INIBIDORES DE PEPTÍDEO CRISTALINOS DO RECEPTOR DE INTERLEUCINA-23, SEUS USOS E MÉTODOS DE PREPARAÇÃO

Abstract

The present invention relates to methods for preparing crystalline forms of a monocyclic peptide compound, or salts or solvates thereof, which is a peptide inhibitor of the interleukin-23 receptor (IL-23R). The crystalline forms are useful in pharmaceutical compositions, methods and / or uses for treatment of autoimmune inflammation diseases and related disorders.

Description

Interleukin-23 Receptor Crystalline Peptide Inhibitors, Their Uses and Preparation Methods - List of Sequences

[001] The contents of the electronic sequence listing (747883NTT-4258PC_SL.xml; size: 13484 bytes; and creation date: January 30, 2024), are incorporated herein by reference in their entirety. RELATED ORDERS

[002] This application claims priority over provisional patent application U.S. No. 63 / 482,512, filed January 31, 2023, as well as provisional patent application U.S. No. 63 / 517,307, filed August 2, 2023. The content of both applications is incorporated herein by reference in its entirety. FIELD

[003] The present invention relates to methods for preparing crystalline monocyclic peptide compounds, and salts or solvates thereof, which are peptide inhibitors of the interleukin-23 receptor (IL-23R). The crystalline monocyclic peptide compounds, and salts or solvates thereof, have favorable rheological (flow) properties, making them suitable for pharmaceutical processing. The peptide inhibitors are useful for the treatment of autoimmune inflammatory diseases and related disorders. BACKGROUND

[004] The cytokine, interleukin-23 (IL-23), has been implicated as playing a crucial role in the pathogenesis of autoimmune inflammation and related diseases and disorders, such as multiple sclerosis, asthma, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases (IBDs), such as ulcerative colitis and Crohn's disease. Studies in acute and chronic mouse models of IBD Petition 870260065706, dated 03 / 07 / 2026, page 6 / 778 2 / 376 reported a primary role for IL-23R and downstream effector cytokines in the pathogenesis of the disease. IL-23R is expressed on various adaptive and innate immune cells, including Th17 cells, γδ T cells, natural killer (NK) cells, dendritic cells, macrophages, and innate lymphoid cells, which are found abundantly in the intestine. On the intestinal mucosal surface, gene expression and protein levels of IL-23R have been found to be elevated in patients with IBD. IL-23 is believed to mediate this effect by promoting the development of a population of pathogenic CD4+ T cells that produce IL-6, IL-17, and tumor necrosis factor (TNF).

[005] IL-23 production is enhanced in the intestine, where it is believed to play a key role in regulating the balance between tolerance and immunity through T cell-dependent and T cell-independent pathways of intestinal inflammation through effects on cytokines associated with T helper 1 (Th1) and Th17, as well as restricting regulatory T cell responses in the intestine, favoring inflammation. Furthermore, polymorphisms in the IL-23 receptor (IL-23R) have been associated with susceptibility to inflammatory bowel diseases (IBDs), further establishing the critical role of the IL-23 pathway in intestinal homeostasis.

[006] Psoriasis (PsO), a chronic skin disease affecting approximately 2% to 3% of the general population, has been shown to be mediated by the body's T-cell inflammatory response mechanisms. IL-23 is one of several interleukins implicated as an important factor in the pathogenesis of psoriasis, presumably maintaining chronic autoimmune inflammation through the induction of interleukin-17, the regulation of memory T cells, and the activation of macrophages. The expression of IL-23 and IL-23R has been shown to be increased in Petition 870260065706, dated 03 / 07 / 2026, page 7 / 778 3 / 376 tissues from patients with psoriasis, and antibodies that neutralize IL-23 showed development of IL-23-dependent psoriasis inhibition in animal models of psoriasis.

[007] IL-23 is a heterodimer composed of a unique p19 subunit and the p40 subunit shared with IL-12, which is a cytokine involved in the development of interferon-γ (IFN-γ)-producing helper T cells 1 (Th1). Although both IL-23 and IL-12 contain the p40 subunit, they have different phenotypic properties. For example, IL-12-deficient animals are susceptible to inflammatory autoimmune diseases, while IL-23-deficient animals are resistant, presumably due to a reduced number of CD4+ T cells producing IL-6, IL-17, and TNF in the CNS of IL-23-deficient animals. IL-23 binds to IL-23R, which is a heterodimeric receptor composed of the IL-12Rβ1 and IL-23R subunits.The binding of IL-23 to IL-23R activates the signaling molecules Jak-stat, Jak2, Tyk2, and Stat1, Stat3, Stat4, and Stat5, although the activation of Stat4 is substantially weaker, and different DNA-binding Stat complexes are formed in response to IL-23 compared to IL-12. IL-23R associates constitutively with Jak2 and in a ligand-dependent manner with Stat3. In contrast to IL-12, which acts primarily on treatment-naive CD4(+) T cells, IL-23 preferentially acts on memory CD4(+) T cells.

[008] Efforts have been made to identify therapeutic moieties that inhibit the IL-23 pathway for use in the treatment of IL-23-related diseases and disorders. Several antibodies that bind to IL-23 or IL-23R have been identified, including ustekinumab, an antibody that binds to the p40 subunit of IL-23, which has been approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn's disease, and colitis. Petition 870260065706, dated 03 / 07 / 2026, p. 8 / 778 4 / 376 moderate to severe active ulcerative colitis. More recently, polypeptide inhibitors that bind to IL-23R and inhibit IL-23 binding to IL-23R have been identified (see, for example, US patent application publication no. 2013 / 0029907). Clinical trials in Crohn's disease or psoriasis with brakinumab (which also targets the common p40 subunit) and tildrakizumab, guselcumab, MEDI2070, and BI-655066 (which target the IL-23-unique p19 subunit) highlight the potential of IL-23 signaling blockade in the treatment of human inflammatory diseases. While these findings are promising, challenges remain regarding the successful application of such therapeutic agents to their target. Effective application can improve the treatment of intestinal inflammation, such as intestinal diseases, including Crohn's disease, ulcerative colitis, and related disorders.

[009] An IL-23R inhibitor was described as peptide no. 104 in PCT publications no. WO 2021 / 146441 and US 2021 / 0261622, which disclosures are incorporated herein by reference in their entirety.

[0010] Peptide compounds, such as those described in PCT publications WO 2021 / 146441 and US 2021 / 0261622, can be manufactured using solid-phase peptide synthesis (SPPS). In solid-phase peptide synthesis, an amino acid or peptide is linked, usually through the C-terminal, to a solid support. New amino acids are added to the linked amino acid or peptide through coupling reactions. Although solid-phase peptide synthesis has been widely used, the process is laborious and often requires purification of the reaction products by chromatography, resulting in high cost, slow processing, and difficulties in scale-up.

[0011] Alternative methods for synthesizing peptides here Petition 870260065706, dated 03 / 07 / 2026, page 9 / 778 5 / 376 described are therefore necessary, particularly those that provide improved handling, such as improved rheological (flow) properties, particle size and hygroscopicity, of peptide inhibitors for use as pharmaceutical ingredients.

[0012] There remains a need in the art to develop methods for preparing interleukin-23 receptor (IL-23R) peptide inhibitors in forms that are suitable for large-scale commercial development and that provide solid forms of the peptide inhibitors with characteristics that improve the handling of the peptide inhibitors for use as pharmaceutical ingredients. For example, there remains a need to develop methods for preparing and isolating IL-23R peptide inhibitor forms that have good rheological properties. The present invention addresses these needs. BRIEF SUMMARY

[0013] Methods are provided here for preparing crystalline forms of an interleukin-23 receptor (IL-23R) peptide inhibitor. Crystalline forms have advantageous properties such as ease of isolation, processability, handling, enhanced purity, and greater physical and chemical stability compared to analogous amorphous forms. These attributes can be particularly important for pharmaceutical agents where large-scale production, reproducibility, and compound purity are required. Crystalline peptide forms can be exceptionally advantageous since the corresponding amorphous forms are often unsuitable for formulation, such as tablet formation.

[0014] In general, the present invention relates to methods for the preparation of monocyclic peptide compounds, or salts of Petition 870260065706, dated 03 / 07 / 2026, page 10 / 778 6 / 376 hydrochloride, solvates, or forms thereof, which have rheological (flow) properties suitable for pharmaceutical processing. The methods of the invention include methods for improving the rheological properties of monocyclic peptide compounds and methods for preparing monocyclic peptide compounds that have rheological properties suitable for manufacturing pharmaceutical compositions. In particular, the present invention relates to a method for preparing a crystalline form of the peptide of SEQ ID NO: 1: Ac-[Pen]*-NT-[W(7-Me)]-[Lys(Ac)]-[Pen]*-Phe[4-(2-aminoethoxy)]-[2Nal]-[THP]-EN-[3-Pal]-Sarc-NH2 (wherein [Pen]*-[Pen]* form a disulfide bond); or a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound, having the structure of formula (I):

[0015] In particular, the present invention provides a method for preparing a crystalline hydrochloride salt form of a compound of formula (I) having the structure: Petition 870260065706, dated 03 / 07 / 2026, p. 11 / 778 7 / 376 or a solvato of him.

[0016] The present invention also relates to a method for preparing a crystalline form of the peptide of SEQ ID NO: 2: Ac-dArg-cyclo[Abu-Gln-Thr-Trp-Gln-Cys]-Phe(2-ae)-2-NaI-ThpGly-GluAsn-Asn-NH2; or a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound, which has the structure of a compound of formula (I): Petition 870260065706, dated 03 / 07 / 2026, p. 12 / 778 8 / 376 (II).

[0017] In another embodiment, the present invention provides a method for preparing a crystalline acetate salt form of a compound of formula (II) having the structure: or a solvato of him. (II),

[0018] In another embodiment, the present invention relates to a method for preparing a crystalline form of the peptide of SEQ ID NO: 3: Ac-[Pen]*-Asn-Thr-Trp(7Me)-Lys(Ac)-[Pen]*-Tyr(2-ea)-2Nal-αMe-LysLys(Ac)-Asn-D-Leu-NH2 (where [Pen]*-[Pen]* form a disulfide bond); or a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound, having the structure of a compound of formula (III): Petition 870260065706, dated 03 / 07 / 2026, p. 13 / 778 9 / 376 (III).

[0019] The present invention also provides a method for preparing a crystalline hydrochloride salt form of a compound of formula (III) having the structure: (III), or a solvato of it.

[0020] The present invention also provides methods for the preparation of crystalline forms of a peptide compound of any of the formulas (I'), (IIa) to (IId), (IIIa) to (IIIf), (IVa) to (IVd), Petition 870260065706, dated 03 / 07 / 2026, p. 14 / 778 10 / 376 or a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound, as described herein. Pharmaceutically acceptable salts of the compound of any of the formulas (I'), (IIa) to (IId), (IIIa) to (IIIf), (IVa) to (IVd) provided herein include hydrochloride salts, bis-hydrochloride salts, acetate salts, fumarate salts, glutarate salts, glycolate salts, mesylate salts, sulfate salts and citrate salts.

[0021] The present invention also provides a method for preparing a crystalline form of a compound of formula (I), or a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound. The pharmaceutically acceptable salts of the compound of formula (I) provided herein include hydrochloride salt, bis-hydrochloride salt, acetate salt, fumarate salt, glutarate salt, glycolate salt, mesylate salt, sulfate salt and citrate salt.

[0022] Additionally, a crystalline form of a free base of a peptide of a compound of formula (I), or of any of the formulas (I'), (IIa) to (IId), (IIIa) to (IIIf), (IVa) to (IVd), or of a solvate thereof of any of the aforementioned compounds, is provided herein, which is prepared in accordance with the methods of the present invention.

[0023] Additionally, a crystalline form of a free base of a compound of formula (I), or of any of the formulas (I'), (IIa) to (IId), (IIIa) to (IIIf), (IVa) to (IVd), or of a solvate thereof of any of the aforementioned compounds, is provided herein, which is prepared in accordance with the methods of the present invention.

[0024] The present invention also provides methods for preparing crystalline forms of a peptide compound of either formula (II) or formula (III), or a pharmaceutically acceptable salt thereof, or a solvate of the foregoing compound, as described herein. Pharmaceutically acceptable salts Petition 870260065706, dated 03 / 07 / 2026, p. 15 / 778 11 / 376 of the compound of either formula (II) or formula (III) given herein may include hydrochloride salts, bis-hydrochloride salts, acetate salts, fumarate salts, glutarate salts, glycolate salts, mesylate salts, sulfate salts and citrate salts.

[0025] Additionally, a crystalline form of a free base of a compound of formula (I), or of any of formulas (II) or (III), or of a solvate thereof of any of the aforementioned compounds, is provided herein, which is prepared in accordance with the methods of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 shows a powder X-ray diffraction (PXRD) pattern of a crystalline form of a hydrochloride salt of a compound of formula (I).

[0027] Figure 2 shows an XRD pattern of a crystalline form of a hydrochloride salt of a compound of formula (I).

[0028] Figure 3 shows an XRD pattern of a crystalline form of a hydrochloride salt of a compound of formula (I).

[0029] Figure 4 shows a thermogravimetric analysis (TGA) graph of a crystalline form of a hydrochloride salt of a compound of formula (I).

[0030] Figure 5 shows a differential scanning calorimetry (DSC) graph of a crystalline form of a hydrochloride salt of a compound of formula (I).

[0031] Figure 6 shows a dynamic vapor sorption (DVS) curve of a crystalline form of a hydrochloride salt of a compound of formula (I).

[0032] Figure 7 shows an XRD pattern of a crystalline form of an acetate salt of a compound of formula (I).

[0033] Figure 8 shows a TGA plot of a crystalline form of an acetate salt of a compound of formula (I). Petition 870260065706, dated 03 / 07 / 2026, page 16 / 778 12 / 376

[0034] Figure 9 shows a DSC plot of a crystalline form of an acetate salt of a compound of formula (I).

[0035] Figure 10 shows a DVS curve of a crystalline form of an acetate salt of a compound of formula (I).

[0036] Figure 11 shows an XRD pattern of a crystalline form of a free base of a compound of formula (I).

[0037] Figure 12 shows a TGA plot of a crystalline form of a free base of a compound of formula (I).

[0038] Figure 13 shows a DSC plot of a crystalline form of a free base of a compound of formula (I).

[0039] Figure 14 shows a DVS curve of a crystalline form of a free base of a compound of formula (I).

[0040] Figure 15 shows an XRD pattern of a crystalline form of a fumarate salt of a compound of formula (I).

[0041] Figure 16 shows a TGA plot of a crystalline form of a fumarate salt of a compound of formula (I).

[0042] Figure 17 shows a DSC plot of a crystalline form of a fumarate salt of a compound of formula (I).

[0043] Figure 18 shows an XRD pattern of a crystalline form of a glutarate salt of a compound of formula (I).

[0044] Figure 19 shows a simultaneous thermal analysis (SDT) thermogram of a crystalline form of a glutarate salt of a compound of formula (I).

[0045] Figure 20 shows a DVS curve of a crystalline form of a glutarate salt of a compound of formula (I).

[0046] Figure 21 shows an XRD pattern of a crystalline form of a glycolate salt of a compound of formula (I).

[0047] Figure 22 shows a simultaneous thermal analysis (SDT) thermogram of a crystalline form of a glycolate salt of a compound of formula (I). Petition 870260065706, dated 03 / 07 / 2026, page 17 / 778 13 / 376

[0048] Figure 23 shows a DVS curve of a crystalline form of a glycolate salt of a compound of formula (I).

[0049] Figure 24 shows an XRD pattern of a crystalline form of a mesylate salt of a compound of formula (I).

[0050] Figure 25 shows a simultaneous thermal analysis (SDT) thermogram of a crystalline form of a mesylate salt of a compound of formula (I).

[0051] Figure 26 shows an XRD pattern of a crystalline form of a sulfate salt of a compound of formula (I).

[0052] Figure 27 shows a simultaneous thermal analysis (SDT) thermogram of a crystalline form of a sulfate salt of a compound of formula (I).

[0053] Figure 28 shows an XRD pattern of a crystalline form of a citrate salt of a compound of formula (I).

[0054] Figure 29 shows an XRD pattern of a crystalline form of a bis-chloride salt of a compound of formula (I).

[0055] Figure 30 shows a TGA plot of a crystalline form of a bis-chloride salt of a compound of formula (I).

[0056] Figure 31 shows a DSC plot of a crystalline form of a bis-chloride salt of a compound of formula (I).

[0057] Figure 32 shows a DVS curve of a crystalline form of a bis-chloride salt of a compound of formula (I).

[0058] Figure 33 is a process flowchart for the preparation of a crystalline form of a compound of formula (I).

[0059] Figure 34 shows polarized light microscopy (PLM) images of a crystalline form of a hydrochloride salt of a compound of formula (II).

[0060] Figure 35 shows PLM images of a crystalline form of a sulfate salt of a compound of formula (II).

[0061] Figure 36 shows PLM images in a way Petition 870260065706, dated 03 / 07 / 2026, page 18 / 778 14 / 376 crystalline of an acetate salt of a compound of formula (II).

[0062] Figure 37 shows a DTP data plot comparing material isolated from SPPS, Liquid Phase Peptide Synthesis (LPPS) and material recovered after tabulation of a crystalline form of a compound of formula (I).

[0063] Figure 38 shows a DTP data plot comparing statically dry vs. dynamically dry material of a crystalline form of a compound of formula (I).

[0064] Figure 39 shows a DTP data plot comparing sieved vs. un-sieved material of a crystalline form of a compound of formula (I).

[0065] Figure 40 shows a DTP data plot comparing milling and sieving vs. a material control of a crystalline form of a compound of formula (I). DETAILED DESCRIPTION I. General

[0066] The present invention relates to methods for preparing crystalline forms of monocyclic peptide compounds, or pharmaceutically acceptable salts or solvates thereof, which are interleukin-23 receptor (IL-23R) peptide inhibitors. The crystalline forms of monocyclic peptide compounds, or pharmaceutically acceptable salts or solvates thereof, have rheological (flow) properties suitable for manufacturing pharmaceutical compositions. The present invention also relates to crystalline forms of a monocyclic peptide compound, or pharmaceutically acceptable salts or solvates thereof, which is an IL-23R peptide inhibitor, which are prepared by the methods of the invention.

[0067] The present invention provides methods for the preparation of Petition 870260065706, dated 03 / 07 / 2026, page 19 / 778 15 / 376 crystalline forms of monocyclic peptide compounds from monocyclic peptide compounds, such as those obtained through Liquid Phase Peptide Synthesis (LPPS). The methods of the present invention provide crystalline forms of the peptide compounds with improved handling, rheological properties, and purity suitable for large-scale commercial manufacturing without the need for chromatography. The monocyclic peptide compounds can be thixotropic materials. The methods of the present invention allow the isolation of crystalline forms of monocyclic peptide compounds that are thixotropic.

[0068] In particular, the present invention provides methods for the preparation of crystalline forms of a hydrochloride salt of a monocyclic peptide compound having the structure of formula (I) (SEQ ID NO: 1):

[0069] The present invention also provides methods for preparing crystalline forms of a peptide compound having the structure of formula (II) (SEQ ID NO: 2): Petition 870260065706, dated 03 / 07 / 2026, p. 20 / 778 16 / 376

[0070] The present invention further provides methods for preparing crystalline forms of a hydrochloride salt of a peptide compound having the structure of formula (III) (SEQ ID NO: 3):

[0071] The present invention also provides the method for preparing crystalline forms of an acetate salt of a peptide compound having the structure of formula (III). Petition 870260065706, dated 03 / 07 / 2026, p. 21 / 778 17 / 376 II. Definitions

[0072] Unless defined otherwise, scientific and technical terms used in conjunction with this application shall have the meanings that are commonly understood by those skilled in the art.

[0073] As used herein, the following terms have the meanings assigned to them, unless otherwise specified.

[0074] A, an or an(an), is an indefinite article when used in reference to a group of substituents or substituent group in the present invention, meaning at least one.

[0075] When referring to a value, approximately includes the stated value + / - 10% of the stated value. For example, approximately 50% includes a range of 45% to 55%, while approximately 20 molar equivalents includes a range of 18 to 22 molar equivalents. Consequently, when referring to a range, approximately refers to each of the stated values ​​+ / - 10% of the stated value at each end of the range. For example, a ratio between approximately 1 and approximately 3 (weight / weight) includes a range of 0.9 to 3.3. In some embodiments, the reference to approximately a value or parameter includes a description of that value or parameter itself. For example, the reference to approximately 20 molar equivalents includes and describes 20 molar equivalents themselves.

[0076] As used in the descriptive report and claims, includes, comprehends, includes, has, can, contains, and variants thereof, as used herein, are intended to be open transition phrases, terms, or words that require the presence of the named resources, groups, ingredients, or steps and do not exclude the presence of additional resources, groups, ingredients, or steps. For example, the language a Petition 870260065706, dated 03 / 07 / 2026, page 22 / 778 18 / 376 peptide of formula (I') comprising the amino acid sequence: X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-X15-X16 (I') means that, in addition to amino acids X3 to X16, the peptide may include, but is not limited to, additional amino acids attached to the N-terminus, additional amino acids attached to the C-terminus, N-terminus or C-terminus capping groups, chemical or biological moieties (including, but not limited to, for example, lipophilic substituents, antibodies, imaging agents, etc.) conjugated to the peptide at any location, and the like. The term comprises, includes, has, may or contains may include embodiments covered by the term consist essentially of or consist of.

[0077] The terms peptide, polypeptide and protein are used interchangeably in the present invention and typically refer to a molecule comprising a chain of two or more amino acids (e.g., L-amino acids, D-amino acids, modified amino acids, amino acid analogs, amino acid mimetics, etc.).

[0078] Unless otherwise indicated, naturally occurring L-amino acids and D-amino acids are both represented by conventional three-letter or one-letter uppercase amino acid designations from Table 1. In some embodiments, naturally occurring L-amino acids are represented by conventional three-letter or one-letter uppercase amino acid designations from Table 2. In some embodiments, D-amino acids are represented by one-letter lowercase amino acid designations corresponding to the one-letter designations from Table 1, i.e., g, a, l, m, f, w, k, q, e, s, p, v, i, c, y, h, r, n, d, t. Table 1: Naturally occurring amino acids G Glycine Gly P Proline Pro Petition 870260065706, dated 03 / 07 / 2026, page 23 / 778 19 / 376 Alanine Ala V Valine Val L Leucine Leu I Isoleucine Ile M Methionine Met C Cysteine ​​Cys F Phenylalanine Phe Y Tyrosine Tyr W Tryptophan Trp H Histidine His K Lysine Lys R Arginine Arg Q Glutamine Gln N Asparagine Asn E Glutamic acid Glu D Aspartic acid Asp S Serine Ser T Threonine Thr

[0079] The term L-amino acid, as used herein, refers to the L-isomeric form of an amino acid, and conversely, the term D-amino acid refers to the D-isomeric form of an amino acid (e.g., (D)Asp or D-Asp; (D)Phe or D-Phe). Amino acid residues in the D-isomeric form may be substituted for any L-amino acid residue, provided the desired function is retained by the peptide. D-amino acids may be indicated in the usual lowercase manner when referred to using one-letter abbreviations. For example, D-arginine may be represented as arg or r. Alternatively, a lowercase d in front of an amino acid may be used to indicate that it is of the D-isomeric form, for example, D-lysine may be represented by dK.

[0080] Less common or unnaturally occurring amino acids are referred to by their full name (e.g., sarcosine, ornithine, etc.), and three- or four-character codes are frequently used for such residues, including Sar or Sarc (sarcosine, i.e., N-methylglycine), Aib (α-aminoisobutyric acid), Dab (2,4-diaminobutanoic acid), Dapa (2,3-diaminopropanoic acid), γ-Glu (γ-glutamic acid), Gaba (γ-aminobutanoic acid), β-Pro (pyrrolidine-3-carboxylic acid), and Abu (2-aminobutyric acid). Petition 870260065706, dated 03 / 07 / 2026, page 24 / 778 20 / 376 uric acid), or as defined below.

[0081] Some useful abbreviations in the description of the invention are defined below in Table 2 below. Table 2: Abbreviations for non-natural amino acids and chemical moieties Abbreviation Definition (1-Me)His (1-methyl)histidine (D)aMeTyr (D)-alpha-Me-tyrosine (D)NMeTyr NMe(D)Tyr or N-Me-(D)tyrosine 1-Nal L-1-naphthylalanine 2-Nal or 2Nal L-2-naphthylalanine 2-Pal or 2Pal L-2-pyridylalanine o nh2 3-Pal or 3Pal L-3-pyridylalanine o nh2 4-amino-4-carboxytetrahydropyran, THP or ThpGly h2nY;o2h 4-Pal or 4Pal L-4-pyridylalanine 0 ΝχΥ NH2 5-Pyal or 5Pyal O Ιίγ nh2 5-pyrimidinealanine Abu Acid 2-aminobutyric Petition 870260065706, dated 03 / 07 / 2026, p. 25 / 778 21 / 376 Abbreviation Definition Ac- acetyl Acvc h2n^^o2h 1-aminocyclopentanecarboxylic acid Aib 2-aminoisobutyric acid α-MeAsn, α-MeAsn α-methyl-L-asparagine α-MeGIn, α-MeGIn α-methyl-L-glutamine α-MeGIu or αMeGIu α-methylglutamic acid α-citrulline α-citrulline α-Ci ... i-Pr Isopropyl Lys(Ac) Ν-ε-acetyl-L-lysine Lys(benzyl,Ac) N£-acetyl-N£-benzyl-L-Lysine or Lys(N-acetyl- N-benzyl) Hi o γΝ^^Α0Η 0 nh2 Petition 870260065706, dated 03 / 07 / 2026, p. 26 / 778 22 / 376 Abbreviation Definition Lys (butyl, Ac) N-acetyl-N-butyl-L-lysine or Lys(N-acetyl-N-butyl) o nh2 Lys (isobutyl, Ac) N-acetyl-N-isobutyl-L-lysine or Lys(N-acetyl-N-isobutyl) \zO 1 i 0 nh2 Lys(propyl, Ac) N-acetyl-N-propyl-L-lysine or Lys(N-acetyl-N-propyl) o nh2 Pen L-penicillamine Pen(sulfoxide) L-penicillamine(sulfoxide) Phe(2-Me) 2-methyl-L-phenylalanine Phe(3-Me) 3-methyl-L-phenylalanine Phe(3,4-dimethoxy) 3,4-dimethoxy-L-phenylalanine Phe(4-Me) 4-methyl-L-phenylalanine Phe[4-(2-aminoethoxy)], Tyr(2-ea) or Phe(2-ae) HV H2N τ' OH 2Quin (S)-2-amino-3-(quinolin-2-yl)propanoic acid or 2-quinolinylalanine Petition 870260065706, dated 03 / 07 / 2026, p. 27 / 778 23 / 376 Abbreviation Definition Quin or 3Quin or 3-Quin L h L.xNH2 CTOH Acid (S)-2-amino-3-(quinolin-3-yl)propanoic or 3-quinolinylalanine Sarc or NMeGly Sarcosine or N-methylglycine W(7-Me) or Trp(7Me) 7-methyl-tryptophan β-Ala, beta-Ala or bA L-β-alanine β-Glu Lp-glutâmic acid βhGln or b-hGln or betahomoGln Lp-homoglutaramine α-MeArg, a-MeArg or alpha-MeArg alpha-methyl-L-arginine α-MeCys, alpha-MeCys ou a-MeCys alpha-methyl-L-cysteine ​​α-MeLeu, a-MeLeu, alpha- MeLeu alpha-methyl-L-leucine α-MeLys(Ac), aMeLys(Ac) or alfaMeLys(Ac) ε-acetyl-alpha-methyl-L-lysine α-MeLys, a-MeLys or alpha-MeLys Alpha-methyl-L-lysine α-MeOrn Alpha-methyl-L-ornithine α-MePhe ou a-MePhe ou a-Me-Phe Alpha-methyl-L-phenylalanine α-MeTrp Alpha-methyl-L-tryptophan Petition 870260065706, 03 / 07 / 2026, pág. 28 / 778 24 / 376 Abbreviation Definition α-MeTyr Alpha-methyl-L-tyrosine

[0082] One skilled in the art will recognize that certain amino acids and other chemical moieties can be modified when linked to another molecule. For example, an amino acid side chain can be modified when it forms an intramolecular bridge with another amino acid side chain, for example, one or more hydrogens can be removed or replaced by the linkage. Consequently, as used herein, reference to an amino acid or modified amino acid present in a peptide dimer of the present invention (e.g., at position X4 or position X9) is intended to include the form of such amino acid or modified amino acid present in the peptide both before and after the formation of the intramolecular linkage.

