during pregnancy. This depression is referred to in this document as perinatal depression. In one form, an individual who experiences perinatal depression has a higher risk of developing PND.

[00407] Atypical depression (AD) is characterized by mood reactivity (e.g., paradoxical anhedonia) and positivity, significant weight gain, or increased appetite. Patients suffering from AD may also experience excessive sleepiness or sleepiness (hypersomnia), a feeling of heaviness in the limbs, and significant social impairment as a consequence of hypersensitivity to perceived interpersonal rejection.

[00408] Melancholic depression is characterized by loss of pleasure (anhedonia) in most or all activities, failure to respond to pleasurable stimuli, depressed mood more pronounced than grief or loss, excessive weight loss, or excessive guilt.

[00409] Major psychotic depression (MPD) or psychotic depression refers to a major depressive episode, particularly of a melancholic nature, where the individual experiences psychotic symptoms such as delusions and hallucinations.

[00410] Catatonic depression refers to major depression involving disturbances in motor behavior and other symptoms. An individual may become mute and stuporous and is immobile or exhibits purposeless or bizarre movements.

[00411] Seasonal affective disorder (SAD) refers to a type of seasonal depression in which an individual has seasonal patterns of depressive episodes that arise in the fall or winter.

[00412] Dysthymia refers to a condition related to depression. Petition 870250101458, dated 05 / 11 / 2025, pp. 172 / 254 167 / 211 are unipolar, where the same physical and cognitive problems are evident. They are not as severe and tend to last longer (e.g., at least 2 years).

[00413] Double depression refers to severely depressed mood (dysthymia) that lasts for at least 2 years and is punctuated by periods of major depression.

[00414] Depressive personality disorder (DPD) refers to a personality disorder with depressive features.

[00415] Recurrent Brief Depression (RBD) refers to a condition in which individuals have depressive episodes about once a month, each episode lasting 2 weeks or less and typically less than 2-3 days.

[00416] Minor depressive disorder or minor depression refers to depression in which at least 2 symptoms are present for 2 weeks.

[00417] Bipolar disorder, or manic-depressive disorder, causes extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). During manic periods, the individual may feel or act abnormally happy, energetic, or irritable. They often make ill-considered decisions without much regard for the consequences. The need for sleep is usually reduced. During depressive periods, there may be crying, poor eye contact with others, and a negative outlook on life. The risk of suicide among those with the disorder is high at over 6% over 20 years, while self-harm occurs in 30-40%. Other mental health problems, such as anxiety disorder and substance use disorder, are commonly associated with bipolar disorder.

[00418] Depression caused by chronic medical conditions refers to depression caused by chronic medical conditions, such as Petition 870250101458, dated 05 / 11 / 2025, pp. 173 / 254 168 / 211 cancer or chronic pain, chemotherapy, chronic stress.

[00419] Treatment-resistant depression refers to a condition in which individuals have been treated for depression, but symptoms do not improve. For example, antidepressants or psychological counseling (psychotherapy) do not alleviate depression symptoms for individuals with treatment-resistant depression. In some cases, individuals with treatment-resistant depression experience symptom improvement, but symptoms relapse. Refractory depression occurs in patients suffering from depression who are resistant to standard pharmacological treatments, including tricyclic antidepressants, MAOIs, SSRIs, and dual- and triple-absorption inhibitors and / or anxiolytic drugs, as well as non-pharmacological treatments (e.g., psychotherapy, electroconvulsive therapy, vagus nerve stimulation, and / or transcranial magnetic stimulation).

[00420] Post-surgical depression refers to feelings of depression that follow a surgical procedure (for example, as a result of having to face mortality). For example, individuals may experience persistent sadness or a dull mood, a loss of pleasure or interest in hobbies and activities normally enjoyed, or a persistent sense of worthlessness or hopelessness.

[00421] Mood disorder associated with women's health conditions or disorders refers to mood disorders (e.g., depression) associated with (e.g., resulting from) a woman's health condition or disorder (e.g., as described in this document).

[00422] Suicidal tendency, suicidal ideation, and suicidal behavior refer to an individual's tendency to commit suicide. Suicidal ideation refers to unusual thoughts or preoccupation with suicide. The range of suicidal ideation varies widely, from, by Petition 870250101458, dated 05 / 11 / 2025, pages 174 / 254 169 / 211 For example, fleeting thoughts to extensive thoughts, detailed planning, role-playing, and / or incomplete attempts. Symptoms include talking about suicide, obtaining the means to commit suicide, withdrawing from social contact, being preoccupied with death, feeling trapped or hopeless about a situation, increasing alcohol or drug use, engaging in risky or self-destructive activities, and saying goodbye to people as if they will not see each other again.