[0083] As used herein, the term NH2 may refer to a free amino group present at the amino terminus of a polypeptide. As used herein, the term OH may refer to a free carboxy group present at the carboxy terminus of a peptide. Furthermore, as used herein, the term Ac or Ac- refers to the protection of acetyl through acylation of the C- or N-terminus of a polypeptide. In certain peptides shown herein, the NH2 located at the C-terminus of the peptide indicates an amino group.

[0084] The term carboxy, as used here, refers to -CO2H.

[0085] The term cyclized, as used herein, refers to a portion of a polypeptide molecule that is linked to another portion of the polypeptide molecule to form a closed ring, such as by forming a disulfide bridge or thioether linkage.

[0086] The term subunit, as used herein, refers to one of a pair of polypeptide monomers that are joined together to form a dimeric peptide composition. Petition 870260065706, dated 03 / 07 / 2026, p. 29 / 778 25 / 376

[0087] The term pharmaceutically acceptable salt, as used herein, represents salts or zwitterionic forms of the peptides or compounds of the present invention that are soluble or dispersible in water or oil, that are suitable for the treatment of diseases without undue toxicity, irritation, and allergic response; that are proportionate to a reasonable risk / benefit ratio and that are effective for their intended use. The salts may be prepared during the final isolation and purification of the compounds or separately by the reaction of an amino group with a suitable acid.Representative acid addition salts include acetate, adipate, alginate, citrate, aspartate, benzoate, benzenesulfonate, bisulfate, butyrate, camphorate, camphorsulfonate, digluconate, glycerophosphate, hemisulfate, heptanoate, hexanoate, formate, fumarate, hydrochloride, hydrobromide, iodide, 2-hydroxyethanesulfonate (isethionate), lactate, maleate, mesitylenesulfonate, methanesulfonate, naphthylenesulfonate, nicotinate, 2-naphthalenesulfonate, oxalate, pamate, pectinate, persulfate, 3-phenylpropiononate, picrate, pivalate, propionate, succinate, tartrate, trichloroacetate, trifluoroacetate, phosphate, glutamate, bicarbonate, para-toluenesulfonate and undecanoate. In addition, the amino groups in the compounds of the present invention can be quaternized with methyl, ethyl, propyl and butyl chlorides, bromides and iodides; dimethyl, diethyl, dibutyl and diamyl sulfates; decyl, lauryl, myristyl and steryl chlorides, bromides and iodides; and benzyl and phenethyl bromides.Examples of acids that can be used to form therapeutically acceptable addition salts include inorganic acids such as hydrochloric, hydrobromic, sulfuric, and phosphoric acids, and organic acids such as oxalic, maleic, succinic, and citric acids. Other examples of pharmaceutically acceptable salts are described in Remington's Pharmaceutical Sciences, 17th edition, Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, PA. Petition 870260065706, dated 03 / 07 / 2026, page 30 / 778 26 / 376 USA, 1985 (and its more recent editions), in the Encyclopaedia of Pharmaceutical Technology, 3rd edition, James Swarbrick (Ed.), Informa Healthcare USA (Inc.), NY, USA, 2007, and in J. Pharm. Sci. 66: 2 (1977). In addition, for a review of suitable salts, see the Handbook of Pharmaceutical Salts: Properties, Selection, and Use by Stahl and Wermuth (Wiley-VCH, 2002).

[0088] The term alkyl includes a linear or branched, non-cyclic or cyclic, saturated aliphatic hydrocarbon containing from 1 to 24 carbon atoms. Representative saturated linear chain alkyls include, but are not limited to, methyl, ethyl, n-propyl, n-butyl, n-pentyl, n-hexyl and the like, while saturated branched alkyls include, without limitation, isopropyl, sec-butyl, isobutyl, tert-butyl, isopentyl and the like. Representative saturated cyclic alkyls include, but are not limited to, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl and the like, while unsaturated cyclic alkyls include, without limitation, cyclopentenyl, cyclohexenyl and the like.

[0089] Halo or halogen refers to the substituents bromine (Br), chlorine (Cl), fluorine (F) or iodine (I).

[0090] The term haloalkyl includes alkyl structures in which at least one hydrogen atom is replaced by a halogen atom. In certain embodiments in which two or more hydrogen atoms are replaced by halogen atoms, the halogen atoms are all identical to each other. In other embodiments in which two or more hydrogen atoms are replaced by halogen atoms, the halogen atoms are not all identical to each other.

[0091] An alkoxy group refers to an (alkyl)O- group, where the alkyl is as defined herein.

[0092] Aminocarbonyl or carboxamide refers to a CONH2 radical. Petition 870260065706, dated 03 / 07 / 2026, p. 31 / 778 27 / 376

[0093] 2-aminoethoxy refers to a radical -OCH2CH2-NH2.

[0094] 2-acetylaminoethoxy refers to the radical -OCH2CH2N(H)C(O)Me.

[0095] The term mammal refers to any species of mammal, such as a human being, mouse, rat, dog, cat, hamster, guinea pig, rabbit, cattle and the like.

[0096] An amino acid analog, for example, a Phe analog or a Tyr analog, means an analog of the referenced amino acid. A variety of amino acid analogs are known and available in the art, including Phe and Tyr analogs. In certain embodiments, an amino acid analog, for example, a Phe analog or a Tyr analog, comprises one, two, three, four, or five substitutions compared to Phe or Tyr, respectively. In certain embodiments, the substitutions are present in the side chains of the amino acids. In certain embodiments, a Phe analog has the structure Phe(R2), where R2 is a Hy, OH, CH3, CO2H, CONH2, CONH2OCH2CH2NH2, t-Bu, OCH2CH2NH2, phenoxy, OCH3, O-allyl, Br, Cl, F, NH2, N3, or guanadino. In certain forms, R2 is CONH2OCH2CH2NH2, OCH3, CONH2, OCH3, or CO2H.Examples of Phe analogs include, but are not limited to: hPhe, Phe(4-OMe), α-Me-Phe, hPhe(3,4-dimethoxy), Phe(4CONH2), Phe(4-phenoxy), Phe(4-guanadino), Phe(4-tBu), Phe(4-CN), Phe(4-Br), Phe(4-OBzl), Phe(4-NH2), BhPhe(4-F), Phe(4-F), Phe(3,5-DiF), Phe(CH2CO2H), Phe(penta-F), Phe(3,4-Cl2), Phe(3,4-F2), Phe(4CF3), ββ-diPheAla, Phe(4-N3), Phe[4-(2-aminoethoxy)], 4-phenylbenzylalanine, Phe(4-CONH2), Phe(3,4-dimethoxy), Phe(4-CF3), Phe(2,3-Cl2) and Phe(2,3-F2). Examples of Tyr analogs include, but are not limited to: hTyr, N-Me-Tyr, Tyr(3-1 Bu), Tyr(4-N3), and βhTyr.

[0097] Substituents are those that result in the formation of stable or chemically viable compounds. As used here, the Petition 870260065706, dated 03 / 07 / 2026, page 32 / 778 28 / 376 The term stable refers to compounds that are not substantially altered when subjected to conditions that allow their production, detection, and preferably their recovery, purification, and use for one or more of the purposes disclosed herein. In some embodiments, a stable compound or a chemically viable compound is one that is not substantially altered when maintained at a temperature of 40 °C or less, in the absence of moisture or other chemically reactive conditions, for at least one week.

[0098] Absorption enhancer refers to a component that improves or facilitates the absorption of a drug by the mucosa in the gastrointestinal tract, such as a permeation enhancer or an intestinal permeation enhancer. As conventionally understood in the art, permeation enhancers (PEs) are agents intended to improve the oral application of therapeutic drugs with low bioavailability.

[0099] PEs are capable of increasing the paracellular and / or transcellular passage of drugs. Pharmaceutical excipients that can increase permeation have been termed absorption-modifying excipients (AMEs). AMEs can be used in oral compositions, for example, as humectants (sodium dodecyl sulfate), antioxidants (e.g., EDTA), and emulsifiers (e.g., macrogol glycerides), and can be specifically included in compositions as PEs to improve bioavailability. PEs can be categorized by how they alter barrier integrity through paracellular or transcellular routes.

[00100] Intestinal permeation enhancer (IPE) refers to a component that improves the bioavailability of a component. Petition 870260065706, dated 03 / 07 / 2026, page 33 / 778 29 / 376 Suitable representative PPIs for use in the present invention include, but are not limited to, various surfactants, fatty acids, medium-chain glycerides, steroidal detergents, acylcarnitine and alkanolcholines, N-acetylated and non-N-acetylated alpha-amino acids and chitosans, other mucoadhesive polymers and the like. For example, a suitable PPI for use in the present invention could be sodium caprate.

[00101] Administration refers to the administration of the composition of the present invention to an individual.

[00102] As used herein, composition or pharmaceutical composition is intended to encompass an invention or product comprising the specified active ingredient (IPA), which may include pharmaceutically acceptable excipients, carriers or diluents described herein, as in specified quantities defined herein, resulting from the combination of specific compounds, as specified ingredients in specified quantities, as described herein.

[00103] Granulated mixture refers to a mixture of two or more agents produced by mixing the two or more agents and granulating them into a particulate form. Such a mixture provides particulate material that is composed of two or more agents. For example, in the present invention, the compositions may include, but are not limited to, granulated mixtures of a hydrochloride salt form of the peptide of SEQ ID NO: 1, or a solvate thereof, and an absorption or permeation enhancer, such as sodium caprate. Such a granulated mixture is formed into a particle or tablet form, which contains a hydrochloride salt form of a compound of formula (I), or a solvate thereof, and sodium caprate. In some embodiments, the compositions may include granulated mixtures comprising sodium caprate. Petition 870260065706, dated 03 / 07 / 2026, p. 34 / 778 30 / 376

[00104] In one embodiment, a pharmaceutical tablet is provided herein comprising a crystalline form of a monocyclic peptide compound prepared by the methods described herein and a pharmaceutical excipient.

[00105] Disintegrant refers to a pharmaceutical excipient that is incorporated into a composition to promote its disintegration when it comes into contact with a liquid. For example, a disintegrant is a pharmaceutically acceptable agent, used in the preparation of tablets, that causes the tablets to disintegrate and release medicinal substances upon contact with moisture. Examples of disintegrants include, without limitation, cross-linked polymers, including cross-linked polyvinylpyrrolidone (crospovidone), cross-linked sodium carboxymethylcellulose (croscarmellose sodium), and sodium starch glycolate with modified starch and the like.Representative disintegrants for use in the present invention may include, but are not limited to, agar-agar, alginic acid, calcium carbonate, microcrystalline cellulose, croscarmellose sodium, crospovidone, polacrilin potassium, sodium starch glycolate, potato or tapioca starch, other starches, pregelatinized starch, clays, other algins, other celluloses, gums (such as gellan), low-substituted hydroxypropylcellulose or mixtures thereof, and the like. In some respects, the disintegrants for use in the present invention may include, but are not limited to, croscarmellose sodium.Additional representative disintegrants for use in the present invention may include, but are not limited to, microcrystalline cellulose, croscarmellose sodium, alginic acid, sodium alginate, crospovidone, cellulose, agar and related gums, sodium starch glycolate, corn starch, potato starch, sodium starch glycolate, Veegum HV, methylcellulose, agar, bentonite, carboxymethylcellulose, alginic acid, combinations thereof. Petition 870260065706, dated 03 / 07 / 2026, page 35 / 778 31 / 376 guar gum and similar products. Representative disintegrants for use in the present invention include, but are not limited to, starches, clays, celluloses, alginates and gums, and crosslinked starches, celluloses and polymers, combinations thereof and similar products.

[00106] Disposed upon refers to the positioning of one phase or coating on top of another phase or coating. This positioning may adapt to the shape of the underlying phase or coating so that the layering of the phases and coatings does not leave substantial gaps between them.

[00107] Enteric coating refers to any of the commonly applied polymeric coatings used for delayed release of active ingredients. As conventionally understood in the art, an enteric coating is generally a polymer barrier applied to the oral drug that prevents its dissolution or disintegration in the gastric environment. This helps protect drugs from stomach acidity, from the stomach's harmful effects of the drug, or to release the drug after the stomach (usually in the upper intestinal tract). Some drugs are unstable at the pH of gastric acid and need to be protected against degradation. An enteric coating is also an effective method for achieving targeted drug establishment (such as gastro-resistant drugs). This delayed release is typically pH-dependent and allows for the release of the active ingredient further into the intestinal tract where the pH differs from that in the stomach.In general, suitable materials used for enteric coatings may include, but are not limited to, fatty acids, waxes, shellac, plastics, and vegetable fibers, wherein such enteric materials may include, but are not limited to, cellulose acetate phthalate, poly(vinyl alcohol) phthalate, shellac, zein, hydroxypropylmethylcellulose phthalate, cellulose acetate trimaleate. Petition 870260065706, dated 03 / 07 / 2026, page 36 / 778 32 / 376 film resins, etc. and the like. Additional examples of enteric coatings for use in the present invention may include, without limitation, those based on aleuritic acid esters, cellulose acetate phthalate (CAP), poly(methacrylic acid-co-methyl methacrylate), poly(vinyl acetate phthalate) (PVAP), cellulose trimellitate acetate (CAT), hydroxypropylmethylcellulose phthalate (HPMCP) and the like. Other suitable materials used for enteric coatings may also include, but are not limited to, copolymers of methacrylic acid, poly(ethyl acrylate of methacrylic acid) 1:1, poly(methyl methacrylate of methacrylic acid) 1:2, poly(ethyl acrylate of methacrylic acid) (L100D-55), combinations of methyl acrylate, methyl methacrylate, hydroxypropylmethylcellulose (HPMC), methacrylic acid (FS30D), Eudragit®, hydroxypropylmethylcellulose acetate succinate (HPMC-AS) and L, M or H type of HPMC-AS.In some embodiments, the enteric coating is placed over a sub-coating.

[00108] Flow agent refers to a substance that is added to a powder to improve its flowability and / or lubricity. Examples of flow agents may include, but are not limited to, magnesium stearate, pyrolyzed silica, starch, talc, and the like.

[00109] Silica refers to a pharmaceutical excipient that can be used as a flow agent (anti-cake formation), adsorbent, and desiccant in solid product forms. It can also be used to increase the mechanical stability and disintegration rate of compositions. Silica can be pyrolyzed, that is, with reference to its production through a pyrogenic process to generate fine silica particles. Pyrolyzed silica particles can vary in size, such as from 5 nm to 100 nm or from 5 to 50 nm. The particles can be non-porous and have a surface area of ​​50 to 1000 m² / g or from 50 to 600 m² / g. Examples of silicas include Aerosil 200, which has Petition 870260065706, dated 03 / 07 / 2026, page 37 / 778 33 / 376 a specific surface area of ​​about 200 m2 / g. Silica can be hydrophilic. Examples of suitable silica materials include, but are not limited to, SiO2, colloidal silicon dioxide, aerosol, colloidal silica, fumed silica, fumed silicon dioxide, colloidal anhydrous silica, colloidal silicon dioxide and the like.

[00110] Lubricant refers to a substance added to a formulation to reduce friction. Compounds that serve as lubricants may also have properties as flow agents. Examples of lubricants may include, but are not limited to, talc, silica, and fats such as vegetable stearin, magnesium stearate, or stearic acid and the like.

[00111] Microcrystalline cellulose or MCC refers to a pharmaceutical-grade cellulose manufactured from refined wood pulp. MCC can be unmodified or chemically modified, such as silicified microcrystalline cellulose (SMCC). MCC can serve as a bulking agent and aid in tablet formation due to its favorable compressibility characteristics.

[00112] Patient or individual refers to a living organism, which includes, but is not limited to, a human individual who suffers from or is prone to a disease or condition that can be treated by administering a pharmaceutical composition as provided in the present invention. Other non-limiting examples may include, but are not limited to, humans, other mammals, cattle, rats, mice, dogs, monkeys, goats, sheep, cows, deer, horses, and other mammalian and similar animals. In some respects, the patient is a human being.

[00113] By pharmaceutically acceptable it is understood that the carrier(s), diluent(s) or excipient(s) must be compatible with the other components or ingredients of the compositions of Petition 870260065706, dated 03 / 07 / 2026, page 38 / 778 34 / 376 present invention, that is, that it is useful, safe, non-toxic, and acceptable for pharmaceutical use. According to the present invention, the approved or approvable pharmaceutically acceptable means are mentioned in the U.S. Pharmacopoeia or other generally recognized pharmacopoeia for use in animals and, more particularly, in humans.

[00114] Hemihydrochloride salts refer to salts that have a substoichiometric amount of hydrochloride. For example, a hemihydrochloride salt may have from about 0.1 to about 0.9 molar equivalents of hydrogen chloride associated with the peptide of SEQ ID NO: 1. Representative and non-limiting hemihydrochloride salts include, but are not limited to, 0.2, 0.3, 0.4, 0.5, 0.6 and 0.7 equivalents of HCl associated with the peptide of SEQ ID NO: 1. With respect to the present invention, the terms hemihydrochloride salt should be indistinguishable from the term partial hydrochloride.In some embodiments, hemi refers to other pharmaceutically acceptable salt forms of the SEQ ID NO: 1 peptide, such as an acetate salt of the SEQ ID NO: 1 peptide, a fumarate salt of the SEQ ID NO: 1 peptide, a glutarate salt of the SEQ ID NO: 1 peptide, a glycolate salt of the SEQ ID NO: 1 peptide, a mesylate salt of the SEQ ID NO: 1 peptide, a bis-hydrochloride salt of the SEQ ID NO: 1 peptide, a citrate salt of the SEQ ID NO: 1 peptide, or a sulfate salt of the SEQ ID NO: 1 peptide.

[00115] Free base of compound of formula (I) refers to the peptide of SEQ ID NO: 1 with the following structure: Petition 870260065706, dated 03 / 07 / 2026, page 39 / 778 35 / 376 in a salt-free form.

[00116] Compound-free base of formula (II) and compound-free base of formula (III) refer to the peptide of SEQ ID NO: 2 and the peptide of SEQ ID NO: 3 in a salt-free form, respectively.

[00117] Crystalline salt of compound of formula (I) refers to a crystalline form of a pharmaceutically acceptable salt of a compound of formula (I), which may include, but is not limited to, a crystalline acetate salt of a compound of formula (I), a crystalline hydrochloride salt of a compound of formula (I), a crystalline fumarate salt of a compound of formula (I), a crystalline glutarate salt of a compound of formula (I), a crystalline glycolate salt of a compound of formula (I), a crystalline mesylate salt of a compound of formula (I), a crystalline citrate salt of a compound of formula (I), a crystalline bis-hydrochloride salt of a compound of formula (I), or a crystalline sulfate salt of a compound of formula (I). Crystalline salt also refers to a crystalline form of a pharmaceutically acceptable salt of a compound of formula (II) or formula (III), which may include, but is not limited to, the salts described herein. Petition 870260065706, dated 03 / 07 / 2026, p. 40 / 778 36 / 376

[00118] The pharmaceutical compositions or compositions of the present invention may be in different pharmaceutically acceptable forms, which may include, but are not limited to, a liquid composition, a tablet or matrix composition, a capsule composition, etc. and the like. When the composition is a tablet composition, the tablet may include, but is not limited to, different layers. The tablet composition may also include, but is not limited to, one or more coatings.

[00119] Silicified microcrystalline cellulose or SMCC refers to a particulate agglomerate of co-processed microcrystalline cellulose and silicon dioxide. Suitable for use in the present invention, SMCC may include, but is not limited to, amounts of about 0.1% to about 20% silicon dioxide, by weight of microcrystalline cellulose, wherein the silicon dioxide may have a particle size of about 1 nanometer (nm) to about 100 microns (µm), based on the average principal particle size. For example, the silicon dioxide may comprise about 0.5% to about 10% of the silicified microcrystalline cellulose, or about 1.25% to about 5%, by weight, relative to the microcrystalline cellulose. Furthermore, silicon dioxide can have a particle size of about 5 nm to about 40 μm, or from about 5 nm to about 50 μm.Silicon dioxide can have a surface area of ​​about 10 m² / g to about 500 m² / g, or about 50 m² / g to about 500 m² / g, or about 175 m² / g to about 350 m² / g. Silicified microcrystalline cellulose is commercially available from several suppliers known to be skilled in the art, including Penwest Pharmaceuticals, Inc., under the trademark PROSOLV®. PROSOLV® is available in several grades, including, for example, PROSOLV® SMCC 50, PROSOLV® SMCC 90, and PROSOLV® HD. Other products include, without limitation, SMCC 50LD, SMCC HD90, and... Petition 870260065706, dated 03 / 07 / 2026, p. 41 / 778 37 / 376 SMCC 90LM and similar models.

[00120] Sodium caprate or NaC10 refers to the compound sodium decanoate (IUPAC name) having the molecular formula CwHwNaO2 and the structural formula: the

[00121] In some embodiments, sodium caprate functions as an absorption enhancer or an excipient in tablet formulations. Sodium caprate is approved by the European Union and the U.S. Food and Drug Administration (FDA) as a direct-to-consumption food additive.

[00122] As used herein, solvate means a physical association of the peptide of SEQ ID NO: 1 of the present invention with one or more solvent molecules. This physical association involves different degrees of bonding, including hydrogen bonding. In certain cases, the solvate will be capable of isolation. The term solvate is intended to encompass both isolable and solution-phase solvates. Non-limiting examples of suitable solvates include hydrates.

[00123] Sorbitol refers to the sugar alcohol D-glycitol and can serve as a binder promoting the adhesion of ingredients in tablet compositions.

[00124] As used herein, sugar alcohol refers to compounds derived from sugars that contain one or more hydroxyl groups. Sugar alcohols may contain multiple -OH groups and may be classified as polyols. Examples of sugar alcohols include, but are not limited to, sorbitol, mannitol, and xylitol.

[00125] Subcoating refers to any number of film layers arranged over the basic tablet that may provide one or more benefits, such as providing a tablet with Petition 870260065706, dated 03 / 07 / 2026, page 42 / 778 38 / 376 a smooth surface to facilitate swallowing of the compositions, accommodate pigmentation to aid pill identification, provide a moisture barrier, and provide a high tensile strength outer layer for the tablet. Such sub-coatings may comprise, but are not limited to, polyvinyl alcohol (PVA) and polyethylene glycol (PEG) graft copolymers. Commercial products providing sub-coatings include the product line under the trade names OPADRY®, OPAGLOS®, and similar. A sub-coating may be additionally covered by one or more additional coatings.

[00126] In some embodiments, the sub-coating refers to any number of film layers disposed over the basic tablet. Examples of suitable materials for cosmetic sub-coatings include a polyvinyl alcohol-polyethylene glycol (PVA-PEG) graft copolymer (e.g., OPADRY® QX). Other coatings include, without limitation, HPMC, HPC, PVA, Eudragit E-based coatings and the like.

[00127] In some embodiments, a sub-coating may be additionally covered by one or more additional coatings, such as an enteric coating or a functional coating. In certain embodiments, a sub-coating comprises one or more of a plasticizer, anti-adherent agent, dyeing agent, HPMC-based coatings, HPC, PVA, and Eudragit E-based coatings. In some embodiments, a sub-coating is covered with one or more additional coatings. In certain embodiments, the one or more additional coatings on the sub-coating are an enteric coating. In other embodiments, the one or more additional coatings on the sub-coating are a functional coating.

[00128] In some respects, an undercoat is not covered Petition 870260065706, dated 03 / 07 / 2026, p. 43 / 778 39 / 376 by one or more additional coatings and is called a cosmetic subcoating. For example, in certain embodiments, a basic tablet is covered by a cosmetic coating and the cosmetic coating is not additionally covered with an enteric coating or a functional coating. In some embodiments, a cosmetic coating may serve as a smooth surface to aid swallowing of the tablet. In some embodiments, a cosmetic coating may provide a vehicle for pigmentation for tablet identification, serve as a smooth surface to aid swallowing of the tablet.

[00129] Basic tablet refers to a mixture of the components of the basic tablet. In some embodiments, the components are one or more of a crystalline form of the peptide of SEQ ID NO: 1, a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound, and suitable excipients. In some embodiments, the suitable excipient is one or more of the following, but not limited to: a filler, a disintegrant, a flow agent, a lubricant, and an absorption enhancer. A sub-coating, a cosmetic coating, an enteric coating, or any combination thereof, may be disposed of on the basic tablet.

[00130] Therapeutically effective quantity refers to an amount of a compound (i.e., a peptide of SEQ ID NO: 1) or pharmaceutical composition useful for treating or alleviating an identified disease or condition or for exhibiting a detectable therapeutic or inhibitory effect. Therapeutically effective quantity additionally includes, in its meaning, a non-toxic but sufficient amount of the specific drug to which reference is made to provide the desired therapeutic effect. The exact amount required will vary from individual to individual depending on factors such as Petition 870260065706, dated 03 / 07 / 2026, page 44 / 778 40 / 376 The patient's general health, the patient's age, etc. The exact amounts will depend on the purpose of the treatment and will be determinable by someone skilled in the art using known techniques (see, for example, Lieberman, Pharmaceutical Dosage Forms (vols. 1 to 3, 1992); Lloyd, The Art, Science and Technology of Pharmaceutical Compounding (1999); Pickar, Dosage Calculations (1999); and Remington: The Science and Practice of Pharmacy, 20th Edition, 2003, Gennaro, Ed., Lippincott, Williams & Wilkins).

[00131] To treat, treating, and treatment refer to any indications of success in the treatment or improvement of an injury, pathology, or condition, including any objective or subjective parameter, such as abatement; remission; reducing symptoms or making the injury, pathology, or condition more tolerable to the patient; slowing the rate of degeneration or decline; making the endpoint of degeneration less debilitating; improving a patient's physical or mental well-being. The treatment or improvement of symptoms may be based on objective or subjective parameters; including the results of a physical examination, neuropsychiatric examinations, and / or a psychiatric evaluation.

[00132] The abbreviation (V / V) refers to the phrase volume by volume, that is, the proportion of a specific substance within a mixture, as measured by volume, or a volume quantity of a component of the composition disclosed herein in relation to the total volume quantity of the composition. Consequently, quantity is a smaller unit and represents a percentage quantity by volume of a component relative to the total volume of the composition. For example, a 2% (V / V) solvent mixture might indicate that 2 mL of a solvent is present in 100 mL of the solvent mixture.

[00133] The abbreviation (p / p) refers to the phrase weight in weight, that is Petition 870260065706, dated 03 / 07 / 2026, p. 45 / 778 41 / 376 is the proportion of a specific substance within a mixture, as measured by weight or mass, or a weight quantity of a component of the composition disclosed herein in relation to the total weight quantity of the composition. Consequently, quantity is a smaller unit and represents a percentage amount by weight of a component relative to the total weight of the composition. For example, a 2% (w / w) solution might indicate that 2 grams of solute are dissolved in 100 grams of solution.

[00134] Systemic routes of administration, as conventionally understood in medical or pharmaceutical techniques, refer to or are defined as a route of administration of a drug, a pharmaceutical composition or formulation, or other substance into the circulatory system in such a way that various body tissues and organs are exposed to the drug, formulation, or other substance. As conventionally understood in the art, administration can occur orally (where the drug or oral preparations are ingested by mouth and absorbed through the gastrointestinal tract), enterally (drug absorption also occurs through the gastrointestinal tract), or parenterally (generally injection, infusion, or implantation, etc.).

[00135] Systemically active peptide drug therapy related to the present invention generally refers to treatment by means of a pharmaceutical composition comprising an active peptide ingredient, wherein said peptide resists immediate metabolism and / or excretion, resulting in its exposure in various body tissues and organs, such as cardiovascular, respiratory, gastrointestinal, nervous or immune systems.

[00136] The systemic drug activity in the present invention is Petition 870260065706, dated 03 / 07 / 2026, page 46 / 778 42 / 376 also refers to treatment using substances that travel through the bloodstream, reaching and affecting cells in various body tissues and organs. Systemic active drugs are transported to their site of action and work throughout the body to attack the physiological processes that cause inflammatory diseases.

[00137] Bioavailability refers to the extent and rate at which the active portion (drug or metabolite) enters the systemic circulation, thus accessing the site of action. The bioavailability of a drug is affected by the properties of the dosage form, which depend in part on its design and manufacture.

[00138] Digestive tract tissue, as used in the present invention, refers to all tissues comprising the organs of the alimentary canal. For example, but not limited to, digestive tract tissue includes tissues of the mouth, esophagus, stomach, small intestine, large intestine, and anus.

[00139] Amorphous refers to a solid material that has no long-range order in the position of its molecules. Partially amorphous refers to a solid material that has little or no long-range order in the position of its molecules. For example, amorphous and partially amorphous materials have less than about 50%, less than about 60%, less than about 70%, less than about 80%, less than about 90%, or less than about 95% crystallinity.

[00140] As used herein, the term Dv50 (or volume D50 or volume-weighted D50) refers to the average particle size based on a volume-weighted particle size distribution. Thus, Dv50 typically describes the particle size (based on a volume-weighted distribution), preferably the diameter of a particle in micrometers (µm), in Petition 870260065706, dated 03 / 07 / 2026, page 47 / 778 43 / 376 that 50% of the particles in the distribution have a size larger and 50% of the particles in the distribution have a size smaller than Dv50. In a volume-weighted distribution, the parameter Dv50 typically refers to the diameter (e.g., in micrometers ^m) of a hypothetical spherical particle, which has the volume of the corresponding real particle in the distribution (which may or may not be spherical).

[00141] As used herein, the term Dv10 refers to the cutoff size (preferably in μm) of particles in a volume-weighted distribution which represent 10% of the total sample volume and have a particle size equal to or smaller than the Dv10 value.

[00142] The term Dv50 (or volume D50 or volume-weighted D50) refers to the average particle size based on a volume-weighted particle size distribution. Thus, Dv50 typically describes the particle size (based on a volume-weighted distribution), preferably the diameter of a particle in micrometers ^m), where 50% of the particles in the distribution have a size larger and 50% of the particles in the distribution have a size smaller than Dv50. In a volume-weighted distribution, the parameter Dv50 typically refers to the diameter (e.g., in micrometers ^m)) of a hypothetical spherical particle, which has the volume of the corresponding real particle in the distribution (which may or may not be spherical).

[00143] As used herein, the term Dv90 refers to the cutoff size (preferably in μm) of particles in a volume-weighted distribution

[00144] which represent 90% of the total sample volume and have a particle size equal to or smaller than the Dv90 value.

[00145] As used herein, range, particle size distribution range, or particle size distribution range. Petition 870260065706, dated 03 / 07 / 2026, page 48 / 778 44 / 376 particle refers to a parameter used to describe the overall width of the particle size distribution observed by laser diffraction. The range of a volume-based size distribution is defined as Range = (Dv90 - Dv10) / Dv50 and gives an indication of how far apart the 10 percent and 90 percent points are, normalized to the midpoint.

[00146] Dv10, Dv50, Dv90 and the particle size distribution range described herein can be measured using a Malvern Mastersizer 3000 laser diffraction particle size analyzer, in combination, and an Aero S dry dispersion unit is used for particle size distribution determination. III. Methods for preparing crystalline forms

[00147] In general, the present invention relates to methods for preparing crystalline forms of monocyclic peptide compounds, or pharmaceutically acceptable salts or solvates thereof. The peptide compounds are interleukin-23 receptor (IL-23R) peptide inhibitors. The crystalline compounds, and crystalline salts, or solvates, are useful in the preparation of pharmaceutical compositions, as defined herein, and in methods and / or uses for the treatment of autoimmune inflammation, and related diseases and disorders, as defined herein.

[00148] According to the present invention, it is possible to provide monocyclic peptide compounds that have excellent rheological properties (flowability) useful for manufacturing pharmaceutical compositions. According to the present invention, it is possible to suppress the agglomeration that reduces the flowability of a pharmaceutical preparation. As a result, the crystalline forms of the monocyclic peptide compound have excellent rheological properties (flowability is achieved), making the crystalline forms suitable for the manufacture of formulations. Petition 870260065706, dated 03 / 07 / 2026, page 49 / 778 45 / 376 pharmaceutical companies.

[00149] In another aspect, the present invention provides a method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, which has rheological properties suitable for manufacturing pharmaceutical compositions, wherein the method comprises the following steps: (a) dissolve the monocyclic peptide compound, or its salt or solvate, in a first solvent; (b) add a first portion of sodium chloride to the mixture obtained in step (a); (c) add crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) add a second portion of sodium chloride to the fluid paste obtained in step (c); (e) Isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (d) and remove the residual solvent.

[00150] In another aspect, the present invention provides a method for improving the rheological properties of a monocyclic peptide compound, or a salt or solvate thereof, wherein the method comprises the following steps: (a) dissolve the monocyclic peptide compound, or its salt or solvate, in a first solvent; (b) add a first portion of sodium chloride to the mixture obtained in step (a); (c) add crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; Petition 870260065706, dated 03 / 07 / 2026, page 50 / 778 46 / 376 (d) add a second portion of sodium chloride to the fluid paste obtained in step (c); (e) Isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (d) and remove the residual solvent.

[00151] In another aspect, the present invention provides a method for preparing a crystalline form of the hydrochloride salt of a monocyclic peptide compound, wherein the monocyclic peptide compound is a compound having the structure: OH HO ^O, where the method comprises the following steps: (a) Dissolving the monocyclic peptide compound comprising a hydrochloride salt of the monocyclic peptide compound in a first solvent, wherein, optionally, the crude monocyclic peptide compound was obtained by a Liquid Phase Peptide Synthesis; (b) add a first portion of sodium chloride to the mixture obtained in step (a); (c) add seeds of crystalline hydrochloride salt of the monocyclic peptide compound to the mixture obtained in step (b) to Petition 870260065706, dated 03 / 07 / 2026, page 51 / 778 47 / 376 obtain a fluid paste; (d) add a second portion of sodium chloride to the fluid paste obtained in step (c); (e) Isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (d) and remove the residual solvent.

[00152] In another aspect, the present invention provides a method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, which has rheological properties suitable for manufacturing pharmaceutical compositions, wherein the method comprises the following steps: (a) dissolve the monocyclic peptide compound, or its salt or solvate, in a first solvent; (b') add a second portion of solvent to the mixture obtained in step (a); (c) add seeds of the crystalline monocyclic peptide compound to the mixture obtained in step (b') to obtain a fluid paste; (d') add a third portion of solvent to the mixture obtained in step (c); (e) isolate a crystalline monocyclic peptide compound from the mixture obtained in step (d') and remove the residual solvent.

[00153] In another aspect, the present invention provides a method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, which has rheological properties suitable for manufacturing pharmaceutical compositions, wherein the method comprises the following steps: (a) dissolve the monocyclic peptide compound, or salt or Petition 870260065706, dated 03 / 07 / 2026, page 52 / 778 48 / 376 solvate of the same, in a first solvent; (h) percolate the mixture obtained in step (a) through an ion exchange resin; (e) Isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (h) and remove the residual solvent. Step (a)

[00154] In step (a), the monocyclic peptide compound, or salt or solvate thereof, is dissolved in a first solvent. In one embodiment, the monocyclic peptide compound, or salt or solvate thereof, that is dissolved in step (a) is an amorphous or partially amorphous form of the monocyclic peptide compound, or salt or solvate thereof. In one embodiment, the monocyclic peptide compound, or salt or solvate thereof, that is dissolved in step (a) comprises the hydrochloride salt of the monocyclic peptide compound. In one embodiment, the monocyclic peptide compound, or salt or solvate thereof, that is dissolved in step (a) comprises an amorphous or partially amorphous form of the hydrochloride salt of the monocyclic peptide compound. In one embodiment, the hydrochloride salt of the monocyclic peptide compound comprises the crude product isolated from the synthesis of the monocyclic peptide compound.

[00155] In some modalities, stage (a) is performed at approximately 25 °C to approximately 60 °C. In some modalities, stage (a) is performed at approximately 25 °C to approximately 55 °C. In some modalities, stage (a) is performed at approximately 35 °C to approximately 50 °C. In some modalities, stage (a) is performed at approximately 40 °C to approximately 45 °C. In some modalities, stage (a) is performed at approximately 40 °C to approximately 55 °C. In some modalities, stage (a) is performed at approximately 45 °C to approximately 50 °C. In some Petition 870260065706, dated 03 / 07 / 2026, p. 53 / 778 49 / 376 modalities, stage (a) is carried out at approximately 50 °C.

[00156] In some embodiments, step (a) is performed at a pH between 5.0 and 6.5. In some embodiments, step (a) is performed at a pH between 5.5 and 6.0.

[00157] In some embodiments, the first solvent in step (a) comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol. In some embodiments, the first solvent in step (a) comprises one or more solvents selected from the group consisting of methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol, 1-pentanol, 1-pentanol, cyclopentanol, 1-hexanol and 1-heptanol, and combinations thereof. In some embodiments, the first solvent in step (a) comprises one or more solvents selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, methyl-1-propanol, 2-methyl-2-propanol and combinations thereof. In some embodiments, the first solvent in step (a) comprises methanol and water.

[00158] In some embodiments, the first solvent in step (a) comprises H2O. In some embodiments, the first solvent in step (a) comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol and H2O. In some embodiments, the first solvent in step (a) comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol and 2-methyl-2-propanol; and H2O. In some embodiments, the first solvent in step (a) consists of methanol and H2O.

[00159] In some embodiments, the first solvent in step (a) comprises methanol and H2O in a ratio of 9:1 to 5:5 by volume. In some embodiments, the first solvent in step (a) comprises methanol and H2O in a ratio of 8:2 to 13:7, or about 7:3 by volume. In some embodiments, the first solvent in step (a) comprises methanol and H2O in a ratio by volume. Petition 870260065706, dated 03 / 07 / 2026, page 54 / 778 50 / 376

[00160] In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (a) is 5% w / v 30% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (a) is 10% w / v 25% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (a) is 15% w / v 20% w / v.

[00161] In some embodiments, the mixture obtained in step (a) is stirred for about 7 hours or less. In some embodiments, the mixture obtained in step (a) is stirred for about 5 hours or less.

[00162] In some embodiments, the mixture obtained in step (a) is stirred at about 35 °C to about 55 °C. In some embodiments, the mixture obtained in step (a) is stirred at about 45 °C. In some embodiments, the mixture obtained in step (a) is stirred at about 50 °C.

[00163] In some embodiments, the mixture obtained in step (a) is stirred until all the hydrochloride salt of the monocyclic peptide compound is dissolved.

[00164] In some embodiments, the first solvent in step (a) comprises methanol and H2O in a ratio of 3:1 and 3:2 by volume.

[00165] In some embodiments, the mixture obtained in step (a) is filtered to provide a solution.

[00166] In some embodiments, step (a) comprises adjusting the pH of the solution to be in the range of about 4.5 to 6.5, about 5 to 6.5, about 5.5 to 6.1, or about 5.5 to 6. In some embodiments, step (a) comprises adjusting the pH of the solution to about 5.8. In some embodiments, step (a) comprises adjusting the pH of the solution to about 5.5 to 6.1. In some embodiments, the pH adjustment may be performed before filtration in step (a). In some embodiments, the pH adjustment may be performed after filtration in step (a). Petition 870260065706, dated 03 / 07 / 2026, page 55 / 778 51 / 376

[00167] In one embodiment, the amount of monocyclic peptide compound dissolved in step (a) is at least 10 kg. In another embodiment, the amount of monocyclic peptide compound dissolved in step (a) is at least 1 kg, at least 2 kg, at least 3 kg, at least 4 kg, at least 5 kg, at least 6 kg, at least 7 kg, at least 8 kg, at least 9 kg, at least 10 kg, at least 11 kg, at least 12 kg, at least 13 kg, at least 14 kg, at least 15 kg. Step (b)

[00168] In step (b), a first portion of sodium chloride is added to the mixture obtained in step (a).

[00169] In some embodiments, in step (b), sodium chloride is an aqueous solution of sodium chloride. In some embodiments, in step (b), sodium chloride is a 0.1 M to 2 M aqueous solution of sodium chloride. In some embodiments, in step (b), sodium chloride is a 0.5 M to 1.5 M aqueous solution of sodium chloride. In some embodiments, in step (b), sodium chloride is an aqueous solution of about 1 M sodium chloride. In some embodiments, in step (b), sodium chloride is an aqueous solution of about 0.96 M sodium chloride.

[00170] In some embodiments, in step (b), sodium chloride is added over a period of at least 10 minutes. In some embodiments, in step (b), sodium chloride is added over a period of at least 30 minutes. In some embodiments, in step (b), sodium chloride is added over a period of at least 45 minutes. In some embodiments, in step (b), sodium chloride is added over a period of approximately 60 minutes. In some embodiments, in step (b), sodium chloride is added over a period of at least approximately Petition 870260065706, dated 03 / 07 / 2026, page 56 / 778 52 / 376 minutes. In some embodiments, in step (b), sodium chloride is added over a period of at least about 2 hours. In some embodiments, in step (b), sodium chloride is added over a period of at least about 3 hours. In some embodiments, in step (b), sodium chloride is added over a period of at least about 4 hours.

[00171] In some embodiments, in step (b), sodium chloride is added at a temperature between about 25 °C and about 55 °C. In some embodiments, in step (b), sodium chloride is added at a temperature between about 35 °C and about 45 °C. In some embodiments, in step (b), sodium chloride is added at a temperature of about 40 °C.

[00172] In some embodiments, in step (b), 1.0 to 13.0 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, in step (b), 5.0 to 12.0 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, in step (b), 7.0 to 12.0 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, in step (b), 10.0 to 12.0 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, in step (b), 10.5 to 11.5 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a).In some embodiments, in step (b), 1.0 to 13.0 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, in... Petition 870260065706, dated 03 / 07 / 2026, page 57 / 778 53 / 376 step (b), 11.0 to 11.5 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, 11.05 molar equivalents of NaCl are added in step (b), based on the amount of monocyclic peptide compound in step (a). In some embodiments, 1.5 to 2.5 molar equivalents of NaCl are added in step (b), based on the amount of monocyclic peptide compound in step (a).

[00173] NaCl. In some embodiments, in step (b), approximately 2.3 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). Step (c)

[00174] In step (c), crystalline hydrochloride salt seeds of the monocyclic peptide compound are added to the mixture obtained in step (b) to obtain a fluid paste.

[00175] In some embodiments, the seeds of crystalline monocyclic peptide compound are obtained by a method comprising the following steps: (i) dissolve the monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, in a first solvent; (ii) add a second solvent to the mixture obtained in step (i); (iii) cool the mixture obtained in step (ii); and (iv) isolate the crystalline monocyclic peptide compound, or salt or solvate thereof, from the mixture obtained from step (iii) and remove residual solvent.

[00176] In some embodiments, the amount of seeds added is from 0.005 to 0.1 molar equivalents based on Petition 870260065706, dated 03 / 07 / 2026, page 58 / 778 54 / 376 amount of monocyclic peptide compound in step (a). In some embodiments, the amount of seeds added is 0.008 to 0.08 equivalents based on the amount of monocyclic peptide compound in step (a). In some embodiments, the amount of seeds added is about 0.01 equivalents based on the amount of monocyclic peptide compound in step (a).

[00177] In some embodiments, the fluid paste obtained in step (c) is left to age for a period of at least 1 hour. In some embodiments, the fluid paste obtained in step (c) is left to age for a period of at least 3 hours. In some embodiments, the fluid paste obtained in step (c) is left to age for a period of at least 5 hours. In some embodiments, the fluid paste obtained in step (c) is left to age for a period of approximately 8 hours.

[00178] In some embodiments, before step (c), the fluid paste is allowed to age at a temperature of about 25 °C to about 55 °C. In some embodiments, before step (c), the fluid paste is allowed to age at a temperature of about 35 °C to about 45 °C. In some embodiments, before step (c), the fluid paste is allowed to age at a temperature of about 40 °C.

[00179] In some embodiments, the seeds of crystalline monocyclic peptide compound are free base crystals of the monocyclic peptide compound.

[00180] In some embodiments, the fluid paste obtained in step (c) is stirred for a period of at least 1 hour. In some embodiments, the fluid paste obtained in step (c) is stirred for a period of at least 3 hours. In some embodiments, the fluid paste obtained in step (c) is stirred for a period of at least 5 Petition 870260065706, dated 03 / 07 / 2026, page 59 / 778 55 / 376 hours. In some embodiments, the fluid paste obtained in step (c) is stirred for a period of about 8 hours. In some embodiments, the fluid paste obtained in step (c) is stirred for about 30 min to 4 h. In some embodiments, the fluid paste obtained in step (c) is stirred for about 1 h to 4 h. In some embodiments, the fluid paste obtained in step (c) is stirred for about 1 h to 3 h. In some embodiments, the fluid paste obtained in step (c) is stirred for about 2 h. In some embodiments, the fluid paste obtained in step (c) is stirred for less than 4 h. In some embodiments, the fluid paste obtained in step (c) is stirred at a temperature of about 35 °C to about 65 °C. In some embodiments, the fluid paste obtained in step (c) is stirred at a temperature of about 45 °C to about 65 °C. In some embodiments, the fluid paste obtained in step (c) is stirred at a temperature of about 50 °C. Step (d)

[00181] In step (d), a second portion of sodium chloride is added to the fluid paste obtained in step (c). Optionally, before or after the addition of the second portion of sodium chloride, the fluid paste may be cooled.

[00182] In some embodiments, in step (d), the fluid paste obtained in step (c) is cooled to a temperature between about 0 °C and about 10 °C. In some embodiments, in step (d), the fluid paste obtained in step (c) is cooled to a temperature between about 3 °C and about 7 °C. In some embodiments, in step (d), the fluid paste obtained in step (c) is cooled to a temperature of about 5 °C.

[00183] In some embodiments, in step (d), the fluid paste is cooled to a temperature between about 0 °C and about 10 °C at a rate of less than 1 °C / min. In some embodiments, in step (d), the fluid paste is cooled to a temperature between about 0 °C and Petition 870260065706, dated 03 / 07 / 2026, p. 60 / 778 56 / 376 approximately 10 °C at a rate less than 0.5 °C / min. In some embodiments, in step (d), the fluid paste is cooled to a temperature between approximately 0 °C and approximately 10 °C at a rate of approximately 0.1 °C / min. In some embodiments, in step (d), the fluid paste is cooled to a temperature between approximately 3 °C and approximately 7 °C at a rate less than 0.5 °C / min. In some embodiments, in step (d), the fluid paste is cooled to a temperature between approximately 3 °C and approximately 7 °C at a rate of approximately 0.1 °C / min.

[00184] In some embodiments, in step (d), the fluid paste is cooled to a temperature of about 5 °C at a rate of less than 0.5 °C / min. In some embodiments, in step (d), the fluid paste is cooled to a temperature of about 5 °C at a rate of about 0.1 °C / min.

[00185] In some embodiments, in step (d), sodium chloride is an aqueous solution of sodium chloride.

[00186] In some embodiments, in step (d), sodium chloride is added at a temperature between about 25 °C and about 55 °C. In some embodiments, in step (d), sodium chloride is added at a temperature between about 35 °C and about 45 °C.

[00187] In some embodiments, in step (d), sodium chloride is a 0.1 M to 2 M aqueous solution of sodium chloride. In some embodiments, in step (d), sodium chloride is a 0.5 to 1.5 M aqueous solution of sodium chloride. In some embodiments, in step (d), sodium chloride is an aqueous solution of about 1 M sodium chloride.

[00188] In some embodiments, at step (d), at least 4.0 molar equivalents of NaCl are added, based on the amount of monocyclic peptide compound in step (a). In some embodiments, at step (d), at least 6.0 molar equivalents are added, based on the amount of compound of Petition 870260065706, dated 03 / 07 / 2026, page 61 / 778 57 / 376 monocyclic peptide in step (a), of NaCl. In some embodiments, in step (d), at least 8.0 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl. In some embodiments, in step (d), at least 7.6 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl. In some embodiments, in step (d), at least 2.0 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl. In some embodiments, in step (d), at least 3.0 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl. In some embodiments, in step (d), approximately 2 to 4 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl.In some embodiments, in step (d), approximately 3 to 4 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl. In some embodiments, in step (d), approximately 3 to 3.5 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl. In some embodiments, in step (d), approximately 3.34 molar equivalents are added, based on the amount of monocyclic peptide compound in step (a), of NaCl.

[00189] In some embodiments, in step (d), sodium chloride is added over a period of at least 30 minutes. In some embodiments, in step (d), sodium chloride is added over a period of at least 1 hour. In some embodiments, in step (d), sodium chloride is Petition 870260065706, dated 03 / 07 / 2026, page 62 / 778 58 / 376 added over a period of at least 2 hours. In some embodiments, in step (d), sodium chloride is added over a period of about 4 hours.

[00190] In some embodiments, the fluid paste obtained in step (d) is left to age for a period of at least 1 hour. In some embodiments, the fluid paste obtained in step (d) is left to age for a period of at least 2 hours. In some embodiments, the fluid paste obtained in step (d) is left to age for a period of at least 3 hours. In some embodiments, the fluid paste obtained in step (d) is left to age for a period of about 5 hours. Step (e)

[00191] In step (e), the crystalline monocyclic peptide compound is isolated and the residual solvent is removed. To isolate the crystalline material, it is important to remove the residual solvent. Residual solvent left on the isolated crystalline peptide compound can cause the crystalline peptide to become thixotropic. Thixotropicity of the peptide compound results in the rupture of crystalline particles, making the particles unsuitable for further processing steps such as tablet formation. Therefore, removal of the residual solvent in step (d) is necessary to maintain the crystalline form and avoid thixotropicity of the particles. In some embodiments, the removal of the residual solvent comprises one or more washing steps. In some embodiments, the removal of the residual solvent comprises two washing steps. In some embodiments, the removal of the residual solvent comprises washing the isolated crystalline peptide compound and then vacuum drying.

[00192] In some embodiments, the residual solvent is removed by washing with a second solvent. In some embodiments, step (e) comprises, first, washing the isolated crystalline peptide with Petition 870260065706, dated 03 / 07 / 2026, page 63 / 778 59 / 376 a mixture of water and alkyl alcohol and then washing with a second solvent. In some embodiments, step (e) comprises first washing with a mixture of water and methanol (e.g., water / methanol: 65% / 35% v / v) and then washing with isopropyl alcohol. In some embodiments, step (e) comprises washing with a mixture of water and methanol (e.g., water / methanol: 65% / 35% v / v), washing with isopropyl alcohol, and then vacuum drying.

[00193] Some embodiments refer to a first washing step of the isolated crystalline peptide with a mixture of water and alkyl alcohol to help remove residual NaCl. The amount of solvent used for the washing step needs to be sufficient to remove residual NaCl while not leading to a substantial loss in yield. In some embodiments, the amount of washing solvent is in the range of 1 to 3 L of water / alkyl alcohol per 1 mol of crystalline peptide compound.In some embodiments, the amount of washing solvent is in the range of 1.5 l to 2 l of water / alkyl alcohol per 1 mol of crystalline peptide compound. In some embodiments, the amount of washing solvent is about 1.93 l of water / alkyl alcohol per 1 mol of crystalline peptide compound. In some embodiments, the alkyl alcohol is methanol. In some embodiments, the solvent used for washing is water / methanol. In some embodiments, the solvent used for washing is water / methanol (65 / 35% v / v).

[00194] Some embodiments refer to a second washing step to remove the mixture of water and alkyl alcohol (e.g., methanol) by washing with isopropyl alcohol so that the solvent used in the first washing step is replaced by isopropyl alcohol. The washing action with isopropyl alcohol is necessary to avoid thixotropicity. The amount of solvent used for the second washing step needs to be sufficient to remove Petition 870260065706, dated 03 / 07 / 2026, page 64 / 778 60 / 376 wastewater and, at the same time, not lead to a substantial loss in yield. In some embodiments, the amount of washing solvent is in the range of 1 l to 3 l of the second solvent per 1 mol of crystalline peptide compound. In some embodiments, the amount of washing solvent is in the range of 1.5 l to 2 l of the second solvent per 1 mol of crystalline peptide compound. In some embodiments, the amount of washing solvent is about 1.93 l of isopropanol per 1 mol of crystalline peptide compound. In some embodiments, the second washing solvent is isopropanol.

[00195] In some embodiments, in step (e), the precipitate is isolated by filtration and then washed and dried.

[00196] In some embodiments, in step (e), the second solvent comprises an alkyl alcohol. In some embodiments, in step (e), the second solvent is an alkyl alcohol other than methanol. In some embodiments, in step (e), the second solvent comprises 2-propanol (isopropyl alcohol, IPA). In some embodiments, in step (e), the second solvent consists essentially of 2-propanol (isopropyl alcohol).

[00197] In some embodiments, in step (e), the precipitate is washed with the second solvent at a rate of 1.5 to 2.5 l per mole of the monocyclic peptide compound from step (a). In some embodiments, in step (e), the precipitate is washed with the second solvent at a rate of about 2 l per mole of the monocyclic peptide compound from step (a).

[00198] In some embodiments, in step (e), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried. In some embodiments, in step (e), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried at a temperature below about 20 °C under vacuum. In Petition 870260065706, dated 03 / 07 / 2026, page 65 / 778 61 / 376 In some embodiments, the crystalline peptide compound is dried at a temperature in the range of about 10 °C to 50 °C. In some embodiments, the crystalline peptide compound is dried at a temperature in the range of about 20 °C to 40 °C. In some embodiments, the crystalline peptide compound is vacuum dried.

[00199] This drying step can remove residual solvent from the crystallization process, such as the removal of isopropyl alcohol. The drying step can occur, for example, at about 20 °C, 30 °C, 40 °C, 50 °C, 60 °C, 70 °C or 80 °C. In another embodiment, the drying step occurs at about 20 °C to 45 °C. In yet another embodiment, the drying step occurs at about 20% relative humidity (RH), 30% RH, 40% RH, 50% RH, 60% RH, 70% RH, 80% RH or 90% RH. In another embodiment, the drying step occurs at 50% to 70% RH, for example, about 65% RH.