[00423] Symptoms of depression include persistent feelings of anxiety or sadness, feelings of helplessness, hopelessness, pessimism, worthlessness, low energy, restlessness, difficulty sleeping, insomnia, irritability, fatigue, motor challenges, loss of interest in pleasurable activities or hobbies, loss of concentration, loss of energy, poor self-esteem, lack of positive thoughts or plans, excessive sleep, excessive hunger, loss of appetite, insomnia, self-harm, suicidal thoughts, and suicide attempts. The presence, severity, frequency, and duration of symptoms can vary from case to case. Symptoms of depression and their relief can be assessed by a doctor or psychologist (for example, through a mental status examination).

[00424] In some modalities, the mood disorder is selected from depression, major depressive disorder, bipolar disorder, dysthymic disorder, anxiety disorders, stress, post-traumatic stress disorder, and obsessive-compulsive disorders. In some ...

Claims

CLAIMS 1. Single-unit dosage form characterized in that it comprises: the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl), wherein the single-unit dosage form is bioequivalent to a reference composition of the same dosage potency administered as one or more dosage forms.

2. Single-unit dosage form according to claim 1, characterized in that the single-unit dosage form and the reference composition have: (i) a different size; (ii) a different shape; (iii) a different size and a different shape; (iv) the same shape but different sizes; or (v) the same size but different shapes.

3. Single-unit dosage form according to claim 1, characterized in that the single-unit dosage form is larger than the reference composition.

4. Single-unit dosage form according to claim 3, characterized in that the reference composition comprises smaller, round 20 mg PRAX-944 tablets.

5. Single-unit dosage form according to any of the preceding claims, characterized in that: (i) the single-unit dosage form is a larger dosage form that exhibits bioequivalence upon administration to an individual in a fed and / or fasted state as per Petition 870250101458, dated 11 / 05 / 2025, page 218 / 254 2 / 13 comparison with administration of a reference composition of the same dosage potency administered as one or more smaller, round 20 mg PRAX-944 tablets to an individual in a fed and / or fasted state; wherein bioequivalence is established by: (a) a 90% confidence interval for AUC that is between about 80% and about 125% and (b) a 90% confidence interval for Cmax that is between about 80% and about 125%.

6. Single-unit dosage form according to any of the preceding claims, characterized in that: (i) it reduces the total number of dosage units (e.g., tablets) needed to deliver a specific dosage potency to an individual; (ii) it is characterized by a physical size and shape (e.g., tablet size and shape) that makes it easier and more convenient for individuals with a movement disorder, optionally essential tremor (ET), to hold; (iii) it can be formulated as single-unit dose potencies of 5 mg, 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg; and / or (iv) it does not require titration to achieve doses > 40 mg.

7. Single-unit dosage form according to any of the preceding claims, characterized in that at least about 50% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 1 hour to about 12 hours upon administration to an individual, optionally Petition 870250101458, 05 / 11 / 2025, p. 219 / 254 3 / 13 wherein at least about 50% of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl) is released within about 1 hour to about 12 hours using USP type I apparatus, medium containing 900 mL of 0.1 M HCl and a paddle speed of 100 rpm.

8. Single-unit dosage form according to any of the preceding claims, characterized in that it comprises from about 1 mg to about 200 mg of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl).

9. Single-unit dosage form according to any of the preceding claims, characterized in that it comprises from about 1% by weight to about 70% by weight of the compound of Formula (I) or a pharmaceutically acceptable salt thereof (for example, the compound of Formula (II), for example, PRAX-944 HCl).

10. Single-unit dosage form, according to any of the preceding claims, characterized in that it further comprises a modified-release polymer.

11. Single-unit dosage form, according to any of the preceding claims, characterized in that the modified-release polymer comprises a matrix polymer, optionally selected from the group consisting of a hydrophilic matrix polymer, a hydrophobic matrix polymer, a polyacrylate polymer, and combinations thereof.

12. Single-unit dosage form according to any of the preceding claims, characterized in that the modified-release polymer comprises: (i) a hydrophilic matrix polymer, optionally selected from the group consisting of hypromellose, HPMC (hydroxypropylmethylcellulose) and combinations thereof, optionally wherein the HPMC (hydroxypropylmethylcellulose) is selected from the group consisting of Methocel K4M, Methocel K100LV, Methocel E50LV and combinations thereof; (ii) a hydrophobic matrix polymer, optionally selected from the group consisting of ethylcellulose, etocel and combinations thereof; and / or (iii) a polyacrylate polymer, optionally selected from the group consisting of Eudragit RL100, Eudragit RS100 and combinations thereof.

13. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 5 mg to 300 mg of a modified-release polymer.

14. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 10% by weight to about 70% by weight of the modified-release polymer.

15. Single-unit dosage form, according to any of the preceding claims, characterized in that the modified-release polymer is hypromellose.

16. Single-unit dosage form, according to any of the preceding claims, characterized in that it further comprises a diluent.

17. Single-unit dosage form according to any of the preceding claims, characterized in that the diluent comprises: (i) a cellulose derivative, optionally a microcrystalline cellulose, optionally a silicified microcrystalline cellulose; Petition 870250101458, dated 05 / 11 / 2025, page 221 / 254 5 / 13 (ii) a starch, optionally selected from the group consisting of a hydrolyzed starch, a pregelatinized starch and combinations thereof); (iii) an anhydrous lactose; (iv) a lactose monohydrate; (v) a dicalcium phosphate (DCP); and / or (vi) a sugar alcohol, optionally selected from the group consisting of sorbitol, xylitol, mannitol and combinations thereof.

18. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 5 mg to about 300 mg of diluent.

19. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 5% by weight to about 50% by weight of diluent.

20. Single-unit dosage form, according to any of the preceding claims, characterized in that the diluent is microcrystalline cellulose, optionally silicified microcrystalline cellulose.

21. Single-unit dosage form, according to any of the preceding claims, characterized in that the diluent is a sugar alcohol, optionally mannitol.

22. Single-unit dosing form, according to any of the preceding claims, characterized in that it further comprises a slider.

23. Single-unit dosage form, according to any of the preceding claims, characterized in that the glide is selected from the group consisting of pyrogenic silica, optionally colloidal silicon dioxide, talc, magnesium carbonate and combinations thereof.

24. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1 mg to about 10 mg of glide.

25. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1% by weight to about 10% by weight of glide.

26. Single-unit dosage form, according to any of the preceding claims, characterized in that the glide is fumed silica, optionally colloidal silicon dioxide.

27. Single-unit dosage form, according to any of the preceding claims, characterized in that it further comprises a lubricant.

28. Single-unit dosage form, according to any of the preceding claims, characterized in that the lubricant is selected from the group consisting of magnesium stearate, calcium stearate, stearic acid, talc, silica, a fat, optionally vegetable stearin and combinations thereof.

29. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1 mg to about 10 mg of lubricant.

30. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1% by weight to about 10% by weight of lubricant.

31. Single-unit dosage form, according to Petition 870250101458, dated 05 / 11 / 2025, pp. 223 / 254 7 / 13, any of the preceding claims, characterized in that the lubricant comprises magnesium stearate.

32. Single-unit dosing form, according to any of the preceding claims, characterized in that it further comprises a coating.

33. Single-unit dosage form, according to any of the preceding claims, characterized in that the coating comprises a film-coating agent.

34. Single-unit dosage form, according to any of the preceding claims, characterized in that the coating comprises compendial-grade polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350 and / or talc.

35. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1 mg to about 20 mg of coating.

36. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1% by weight to about 10% by weight of coating.

37. Single-unit dosage form, according to any of the preceding claims, characterized in that the coating comprises Opadry® II white 85F18422.

38. Single-unit dosage form, according to any of the preceding claims, characterized in that it is a tablet, optionally formulated for oral administration.

39. Single-unit dosage form, according to any of the preceding claims, characterized by the fact that it is an oblong tablet, an oval tablet or a capsule-shaped tablet, optionally wherein the tablet is not a round tablet.

40. Single-unit dosage form, according to any of the preceding claims, characterized in that it has a total weight of about 200 mg to about 600 mg per dosage unit (e.g., per tablet).

41. Single-unit dosing form, according to any of the preceding claims, characterized in that it has a length of about 1 mm to about 30 mm.

42. Single-unit dosing form, according to any of the preceding claims, characterized in that it has a width of about 1 mm to about 10 mm.

43. Single-unit dosing form, according to any of the preceding claims, characterized in that it has a length of about 14 to about 16 mm and a width of about 5 mm to about 7 mm.

44. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises PRAX-944 HCl in an amount equivalent to about 5.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet).

45. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises PRAX-944 HCl in an amount equivalent to about 10.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet).

46. ​​Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises PRAX-944 HCl in an amount equivalent to Petition 870250101458, dated 05 / 11 / 2025, page 225 / 254 9 / 13 approximately 20.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet).

47. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 1% by weight to about 10% by weight of PRAX-944 HCl, optionally from about 15 mg to about 25 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

48. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises PRAX-944 HCl in an amount equivalent to about 40.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet).

49. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 5% by weight to about 15% by weight of PRAX-944 HCl, optionally from about 40 mg to about 50 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

50. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises PRAX-944 HCl in an amount equivalent to about 80.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet).

51. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 15% by weight to about 25% by weight of PRAX-944 HCl, optionally from about 85 mg to about 95 mg of PRAX-944 HCl per dosage unit (e.g., per tablet). Petition 870250101458, dated 05 / 11 / 2025, pp. 226 / 254 10 / 13 52. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises PRAX-944 HCl in an amount equivalent to about 120.0 mg of PRAX-944 free base per dosage unit (e.g., per tablet).

53. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises from about 25% by weight to about 35% by weight of PRAX-944 HCl, optionally from about 125 mg to about 135 mg of PRAX-944 HCl per dosage unit (e.g., per tablet).

54. Single-unit dosage form according to any of the preceding claims, characterized in that it further comprises one or more of (i) a modified-release polymer, optionally from about 35% by weight to about 45% by weight of modified-release polymer, optionally from about 175 mg to about 185 mg of modified-release polymer per dosage unit (e.g., per tablet); (ii) a soluble diluent, optionally from about 6% by weight to about 10% by weight of soluble diluent, optionally from about 34 mg to about 38 mg of soluble diluent per dosage unit (e.g., per tablet); (iii) a slider, optionally from about 1% by weight to about 3% by weight of slider, optionally from about 6 mg to about 8 mg of slider per dosage unit (e.g., per tablet);(iv) a lubricant, optionally from about 0.5% by weight to about 2% by weight of lubricant, optionally from about 3 mg to about 6 mg of lubricant per dosage unit (for example, per tablet); and (v) a coating, optionally from about 12% by weight to about 15% by weight of coating, optionally from about 1 mg to about 5 mg of coating per dosage unit (for example, per tablet).

55. Single-unit dosage form according to any of the preceding claims, characterized in that it comprises a formulation as set forth in any of Tables 6-16, optionally comprising: (i) prototype large tablet 01 (58% K4M Round) (DC); (ii) prototype large tablet 01 (58% K4M Dragee) (DC); (iii) prototype large tablet 04 (58% K4M) (DG); (iv) prototype large tablet 23 (50% K4M); (v) prototype large tablet 28 (58% K100LV); (vi) prototype large tablet 34 (50% K100LV, 8% Mannitol EG); (vii) prototype large tablet 36 (50% K100LV, 8% Mannitol IG); (viii) prototype large tablet 52 (28% K100LV, 30% E50LV); (ix) prototype large tablet 53 (40% K100LV, 8% Mannitol IG); or (x) prototype large tablet 54 (46% K100LV, 12% Mannitol IG).

56. Single-unit dosage form, according to any of the preceding claims, characterized in that it comprises a prototype large tablet 53 (40% K100LV, 8% Mannitol IG). Petition 870250101458, dated 05 / 11 / 2025, pp. 228 / 254 12 / 13 57. Pharmaceutical composition characterized in that it comprises a single-unit dosage form, as defined in any of the preceding claims, and at least one pharmaceutically acceptable vehicle or excipient.

58. A method for treating a disease or condition related to aberrant function or activity of a T-type calcium channel in an individual in need thereof, the method characterized in that it comprises administering to the individual a therapeutically effective amount of the single-unit dosage form, as defined in any one of claims 1 to 56, or the pharmaceutical composition, as defined in claim 57.

59. A method for treating a tremor in an individual in need thereof, characterized in that it comprises administering to the individual a therapeutically effective amount of the single-unit dosage form, as defined in any one of claims 1 to 56, or the pharmaceutical composition, as defined in claim 57.

60. A method for treating an essential tremor in an individual in need thereof, characterized in that it comprises administering to the individual a therapeutically effective amount of the single-unit dosage form, as defined in any one of claims 1 to 56, or the pharmaceutical composition, as defined in claim 57.

61. Method according to claim 60, characterized in that it results in a reduction of essential tremor as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) score.

62. Method, according to claim 60 or 61, characterized in that the reduction of essential tremor is assessed by the upper limb score of the Essential Tremor Assessment Scale (TETRAS).

63. Method, according to any one of claims 60 to 62, characterized in that the reduction of essential tremor is assessed by TETRA-ADL (activities of daily living).

64. Method, according to any one of claims 60 to 63, characterized in that the reduction of essential tremor is assessed by the score of the TETRAS performance subscale or individual TETRAS performance items.

65. A method according to any one of claims 60 to 64, characterized in that it results in a reduction of essential tremor, as assessed by an accelerometer-based upper limb score.

66. Method, according to any one of claims 60 to 65, characterized in that it results in a reduction of the sigma frequency band.

67. Method, according to any one of claims 60 to 66, characterized in that the essential tremor is upper limb tremor.

Images