[00200] In some embodiments, the amount of residual IPA in the crystalline peptide compound is less than 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, or 4000 ppm after the drying step. In some embodiments, the amount of residual IPA is less than 5000 ppm after the drying step. In some embodiments, the amount of residual methanol in the crystalline peptide compound is less than 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, or 2000 ppm after the drying step. In some embodiments, the amount of residual methanol is less than 3000 ppm after the drying step.

[00201] In some embodiments, the amount of water in the crystalline peptide compound is in the range of about 3 to 10%, 4 to 8%, or 4 to 6% by weight after the drying step. In some embodiments, the amount of water in the crystalline peptide compound is in the range of about 4 to 6% after the drying step. Petition 870260065706, dated 03 / 07 / 2026, page 66 / 778 62 / 376 In some embodiments, the drying step comprises drying the crystalline peptide compound under relative humidity in the range of 50 to 70% in vacuum while moisture is supplied with a flow of humidified nitrogen, and drying continues until the water content of the crystalline peptide compound is in the range of about 3 to 10% by weight.

[00202] In some embodiments, in step (e), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried under relative humidity between about 45% and about 75%. In some embodiments, in step (e), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried under relative humidity between about 50% and about 70%.

[00203] In some embodiments, the crystalline monocyclic peptide compound is obtained in step (e) in the form of the hydrochloride salt.

[00204] In some embodiments, the crystalline monocyclic peptide compound is obtained in step (e) in the form of the acetate salt.

[00205] In some embodiments, the crystalline monocyclic peptide compound is obtained in step (e) in the form of a free base crystalline solid.

[00206] In some embodiments, the crystalline monocyclic peptide compound obtained in step (e) is dissolved in a solvent, which is removed by lyophilization. Stage (b')

[00207] In step (b'), a second portion of a solvent is added to the mixture obtained in step (a).

[00208] In some embodiments, the second solvent in step (b') comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol. In some embodiments, the second solvent in step (b') comprises a solvent selected from the group consisting of methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl Petition 870260065706, dated 03 / 07 / 2026, page 67 / 778 63 / 376 2-propanol, 1-pentanol, 1-pentanol, cyclopentanol, 1-hexanol and 1-heptanol and combinations thereof. In some embodiments, the second solvent in step (b') comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol and combinations thereof. In some embodiments, the second solvent in step (b') comprises methanol.

[00209] In some embodiments, the second solvent in step (b') comprises H2O. In some embodiments, the second solvent in step (b') comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol and H2O. In some embodiments, the second solvent in step (b') comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol and 2-methyl-2-propanol; and H2O. In some embodiments, the second solvent in step (b') comprises methanol and H2O.

[00210] In some embodiments, the second solvent in step (b') comprises methanol and H2O in a ratio of 9:1 to 5:5 by volume. In some embodiments, the second solvent in step (b') comprises methanol and H2O in a ratio of 8:2 to 13:7, or about 7:3 by volume.

[00211] In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (b') is 5% w / v 30% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (b') is 10% w / v 25% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (b') is 15% w / v 20% w / v.

[00212] In some embodiments, the mixture obtained in step (b') is stirred for about 7 hours or less. In some embodiments, the mixture obtained in step (b') is stirred for about 5 hours or less. Petition 870260065706, dated 03 / 07 / 2026, page 68 / 778 64 / 376

[00213] In some embodiments, the mixture obtained in step (b') is stirred at about 35 °C to about 55 °C. In some embodiments, the mixture obtained in step (b') is stirred at about 45 °C.

[00214] In some embodiments, the second portion of a solvent is omitted.

[00215] In some embodiments, the mixture obtained in step (b') is cooled from about 10 °C to about 25 °C. In some embodiments, the cooling process of the mixture obtained in step (b') is completed in 15 to 60 minutes. In some embodiments, the cooling process of the mixture obtained in step (b') is completed in 45 minutes. In some embodiments, the cooling process of the mixture obtained in step (b') is completed in 20 minutes. Stage (d')

[00216] In step (d'), a third portion of a solvent is added to the mixture obtained in step (c).

[00217] In some embodiments, the third solvent in step (d') comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol. In some embodiments, the third solvent in step (d') comprises a solvent selected from the group consisting of methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol, 1-pentanol, 1-pentanol, cyclopentanol, 1-hexanol and 1-heptanol and combinations thereof. In some embodiments, the third solvent in step (d') comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol and combinations thereof. In some embodiments, the third solvent in step (d') comprises methanol.

[00218] In some embodiments, the third solvent in step (d') comprises H2O. In some embodiments, the third solvent in step (d') comprises an alkyl alcohol, such as a C1-C12 alcohol. Petition 870260065706, dated 03 / 07 / 2026, page 69 / 778 65 / 376 alkyl and H2O. In some embodiments, the third solvent in step (d') comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol and 2-methyl-2-propanol; and H2O. In some embodiments, the third solvent in step (d') comprises methanol and H2O.

[00219] In some embodiments, the third solvent in step (d') comprises methanol and H2O in a ratio of 9:1 to 5:5 by volume. In some embodiments, the third solvent in step (d') comprises methanol and H2O in a ratio of 8:2 to 13:7, or about 7:3 by volume.

[00220] In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (d') is 5% w / v 30% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (d') is 10% w / v 25% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (d') is 15% w / v 20% w / v.

[00221] In some embodiments, the mixture obtained in step (d') is stirred for about 7 hours or less. In some embodiments, the mixture obtained in step (d') is stirred for about 5 hours or less.

[00222] In some embodiments, the mixture obtained in step (d') is stirred at about 35 °C to about 55 °C. In some embodiments, the mixture obtained in step (d') is stirred at about 45 °C.

[00223] In some embodiments, the third portion of a solvent is omitted.

[00224] In some embodiments, the third portion of a solvent is added over the course of 1 to 5 hours. In some embodiments, the third portion of a solvent is added over the course of 3 hours. In some embodiments, the third portion of a solvent is added over the course of 1 to 5 hours. Petition 870260065706, dated 03 / 07 / 2026, p. 70 / 778 66 / 376

[00225] In some embodiments, the mixture obtained in step (d') is cooled to -10 to 10 °C.

[00226] In some embodiments, the mixture obtained in step (d') is cooled to -10 to 10 °C and the mixture is stirred for 6 to 18 hours.

[00227] In some embodiments, the mixture obtained in step (d') is cooled to -10 to 10 °C and stirred for 6 to 18 hours, then heated to 20 to 30 °C and stirred for 2 to 6 hours.

[00228] In some embodiments, the mixture obtained in step (d') is cooled to -10 to 10 °C and stirred for 6 to 18 hours, then heated to 20 to 30 °C and stirred for 2 to 6 hours, then cooled to -10 to 10 °C and stirred for 6 to 18 hours. Stage (h)

[00229] In step (h), the ion exchange resin is an anion exchange resin. In some embodiments, the ion exchange resin is an acetate anion exchange resin.

[00230] In some embodiments, the ion exchange resin is washed with a washing solvent. In some embodiments, the washing solvent in step (h) comprises H2O. In some embodiments, the washing solvent in step (h) comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol and H2O. In some embodiments, the washing solvent in step (h) comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol and 2-methyl-2-propanol; and H2O. In some embodiments, the washing solvent in step (h) comprises methanol and H2O. Starting material

[00231] In some embodiments, the method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, further comprises preparing the monocyclic peptide compound by a synthesis Petition 870260065706, dated 03 / 07 / 2026, page 71 / 778 67 / 376 of peptide in solid phase or a Liquid Phase Peptide Synthesis. In some embodiments, the method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt thereof, further comprises preparing the monocyclic peptide compound by a Liquid Phase Peptide Synthesis.

[00232] The method of the present invention provides a method for improving the rheological properties of the monocyclic peptide compound obtained by Liquid Phase Peptide Synthesis.

[00233] Consequently, in another aspect, the present invention provides a method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, comprising the following steps: (a) dissolving the monocyclic peptide compound, or salt or solvate thereof, in a first solvent; wherein the monocyclic peptide compound is obtained by a Liquid Phase Peptide Synthesis; (b) add a first portion of sodium chloride to the mixture obtained in step (a); (c) add crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) add a second portion of sodium chloride to the fluid paste obtained in step (c); (e) Isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture and remove residual solvent. Methods for obtaining the crystalline free base.

[00234] In another aspect, the present invention provides a method for preparing a crystalline form of a compound of Petition 870260065706, dated 03 / 07 / 2026, pp. 72 / 778 68 / 376 monocyclic peptide, or a pharmaceutically acceptable salt thereof, comprising the following steps: (a) Dissolve a hydrochloride salt of the monocyclic peptide compound in a first solvent; (b) add a first portion of sodium chloride to the mixture obtained in step (a); (c) add crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) add a second portion of sodium chloride to the fluid paste obtained in step (c); (e) isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (e) and wash with a second solvent; (f) dissolve the hydrochloride salt obtained in step (e) in aqueous hydrochloric acid; (g) add a buffer solution to the mixture obtained in step (f) over a period of at least 10 hours; and (h) isolate a crystalline monocyclic peptide compound in the form of the free base from the mixture.

[00235] In some embodiments, in step (f), the amount of hydrochloric acid added is 1 to 2 molar equivalents. In some embodiments, in step (f), the amount of hydrochloric acid added is 1.3 to 1.7 molar equivalents. In some embodiments, in step (f), the amount of hydrochloric acid added is about 1.5 molar equivalents.

[00236] In some embodiments, the buffer solution in step (g) is a phosphate buffer having a pH between pH 7.0 and pH 9.0. In some embodiments, the buffer solution in step (g) is a phosphate buffer having a pH between pH 7.5 and pH 8.5. In some Petition 870260065706, dated 03 / 07 / 2026, page 73 / 778 69 / 376 modes, the buffer solution in step (g) is a phosphate buffer that has a pH of about 8. Methods for preparing alternative salts

[00237] In another aspect, the present invention provides a method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, comprising the following steps: (a) dissolve the monocyclic peptide compound, or its salt or solvate, in a first solvent; (b) add a first portion of sodium chloride to the mixture obtained in step (a); (c) add crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) add a second portion of sodium chloride to the fluid paste obtained in step (c); (e) isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (d) and remove the residual solvent; (f) dissolve the hydrochloride salt obtained in step (e) in aqueous hydrochloric acid; (g) add a buffer solution to the mixture obtained in step (f) over a period of at least 10 hours; and (h) isolate a crystalline monocyclic peptide compound in the form of the free base from the mixture; (i) dissolve the free crystalline base of the monocyclic peptide compound in a second solvent; (j) add a solution comprising a counterion to the mixture obtained in step (a); (k) add an antisolvent; Petition 870260065706, dated 03 / 07 / 2026, pp. 74 / 778 70 / 376 (l) isolate the crystalline salt of the monocyclic peptide compound from the mixture obtained from step (k).

[00238] In some embodiments, the second solvent in step (j) comprises methanol and / or water.

[00239] In some embodiments, the antisolvent is an organic solvent. In some embodiments, the antisolvent is a solvent selected from an alkyl alcohol, such as a C1-C12 alkyl alcohol, alkyl ethers, such as diethyl ether, alkanes, such as heptane and hexane, ethyl acetate, toluene, and acetonitrile. In some embodiments, the antisolvent is selected from the group consisting of tert-butyl methyl ether (TBME), acetonitrile, and isopropanol (2-propanol).

[00240] In some embodiments, the solution comprising a contraion is a solution comprising a contraion selected from the group consisting of fumarate, glutarate, glycolate, mesylate, sulfate and citrate. Methods for obtaining crystalline seeds

[00241] The present invention further provides methods for preparing seeds of a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt thereof.

[00242] Consequently, in a further aspect, the present invention provides a method for the preparation of a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt thereof, comprising the following steps: (i) dissolve the monocyclic peptide compound, or a pharmaceutically acceptable salt thereof, in a first solvent; (ii) add a second solvent to the mixture obtained in step (i); (iii) cool the mixture obtained in step (ii); and Petition 870260065706, dated 03 / 07 / 2026, pp. 75 / 778 71 / 376 (iv) isolate the crystalline monocyclic peptide compound, or salt thereof, from the mixture obtained from step (iii) and remove residual solvent. Stage (i)

[00243] In some embodiments, step (i) is carried out at a temperature of about 15 °C to about 80 °C. In some embodiments, step (i) is carried out at a temperature of about 25 °C to about 55 °C. In some embodiments, step (i) is carried out at a temperature of about 30 °C to about 50 °C or about 35 °C to about 45 °C. In some embodiments, step (i) is carried out at a temperature of about 40 °C.

[00244] In some embodiments, the first solvent comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol. In some embodiments, the first solvent comprises a solvent selected from the group consisting of methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol, 1-pentanol, 1-pentanol, cyclopentanol, 1-hexanol and 1-heptanol, and combinations thereof. In some embodiments, the first solvent comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol and combinations thereof. In some embodiments, the first solvent comprises methanol.

[00245] In some embodiments, the first solvent comprises H2O. In some embodiments, the first solvent comprises an alkyl alcohol, such as a C1-C12 alkyl alcohol and H2O. In some embodiments, the first solvent comprises a solvent selected from the group consisting of methanol, ethanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol; and H2O. In some embodiments, the first solvent comprises methanol and H2O. Petition 870260065706, dated 03 / 07 / 2026, pages 76 / 778 72 / 376

[00246] In some embodiments, the first solvent comprises methanol and H2O in a ratio of 9:1 to 5:5 by volume. In some embodiments, the first solvent comprises methanol and H2O in a ratio of 8:2 to 13:7 or about 7:3 by volume.

[00247] In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (i) is 5% w / v 20% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (i) is 8% w / v 12% w / v or about 10% w / v. In some embodiments, the concentration of the monocyclic peptide compound in the mixture obtained in step (i) is about 10% w / v. Stage (ii)

[00248] In some embodiments, in step (ii), the second solvent is added over a period of time of at least 1 hour. In some embodiments, in step (ii), the second solvent is added over a period of time of at least 5 hours, or at least 6 hours, or at least 7 hours. In some embodiments, in step (ii), the second solvent is added over a period of time of about 10 hours.

[00249] In some embodiments, in step (ii), the ratio between the first solvent and the second solvent is 3:1 to 1:3 by volume. In some embodiments, in step (ii), the ratio between the first solvent and the second solvent is 6:4 to 4:6 by volume. In some embodiments, in step (ii), the ratio between the first solvent and the second solvent is about 1:1 by volume.

[00250] In some embodiments, the second solvent comprises H2O. In some embodiments, the second solvent consists essentially of H2O. Stage (iii)

[00251] Optionally, the mixture obtained in step (ii) is cooled Petition 870260065706, dated 03 / 07 / 2026, pp. 77 / 778 73 / 376 before stage (iv).

[00252] In some embodiments, in step (iii), the mixture obtained in step (ii) is cooled to a temperature between about 0 °C and about 10 °C. In some embodiments, in step (iii), the mixture obtained in step (ii) is cooled to a temperature between about 3 °C and about 7 °C. In some embodiments, in step (iii), the mixture obtained in step (ii) is cooled to a temperature of about 5 °C.

[00253] In some embodiments, in step (iii), the mixture obtained in step (ii) is cooled to a temperature between about 0 °C and about 10 °C at a rate less than 1 °C / min. In some embodiments, in step (iii), the mixture obtained in step (ii) is cooled to a temperature between about 0 °C and about 10 °C at a rate less than 0.5 °C / min. In some embodiments, in step (iii), the cooling rate is less than 0.1 °C / min or about 0.05 °C / min.

[00254] In some embodiments, before step (iii) and after the addition of the second solvent, the temperature of the mixture is maintained for a period of time of at least 1 hour. In some embodiments, before step (iii) and after the addition of the second solvent, the temperature of the mixture is maintained for a period of time of at least 4 hours. In some embodiments, before step (iii) and after the addition of the second solvent, the temperature of the mixture is maintained for a period of time of at least 7 hours. In some embodiments, before step (iii) and after the addition of the second solvent, the temperature of the mixture is maintained for a period of time of about 9 hours.

[00255] In some modes, after step (iii), the temperature is maintained for a period of at least 30 minutes. In some modes, after step (iii), the temperature is maintained for a period of at least 60 minutes. In some modes, after step (iii), the temperature is maintained for a Petition 870260065706, dated 03 / 07 / 2026, pp. 78 / 778 74 / 376 time period of at least 90 minutes. In some modalities, after step (iii), the temperature is maintained for a time period of approximately 2 hours.

[00256] In some embodiments, after step (iii), the mixture is heated to a temperature of about 25 °C to about 55 °C and then cooled to a temperature between about 0 °C and about 10 °C. In some embodiments, after step (iii), the mixture is heated to a temperature of about 35 °C to about 45 °C and then cooled to a temperature between about 3 °C and about 7 °C.

[00257] In some embodiments, after step (iii), the mixture is heated to a temperature of about 40 °C and then cooled to a temperature of about 5 °C. Stage (iv)

[00258] In some embodiments, in step (iv), the third solvent comprises an alkyl alcohol. In some embodiments, in step (iv), the third solvent is an alkyl alcohol other than methanol. In some embodiments, in step (iv), the third solvent comprises 2-propanol (isopropyl alcohol). In some embodiments, in step (iv), the third solvent consists essentially of 2-propanol (isopropyl alcohol).

[00259] In some embodiments, in step (iv), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried. In some embodiments, in step (iv), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried at a temperature below about 20 °C under vacuum.

[00260] In some embodiments, the monocyclic peptide compound isolated in step (iv) is in the form of the hydrochloride salt. Milling / sieving

[00261] In one embodiment, to obtain the crystalline form of a monocyclic peptide compound in a particle form that has Petition 870260065706, dated 03 / 07 / 2026, pp. 79 / 778 75 / 376 Particle size and / or particle size distribution, as described herein, a person skilled in the art may use methods such as a grinding process or a sieving process. For example, after the isolation step, the monocyclic peptide compound may be treated with a sieving step. The subsequent sieving step may remove finer and larger particles, which may impair obtaining the rheological properties suitable for pharmaceutical processing. In one embodiment, the isolated crystalline monocyclic peptide is passed through a suitable sieve. In some embodiments, the sieve mesh size is about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 8 mm, or 10 mm. In some embodiments, the sieve mesh size is about 2 mm. In some embodiments, the sieve mesh size is about 4 mm. Drying step

[00262] In one embodiment, to obtain the crystalline form of a monocyclic peptide compound, one skilled in the art may dry the isolated crystalline monocyclic peptide. This drying step may, for example, remove residual solvent from the crystallization process, such as the removal of isopropyl alcohol. The drying step may occur, for example, at about 20 °C, 30 °C, 40 °C, 50 °C, 60 °C, 70 °C, or 80 °C. In another embodiment, the drying step occurs at about 20 °C to 45 °C. In yet another embodiment, the drying step occurs at about 20% relative humidity (RH), 30% RH, 40% RH, 50% RH, 60% RH, 70% RH, 80% RH, or 90% RH. In another method, the drying stage occurs at 50% to 70% RH, for example, around 65% RH. In some methods, moisture is supplied using nitrogen as the carrier gas.

[00263] The drying stage may, for example, include Petition 870260065706, dated 03 / 07 / 2026, page 80 / 778 76 / 376 Static drying or dynamic drying. The static drying step occurs with little or no agitation of the crystalline form during the drying process. The dynamic drying step involves agitating the crystalline monocyclic peptide compound during the drying step. The dynamic drying step may additionally involve heating, vacuum exposure, or exposure to nitrogen gas. Rheological properties (fluidity)

[00264] By using the methods of the present invention, it is possible to improve the rheological properties of monocyclic peptide compounds, particularly those obtained using Liquid Phase Peptide Synthesis.

[00265] Consequently, the present invention provides methods for the preparation of a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt thereof, which has rheological properties suitable for manufacturing pharmaceutical compositions.

[00266] Appropriately, pharmaceutical processing factors are important, such as defined particle size and shape; particle size uniformity; mixture homogeneity; flowability; moisture content; ability to be compactly formed under pressure.

[00267] Rheological properties are those used to distinguish the fluidity of a material. In particular, the rheological properties suitable for manufacturing pharmaceutical compositions can be selected from conditioned apparent density, compressibility, basic flow energy, stability index, cohesion, flow function, angle of internal friction, effective angle of internal friction, and angle of wall friction, and combinations thereof. Flow properties are measured according to Petition 870260065706, dated 03 / 07 / 2026, page 81 / 778 77 / 376 standardized methods known in the art. IV. Interleukin-23 Receptor Peptide (IL-23R) Inhibitors

[00268] The monocyclic peptide compounds of the present invention are interleukin-23 receptor peptide inhibitors. The peptide compounds of the present invention include peptides comprising or consisting of any of the amino acid sequences described herein, wherein the compounds have any of the structures described herein, including compounds comprising any of the peptide sequences described herein, and dimers of any of such peptides and compounds. Illustrative peptides of the invention comprise an amino acid sequence or structure described in any of the accompanying tables.

[00269] In a first aspect, the monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, comprises an amino acid sequence of formula (I'): X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-X15-X16 (I') wherein X3 is absent or is any amino acid; X4 is Abu, Cys, (D)Cys, alpha-MeCys, (D)Pen, Pen or Pen(sulfoxide); X5 is Cit, Glu, Gly, Gly substituted, Leu, Ile, beta-Ala, Ala, Lys, Asn, Pro, Ser, alpha-MeGln, alpha-MeLys, alpha-MeLeu, alpha-MeAsn, Lys(Ac), alpha-MeLys(Ac), Dab(Ac), Dap(Ac), homo-Lys(Ac), or Ac(Ac); X6 is Thr, Aib, Asp, Dab, Gly, Pro, Ser, alpha-MeGln, alphaMeLys, alpha-MeLeu, alpha-MeAsn, alpha-MeThr, alpha-MeSer or Val; X7 is Trp substituted or unsubstituted; X8 is Gln, alpha-MeLys, alpha-MeLeu, alpha-MeLys(Ac), betahomoGln, Cit, Glu, Phe, substituted Phe, Tyr, Asn, Thr, Val, Aib, alphaMeGln, alpha-MeAsn, Lys(Ac), Dab(Ac), Dap(Ac), ho-Al, Petition 870260065706, of 03 / 07 / 2026, p. 82 / 778 78 / 376 2-Nal, Lys(b-Ala), Lys(Gly), Lys(Benzyl, Ac), Lys(butyl, Ac), Lys(isobutyla,Ac), Lys(propyla,Ac) or Trp; X9 is Abu, Cys, (D)Cys, alpha-MeCys, (D)Pen, Pen or Pen(sulfoxide); X10 is Tyr, or substituted Tyr, unsubstituted Phe, or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy, or 2-acetylaminoethoxy; and X11 is substituted or unsubstituted 2-Nal, Phe(2-Me), Phe(3-Me), Phe(4-Me), Phe(3,4-dimethoxy), 2Quin, 3Quin, 1-Nal, unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, hydroxy or alkoxy; X12 é 4-amino-4-carboxitetra-hidropirano (THP), Acvc, alfaMeLys, alfa-MeLeu, alfa-MeArg, alfa-MePhe, alfa-MeLeu, alfa-MeLys, alfa-MeAsn, alfa-MeTyr, Ala, ciclo-hexilAla, Lys ou Aib; X13 is any amino acid; X14 is any amino acid; and X15 é Ala, Arg, Asn, Asp, Cys, Glu, Gln, Gly, His substituído ou não substituído, (D)His, Ile, Lue, (D)Lue, Lys, (D)Lys, Met, 2Pal, 3Pal ou 4Pal, Phe, Pro, 5-Pyal, 2Quin, 3Quin, Ser, Thr, Trp, Tyr, Val; X16 is absent or is any amino acid; where 2Pal is alanine substituted by 2-pyridyl, 3Pal is alanine substituted by 3-pyridyl, and 4Pal is alanine substituted by 4-pyridyl. ON' nh2 (2Pal), k 0 NH2 0 nh2 / oi_. ix2 (3Pal) or OH (4Pal); and Petition 870260065706, dated 03 / 07 / 2026, p. 83 / 778 79 / 376 5Pyal or (5-Pyal) is alanine substituted with 5-pyrimidine: the where X4 and X9 form a disulfide bond or a thioether bond.

[00270] In certain embodiments, the peptide compound inhibits the binding of interleukin 23 (IL 23) and an IL 23 receptor.

[00271] In certain embodiments, X7 is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, hydroxy, alkoxy, substituted or unsubstituted aryl, or substituted or unsubstituted heteroaryl.

[00272] In certain embodiments, X10 is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy.

[00273] In certain embodiments, X11 is 2-Nal, 2-Nal substituted with alkyl or hydroxy, Phe(2-Me), Phe(3-Me), Phe(4-Me), Phe(3,4-dimethoxy) or 1-Nal.

[00274] In certain modalities, X11 is 2-Nal, or 1-Nal.

[00275] In certain embodiments, X11 is 2-Nal or 2-Nal substituted with alkyl or hydroxyl.

[00276] In certain modalities, X11 is 2-Nal.

[00277] In certain forms, X15 is 5-Pyal, His, (D)His, (1Me)His, (3-Me)His, Lys, (D)Lys, Lue, (D)Leu, 2Pal, 3Pal, 4Pal, 2Quin or 3Quin.

[00278] In certain modalities, X15 is 5-Pyal, His, (D)His, (1Me)His, (3-Me)His, (D)Lys, (D)Leu, 2Pal, 3Pal, 4Pal; and X16 is absent or is Sarc.

[00279] In some forms, X15 is 2Pal, 3Pal or 4Pal; and X16 is absent.

[00280] In certain embodiments, X16 is any D-amino acid.

[00281] In certain embodiments, the peptide compound Petition 870260065706, dated 03 / 07 / 2026, p. 84 / 778 80 / 376 comprises an amino acid sequence of the formula (IIa), (IIb), (IIc) or (IId): X3-X4-X5-X6-X7-X8-X9-[Phe]-X11-X12-X13-X14-X15-X16 (IIb), or X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-[Pal]-X16 (IId) where Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl or substituted or unsubstituted heteroaryl; where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is 2-Nal not replaced; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X3 to X16 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an Abu-Cys or Abu-Pen thioether linkage.

[00282] In certain embodiments, the peptide compound comprises an amino acid sequence of the formula (IIa), (IIb), (IIc) or (IId): X3-X4-X5-X6-[Trp]-X8-X9-X10-X11-X12-X13-X14-X15-X16 (IIa), X3-X4-X5-X6-X7-X8-X9-X10-[2-Nal]-X12-X13-X14-X15-X16 (IIc), or substituted or Trp substituted by cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl, or substituted or unsubstituted heteroaryl; where Phe is either unsubstituted Phe or Phe substituted by Petition 870260065706, dated 03 / 07 / 2026, p. 85 / 778 81 / 376 halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is 2-Nal not replaced; where Pal is 2Pal, 3Pal or 4Pal; where X16 is Sarc; and, unless otherwise indicated, X3 to X15 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an AbuCys or Abu-Pen thioether linkage.

[00283] In certain embodiments, the peptide compound comprises an amino acid sequence of the formula (IIIa), (IIIb), (IIIc), (IIId), (IIIe) or (IIIf): X4- X5-X6-[Trp]-X8- X9-X10-X11-X12-X13-X14-[Pal]-X16 (IIIc), X4-X5-X6-X7-X8-X9-[Phe]-X10-X11-X12-X13-X14-[Pal]-X16 (IIIe) or wherein Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl, or substituted or unsubstituted heteroaryl; where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is 2-Nal not replaced; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X4 to X16 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an Abu-Cys thioether linkage or Petition 870260065706, dated 03 / 07 / 2026, p. 86 / 778 82 / 376 Abu-Pen.

[00284] In certain embodiments, the peptide compound comprises an amino acid sequence of the formula (IVa), (IVb), (IVc), (IVd) or (IVe): X4-X5-X6-[Trp]-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-X15-X16 (IVa), X5-X6-X7-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-[Pal]-X16 (IVc), or X4-X5-X6-[Trp]-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-[Pal]-X16 (IVe) wherein Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl or substituted or unsubstituted heteroaryl; where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is 2-Nal not replaced; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X4 to X16 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an Abu-Cys or Abu-Pen thioether linkage.

[00285] In certain embodiments, the monocyclic peptide is a peptide where the peptide is cyclized via a Pen-Pen disulfide bond or via an Abu-Cys or Abu-Pen thioether bond.

[00286] In certain embodiments, X4 is (D)Pen, Pen or Pen(sulfoxide).

[00287] In certain embodiments, Petition 870260065706, dated 03 / 07 / 2026, p. 87 / 778 83 / 376 Gln or Asp.

[00288] In certain embodiments, X4 or X9 is independently Cys, (D)Cys, alpha-MeCys, (D)Pen or Pen; and the link between X4 and X9 is a disulfide bond.

[00289] In certain modalities, X5 is Asn, Ser, Gln or Glu.

[00290] In certain modalities, X5 is Asn.

[00291] In certain embodiments, X6 is Thr, Aib, Asp, Dab, Gly, Pro, Ser, alpha-MeGln, alpha-MeLys, alpha-MeLeu, alpha-MeAsn, alpha-MeThr, alphaMeSer or Val.

[00292] In certain modes, X6 is Thr.

[00293] In certain embodiments, In certain embodiments, X8 is Lys(Gly) or Lys(bAla).

[00294] In certain embodiments, X8 is Gln, alpha-Me-Lys, alphaMeLys(Ac), Lys(Ac) or Glu.

[00295] In certain modalities, X8 is Gln. In certain modalities, X8 is Lys(Ac).

[00296] In certain modalities, X9 is Pen, (D)Pen, Cys, (D)Cys, or alpha-MeCys. In certain modalities, X9 is Pen or (D)Pen.

[00297] In certain embodiments, X4 is Pen and X9 is Pen, and the linkage is a disulfide bond. In certain embodiments, X4 or X9 is Abu; and the linkage between X4 and X9 is a thioether bond.

[00298] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X10 is Phe, Phe[4-(2-aminoethoxy)], Phe[4-(2-acetylaminoethoxy)] or Phe(4-CONH2).

[00299] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X10 is Phe[4-(2-aminoethoxy)] or Phe[4-(2-acetylaminoethoxy)]. In certain embodiments, X10 is Phe[4-(2-aminoethoxy)]. Petition 870260065706, dated 03 / 07 / 2026, p. 88 / 778 84 / 376

[00300] In certain embodiments, X12 is 4-amino-4-carboxytetrahydropyran (THP), alpha-MeLys, alpha-MeLeu, Ala, cyclohexylAla, Lys or Aib.

[00301] In certain embodiments, X12 is 4-amino-4-carboxytetrahydropyran (THP), alpha-MeLys or alpha-MeLeu.

[00302] In certain modalities, X12 is alpha-MeLeu. In certain modalities, X12 is THP.

[00303] In certain embodiments, where Y2 is an amino acid. In certain embodiments,

[00304] In certain modalities, X13 is Glu, Gln, Lys(Ac) or Lys.

[00305] In certain modalities, X13 is Lys(Ac) or Lys.

[00306] In certain modalities, X13 is Lys(Ac). In certain modalities, X13 is Glu.

[00307] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is an unsubstituted Trp.

[00308] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp substituted with N-phenylacetamide, cyano, halo, alkyl, haloalkyl, hydroxy or alkoxy; and X11 is as described for formula (I).

[00309] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp substituted with N-phenylacetamide, cyano, halo, alkyl, haloalkyl, hydroxy or alkoxy; and the substitution is at position 4, 5, 6 or 7.

[00310] In certain modalities, particularly in relation to Petition 870260065706, dated 03 / 07 / 2026, p. 89 / 778 85 / 376 formulas (IIa) to (IId), (IIIa) to (IlIf) and (IVa) to (IVe), X7 is Trp substituted with N-phenylacetamide, cyano, F, Cl, Br, I, Me, Et, i-Pr, n-Pr, n-Bu, t-Bu, CF3, hydroxy, OMe or OEt; and the substitution is at position 4, 5, 6 or 7.

[00311] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp replaced by 7-(N-phenylacetamide), 5-F, 6-F, 7-F, 5-Cl, 6-Cl, 7-Cl, 5-Me, 6-Me, 7Me, 5-OH, 6-OH, 7-OH, 5-OMe, 6-OMe or 7-OMe.

[00312] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp replaced by 7-(N-phenylacetamide), 7-Me, 5-F, 7-F, 6-Cl, 6-Me, 4-OMe, 5-OMe or 5-Br.

[00313] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp replaced by 7-(N-phenylacetamide), 7-Me, 6-Me, 4-OMe or 6-Cl.

[00314] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp replaced by 7-(N-phenylacetamide) or 7-Me.

[00315] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp substituted by phenyl, substituted phenyl or tienyl.

[00316] In certain embodiments, X7 is Trp substituted with cyano, halo, alkyl, haloalkyl, hydroxy, alkoxy, phenyl, substituted phenyl or thienyl.

[00317] In certain embodiments, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp substituted by i) unsubstituted phenyl or substituted by cyano, halo, alkyl, haloalkyl, aryl-hydroxy, alkoxy or haloalkoxy; or ii) thienyl.

[00318] In certain modalities, particularly in relation to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp substituted Petition 870260065706, dated 03 / 07 / 2026, p. 90 / 778 86 / 376 by unsubstituted phenyl or substituted by Me, Et, n-Pr, i-Pr, t-Bu, OMe, OEt, Cl, F, CF3, OCF3, phenyl, substituted phenyl or starch.

[00319] In certain modalities, particularly in relation to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp replaced by 7-Me.

[00320] In certain embodiments, particularly in relation to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X7 is Trp replaced by 7-Ph.

[00321] In certain modalities, particularly in relation to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X16 is absent. In certain modalities, particularly in relation to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X16 is Sarc.

[00322] In a particular embodiment, particularly with regard to formulas (IIa) to (IId), (IIIa) to (IIIf) and (IVa) to (IVe), X3 is absent.

[00323] In certain embodiments, the peptide compound is Ac-[Pen]-NT-[W(7-Me)]-[Lys(Ac)]-[Pen]-Phe[4-(2-aminoethoxy)]-[2-Nal][THP]-EN-[3Pal]-[Sarc]-NH2 (SEQ ID NO: 1), wherein the peptide compound is cyclized via a Pen-Pen disulfide linkage, or a pharmaceutically acceptable salt thereof.

[00324] In certain embodiments, the peptide compound is Ac[Pen]-NT-[W(7-Me)]-[Lys(Ac)]-[Pen]-Phe[4-(2-aminoethoxy)]-[2-Nal][THP]-EN-[3Pal]-[Sarc]-NH2; (SEQ ID NO: 1) Petition 870260065706, dated 03 / 07 / 2026, p. 91 / 778 87 / 376 or a pharmaceutically acceptable salt thereof.

[00325] In certain embodiments, the peptide compound is AcdArg-cyclo[Abu-Gln-Thr-Trp-Gln-Cys]-Phe(2-ae)-2-NaI-ThpGly-GluAsn-Asn-NH2; (SEQ ID NO: 2): or a pharmaceutically acceptable salt thereof. Petition 870260065706, dated 03 / 07 / 2026, p. 92 / 778 88 / 376

[00326] In certain embodiments, the peptide compound is Ac[Pen]*-Asn-Thr-Trp(7Me)-Lys(Ac)-[Pen]*-Tyr(2-ea)-2Nal-aMe-LysLys(Ac)-Asn-D-Leu-NH2 (wherein [Pen]*-[Pen]* form a disulfide bond); (SEQ ID NO: 3): o)—\ HO. H / —NH HN NH HN NH2, or a pharmaceutically acceptable salt thereof. V. Crystalline forms

[00327] Crystalline forms of an interleukin-23 receptor (IL-23R) peptide inhibitor are provided herein. Crystalline forms of a compound of formula (I) were unexpectedly obtained and isolated. Pharmaceutically acceptable crystalline salt forms of a compound of formula (I) were prepared, isolated, and deemed suitable for use in pharmaceutical formulations. In this way, crystalline peptide forms can be exceptionally advantageous, since the corresponding amorphous forms are often unsuitable for formulation, such as tablet formation.

[00328] In one aspect, the present invention relates to a pharmaceutical composition of a crystalline salt of a compound of formula (I): Petition 870260065706, dated 03 / 07 / 2026, p. 93 / 778 89 / 376 a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound.

[00329] In another aspect, the present invention relates to a crystalline free base form of a compound of formula (I).

[00330] In one aspect, the present invention relates to a pharmaceutical composition of a hydrochloride salt of a peptide from SEQ ID NO: 1.

[00331] In one aspect, the present invention relates to a pharmaceutical composition of a hydrochloride salt of a compound of formula (I).

[00332] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of the hydrochloride salt of a peptide from SEQ ID NO: 1.

[00333] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of a pharmaceutically acceptable salt of a peptide from SEQ ID NO: 1. The crystalline form of a pharmaceutically acceptable salt of a peptide from SEQ ID NO: 1 may be a crystalline hydrochloride salt, a crystalline acetate salt, a crystalline fumarate salt, a crystalline glycolate salt, a crystalline glutarate salt, a mesylate salt Petition 870260065706, dated 03 / 07 / 2026, page 94 / 778 90 / 376 crystalline, a crystalline sulfate salt, a crystalline bis-chloride salt and a crystalline citrate salt of a peptide from SEQ ID NO: 1.

[00334] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of the hydrochloride salt of a compound of formula (I).

[00335] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of a pharmaceutically acceptable salt of a compound of formula (I). The crystalline form of a pharmaceutically acceptable salt of a compound of formula (I) may be a crystalline hydrochloride salt, a crystalline acetate salt, a crystalline fumarate salt, a crystalline glycolate salt, a crystalline glutarate salt, a crystalline mesylate salt, a crystalline sulfate salt, a crystalline bis-hydrochloride salt and a crystalline citrate salt of a compound of formula (I).

[00336] In some respects, the crystalline hydrochloride salt form of a compound of formula (I) has the structure: a solvato of the same.

[00337] In other respects, the crystalline hydrochloride salt form of a compound of formula (I) is distinguished by a powder X-ray diffraction (PXRD) pattern, as substantially presented in Petition 870260065706, dated 03 / 07 / 2026, p. 95 / 778 91 / 376 Figure 1. In some respects, the crystalline hydrochloride salt form, or solvate thereof, is a hemihydrochloride salt. In some embodiments, the crystalline hydrochloride salt form of a compound of formula (I) is distinguished by an XRD pattern, as shown substantially in Figure 1 or Figure 2.

[00338] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a crystalline hydrochloride salt, or solvate thereof, described herein, and one or more pharmaceutically acceptable excipients.

[00339] In other respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a crystalline salt, or solvate thereof, described herein and one or more pharmaceutically acceptable excipients. Freebase form

[00340] In some embodiments, the compound of formula (I) is a free base of the compound of formula (I). In some embodiments, the free base of the compound of formula (I) is crystalline. In some embodiments, the free base of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the free base of the compound of formula (I) is a hydrate. In some other embodiments, the free base of the compound of formula (I) is crystalline and in the form of a solvate.

[00341] In some embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 7.7, 9.1, 9.6 and 13.3 + / - 0.2 degrees two theta. In some embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two Petition 870260065706, dated 03 / 07 / 2026, p. 96 / 778 92 / 376 theta angles selected from 3.3, 5.8, 7.7, 9.1, 9.6 and 13.3 + / - 0.3 degrees two theta. In some embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 7.7, 9.1, 9.6 and 13.3 + / - 0.4 degrees two theta.

[00342] In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.9, 13.3, 14.0, 14.8, 15.4, 16.0, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.2 degrees two theta. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.9, 13.3, 14.0, 14.8, 15.4, 16.0, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.3 degrees two theta.In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.9, 13.3, 14.0, 14.8, 15.4, 16.0, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.4 degrees two theta.

[00343] In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.9, 13.3, 14.0, 14.8, 15.4, 16.0, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.2 degrees two theta. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having Petition 870260065706, dated 03 / 07 / 2026, p. 97 / 778 93 / 376 is an XRD pattern that has diffraction peaks at two theta angles among at least 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.9, 13.3, 14.0, 14.8, 15.4, 16.0, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.3 degrees two theta. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.9, 13.3, 14.0, 14.8, 15.4, 16.0, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.4 degrees two theta.

[00344] In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.8, 13.3, 14.0, 14.8, 15.4, 16.0, 16.8, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.2 degrees two theta. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.8, 13.3, 14.0, 14.8, 15.4, 16.0, 16.8, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.3 degrees two theta.In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.8, 13.3, 14.0, 14.8, 15.4, 16.0, 16.8, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.4 degrees two theta.

[00345] In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.8, 13.3, Petition 870260065706, dated 03 / 07 / 2026, p. 98 / 778 94 / 376 14.0, 14.8, 15.4, 16.0, 16.8, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.2 degrees two theta. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.8, 13.3, 14.0, 14.8, 15.4, 16.0, 16.8, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.3 degrees two theta. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.3, 5.8, 6.5, 6.8, 7.7, 8.3, 9.1, 9.6, 10.2, 11.1, 12.4, 12.8, 13.3, 14.0, 14.8, 15.4, 16.0, 16.8, 17.3, 18.0, 18.5, 18.9, 19.4, 20.0 and 20.5 + / - 0.4 degrees two theta.In some embodiments, the crystalline free base salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 11.

[00346] In some embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having endothermic peaks at about 71.0 °C and / or about 130.2 °C, as determined by DSC. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having substantially a DSC curve, as shown in Figure 13.

[00347] In some embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 3.7% from about 26.5 °C to about 70.0 °C and a weight loss of about 2.7% from 70.0 °C to about 170.0 °C, as determined by TGA. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, is distinguished by having a TGA plot, as shown substantially in Figure 12. In some embodiments, the Petition 870260065706, dated 03 / 07 / 2026, p. 99 / 778 95 / 376 crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a DVS plot, as shown substantially in Figure 14.

[00348] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline free base of the compound of formula (I), or solvate thereof, described herein and one or more pharmaceutically acceptable excipients. Salt ratios

[00349] In some embodiments, the compound of formula (I) is in the form of a pharmaceutically acceptable salt. In certain embodiments, the pharmaceutically acceptable salt of the compound of formula (I) is crystalline. In some embodiments, a crystalline pharmaceutically acceptable salt of a compound of formula (I) comprises a cationic form of the compound of formula (I) and a pharmaceutically acceptable anion. For example, a crystalline hydrochloride salt of a compound of formula (I) comprises the compound of formula (I) in its cationic form and a chloride anion. The salt compositions described herein include a salt of a compound of formula (I), wherein the salt is a pharmaceutically acceptable salt chosen from an acetate salt, a fumarate salt, a glycolate salt, a glutarate salt, a mesylate salt, a sulfate salt, a citrate salt, a bis-hydrochloride salt, and the like.

[00350] In some embodiments, the pharmaceutically acceptable salt of a compound of formula (I) is a hydrochloride salt and the anion is chloride. In some embodiments, the salt of a compound of formula (I) is an acetate salt and the anion is acetate. In some embodiments, the salt of a compound of formula (I) is a fumarate salt and the anion is fumarate. In some embodiments, the salt of a compound of formula (I) is a glutarate salt and the anion is glutarate. Petition 870260065706, dated 03 / 07 / 2026, p. 100 / 778 96 / 376 In some embodiments, the salt of a compound of formula (I) is a glycolate salt and the anion is glycolate. In some embodiments, the salt of a compound of formula (I) is a mesylate salt and the anion is mesylate.

[00351] In some embodiments, the salt of a compound of formula (I) is a sulfate salt and the anion is sulfate. In some embodiments, the salt of a compound of formula (I) is a citrate salt and the anion is citrate. In some embodiments, the salt of a compound of formula (I) is a bis-hydrochloride salt and the anion is chloride.

[00352] In some embodiments, the molar equivalents of an anion of a crystalline salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of an anion of a salt of a compound of formula (I) relative to one mole of the compound of formula (I) are about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, about 1.0, about 1.1, about 1.2, about 1.3, about 1.4, about 1.5, about 1.6, about 1.7, about 1.8, about 1.9 or approximately 2.0, including any intermediate amounts and fractions thereof.

[00353] In some embodiments, the molar equivalents of a chloride anion of a crystalline hydrochloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a chloride anion of a crystalline hydrochloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.4 to about 1.5. In other embodiments, the molar equivalents of a chloride anion of a crystalline hydrochloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.5 to about 1.0. Petition 870260065706, dated 03 / 07 / 2026, p. 101 / 778 97 / 376 In certain embodiments, the molar equivalents of a chloride anion of a crystalline hydrochloride salt of the compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.6 to about 0.7.

[00354] In some embodiments, the molar equivalents of an acetate anion of a crystalline acetate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of an acetate anion of a crystalline acetate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.4 to about 1.5. In other embodiments, the molar equivalents of an acetate anion of a crystalline acetate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.5 to about 1.0. In certain embodiments, the molar equivalents of acetate of a crystalline acetate salt of the compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.6 to about 0.7.In certain embodiments, the molar equivalents of one acetate of a crystalline acetate salt of the compound of formula (I) with respect to one mole of the compound of formula (I) are approximately 0.65.

[00355] In some embodiments, the molar equivalents of a fumarate anion of a crystalline fumarate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a fumarate anion of a crystalline fumarate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.4 to about 1.5. In other embodiments, the molar equivalents of a fumarate anion of a crystalline fumarate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.5 to about 1.0. Petition 870260065706, dated 03 / 07 / 2026, p. 102 / 778 98 / 376 In other embodiments, the molar equivalents of a fumarate anion of a crystalline fumarate salt of a compound of formula (I) relative to a mole of the compound of formula (I) are from about 1.0 to about 1.5. In other embodiments, the molar equivalents of a fumarate anion of a crystalline fumarate salt of a compound of formula (I) relative to a mole of the compound of formula (I) are from about 1.5 to about 2.0.

[00356] In some embodiments, the molar equivalents of a glutarate anion of a crystalline glutarate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a glutarate anion of a crystalline glutarate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 1.0. In other embodiments, the molar equivalents of a glutarate anion of a crystalline glutarate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.3 to about 0.6. In certain embodiments, the molar equivalents of a glutarate anion of a crystalline glutarate salt of the compound of formula (I) relative to one mole of the compound of formula (I) are about 0.5.

[00357] In some embodiments, the molar equivalents of a glycolate anion of a crystalline glycolate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a glycolate anion of a crystalline glycolate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 1.0. In other embodiments, the molar equivalents of a glycolate anion of a crystalline glycolate salt of a compound of formula (I) in Petition 870260065706, dated 03 / 07 / 2026, p. 103 / 778 99 / 376 The ratio of one mole of the compound of formula (I) is about 0.3 to about 0.6. In certain embodiments, the molar equivalents of a glycolate anion of a crystalline glycolate salt of the compound of formula (I) relative to one mole of the compound of formula (I) are about 0.5.

[00358] In some embodiments, the molar equivalents of a mesylate anion of a crystalline mesylate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a mesylate anion of a crystalline mesylate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.0 to about 2.0. In other embodiments, the molar equivalents of a mesylate anion of a crystalline mesylate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.5 to about 2.0. In other embodiments, the molar equivalents of a mesylate anion of a crystalline mesylate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.8 to about 1.9.In certain embodiments, the molar equivalents of a mesylate anion of a crystalline mesylate salt of the compound of formula (I) relative to one mole of the compound of formula (I) are approximately 1.8.

[00359] In some embodiments, the molar equivalents of a sulfate anion of a crystalline sulfate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a sulfate anion of a crystalline sulfate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.0 to about 2.0. In other embodiments, molar equivalents of a sulfate anion of a Petition 870260065706, dated 03 / 07 / 2026, p. 104 / 778 100 / 376 crystalline sulfate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.5 to about 2.0. In other embodiments, the molar equivalents of a sulfate anion of a crystalline sulfate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.5 to about 1.7. In certain embodiments, the molar equivalents of a sulfate anion of a crystalline sulfate salt of the compound of formula (I) relative to one mole of the compound of formula (I) are from about 1.6.

[00360] In some embodiments, the molar equivalents of a citrate anion of a crystalline citrate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the molar equivalents of a citrate anion of a crystalline citrate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.4 to about 1.5. In other embodiments, the molar equivalents of a citrate anion of a crystalline citrate salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.5 to about 1.0. In other embodiments, the molar equivalents of a citrate anion of a crystalline citrate salt of a compound of formula (I) relative to a mole of the compound of formula (I) are from about 1.0 to about 1.5.In other embodiments, the molar equivalents of a citrate anion of a crystalline citrate salt of a compound of formula (I) relative to a mole of the compound of formula (I) are from about 1.5 to about 2.0.

[00361] In some embodiments, the molar equivalents of a chloride anion of a crystalline bis-chloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are from about 0.2 to about 2.0. In some embodiments, the Petition 870260065706, dated 03 / 07 / 2026, p. 105 / 778 101 / 376 molar equivalents of a chloride anion of a crystalline bis-chloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are about 1.0 to about 2.0. In other embodiments, the molar equivalents of a chloride anion of a crystalline bis-chloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are about 1.5 to about 2.0. In certain embodiments, the molar equivalents of a chloride anion of a crystalline hydrochloride salt of the compound of formula (I) relative to one mole of the compound of formula (I) are about 1.9 to about 2.0. In certain embodiments, the molar equivalents of a chloride anion of a crystalline bis-chloride salt of a compound of formula (I) relative to one mole of the compound of formula (I) are about 2.0. Salt forms Hydrochloride salt

[00362] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a hydrochloride salt. In some embodiments, a hydrochloride salt of the compound of formula (I) is crystalline. In some embodiments, the hydrochloride salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the hydrochloride salt of the compound of formula (I) is a hydrate. In some other embodiments, the hydrochloride salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00363] In certain embodiments, the solvate of the hydrochloride salt of the compound of formula (I) is a hydrate having a water content of about 1 to 20%, 2 to 15%, 3 to 10%, 4 to 8%, 4 to 6% or about 5%.

[00364] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a hydrochloride salt. In some embodiments, a hydrochloride salt of the compound of formula (I) Petition 870260065706, dated 03 / 07 / 2026, p. 106 / 778 102 / 376 is crystalline. In some embodiments, the hydrochloride salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the hydrochloride salt of the compound of formula (I) is a hydrate. In some other embodiments, the hydrochloride salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00365] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9, + / - 0.3 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00366] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 10.0, 10.7, 12.2, 13.9, 15.7 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of SEQ ID NO: 1, or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 10.0, 10.7, 12.2, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more peaks of Petition 870260065706, dated 03 / 07 / 2026, p. 107 / 778 103 / 376 diffraction at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 10.0, 10.7, 12.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00367] In other embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.3, 6.9, 7.7, 8.6, 9.3, 10.0, 10.7, 11.5, 12.0, 13.1, 13.3, 14.0, 14.8, 15.8, 17.1, 17.6, 18.1, 18.6, 19.3, 20.5, 20.7 or 21.8 + / - 0.2 degrees two theta. In other embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.3, 6.9, 7.7, 8.6, 9.3, 10.0, 10.7, 11.5, 12.0, 13.1, 13.3, 14.0, 14.8, 15.8, 17.1, 17.6, 18.1, 18.6, 19.3, 20.5, 20.7 or 21.8 + / - 0.3 degrees two theta.In other embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.3, 6, 9, 7.7, 8.6, 9.3, 10.0, 10.7, 11.5, 12.0, 13.1, 13.3, 14.0, 14.8, 15.8, 17.1, 17.6, 18.1, 18.6, 19.3, 20.5, 20.7 or 21.8 + / - 0.4 degrees two theta.

[00368] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 4.3, 6.9, 7.7, 8.6, 9.3, 10.0, 10.7, 11.5, 12.0, 13.1, 13.3, 14.0, 14.8, 15.8, 17.1, 17.6, 18.1, 18.6, 19.3, 20.5, 20.7 or 21.8 + / - 0.2 degrees two theta. In some embodiments, the hydrochloride salt Petition 870260065706, dated 03 / 07 / 2026, p. 108 / 778 104 / 376 crystalline compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 4.3, 6.9, 7.7, 8.6, 9.3, 10.0, 10.7, 11.5, 12.0, 13.1, 13.3, 14.0, 14.8, 15.8, 17.1, 17.6, 18.1, 18.6, 19.3, 20.5, 20.7 or 21.8 + / - 0.3 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 4.3, 6.9, 7.7, 8.6, 9.3, 10.0, 10.7, 11.5, 12.0, 13.1, 13.3, 14.0, 14.8, 15.8, 17.1, 17.6, 18.1, 18.6, 19.3, 20.5, 20.7 or 21.8 + / - 0.4 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 1.In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 2.

[00369] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 9.4, 10.0, 10.8, 11.5, 12.0, 12.2, 12.8, 13.1, 13.3, 13.8, 13.9, 14.2, 14.4, 14.7, 15.3, 15.7, 16.2, 16.4, 17.2, 17.6, 18.2, 18.7, 19.2, 19.6, 19.9, 20.5 and 20.8 + / - 0.2 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 9.4, 10.0, 10.8, 11.6, 12.0, 12.2, 12.8, 13.1, 13.3, 13.8, 13.9, 14.2, 14.4, 14.7, 15.3, 15.7, 16.2, 16.4, 17.2, 17.6, 18.2, 18.7, 19.2, 19.6, 19.9, 20.5 and 20.8 + / - 0.3 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), Petition 870260065706, dated 03 / 07 / 2026, p. 109 / 778 105 / 376 or solvate thereof, is distinguished by having a P-type XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 9.4, 10.0, 10.8, 11.5, 12.0, 12.2, 12.8, 13.1, 13.3, 13.8, 13.9, 14.2, 14.4, 14.7, 15.3, 15.7, 16.2, 16.4, 17.2, 17.6, 18.2, 18.7, 19.2, 19.6, 19.9, 20.5 and 20.8 + / - 0.4 degrees two breast.

[00370] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 9.4, 10.0, 10.8, 11.5, 12.0, 12.2, 12.8, 13.1, 13.3, 13.8, 13.9, 14.2, 14.4, 14.7, 15.3, 15.7, 16.2, 16.4, 17.2, 17.6, 18.2, 18.7, 19.2, 19.6, 19.9, 20.5 and 20.8 + / - 0.2 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 9.4, 10.0, 10.8, 11.5, 12.0, 12.2, 12.8, 13.1, 13.3, 13.8, 13.9, 14.2, 14.4, 14.7, 15.3, 15.7, 16.2, 16.4, 17.2, 17.6, 18.2, 18.7, 19.2, 19.6, 19.9, 20.5 and 20.8 + / - 0.3 degrees two theta.In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.3, 9.4, 10.0, 10.8, 11.5, 12.0, 12.2, 12.8, 13.1, 13.3, 13.8, 13.9, 14.2, 14.4, 14.7, 15.3, 15.7, 16.2, 16.4, 17.2, 17.6, 18.2, 18.7, 19.2, 19.6, 19.9, 20.5 and 20.8 + / - 0.4 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 3.

[00371] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by a Petition 870260065706, dated 03 / 07 / 2026, p. 110 / 778 106 / 376 XRD standard, as shown substantially in Figure 1, Figure 2 or Figure 3.

[00372] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having endothermic peaks at about 81.4 °C, as determined by differential scanning calorimetry (DSC). In certain embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a DSC curve, as substantially shown in Figure 5.

[00373] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 5.6%, from about 26.5 °C to about 160.0 °C, as determined by thermogravimetric analysis (TGA). In certain embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a TGA plot, as shown substantially in Figure 4. In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a DVS plot, as shown substantially in Figure 6.

[00374] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, described herein and one or more pharmaceutically acceptable excipients. Acetate salt

[00375] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is an acetate salt. In some embodiments, the acetate salt of the compound of formula (I) is crystalline. In some embodiments, the acetate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the Petition 870260065706, dated 03 / 07 / 2026, p. 111 / 778 107 / 376 The acetate salt solvate of the compound of formula (I) is a hydrate. In some other embodiments, the acetate salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00376] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00377] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00378] In some embodiments, the crystalline acetate salt of Petition 870260065706, dated 03 / 07 / 2026, p. 112 / 778 108 / 376 compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00379] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.3 degrees two breast.In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1. Petition 870260065706, dated 03 / 07 / 2026, p. 113 / 778 109 / 376 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.4 degrees two theta.

[00380] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least three diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.2 degrees two theta. In some embodiments, the crystalline hydrochloride salt of the peptide with SEQ ID NO: 1, or its solvate, is distinguished by having an XRD pattern that has at least three diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4. + / - 0.3 degrees two theta.In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least three diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.4 degrees two breast.

[00381] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the peptide of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least Petition 870260065706, dated 03 / 07 / 2026, p. 114 / 778 110 / 376 two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XP RD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.4 degrees two theta.

[00382] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least three diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at three theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.3 degrees two theta.In some embodiments, the crystalline hydrochloride salt of the peptide with SEQ ID NO: 1, or the solvate thereof, is distinguished by having an XRD pattern that has at least three diffraction peaks at two theta angles selected from 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.4 degrees two theta. Petition 870260065706, dated 03 / 07 / 2026, p. 115 / 778 111 / 376

[00383] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.3 degrees two theta.In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1 and 19.4 + / - 0.4 degrees two theta.

[00384] In some embodiments, the crystalline acetate salt of the peptide of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and Petition 870260065706, dated 03 / 07 / 2026, p. 116 / 778 112 / 376 20.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.8, 7.0, 7.6, 7.7, 8.5, 8.6, 9.2, 9.9, 10.1, 10.4, 10.6, 10.7, 11.2, 11.4, 11.8, 12.1, 12.8, 13.1, 13.8, 14.3, 14.5, 15.2, 15.5, 15.9, 17.2, 17.4, 18.0, 18.4, 19.1, 19.4 and 20.1 + / - 0.4 degrees two theta. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 7.

[00385] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having endothermic peaks around 80.7 °C and / or around 240.7 °C, as determined by DSC. In certain embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having a DSC curve, as shown substantially in Figure 9.

[00386] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 5.8%, from about 26.5 °C to about 150.0 °C, as determined by TGA. In certain embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having a TGA plot, as shown substantially in Figure 8. In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, is distinguished by having a DVS plot, as shown substantially in Figure 10.

[00387] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline acetate salt of the compound of Petition 870260065706, dated 03 / 07 / 2026, p. 117 / 778 113 / 376 formula (I), or solvate thereof, described herein and a pharmaceutically acceptable excipient. Fumarate salt

[00388] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a fumarate salt. In some embodiments, the fumarate salt of the compound of formula (I) is crystalline. In some embodiments, the fumarate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the fumarate salt of the compound of formula (I) is a hydrate. In some other embodiments, the fumarate salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00389] In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00390] In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), Petition 870260065706, dated 03 / 07 / 2026, p. 118 / 778 114 / 376 or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00391] In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00392] In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 12.8, 13.3, 14.0, 14.7, 15.7, 17.0, 17.6, 19.1, 20.4, 21.7, 23.1, 24.2, 25.4 and 27.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that Petition 870260065706, dated 03 / 07 / 2026, p. 119 / 778 115 / 376 has two or more diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 12.8, 13.3, 14.0, 14.7, 15.7, 17.0, 17.6, 19.1, 20.4, 21.7, 23.1, 24.2, 25.4 and 27.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 12.8, 13.3, 14.0, 14.7, 15.7, 17.0, 17.6, 19.1, 20.4, 21.7, 23.1, 24.2, 25.4 and 27.1 + / - 0.4 degrees two theta.

[00393] In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 12.8, 13.3, 14.0, 14.7, 15.7, 17.0, 17.6, 19.1, 20.4, 21.7, 23.1, 24.2, 25.4 and 27.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 12.8, 13.3, 14.0, 14.7, 15.7, 17.0, 17.6, 19.1, 20.4, 21.7, 23.1, 24.2, 25.4 and 27.1 + / - 0.3 degrees two theta.In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 12.8, 13.3, 14.0, 14.7, 15.7, 17.0, 17.6, 19.1, 20.4, 21.7, 23.1, 24.2, 25.4 and 27.1 + / - 0.4 degrees two theta. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 15.

[00394] In some embodiments, the crystalline fumarate salt of Petition 870260065706, dated 03 / 07 / 2026, p. 120 / 778 The crystalline fumarate salt of the compound of formula (I), or its solvate, is distinguished by having an endothermic peak around 65.3 °C, as determined by DSC. In certain embodiments, the crystalline fumarate salt of the compound of formula (I), or its solvate, is distinguished by having a DSC curve, as substantially shown in Figure 17. In some embodiments, the crystalline fumarate salt of the compound of formula (I), or its solvate, is distinguished by having a weight loss of about 4.4%, from about 26.5 °C to about 110.0 °C, as determined by TGA. In certain embodiments, the crystalline fumarate salt of the compound of formula (I), or its solvate, is distinguished by having a TGA graph, as substantially shown in Figure 16.

[00395] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline fumarate salt of the compound of formula (I), or solvate thereof, described herein and a pharmaceutically acceptable excipient. Glutarate salt

[00396] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a glutarate salt. In some embodiments, the glutarate salt of the compound of formula (I) is crystalline. In some embodiments, the glutarate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the glutarate salt of the compound of formula (I) is a hydrate. In some other embodiments, the glutarate salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00397] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two Petition 870260065706, dated 03 / 07 / 2026, p. 121 / 778 117 / 376 theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00398] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00399] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof Petition 870260065706, dated 03 / 07 / 2026, p. 122 / 778 118 / 376 itself is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00400] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.6, 8.5, 9.2, 9.9, 10.8, 11.9, 13.0, 13.9, 15.7, 17.0, 17.6, 18.6, 19.2, 20.3, 20.7, 21.4, 23.3 and 25.3 + / - 0.2 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.6, 8.5, 9.2, 9.9, 10.8, 11.9, 13.0, 13.9, 15.7, 17.0, 17.6, 18.6, 19.2, 20.3, 20.7, 21.4, 23.3 and 25.3 + / - 0.3 degrees two theta.In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.6, 8.5, 9.2, 9.9, 10.8, 11.9, 13.0, 13.9, 15.7, 17.0, 17.6, 18.6, 19.2, 20.3, 20.7, 21.4, 23.3 and 25.3 + / - 0.4 degrees two theta.

[00401] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.6, 8.5, 9.2, 9.9, 10.8, 11.9, 13.0, 13.9, 15.7, 17.0, 17.6, 18.6, 19.2, 20.3, 20.7, 21.4, 23.3 and 25.3 + / - 0.2 degrees two theta. In some embodiments, the crystalline glutarate salt Petition 870260065706, dated 03 / 07 / 2026, p. 123 / 778 119 / 376 of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.6, 8.5, 9.2, 9.9, 10.8, 11.9, 13.0, 13.9, 15.7, 17.0, 17.6, 18.6, 19.2, 20.3, 20.7, 21.4, 23.3 and 25.3 + / - 0.3 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.6, 8.5, 9.2, 9.9, 10.8, 11.9, 13.0, 13.9, 15.7, 17.0, 17.6, 18.6, 19.2, 20.3, 20.7, 21.4, 23.3 and 25.3 + / - 0.4 degrees two theta. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 18.

[00402] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an endothermic peak around 224.0 °C, as determined by simultaneous thermal analysis (SDT). In certain embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as substantially shown in Figure 19. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 6.4%, from about 26.5 °C to about 125.0 °C, as determined by SDT. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, is distinguished by having a DVS graph, as substantially shown in Figure 20.

[00403] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline glutarate salt of the compound of Petition 870260065706, dated 03 / 07 / 2026, p. 124 / 778 120 / 376 formula (I), or solvate thereof, described herein and a pharmaceutically acceptable excipient. Glycolate salt of a peptide SEQ ID NO: 1

[00404] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a glycolate salt. In some embodiments, the glycolate salt of the compound of formula (I) is crystalline. In some embodiments, the glycolate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the glycolate salt of the compound of formula (I) is a hydrate. In some other embodiments, the glycolate salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00405] In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00406] In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), Petition 870260065706, dated 03 / 07 / 2026, p. 125 / 778 121 / 376 or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00407] In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00408] In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.7, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 13.1, 14.0, 15.8, 17.1, 17.7, 19.2, 20.2, 20.8, 21.6, 25.4 and 29.5 + / - 0.2 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is Petition 870260065706, dated 03 / 07 / 2026, p. 126 / 778 122 / 376 is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.7, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 13.1, 14.0, 15.8, 17.1, 17.7, 19.2, 20.2, 20.8, 21.6, 25.4 and 29.5 + / - 0.3 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.7, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 13.1, 14.0, 15.8, 17.1, 17.7, 19.2, 20.2, 20.8, 21.6, 25.4 and 29.5 + / - 0.4 degrees two theta.

[00409] In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.7, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 13.1, 14.0, 15.8, 17.1, 17.7, 19.2, 20.2, 20.8, 21.6, 25.4 and 29.5 + / - 0.2 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.7, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 13.1, 14.0, 15.8, 17.1, 17.7, 19.2, 20.2, 20.8, 21.6, 25.4 and 29.5 + / - 0.3 degrees two theta.In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.7, 8.5, 9.2, 10.0, 10.7, 11.5, 12.0, 13.1, 14.0, 15.8, 17.1, 17.7, 19.2, 20.2, 20.8, 21.6, 25.4 and 29.5 + / - 0.4 degrees two theta. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 21.

[00410] In some embodiments, the crystalline glycolate salt of Petition 870260065706, dated 03 / 07 / 2026, p. 127 / 778 123 / 376 compound of formula (I), or solvate thereof, is distinguished by having an endothermic peak around 237.0 °C, as determined by SDT. In certain embodiments, the crystalline glycolate salt of compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as shown substantially in Figure 22.

[00411] In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 5.1%, from about 26.5 °C to about 100.0 °C, as determined by SDT. In certain embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as shown substantially in Figure 22. In some embodiments, the crystalline glycolate salt of the compound of formula (I), or solvate thereof, is distinguished by having a DVS graph, as shown substantially in Figure 23.

[00412] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline glycolate salt of the compound of formula (I), or solvate thereof, described herein and one or more pharmaceutically acceptable excipients. Sulfate salt of a peptide SEQ ID NO: 1

[00413] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a sulfate salt. In some embodiments, the sulfate salt of the compound of formula (I) is crystalline. In some embodiments, the sulfate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the sulfate salt of the compound of formula (I) is a hydrate. In some other embodiments, the sulfate salt of the compound of formula (I) is crystalline and in the form of a solvate. Petition 870260065706, dated 03 / 07 / 2026, p. 128 / 778 124 / 376

[00414] In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00415] In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.2 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.3 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.4 degrees two theta.

[00416] In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.1, 6.8, 7.6, 9.2, 9.6, 10.3, 11.3, Petition 870260065706, dated 03 / 07 / 2026, p. 129 / 778 125 / 376 12.5, 13.7, 16.8, 17.9, 18.4, 19.8, 20.7, 21.3 and 22.7 + / - 0.2 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.1, 6.8, 7.6, 9.2, 9.6, 10.3, 11.3, 12.5, 13.7, 16.8, 17.9, 18.4, 19.8, 20.7, 21.3 and 22.7 + / - 0.3 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.1, 6.8, 7.6, 9.2, 9.6, 10.3, 11.3, 12.5, 13.7, 16.8, 17.9, 18.4, 19.8, 20.7, 21.3 and 22.7 + / - 0.4 degrees two theta.

[00417] In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles selected from at least 4.1, 6.8, 7.6, 9.2, 9.6, 10.3, 11.3, 12.5, 13.7, 16.8, 17.9, 18.4, 19.8, 20.7, 21.3 and 22.7 + / - 0.2 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles selected from at least 4.1, 6.8, 7.6, 9.2, 9.6, 10.3, 11.3, 12.5, 13.7, 16.8, 17.9, 18.4, 19.8, 20.7, 21.3 and 22.7 + / - 0.3 degrees two theta.In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles selected from at least 4.1, 6.8, 7.6, 9.2, 9.6, 10.3, 11.3, 12.5, 13.7, 16.8, 17.9, 18.4, 19.8, 20.7, 21.3 and 22.7 + / - 0.4 degrees two theta. In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 26.

[00418] In some embodiments, the crystalline sulfate salt of Petition 870260065706, dated 03 / 07 / 2026, p. 130 / 778 126 / 376 compound of formula (I), or solvate thereof, is distinguished by having an endothermic peak around 255.0 °C, as determined by SDT. In certain embodiments, the crystalline sulfate salt of compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as shown substantially in Figure 27.

[00419] In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 4.4%, from about 26.5 °C to about 80.0 °C, as determined by SDT. In certain embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as shown substantially in Figure 27.

[00420] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline sulfate salt of the compound of formula (I), or solvate thereof, described herein and a pharmaceutically acceptable excipient. Mesylate salt of a peptide with SEQ ID NO: 1

[00421] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a mesylate salt. In some embodiments, the mesylate salt of the compound of formula (I) is crystalline. In some embodiments, the mesylate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the mesylate salt of the compound of formula (I) is a hydrate. In some other embodiments, the mesylate salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00422] In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two Petition 870260065706, dated 03 / 07 / 2026, p. 131 / 778 127 / 376 selected theta angles from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00423] In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.2 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.3 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.4 degrees two theta.

[00424] In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 4.1, 6.8, 7.6, 9.2, 9.6, 11.3, 12.5, 13.7, 15.5, 16.6, 18.4, 19.8, 20.6, 22.8 and 27.8 degrees two theta + / - 0.2 degrees two theta. In some embodiments, the crystalline mesylate salt Petition 870260065706, dated 03 / 07 / 2026, p. 132 / 778 128 / 376 of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 4.1, 6.8, 7.6, 9.2, 9.6, 11.3, 12.5, 13.7, 15.5, 16.6, 18.4, 19.8, 20.6, 22.8 and 27.8 degrees two theta + / - 0.3 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 4.1, 6.8, 7.6, 9.2, 9.6, 11.3, 12.5, 13.7, 15.5, 16.6, 18.4, 19.8, 20.6, 22.8 and 27.8 degrees two theta + / - 0.4 degrees two theta.

[00425] In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 4.1, 6.8, 7.6, 9.2, 9.6, 11.3, 12.5, 13.7, 15.5, 16.6, 18.4, 19.8, 20.6, 22.8 and 27.8 degrees two theta + / - 0.2 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 4.1, 6.8, 7.6, 9.2, 9.6, 11.3, 12.5, 13.7, 15.5, 16.6, 18.4, 19.8, 20.6, 22.8 and 27.8 degrees two theta + / - 0.3 degrees two theta.In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 4.1, 6.8, 7.6, 9.2, 9.6, 11.3, 12.5, 13.7, 15.5, 16.6, 18.4, 19.8, 20.6, 22.8 and 27.8 degrees two theta + / - 0.4 degrees two theta. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 24.

[00426] In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having Petition 870260065706, dated 03 / 07 / 2026, p. 133 / 778 129 / 376 an endothermic peak around 242.1 °C, as determined by SDT. In certain embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as substantially shown in Figure 25. In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 5.4%, from about 26.5 °C to about 80.0 °C, as determined by SDT. In certain embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, is distinguished by having an SDT thermogram, as substantially shown in Figure 25.

[00427] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline mesylate salt of the compound of formula (I), or solvate thereof, described herein and a pharmaceutically acceptable excipient. Citrate salt of a peptide with SEQ ID NO: 1

[00428] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a citrate salt. In some embodiments, the citrate salt of the compound of formula (I) is crystalline. In some embodiments, the citrate salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the citrate salt of the compound of formula (I) is a hydrate. In some other embodiments, the citrate salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00429] In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline citrate salt of the compound Petition 870260065706, dated 03 / 07 / 2026, p. 134 / 778 130 / 376 of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees two theta.

[00430] In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.2 degrees two theta. In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.3 degrees two theta. In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6, 9.2, 9.6, 11.3, 12.5, 16.7 and 18.4 + / - 0.4 degrees two theta.

[00431] In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.0, 7.6, 8.4, 9.3, 10.0, 10.8, 12.2, 13.1, 13.9, 14.1, 15.3, 15.9, 16.3, 17.0, 17.4, 17.9, 19.0, 19.5, 19.8, 20.5, 22.0, 23.1, 24.4, 24.8, 25.2, 26.5, 29.1, 30.5, 32.1, 33.1 and 33.5 + / - 0.2 degrees two theta. In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least Petition 870260065706, dated 03 / 07 / 2026, p. 135 / 778 131 / 376 two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.0, 7.6, 8.4, 9.3, 10.0, 10.8, 12.2, 13.1, 13.9, 14.1, 15.3, 15.9, 16.3, 17.0, 17.4, 17.9, 19.0, 19.5, 19.8, 20.5, 22.0, 23.1, 24.4, 24.8, 25.2, 26.5, 29.1, 30.5, 32.1, 33.1 and 33.5 + / - 0.3 degrees two theta. In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.8, 4.3, 6.9, 7.0, 7.6, 8.4, 9.3, 10.0, 10.8, 12.2, 13.1, 13.9, 14.1, 15.3, 15.9, 16.3, 17.0, 17.4, 17.9, 19.0, 19.5, 19.8, 20.5, 22.0, 23.1, 24.4, 24.8, 25.2, 26.5, 29.1, 30.5, 32.1, 33.1 and 33.5 + / - 0.4 degrees two theta.

[00432] In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.0, 7.6, 8.4, 9.3, 10.0, 10.8, 12.2, 13.1, 13.9, 14.1, 15.3, 15.9, 16.3, 17.0, 17.4, 17.9, 19.0, 19.5, 19.8, 20.5, 22.0, 23.1, 24.4, 24.8, 25.2, 26.5, 29.1, 30.5, 32.1, 33.1 and 33.5 + / - 0.2 degrees two theta. In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.0, 7.6, 8.4, 9.3, 10.0, 10.8, 12.2, 13.1, 13.9, 14.1, 15.3, 15.9, 16.3, 17.0, 17.4, 17.9, 19.0, 19.5, 19.8, 20.5, 22.0, 23.1, 24.4, 24.8, 25.2, 26.5, 29.1, 30.5, 32.1, 33.1 and 33.5 + / - 0.3 degrees two theta.In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.8, 4.3, 6.9, 7.0, 7.6, 8.4, 9.3, 10.0, 10.8, 12.2, 13.1, 13.9, 14.1, 15.3, 15.9, 16.3, 17.0, 17.4, 17.9, 19.0, 19.5, 19.8, 20.5, 22.0, 23.1, 24.4, 24.8, 25.2, 26.5, 29.1, 30.5, 32.1, 33.1 and 33.5 + / - 0.4 degrees two theta. In some forms, the crystalline citrate salt. Petition 870260065706, dated 03 / 07 / 2026, p. 136 / 778 132 / 376 of the compound of formula (I), or solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 28.

[00433] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline citrate salt of the compound of formula (I), or solvate thereof, described herein and a pharmaceutically acceptable excipient. Bis-chloride salt of a peptide with SEQ ID NO: 1

[00434] In some embodiments, a pharmaceutically acceptable salt of a compound of formula (I) is a bis-hydrochloride salt. In some embodiments, the bis-hydrochloride salt of the compound of formula (I) is crystalline. In some embodiments, the bis-hydrochloride salt of the compound of formula (I) is in the form of a solvate. In certain embodiments, the solvate of the bis-hydrochloride salt of the compound of formula (I) is a hydrate. In some other embodiments, the bis-hydrochloride salt of the compound of formula (I) is crystalline and in the form of a solvate.

[00435] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.2 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.3 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 4.2, 6.9, 7.6 and 9.2 + / - 0.4 degrees. Petition 870260065706, dated 03 / 07 / 2026, p. 137 / 778 133 / 376 teat.

[00436] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has two or more diffraction peaks at two theta angles selected from 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta.

[00437] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.2 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.3 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles at least 3.8, 4.2, 6.9, 7.6, 8.5, 9.2, 10.0, 10.7, 12.1, 13.9, 15.8 or 17.1 + / - 0.4 degrees two theta. Petition 870260065706, dated 03 / 07 / 2026, p. 138 / 778 134 / 376

[00438] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.4, 4.6, 6.1, 8.3, 8.7, 9.1, 9.4, 9.8, 10.1, 11.1, 11.4, 12.0, 12.4, 13.6, 15.1, 15.9, 16.1, 16.7, 17.8, 18.4, 18.7, 19.4, 19.9 and 20.8 + / - 0.2 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.4, 4.6, 6.1, 8.3, 8.7, 9.1, 9.4, 9.8, 10.1, 11.1, 11.4, 12.0, 12.4, 13.6, 15.1, 15.9, 16.1, 16.7, 17.8, 18.4, 18.7, 19.4, 19.9 and 20.8 + / - 0.3 degrees two theta.In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has at least two diffraction peaks at two theta angles selected from 3.4, 4.6, 6.1, 8.3, 8.7, 9.1, 9.4, 9.8, 10.1, 11.1, 11.4, 12.0, 12.4, 13.6, 15.1, 15.9, 16.1, 16.7, 17.8, 18.4, 18.7, 19.4, 19.9 and 20.8 + / - 0.4 degrees two theta.

[00439] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.4, 4.6, 6.1, 8.3, 8.7, 9.1, 9.4, 9.8, 10.1, 11.1, 11.4, 12.0, 12.4, 13.6, 15.1, 15.9, 16.1, 16.7, 17.8, 18.4, 18.7, 19.4, 19.9 and 20.8 + / - 0.2 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.4, 4.6, 6.1, 8.3, 8.7, 9.1, 9.4, 9.8, 10.1, 11.1, 11.4, 12.0, 12.4, 13.6, 15.1, 15.9, 16.1, 16.7, 17.8, 18.4, 18.7, 19.4, 19.9 and 20.8 + / - 0.3 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula Petition 870260065706, dated 03 / 07 / 2026, p. 139 / 778 135 / 376 (I), or the solvate thereof, is distinguished by having an XRD pattern that has diffraction peaks at two theta angles among at least 3.4, 4.6, 6.1, 8.3, 8.7, 9.1, 9.4, 9.8, 10.1, 11.1, 11.4, 12.0, 12.4, 13.6, 15.1, 15.9, 16.1, 16.7, 17.8, 18.4, 18.7, 19.4, 19.9 and 20.8 + / - 0.4 degrees two theta. In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or the solvate thereof, is distinguished by an XRD pattern, as shown substantially in Figure 29.

[00440] In some embodiments, the crystalline bis-hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having endothermic peaks at about 79.5 °C and / or about 235.3 °C, as determined by DSC. In certain embodiments, the crystalline bis-hydrochloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a DSC curve, as shown substantially in Figure 31.

[00441] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a weight loss of about 11.3%, from about 26.5 °C to about 190.0 °C, as determined by TGA. In certain embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a TGA plot, as shown substantially in Figure 30.

[00442] In some embodiments, the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, is distinguished by having a DVS plot, as shown substantially in Figure 32.

[00443] In some respects, the present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of the crystalline bis-chloride salt of the compound of formula (I), or solvate thereof, described herein and an excipient Petition 870260065706, dated 03 / 07 / 2026, p. 140 / 778 136 / 376 pharmaceutically acceptable. Purity

[00444] In some embodiments, the crystalline salt of the compound of formula (I), or solvate thereof, produced by the methods described herein has a purity level of at least about 85%, at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least 98% or at least about 99%, as determined by ultra-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC) or other suitable methods. In some embodiments, the crystalline salt of the compound of formula (I), or solvate thereof, has a purity level between about 90% and 100%.In some embodiments, the crystalline salt of the compound of formula (I), or solvate thereof, has a purity level of at least about 95.0%, about 96.0%, about 97.0%, about 98.0%, about 99.0%, about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or about 99.9%, including any intermediate amounts and fractions thereof. In other embodiments, the crystalline salt of the compound of formula (I), or solvate thereof, has a purity level between about 95.0% and 99.9%. In some embodiments, the crystalline salt of the compound of formula (I), or its solvate, has a purity level of at least 95%. In some embodiments, the crystalline salt of the compound of formula (I), or its solvate, has a purity level of at least 96%. In some embodiments, the crystalline salt of the compound of formula (I), or its solvate, has a purity level of at least 97%.In some forms, the crystalline salt of the compound. Petition 870260065706, dated 03 / 07 / 2026, p. 141 / 778 137 / 376 of formula (I), or the solvate thereof, has a purity level of at least 98%. In some embodiments, the crystalline salt of the compound of formula (I), or the solvate thereof, has a purity level of at least 99%. In some embodiments, the crystalline salt of the compound of formula (I), or the solvate thereof, has a purity level of at least 99.5%.

[00445] In some embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, has a purity level of at least about 95.0%, about 96.0%, about 97.0%, about 98.0%, about 99.0%, about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or about 99.9%, including any intermediate amounts and fractions thereof. In other embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, has a purity level between about 99.0% and 99.5%. In certain embodiments, the crystalline hydrochloride salt of the compound of formula (I), or solvate thereof, has a purity level of at least 99.0%.

[00446] In some embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, has a purity level of at least about 95.0%, about 96.0%, about 97.0%, about 98.0%, about 99.0%, about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or about 99.9%, including any intermediate amounts and fractions thereof. In certain embodiments, the crystalline acetate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 99.0%. In other embodiments, the crystalline salt of the compound of formula (I), or solvate thereof, has a purity level between about 99.0% and 99.5%. Petition 870260065706, dated 03 / 07 / 2026, p. 142 / 778 138 / 376

[00447] In some embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 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% or about 99%, including any intermediate amounts and fractions thereof. In other embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, has a purity level between about 86% and 90%. In other embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, has a purity level between about 86% and 87%. In certain embodiments, the crystalline fumarate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 86%.

[00448] In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, has a purity level of at least about 95.0%, about 96.0%, about 97.0%, about 98.0%, about 99.0%, about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or about 99.3%, including any intermediate amounts and fractions thereof. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, has a purity level between about 85% and 90%. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, has a purity level between about 90% and 95%. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, has a purity level between about 95% and 99%.In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, has a purity level between approximately. Petition 870260065706, dated 03 / 07 / 2026, p. 143 / 778 139 / 376 of 99.0% and 99.5%. In some embodiments, the crystalline glutarate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 99.0%.

[00449] In some embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 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% or about 99%, including any intermediate amounts and fractions thereof. In other embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, has a purity level between about 90% and 95%. In other embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, has a purity level between about 95% and 99%. In other embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, has a purity level between about 90% and 92%.In certain embodiments, the crystalline mesylate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 90%.

[00450] In some embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 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% or about 99%, including any intermediate amounts and fractions thereof. In other embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, has a purity level between about 90% and 95%. In other embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, has a purity level between approximately Petition 870260065706, dated 03 / 07 / 2026, p. 144 / 778 140 / 376 of 95% and 99%. In other embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, has a purity level between about 90% and 92%. In certain embodiments, the crystalline sulfate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 91%.

[00451] In some embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, has a purity level of at least about 95.0%, about 96.0%, about 97.0%, about 98.0%, about 99.0%, about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or about 99.9%, including any intermediate amounts and fractions thereof. In other embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, has a purity level between about 99.0% and 99.9%. In certain embodiments, the crystalline citrate salt of the compound of formula (I), or solvate thereof, has a purity level of at least 99.5%.

[00452] In some embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, has a purity level of at least about 95.0%, about 96.0%, about 97.0%, about 98.0%, about 99.0%, about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or about 99.3%, including any intermediate amounts and fractions thereof. In certain embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, has a purity level of at least 97.0%. In certain embodiments, the crystalline free base of the compound of formula (I), or its solvate, has a purity level of at least 98.0%. In certain embodiments, the crystalline free base of the compound of formula (I), or its solvate, has a purity level of Petition 870260065706, dated 03 / 07 / 2026, p. 145 / 778 141 / 376 purity of at least 99.0%. In other embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, has a purity level between about 97.0% and 98.0%. In other embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, has a purity level between about 98.0%. In other embodiments, the crystalline free base of the compound of formula (I), or solvate thereof, has a purity level between about 99.0%. Crystalline forms of formula (II)

[00453] In one aspect, the present invention relates to a pharmaceutical composition of a crystalline salt of a compound of formula (II): or a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound.

[00454] In another aspect, the present invention relates to a crystalline free base form of a compound of formula (II).

[00455] In one aspect, the present invention relates to a pharmaceutical composition of a hydrochloride salt of a peptide from SEQ ID NO: 2.

[00456] In one aspect, the present invention relates to a pharmaceutical composition of a hydrochloride salt of a compound of formula (II). Petition 870260065706, dated 03 / 07 / 2026, p. 146 / 778 142 / 376

[00457] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of the hydrochloride salt of a peptide from SEQ ID NO: 2.

[00458] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of a pharmaceutically acceptable salt of a peptide from SEQ ID NO: 2. The crystalline form of a pharmaceutically acceptable salt of a peptide from SEQ ID NO: 2 may be a crystalline hydrochloride salt, a crystalline acetate salt, a crystalline fumarate salt, a crystalline glycolate salt, a crystalline glutarate salt, a crystalline mesylate salt, a crystalline sulfate salt, a crystalline bis-hydrochloride salt and a crystalline citrate salt of a peptide from SEQ ID NO: 2.

[00459] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of the hydrochloride salt of a compound of formula (II).

[00460] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of a pharmaceutically acceptable salt of a compound of formula (II). The crystalline form of a pharmaceutically acceptable salt of a compound of formula (II) may be a crystalline hydrochloride salt, a crystalline acetate salt, a crystalline fumarate salt, a crystalline glycolate salt, a crystalline glutarate salt, a crystalline mesylate salt, a crystalline sulfate salt, a crystalline bis-hydrochloride salt and a crystalline citrate salt of a compound of formula (II).

[00461] In some respects, the crystalline hydrochloride salt form of a compound of formula (II) has the structure: Petition 870260065706, dated 03 / 07 / 2026, page 147 / 778 143 / 376 nh2 a solvato of the same. Crystal forms of formula (III)

[00462] In one aspect, the present invention relates to a pharmaceutical composition of a crystalline salt of a compound of formula (III): nh2ou a pharmaceutically acceptable salt thereof, or a solvate of the aforementioned compound.

[00463] In another aspect, the present invention relates to a crystalline free base form of a compound of formula (III).

[00464] In one aspect, the present invention relates to a pharmaceutical composition of a hydrochloride salt of a peptide of SEQ ID NO: 3.

[00465] In one aspect, the present invention relates to a Petition 870260065706, dated 03 / 07 / 2026, p. 148 / 778 144 / 376 pharmaceutical composition of a hydrochloride salt of a compound of formula (III).

[00466] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of the hydrochloride salt of a peptide from SEQ ID NO: 3.

[00467] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of a pharmaceutically acceptable salt of a peptide from SEQ ID NO: 3. The crystalline form of a pharmaceutically acceptable salt of a peptide from SEQ ID NO: 3 may be a crystalline hydrochloride salt, a crystalline acetate salt, a crystalline fumarate salt, a crystalline glycolate salt, a crystalline glutarate salt, a crystalline mesylate salt, a crystalline sulfate salt, a crystalline bis-hydrochloride salt and a crystalline citrate salt of a peptide from SEQ ID NO: 3.

[00468] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of the hydrochloride salt of a compound of formula (III).

[00469] In another aspect, the present invention relates to a pharmaceutical composition of a crystalline form of a pharmaceutically acceptable salt of a compound of formula (III). The crystalline form of a pharmaceutically acceptable salt of a compound of formula (III) may be a crystalline hydrochloride salt, a crystalline acetate salt, a crystalline fumarate salt, a crystalline glycolate salt, a crystalline glutarate salt, a crystalline mesylate salt, a crystalline sulfate salt, a crystalline bis-hydrochloride salt and a crystalline citrate salt of a compound of formula (III).

[00470] In some respects, the crystalline hydrochloride salt form of a compound of formula (III) has the structure: Petition 870260065706, dated 03 / 07 / 2026, page 149 / 778 145 / 376 nh2ou um solvato do mesmo. VI. Particle size of crystalline forms

[00471] In one embodiment, the method provided herein for the crystallization of the compound of formula (I) yields a crystalline material distinguished by laser diffraction (LD) having an average particle size distribution range (PSD) of about 1 to 100 μm. In another embodiment, the crystalline material distinguished has an average particle size distribution range of about 1 to 90 μm. In yet another embodiment, the crystalline material has a particle size distribution range of about 2 to 80 μm. In yet another embodiment, the crystalline material has a particle size distribution range of about 3 to 70 μm.

[00472] In one embodiment, the DTP of the crystalline compound of formula (I) is distinguished by having a Dv10 in the range of about 1 μm to 30 μm. In another embodiment, the DTP is distinguished by having a Dv10 in the range of about 2 μm to 20 μm. In yet another embodiment, the DTP is distinguished by having a Dv10 in the range of about 3 μm to 10 μm.

[00473] In one embodiment, the DTP of the crystalline compound of formula (I) is distinguished by having a Dv50 in the range of 3 μm to 80 μm. In another embodiment, the DTP is distinguished by having a Dv50 in the range Petition 870260065706, dated 03 / 07 / 2026, p. 150 / 778 146 / 376 from 5 μm to 60 μm. In yet another embodiment, DTP is distinguished by having a Dv50 in the range of 10 μm to 40 μm. In some embodiments, the crystalline compound has a Dv50 in the range of about 8 to 50 μm. In some embodiments, the crystalline compound has a Dv50 in the range of about 10 to 30 μm. In some embodiments, the crystalline compound has a Dv50 in the range of about 10 to 25 μm. In one embodiment, the DTP of the crystalline compound is distinguished by having a Dv50 in the range of 5 μm to 60 μm, 10 μm to 55 μm, 15 μm to 25 μm, 15 μm to 16 μm, and 20 μm to 24 μm.

[00474] In one embodiment, the DTP of the crystalline compound of formula (I) is distinguished by having a Dv90 in the range of 10 μm to 110 μm. In another embodiment, the DTP is distinguished by having a Dv90 in the range of 20 μm to 100 μm. In yet another embodiment, the DTP is distinguished by having a Dv90 in the range of 30 μm to 90 μm.

[00475] In certain embodiments, the DTP values ​​of the crystalline compound of formula (I) are as follows: 4 μm to 6 μm (Dv10); 14 μm to 19 μm (Dv50); and 34 μm to 60 μm (Dv90).

[00476] In certain embodiments, the DTP values ​​of the crystalline compound of formula (I) are as follows: 4.5 μm to 5.4 μm (Dv10); 14 μm to 19 μm (Dv50); and 34 μm to 60 μm (Dv90).

[00477] In another embodiment, the DTP includes Dv10 in the range of about 3.0 μm to 11 μm; Dv50 in the range of 11 μm to 33 μm; and Dv90 in the range of 34 μm to 90 μm. In yet another embodiment, the DTP values ​​of the crystalline compound of formula (I) are as follows: about 9 μm (Dv10); about 26 μm (Dv50); and about 61 μm (Dv90). In yet another embodiment the DTP values ​​of the crystalline compound of formula (I) are as follows: about 3 μm (Dv10); about 11 μm (Dv50); and about 34 μm (Dv90).

[00478] In one embodiment, the method given here for the crystallization of the compound of formula (I) yields a crystalline material. Petition 870260065706, dated 03 / 07 / 2026, p. 151 / 778 147 / 376 distinguished, by means of laser diffraction (LD), by having a particle size distribution range (PSD) of 1 to 3. In certain embodiments, the range is 1.5 to 3.5. In certain embodiments, the PSD range of the crystalline hydrochloride salt of the compound of formula (I) is about 2.2. In some embodiments, the particle size distribution range is less than 5, 4 or 3. In some embodiments, the particle size distribution range is less than 3. In some embodiments, the particle size distribution range is less than 4. In some embodiments, the particle size distribution range is less than 5.

[00479] In one embodiment, the method provided herein for the crystallization of the compound of formula (I) yields a crystalline material distinguished, by means of laser diffraction (LD), by having a particle size distribution range (PSD) of 1.99 to 2.90. In certain embodiments, the range is 1.99 to 2.47. In a certain embodiment, the PSD range of the crystalline hydrochloride salt of the compound of formula (I) is about 2.21.

[00480] In one embodiment, the DTP values ​​and ranges described above are measurements of the crystalline hydrochloride salt of the compound of formula (I). VII. Synthesis methods

[00481] Compounds of formula (I'), or a pharmaceutically acceptable salt or solvate thereof, may be prepared using solid-phase peptide synthesis or convergent liquid-phase synthesis. For example, the cyclic peptide molecule may be made in a liquid phase by coupling the cyclic portion to a linear portion in a liquid-phase reaction medium.

[00482] However, further processing is required to provide solid forms of the peptide inhibitors with the desired characteristics. Petition 870260065706, dated 03 / 07 / 2026, page 152 / 778 148 / 376 that provide improved handling, such as improved rheological (flow) properties, particle size and hygroscopicity, compared to peptide inhibitors for use as pharmaceutical ingredients. VIII. Pharmaceutical compositions

[00483] In general, the present invention relates to compositions and pharmaceutical forms of hydrochloride salts of interleukin-23 receptor peptide inhibitors (IL-23R), or solvates thereof, to corresponding pharmaceutical compositions, methods and / or uses for the treatment of autoimmune inflammation, and related diseases and disorders, as defined herein.

[00484] Additionally, the present invention relates to compositions and pharmaceutical forms of crystalline salts of interleukin-23 receptor peptide inhibitors (IL-23R), or solvates thereof, to corresponding pharmaceutical compositions, methods and / or uses for the treatment of autoimmune inflammation, and related diseases and disorders, as defined herein.

[00485] In one aspect, the present invention relates to a pharmaceutical composition of a hydrochloride salt of a compound of formula (I): Ac-[Pen]*-NT-[W(7-Me)]-[Lys(Ac)]-[Pen]*-Phe[4-(2-aminoethoxy)]-[2Nal]-[THP]-EN-[3-Pal]-Sarc-NH2 (where ([Pen]*-[Pen]* form a disulfide bond); and which has the chemical structure shown below: Petition 870260065706, dated 03 / 07 / 2026, p. 153 / 778 149 / 376 a corresponding solvato of his.

[00486] In some embodiments, the monocyclic peptide comprises an amino acid sequence of Ac-[Pen]-NT-[W(7Me)]-[Lys(Ac)]-[Pen]-[Phe(4-(2-aminoethoxy))]-[2-Nal]-[THP]-EN-[3Pal][Sarc]-NH2, wherein the monocyclic peptide is cyclized via a Pen-Pen disulfide bond; or a pharmaceutically acceptable salt thereof. In any of the aforementioned embodiments, one or more amino acids are in the L configuration. In certain embodiments, all amino acids are in the L configuration.

[00487] In some embodiments, the crystalline form of a compound of formula (I), or solvate thereof, has a moisture content in the range of about 0.1% to about 20%, 0.5% to about 15%, about 1% to about 10%, about 1% to about 5%, about 1% to about 4%, about 1% to about 3%, about 0.1% to about 5%, about 0.1% to about 4% or about 0.1% to about 3% by weight. In some embodiments, the crystalline form of a compound of formula (I), or solvate thereof, has a moisture content level of about 0.1%, 0.5%, 1%, 1.5%, 2%, 2.7%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 7%, 8%, 9% or Petition 870260065706, dated 03 / 07 / 2026, p. 154 / 778 150 / 376 % by weight. In some embodiments, the crystalline form of a compound of formula (I), or solvate thereof, has a moisture content level greater than about 0.1 %, 0.5 %, 1 %, 1.5 %, 2 %, 2.7 %, 3 %, 3.5 %, 4 %, 4.5 %, 5 % or 5.5 % by weight. In some embodiments, the crystalline form of a compound of formula (I), or solvate thereof, has a moisture content level less than about 1%, 1.5%, 2%, 2.7%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 7%, 8%, 9% or 10% by weight.

[00488] In some embodiments, the amount of a crystalline form of a compound of formula (I), or solvate thereof, in the composition is in the range of about 0.1% to about 65%, about 0.1% to about 60%, about 0.1% to about 55%, about 0.1% to about 50%, about 0.1% to about 45%, about 0.1% to about 40%, about 0.1% to about 35%, about 0.1% to about 30%, about 0.1% to about 25%, about 0.1% to about 20%, about 0.1% to about 15%, about 0.1% to about 10% or about 0.1% to approximately 5% by weight.In some embodiments, the amount of a crystalline form of a compound of formula (I), or solvate thereof, in the composition is in the range of about 1% to about 65%, about 1% to about 60%, about 1% to about 55%, about 1% to about 50%, about 1% to about 45%, about 1% to about 40%, about 1% to about 35%, about 1% to about 30%, about 1% to about 25%, about 1% to about 20%, about 1% to about 15%, about 1% to about 10% or about 1% to about 5% by weight. In some embodiments, the amount of a crystalline form of a compound of formula (I), or solvate thereof, in the composition is in the range of about 2% to about 65%, about 2% to about 60%, about 2% to about 55%, about 2% to about 50%, about 2% to about 45%, about 2% to about 40%. Petition 870260065706, dated 03 / 07 / 2026, p. 155 / 778 151 / 376 about 2% to about 35%, about 2% to about 30%, about 2% to about 25%, about 2% to about 20%, about 2% to about 15%, about 2% to about 10% or about 2% to about 5% by weight. In some embodiments, the amount of a crystalline form of a compound of formula (I), or solvate thereof, in the composition is in the range of about 5% to about 65%, about 5% to about 60%, about 5% to about 55%, about 5% to about 50%, about 5% to about 45%, about 5% to about 40%, about 5% to about 35%, about 5% to about 30%, about 5% to about 25%, about 5% to about 20%, about 5% to about 15% or about 5% to about 10% by weight. In some embodiments, the amount of a crystalline form of a compound of formula (I), or solvate thereof, in the composition is in the range of about 1%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60% or 65% by weight.

[00489] In another aspect, the hydrochloride salt of a compound of formula (I), or corresponding solvate thereof, may be present in any form, as a hydrate or another solvate.

[00490] In some respects, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be provided in crystalline form, in amorphous form, or in semicrystalline form. In some respects, the hydrochloride salt of a compound of formula (I), or solvate thereof, is a crystalline form.

[00491] In some respects, the hydrochloride salt of a compound of formula (I), or solvate thereof, is an amorphous form. In some respects, the hydrochloride salt of a compound of formula (I), or solvate thereof, is a semicrystalline form.

[00492] In one aspect, the composition of a hydrochloride salt of a compound of formula (I), or solvate thereof, is a salt of Petition 870260065706, dated 03 / 07 / 2026, p. 156 / 778 152 / 376 hemihydrochloride. In some respects, the hemihydrochloride salt has from about 0.1 to about 0.9, as from about 0.2 to about 0.8 or from about 0.3 to about 0.7, molar equivalents of hydrogen chloride compared to the compound of formula (I). In some respects, the hemihydrochloride salt has about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8 or about 0.9 molar equivalents of hydrogen chloride compared to the compound of formula (I). In some respects, the hemihydrochloride salt has about 0.5 molar equivalents of hydrogen chloride compared to the compound of formula (I).

[00493] In some aspects, the hydrochloride salt form of a compound of formula (I), or solvate thereof, may be a hydrate. In some aspects, the hydrate of the hydrochloride salt of a compound of formula (I) has from about 0.2 to about 100 molar equivalents of water compared to the compound of formula (I). In another aspect, the hydrate may be present in a range of about 2% w / w to about 10% w / w of water compared to the hydrochloride salt of the compound of formula (I). The present invention relates to hydrochloride salt compositions of the present invention, which may be in a liquid or solid composition.

[00494] In some embodiments, the hydrochloride salt form of a compound of formula (I), or solvate thereof, has a moisture content in the range of about 0.1% to about 20%, 0.5% to about 15%, about 1% to about 10%, about 1% to about 5%, about 1% to about 4%, about 1% to about 3%, about 0.1% to about 5%, about 0.1% to about 4% or about 0.1% to about 3% by weight. In some embodiments, the hydrochloride salt form of a compound of formula (I), or solvate thereof, has a moisture content level of about 0.1%, 0.5%, 1%, 1.5%, 2%, 2.7%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 7%, 8%, 9% Petition 870260065706, dated 03 / 07 / 2026, p. 157 / 778 153 / 376 or 10% by weight. In some embodiments, the hydrochloride salt form of a compound of formula (I), or solvate thereof, has a moisture content level greater than about 0.1%, 0.5%, 1%, 1.5%, 2%, 2.7%, 3%, 3.5%, 4%, 4.5%, 5% or 5.5% by weight. In some embodiments, the hydrochloride salt form of a compound of formula (I), or solvate thereof, has a moisture content level less than about 1%, 1.5%, 2%, 2.7%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 7%, 8%, 9% or 10% by weight.

[00495] The hydrochloride salt compositions of the present invention can be administered to an individual or patient by any means in accordance with therapeutic administration, which achieves the intended purpose or pharmaceutical efficacy. Examples include administration by oral, parenteral, subcutaneous, intravenous, intramuscular, intraperitoneal, transdermal, topical, buccal, or ocular routes. In some respects, the administration of the hydrochloride salt composition of the present invention is adapted for oral administration.

[00496] In another aspect, the present invention provides a composition comprising a hydrochloride salt of a compound of formula (I), or a solvate thereof, in an amount of about 0.1% to about 15% (w / w) of the composition and one or more pharmaceutically acceptable excipients.

[00497] In another aspect, the present invention provides a composition comprising: a hydrochloride salt of a compound of formula (I), or a solvate thereof; and an aqueous phosphate-buffered solution of about 50 mM at pH 7.4.

[00498] In another aspect, the present invention relates to a composition comprising a hydrochloride salt of a compound of formula (I), or solvate thereof, in an amount of about 0.1% to about 15% (w / w) of the composition; an absorption enhancer in an amount of about 10% to about 60% (w / w); Petition 870260065706, dated 03 / 07 / 2026, p. 158 / 778 154 / 376 and one or more pharmaceutically acceptable excipients.

[00499] In some embodiments, the amount of hydrochloride salt of a compound of formula (I), or solvate thereof, in the composition is in the range of about 0.1% to about 65%, about 0.1% to about 60%, about 50%, about 40%, about 30%, about 20%, about 0.1% to about 55%, to about 45%, to about 35%, to about 25%, to about 15%, about 0.1% to about 0.1% to about 0.1% to about 0.1% to about 0.1% to about 10% or approximately 0.1% to approximately 5% by weight.In some embodiments, the amount of hydrochloride salt of a compound of formula (I), or solvate thereof, in the composition is in the range of about 1% to about 65%, about 1% to about 60%, about 1% to about 55%, about 1% to about 50%, about 1% to about 45%, about 1% to about 40%, about 1% to about 35%, about 1% to about 30%, about 1% to about 25%, about 1% to about 20%, about 1% to about 15%, about 1% to about 10% or about 1% to about 5% by weight.In some embodiments, the amount of hydrochloride salt of a compound of formula (I), or solvate thereof, in the composition is in the range of about 2% to about 65%, about 2% to about 60%, about 2% to about 55%, about 2% to about 50%, about 2% to about 45%, about 2% to about 40%, about 2% to about 35%, about 2% to about 30%, about 2% to about 25%, about 2% to about 20%, about 2% to about 15%, about 2% to about 10% or about 2% to about 5% by weight. In some embodiments, the amount of hydrochloride salt of a compound of formula (I), or solvate thereof, in the composition is in the range of about 5% to about 65%, about 5% to about 60%, about 5% to about 55%, about 5% to. Petition 870260065706, dated 03 / 07 / 2026, p. 159 / 778 155 / 376 about 50%, about 5% to about 45%, about 5% to about 40%, about 5% to about 35%, about 5% to about 30%, about 5% to about 25%, about 5% to about 20%, about 5% to about 15% or about 5% to about 10% by weight. In some embodiments, the amount of hydrochloride salt of a compound of formula (I), or solvate thereof, in the composition is in the range of about 1%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60% or 65% by weight.

[00500] In another aspect, the present invention provides a composition comprising a hydrochloride salt of a compound of formula (I), or solvate thereof, in an amount of about 0.1% to about 15% (w / w) of the composition, sodium caprate in an amount of about 20% to about 45% (w / w) of the composition and microcrystalline cellulose.

[00501] In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in any amount from about 0.1% to about 15% (w / w) of the composition. For example, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 0.5% to about 15% (w / w), or from about 1% to about 10%, or from about 0.5% to about 5%, or from about 0.5% to about 3%, or from about 1% to about 3%, or from about 1.5% to about 2.5% or from about 1.5% to about 2.0% (w / w) of the composition. In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, is present in an amount of about 1% to about 5% (w / w).

[00502] In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 1 to about 5% (w / w). For example, the hydrochloride salt of a compound of formula (I), or solvate thereof, may Petition 870260065706, dated 03 / 07 / 2026, p. 160 / 778 156 / 376 being present in amounts including about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14% or about 15% (w / w) of the composition, and any intermediate fractional amount. In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 1.8% (w / w).

[00503] In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in any amount, such as from about 1 mg to about 1000 mg, from about 1 mg to about 500 mg, from about 1 mg to about 100 mg, from about 10 mg to about 50 mg, from about 20 mg to about 40 mg, or from about 20 mg to about 30 mg. In another aspect, the amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be from about 1 mg to about 1000 mg. In another aspect, the amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be from about 5 mg to about 300 mg. In another aspect, the amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, is from about 25 mg to about 150 mg. In another aspect, the amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be from about 25 mg to about 100 mg.In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 1 mg to about 100 mg. In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 20 mg to about 40 mg. In another aspect, the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 20 mg to about 30 mg.

[00504] In yet another aspect, the hydrochloride salt of a Petition 870260065706, dated 03 / 07 / 2026, p. 161 / 778 157 / 376 compound of formula (I), or solvate thereof, may be present in an amount of about 5 mg, about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg or about 150 mg, including any intermediate amounts and fractions thereof. In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in about 5 mg. In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in about 10 mg. In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in about 25 mg. In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or solvate thereof, may be present in about 50 mg.In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or its solvate, may be present in about 75 mg. In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or its solvate, may be present in about 100 mg. In another aspect, an amount of the hydrochloride salt of a compound of formula (I), or its solvate, may be present in about 150 mg.

[00505] In another aspect, the amount of the crystalline form of a pharmaceutically acceptable salt of a compound of formula (I), or solvate thereof, may be present in an amount of about 5 mg, about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, about 1000 mg, about 1100 mg, about 1200 mg, about 1300 mg or about 1400 mg, including any intermediate amounts and fractions thereof. Petition 870260065706, dated 03 / 07 / 2026, p. 162 / 778 158 / 376

[00506] In general, the pharmaceutical compositions of the present invention can be formed in different dosage forms prepared using conventional materials and techniques known in the pharmaceutical and formulating arts, which may include, but are not limited to, techniques such as mixing, blending and the like, as presented throughout this disclosure. Furthermore, the pharmaceutical composition used to form dosage forms may also include, but is not limited to, suitable adjuvants, carriers, excipients or stabilizers, etc., and may be in solid or liquid form, such as solid or liquid dosage forms, which may include, but are not limited to, tablets, capsules, powders, solutions, suspensions or emulsions and the like, etc. According to the present invention, solid unit dosage forms may be other conventional types known in the art.

[00507] Suitable compositions of the present invention may be in different forms, including, but not limited to, a liquid, a tablet, a capsule, etc. and the like. In some respects, the composition may be a tablet composition or a capsule composition.

[00508] In addition, suitable for use in the present invention are solutions which may include, but are not limited to, aqueous solutions, saline solutions, aqueous solutions of dextrose and related sugars, and glycols such as propylene glycol or polyethylene glycol, buffered solutions and the like, etc., are preferred liquid carriers, particularly for injectable solutions. Under normal storage and use conditions, these preparations contain a preservative to prevent the growth of microorganisms.

[00509] The compositions of the present invention may include a variety of other pharmaceutically acceptable components or excipients, such as, including but not limited to, an agent of Petition 870260065706, dated 03 / 07 / 2026, page 163 / 778 159 / 376 fluidity, a lubricant, a disintegrant, a binder, a desiccant, a filler and other components or excipients, and the like. These components are described herein.

[00510] According to the present invention, the compositions described herein may include at least one filler. In some respects, a composition of the present invention may comprise a filler, including, but not limited to, one or more of alpha cellulose, beta cellulose, gamma cellulose, starch, modified starch, sorbitol, mannitol, lactose, dextrose, sucrose, dibasic calcium phosphate, tribasic calcium phosphate, or calcium carbonate and the like. In some respects, a composition of the present invention may include mannitol. In some respects, a composition of the present invention may include sorbitol.

[00511] Representative fillers for use in the compositions of the present invention may include, but are not limited to, starch, lactitol, lactose, an inorganic calcium salt, microcrystalline cellulose, sucrose, combinations thereof, and the like. Additional fillers or diluents for use in the compositions of the present invention may include, but are not limited to, fillers or diluents conventionally known in the art, i.e., those typically used in the formulation of pharmaceutical compounds. Examples of such fillers or diluents for use according to the present invention may include, but are not limited to, sugars such as lactose, dextrose, glucose, sucrose, cellulose, starches and carbohydrate derivatives, polysaccharides (including dextrates and maltodextrin), polyols (including mannitol, xylitol, and sorbitol), cyclodextrins, calcium carbonates, magnesium carbonates, microcrystalline cellulose, combinations thereof, and the like.In some respects, such fillers or diluents suitable for use in the present invention may include, but are not limited to, lactose, microcrystalline cellulose, combinations thereof, and... Petition 870260065706, dated 03 / 07 / 2026, p. 164 / 778 160 / 376 similar.

[00512] Furthermore, in another aspect, a filler for use in the present invention may be present in an amount of about 1% to about 99% (w / w) of the composition, or from about 1% to about 50%, or from about 1% to about 25%, or from about 1% to about 20%, or from about 1% to about 10%, or from 2% to about 8%, or from about 3% to about 5% (w / w) of a composition described herein. Furthermore, such filler may also be present in an amount of about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or about 10% (w / w) of the composition, which may include any intermediate fractional amount as defined.

[00513] In some embodiments, the filler is present in an amount of about 10% to about 95% (w / w) of the composition, as defined in this descriptive report. In some embodiments, the filler is present in an amount of about 25% to about 95% (w / w) of the composition, as defined in this descriptive report. In some embodiments, the filler is present in an amount of about 30% to about 90% (w / w) of the composition, as defined in this descriptive report. In some embodiments, the filler is present in an amount of about 10% to about 50% (w / w) of the composition, as defined in this descriptive report. In some embodiments, the filler is present in an amount of about 10% to about 40% (w / w) of the composition, as defined in this descriptive report.In some embodiments, the filler is present in an amount of about 10% to about 30% (w / w) of the composition, as defined in this descriptive report. In some embodiments, the filler is present in an amount of about 10% to about 20% (w / w) of the composition, as defined in this descriptive report. Petition 870260065706, dated 03 / 07 / 2026, p. 165 / 778 161 / 376 present descriptive report. In certain embodiments, the load is present in an amount of approximately 10% to approximately 15% (w / w). In certain embodiments, the load is present in an amount of approximately 12% (w / w).

[00514] In some aspects, the composition may additionally include microcrystalline cellulose. Several types of microcrystalline cellulose may be suitable for use in the compositions described herein, for example, microcrystalline cellulose may be selected from, but not limited to, MICROCEL® or AVICEL® types: PH101, PH102, PH103, PH105, PH112, PH113, PH200, PH301, and similar types, and other types of microcrystalline cellulose, such as silicified microcrystalline cellulose. In one aspect, a composition for use in the present invention may include microcrystalline cellulose (AVICEL PH102). In another aspect, a composition suitable for use in the present invention may include microcrystalline cellulose (AVICEL PH101).

[00515] In another aspect, microcrystalline cellulose may be present in an amount of about 1% to about 99% (w / w) of the composition, or about 1% to about 50%, or about 1% to about 25%, or about 1% to about 20%, or about 1% to about 10%, or 2% to about 8%, or about 3% to about 5% (w / w) of a composition described herein. In some aspects, microcrystalline cellulose may also be present in an amount of about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or about 10% (w / w) of the composition, which may include any intermediate fractional amount, as defined. In some aspects, microcrystalline cellulose may also be present in an amount of about 3% to about 5% (w / w) of a composition.

[00516] In some respects, the composition may additionally include silicified microcrystalline cellulose. In some Petition 870260065706, dated 03 / 07 / 2026, p. 166 / 778 162 / 376 aspects, the silicified microcrystalline cellulose may be, but is not limited to, SMCC 50, SMCC 50LD, SMCC 90, SMCC HD90 or SMCC 90LM and the like. In some aspects, the silicified microcrystalline cellulose may be SMCC 50, SMCC 50LD, SMCC 90, SMCC HD90 or SMCC 90LM. Without adhering to the theory, it is understood that the silicified microcrystalline cellulose protects an enteric coating against premature erosion by a sodium caprate present in the composition. Silicified microcrystalline cellulose may be present in any amount suitable for use in the present invention. For example, SMCC may be present in an amount of about 1 to about 99% (w / w) of the composition, or about 10% to about 50%, or about 20% to about 50%, or about 25% to about 45%, or about 30% to about 40%, or about 35% to about 37% (w / w) of the composition.In some aspects, the amount of silicified microcrystalline cellulose is about 30% to about 70% (w / w) of the composition. In some aspects, the amount of silicified microcrystalline cellulose is about 65% to about 85% (w / w) of the composition. In some aspects, the amount of silicified microcrystalline cellulose is about 66.5% to about 81.3% (w / w) of the composition. In some aspects, the amount of silicified microcrystalline cellulose is about 31.3%, about 36.6%, about 37.7%, about 50.9%, about 52%, about 65.2%, about 71.5%, about 79% or about 80.5% of the composition. SMCC may be present in an amount of approximately 30% (w / w) of the composition, or approximately 31%, 32%, 33%, 34%, 35%, 36%, 36.1%, 36.2%, 36.3%, 36.4%, 36.5%, 36.6%, 36.7%, 36.8%, 36.9%, 37%, 38%, 39% or approximately 40% (w / w) of the composition.

[00517] In some modalities, SMCC is present in an amount of about 20% to about 90% (p / p), which includes, but Petition 870260065706, dated 03 / 07 / 2026, p. 167 / 778 163 / 376 is not limited to any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 25% to about 85% (w / w), which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 25% to about 45% (w / w), which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 30% to about 40% (w / w), which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 65% to about 90% (w / w), which includes, but is not limited to, any intermediate fractional amount. In some forms, SMCC is present in an amount of approximately 70% to approximately 85% (w / w), which includes, but is not limited to, any intermediate fractional amounts.In some embodiments, SMCC is present in an amount of about 70% to about 75% (w / w), which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 80% to about 85% (w / w), which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 30%. In some embodiments, SMCC is present in an amount of about 40%, which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 50%, which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 60%, which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in... Petition 870260065706, dated 03 / 07 / 2026, page 168 / 778 164 / 376 an amount of about 70%, which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 80%, which includes, but is not limited to, any intermediate fractional amount. In some embodiments, SMCC is present in an amount of about 90%, which includes, but is not limited to, any intermediate fractional amount.

[00518] In some embodiments, SMCC is a mixture of microcrystalline cellulose and colloidal silicon dioxide.

[00519] In some aspects, the composition may additionally include one or more of the following: alpha cellulose, beta cellulose, gamma cellulose, starch, modified starch, sorbitol, mannitol, lactose, dextrose, sucrose, dibasic calcium phosphate, tribasic calcium phosphate, or calcium carbonate. In some aspects, the composition may additionally include mannitol.

[00520] In some aspects, a composition of the present invention may include sorbitol. For example, for use in the present invention, sorbitol may be present in an amount of about 1% to about 99% (w / w) of the composition, or about 1% to about 50%, or about 1% to about 25%, or about 5% to about 25%, or about 5% to about 20%, or about 5% to about 15%, or about 8% to about 12% (w / w) of the composition. In another aspect, sorbitol may be present in an amount of about 5% (w / w) of the composition, or about 6%, 7%, 8%, 9%, 10%, 10.1%, 10.2%, 10.3%, 10.4%, 10.5%, 10.6%, 10.7%, 10.8%, 10.9%, 11%, 12%, 13%, 14% or about 15% (w / w) of the composition. In some aspects, the composition also includes sorbitol in an amount of about 5% to about 15% (w / w) of the composition. In some aspects, the amount of sorbitol is about 10% to about 15% (w / w) of the composition. In some Petition 870260065706, dated 03 / 07 / 2026, page 169 / 778 165 / 376 aspects, the composition includes sorbitol in an amount of approximately 10.7% (w / w) of the composition.

[00521] In some embodiments, a composition of the present invention may include mannitol. For example, for use in the present invention, mannitol may be present in an amount of about 1% to about 99% (w / w) of the composition, or about 1% to about 50%, or about 1% to about 25%, or about 5% to about 25%, or about 5% to about 20%, or about 5% to about 15%, or about 8% to about 12% (w / w) of the composition. In another embodiment, mannitol may be present in an amount of about 5% (w / w) of the composition, or about 6%, 7%, 8%, 9%, 10%, 10.1%, 10.2%, 10.3%, 10.4%, 10.5%, 10.6%, 10.7%, 10.8%, 10.9%, 11%, 12%, 13%, 14%, or about 15% (w / w) of the composition, which includes, but is not limited to, any intermediate fractional amounts. In some embodiments, the composition also includes mannitol in an amount of about 5% to about 15% (w / w) of the composition.In some embodiments, the amount of mannitol is about 10% to about 15% (w / w) of the composition. In some embodiments, the composition includes mannitol in an amount of about 10.7% (w / w) of the composition.

[00522] In one embodiment, the amount of sugar alcohol may be present in the range of about 1% to about 50% (w / w) of the composition, or from about 5% to about 50%, or from about 5% to about 30%, or from about 10% to about 30% (w / w) of the composition. In some aspects, the amount of sugar alcohol may be present in an amount of about 1%, 2.5%, 5%, 7.5%, 10%, 12.5%, 15%, 17.5% or about 20% (w / w) of the composition. In some respects, the amount of sugar alcohol present may be greater than approximately 1%, 2.5%, 5%, 7.5%, 10%, 12.5%, 15%, 17.5%, or approximately 20% (w / w) of the Petition 870260065706, dated 03 / 07 / 2026, p. 170 / 778 166 / 376 composition. In some embodiments, the amount of sugar alcohol may be present in an amount less than about 5%, 7.5%, 10%, 12.5%, 15%, 17.5% or about 20% (w / w) of the composition.

[00523] In some embodiments, the pharmaceutical composition described herein does not include a sugar alcohol. In some embodiments, the pharmaceutical composition described herein does not include sorbitol. In some embodiments, the pharmaceutical composition described herein does not include mannitol.

[00524] The composition of the invention may include, but is not limited to, at least one disintegrant in a therapeutically effective amount for use, as determined according to the present invention. Representative disintegrants for use in the present invention include, but are not limited to, starches, clays, celluloses, alginates and gums, and crosslinked starches, celluloses and polymers, combinations thereof and the like. Additional representative disintegrants for use in the present invention may include, but are not limited to, microcrystalline cellulose, croscarmellose sodium, alginic acid, sodium alginate, crospovidone, cellulose, agar and related gums, sodium starch glycolate, corn starch, potato starch, sodium starch glycolate, Veegum HV, methylcellulose, agar, bentonite, carboxymethylcellulose, alginic acid, guar gum combinations thereof and the like.

[00525] In some respects, the disintegrant is a cross-linked carboxymethylcellulose (croscarmellose), a starch glycolate, a polyvinylpyrrolidone, a sago starch, plantago husk, a silicate, or a soy polysaccharide. In some respects, the disintegrant is croscarmellose sodium or crospovidone. In some respects, the disintegrants for use in the present invention may include, but are not limited to, croscarmellose sodium. In some respects, a disintegrant for use in the present invention may Petition 870260065706, dated 03 / 07 / 2026, page 171 / 778 167 / 376 include crospovidone. In some aspects, a disintegrant may be present in an amount of about 1% to about 99% (w / w) of a composition of the present invention, or from about 1% to 50%, or from about 1% to about 25%, or from about 1% to about 20%, or from about 1% to about 10%, or from about 2% to about 8%, or from about 4% to about 6% (w / w) of the composition. The disintegrants for use in the present invention may also be present in an amount of about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11% or about 12% (w / w) of the composition, which includes, but is not limited to, any intermediate fractional amount. In some aspects, an amount of the disintegrant may be present from about 1% to about 10% (w / w) of a composition of the present invention. In some aspects, an amount of the disintegrant may be present from about 8% to about 12% (w / w) of a composition of the present invention.In some aspects, an amount of the disintegrant may be present from about 3% to about 8% (w / w) of a composition of the present invention.

[00526] In another aspect, a composition of the present invention may also include, but is not limited to, silica in any quantity for the purposes of the present invention. In particular, silica is exemplified by Aerosil 200 which has a specific surface area of ​​about 200 m2 / g. Alternatives to silica may include, but are not limited to, talc, sodium ferrocyanide, potassium ferrocyanide, calcium carbonate, magnesium carbonate, silicon dioxide, precipitated silica, sodium aluminosilicate, combinations thereof and the like.

[00527] In some aspects, a composition of the present invention may additionally comprise silica. In one aspect, silica may be present in the compositions of the present invention. Petition 870260065706, dated 03 / 07 / 2026, p. 172 / 778 168 / 376 invention in an amount of about 0.1% to about 10% (w / w) of the composition, or about 0.1% to about 5%, or about 0.1% to about 2%, or about 0.1% to about 1.5%, or about 0.1% to about 1.25%, or about 0.5% to about 1.5%, or about 1.0% to about 1.25%, or about 0.1% to about 1%, or about 0.3% to about 0.7% (w / w) of the composition of the present invention. For example, the silica used in the present invention may be present in an amount of about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4% or about 1.5% (w / w) of the composition, including any intermediate fractional amounts, as defined. In another aspect, a composition of the present invention may additionally include an amount of silica of about 0.1% to about 1.5% (w / w) of the composition.In another aspect, a composition of the present invention may additionally include an amount of silica of about 0.5% to about 2% (w / w) of the composition. In another aspect, a composition of the present invention may additionally include an amount of silica of about 0.3% to about 0.7% (w / w) of the composition. In further aspects, a composition of the present invention may additionally include an amount of silica of about 0.5% (w / w) of the composition. In some aspects, the composition may additionally comprise silica in an amount of about 1% (w / w) of the composition. Examples of suitable silica materials include, but are not limited to, colloidal silicon dioxide, aerosol, colloidal silica, pyrogenic silica, pyrogenic silicon dioxide, colloidal anhydrous silica, colloidal silicon dioxide and the like. In some embodiments, the silica is colloidal silica.

[00528] The composition may also include a binder. Binders for use in the compositions of the present invention include Petition 870260065706, dated 03 / 07 / 2026, page 173 / 778 169 / 376 binders commonly used in the formulation of pharmaceutical products. Examples of binders for use in the present invention may include, but are not limited to, cellulose derivatives (including hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose and sodium carboxymethylcellulose), glycol, sucrose, dextrose, corn syrup, polysaccharides (including acacia, tragacanth, guar gum, alginates and starch), corn starch, pregelatinized starch, modified corn starch, gelatin, polyvinylpyrrolidone, polyethylene, polyethylene glycol, combinations thereof and the like.

[00529] In some embodiments, the binder is hydropropyl methylcellulose (HPMC). In some embodiments, the binders for use in the present invention may be present in an amount of about 0.25%, 0.5%, 0.75%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11% or about 12% (w / w) of the composition, which includes, but is not limited to, any intermediate fractional amount.

[00530] In the present invention, the composition may include a lubricant in any amount suitable for use, as described herein. Examples of lubricants suitable for use in the present invention may include, but are not limited to, magnesium carbonate, magnesium lauryl sulfate, calcium silicate, talc, pyrolyzed silicon dioxide, combinations thereof and the like. Other suitable and useful lubricants may include, but are not limited to, magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, polyethylene glycol, sodium lauryl sulfate, magnesium lauryl sulfate, sodium benzoate, colloidal silicon dioxide, magnesium oxide, microcrystalline cellulose, starches, mineral oil, waxes, glyceryl behenate, polyethylene glycol, sodium acetate, sodium chloride, combinations thereof and the like.

[00531] In some respects, the lubricant may include, but is not Petition 870260065706, dated 03 / 07 / 2026, page 174 / 778170 / 376 limits a, magnesium stearate. In one aspect, an amount of the lubricant may be present from about 0.1% to about 10% (w / w) of the composition, or from about 0.1% to about 5%, or from about 0.1% to about 2.5%, or from about 0.1% to about 1%, or from about 0.1% to about 0.5% (w / w) of the composition. In some aspects, an amount of the lubricant may be present from about 0.5% to about 2.5% or from about 0.5% to about 2.0% (w / w) of the composition. In some aspects, an amount of the lubricant may be present from about 0.1% to about 0.5% (w / w) of the composition. In some aspects, the amount of lubricant is about 0.3% to about 0.7% (w / w) of the composition. In some aspects, the amount of lubricant is about 0.5% (w / w) of the composition.The lubricant may also be present in an amount of approximately 0.10% (w / w) of the composition, or approximately 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, 0.20%, 0.21%, 0.22%, 0.23%, 0.24%, 0.25%, 0.26%, 0.27%, 0.28%, 0.29% or approximately 0.30% (w / w) of the composition. The lubricant may also be present in an amount of about 0.5% (w / w) of the composition, or about 0.75%, 1.0%, 1.25%, 1.5%, 1.75%, 2.0% or about 2.5% (w / w) of the composition. In some aspects, the lubricant may be present in an amount of about 0.25% (w / w).

[00532] In some respects, the composition includes: (i) the hydrochloride salt of the compound of formula (I), or solvate thereof, in an amount of about 0.2% to about 15% (w / w) of the composition; (ii) a silicified microcrystalline cellulose in an amount of about 66.5% to about 81.3% (w / w) of the composition; (iii) sorbitol in an amount of about 12.5% ​​(w / w) of the composition; (iv) a disintegrant in an amount of about 5% (w / w) of the composition; (v) silica in an amount of about 0.5% Petition 870260065706, dated 03 / 07 / 2026, pp. 175 / 778 171 / 376 (w / w) of the composition; and (vi) a lubricant in an amount of about 0.5% (w / w) of the composition.

[00533] In some embodiments, the pharmaceutical composition includes: (i) the crystalline form of the pharmaceutically acceptable salt of the compound of formula (I), or a solvate thereof, in an amount of about 0.1% to about 60% (w / w) of the composition; (ii) a silicified microcrystalline cellulose in an amount of about 40% to about 85% (w / w) of the composition; (iii) a disintegrant in an amount of about 5% to about 10% (w / w) of the composition; (iv) silica in an amount of about 0.1% to about 1.0% (w / w) of the composition; and (v) a lubricant in an amount of about 0.5% to about 1.5% (w / w) of the composition.

[00534] In some embodiments, the pharmaceutical composition includes: (i) the crystalline form of the pharmaceutically acceptable salt of the compound of formula (I), or a solvate thereof, in an amount of about 10% to about 20% (w / w) of the composition; (ii) silicified microcrystalline cellulose in an amount of about 85% (w / w) of the composition; (iii) crospovidone in an amount of about 5% (w / w) of the composition; (iv) silica in an amount of about 0.2% (w / w) of the composition; and (v) magnesium stearate in an amount of about 0.5% of the composition.

[00535] In some embodiments, the pharmaceutical composition includes: (i) an absorption enhancer in an amount of about 5% to about 65% (w / w) of the composition; (ii) the crystalline form of the pharmaceutically acceptable salt of the compound of formula (I), or a solvate thereof, in an amount of about 0.1% to about 15% (w / w) of the composition; and (iii) a silicified microcrystalline cellulose in an amount of about 10% to about 50% (w / w) of the composition. Petition 870260065706, dated 03 / 07 / 2026, pp. 176 / 778 172 / 376

[00536] In some embodiments, the pharmaceutical composition includes: (i) an absorption enhancer in an amount of about 30% to about 45% (w / w) of the composition; (ii) a disintegrant in an amount of about 5% to about 10% (w / w) of the composition; and (iii) the crystalline form of the pharmaceutically acceptable salt of the compound of formula (I), or a solvate thereof, in an amount of about 0.5% to about 15% (w / w) of the composition; (iv) a silicified microcrystalline cellulose in an amount of about 30% to about 40% (w / w) of the composition; (v) a silica in an amount of about 0.2% to about 1.5% (w / w) of the composition; (vi) a disintegrant in an amount of about 5% to about 10% (w / w) of the composition; (vii) a filler in an amount of about 7.5% to about 15% (w / w) of the composition; and (viii) a lubricant in an amount of about 0.2% to about 1.5% (w / w) of the composition.

[00537] In some embodiments, the pharmaceutical composition includes: (i) a crystalline form of a pharmaceutically acceptable salt of a compound of formula (I), or a solvate thereof, in an amount of about 10% to about 20% (w / w) of the composition; (ii) an absorption enhancer in an amount of about 30% to about 45% (w / w) of the composition; (iii) a disintegrant in an amount of about 0.5% to about 1.0% (w / w) of the composition; (iv) crospovidone in an amount of about 5% (w / w) of the composition; (vi) microcrystalline cellulose in an amount of about 1.3% (w / w) of the composition; (vii) a silicified microcrystalline cellulose in an amount of about 34.8% to about 39.7% (w / w) of the composition; (viii) mannitol in an amount of about 10.7% (w / w) of the composition; (ix) crospovidone in an amount of about 5% (w / w) of the composition; (x) silica in an amount of about 1.0% (w / w) of the composition; and (xi) magnesium stearate Petition 870260065706, dated 03 / 07 / 2026, pp. 177 / 778 173 / 376 in an amount of approximately 0.5% (w / w) of the composition.

[00538] In some embodiments, the pharmaceutical composition includes: (i) sodium caprate in an amount of about 38.5% (w / w) of the composition; (ii) hydroxypropylmethylcellulose in an amount of about 0.8% (w / w) of the composition; (iii) the crystalline form of the pharmaceutically acceptable salt of the compound of formula (I), or a solvate thereof, in an amount of about 3.9% (w / w) of the composition; (iv) silicified microcrystalline cellulose in an amount of about 39.7% (w / w) of the composition; (v) mannitol in an amount of about 10.7% (w / w) of the composition; (vi) crospovidone in an amount of about 5% to about 7.5% (w / w) of the composition; (vii) silica in an amount of about 0.5% to about 1.0% (w / w) of the composition;and (viii) magnesium stearate in an amount of about 0.5% (w / w) of the composition.

[00539] In some embodiments, the pharmaceutical composition includes: (i) a crystalline form of a pharmaceutically acceptable salt of a compound of formula (I), or a solvate thereof, in an amount of about 10% to about 20% (w / w) of the composition; (ii) an absorption enhancer in an amount of about 30% to about 45% (w / w) of the composition; (iii) a disintegrant in an amount of about 0.5% to about 1.0% (w / w) of the composition; (iv) crospovidone in an amount of about 5% (w / w) of the composition; (v) microcrystalline cellulose in an amount of about 1.3% (w / w) of the composition; (vi) silicified microcrystalline cellulose in an amount of about 34.8% to about 39.7% (w / w) of the composition; (vii) mannitol in an amount of about 10.7% (w / w) of the composition; (viii) crospovidone in an amount of about 5% (w / w) of the composition;(ix) silica in an amount of about 1.0% (w / w) of the composition; and (x) magnesium stearate in an amount of about 0.5% (w / w) of the composition. Petition 870260065706, dated 03 / 07 / 2026, pp. 178 / 778 174 / 376

[00540] In some respects, the composition includes: (i) the hydrochloride salt of the compound of formula (I), or solvate thereof, in an amount of about 1% (w / w) of the composition; (ii) a silicified microcrystalline cellulose in an amount of about 80.5% (w / w) of the composition; (iii) sorbitol in an amount of about 12.5% ​​(w / w) of the composition; (iv) crospovidone in an amount of about 5% (w / w) of the composition; (v) silica in an amount of about 0.5% (w / w) of the composition; and (vi) magnesium stearate in an amount of about 0.5% (w / w) of the composition.

[00541] In some respects, the composition includes: (i) the hydrochloride salt of the compound of formula (I), or solvate thereof, in an amount of about 2.5% (w / w) of the composition; (ii) a silicified microcrystalline cellulose in an amount of about 79% (w / w) of the composition; (iii) sorbitol in an amount of about 12.5% ​​(w / w) of the composition; (iv) crospovidone in an amount of about 5% (w / w) of the composition; (v) silica in an amount of about 0.5% (w / w) of the composition; and (vi) magnesium stearate in an amount of about 0.5% (w / w) of the composition.

[00542] In some respects, the composition includes: (i) the hydrochloride salt of the compound of formula (I), or solvate thereof, in an amount of about 10% (w / w) of the composition; (ii) a silicified microcrystalline cellulose in an amount of about 71.5% (w / w) of the composition; (iii) sorbitol in an amount of about 12.5% ​​(w / w) of the composition; (iv) crospovidone in an amount of about 5% (w / w) of the composition; (v) silica in an amount of about 0.5% (w / w) of the composition; and (vi) magnesium stearate in an amount of about 0.5% (w / w) of the composition. The tablet composition may also include one or more coatings.

[00543] The composition described here may include a variety of Petition 870260065706, dated 03 / 07 / 2026, p. 179 / 778 175 / 376 other pharmaceutically acceptable components or excipients, such as, including but not limited to, a flow agent, a lubricant, a disintegrant, a binder, a desiccant, a filler and other components or excipients, and the like.

[00544] The composition described herein may include at least one disintegrant in any suitable amount according to the present invention. Representative disintegrants for use in the present invention may include, but are not limited to, agar-agar, alginic acid, calcium carbonate, microcrystalline cellulose, croscarmellose sodium, crospovidone, polacrilin potassium, sodium starch glycolate, potato or tapioca starch, other starches, pregelatinized starch, clays, other algins, other celluloses, gums (such as gellan), low-substituted hydroxypropylcellulose or mixtures thereof, and the like. In one aspect, the disintegrant may include croscarmellose sodium. In one aspect, the disintegrant may include crospovidone.In another aspect, the suitable disintegrant may, but is not limited to, being present in an amount of about 1% (w / w), 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or about 10% (w / w) of the composition, including any intermediate fractional amounts, as defined in the present invention. In other aspects of the present invention, the disintegrant may, but is not limited to, being present in an amount of about 1% to about 10% (w / w) of the composition. In other aspects, the disintegrant may be present in an amount of about 5.0% (w / w) of the composition.

[00545] In some aspects, microcrystalline cellulose may be present in an amount of about 1% to about 10% (w / w) of the composition. In some aspects, microcrystalline cellulose may be present in an amount of about 3.9% (w / w) of the composition. Petition 870260065706, dated 03 / 07 / 2026, p. 180 / 778 176 / 376

[00546] In some aspects, the composition may additionally comprise silica. In some aspects, the composition may additionally comprise silica in an amount of about 0.1% to about 1.5% (w / w) of the composition. For example, silica may be present in an amount of about 0.1%, 0.2%, 0.25%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.75%, 0.8%, 0.9%, 1.0% or about 1.5% (w / w) of the composition, including any intermediate fractional amounts, as defined herein. In some aspects, the composition may additionally comprise silica in an amount of about 0.3% to about 0.7% (w / w) of the composition. In some aspects, the composition may additionally comprise silica in an amount of about 0.5% to about 2% (w / w) of the composition. In some aspects, the composition may additionally comprise silica in an amount of about 0.5% (w / w) of the composition.

[00547] In another aspect, the composition of the present invention may further comprise at least one of: a disintegrant in an amount of about 1% to about 10% (w / w) of the composition, microcrystalline cellulose in an amount of about 1% to about 10% (w / w) of the composition, hydrophilic silica in an amount of about 0.1% to about 1.5% (w / w) of the composition, or sorbitol in an amount of about 5% to about 15% (w / w) of the composition.

[00548] In yet another aspect, the composition may further comprise: a disintegrant in an amount of about 1% to about 10% (w / w) of the composition; microcrystalline cellulose in an amount of about 1% to about 10% (w / w) of the composition; silica in an amount of about 0.1% to about 1.5% (w / w) of the composition; and sorbitol in an amount of about 5% to about 15% (w / w) of the composition. Petition 870260065706, dated 03 / 07 / 2026, p. 181 / 778 177 / 376

[00549] In some respects, the compositions of the present invention may further comprise at least one of: microcrystalline cellulose in an amount of about 3.9% (w / w); sorbitol in an amount of about 10.7% (w / w); a disintegrant in an amount of about 5.0% (w / w); and silica in an amount of about 0.5% (w / w).

[00550] In some aspects, the compositions may further comprise: microcrystalline cellulose in an amount of about 3.9% (w / w); sorbitol in an amount of about 10.7% (w / w); a disintegrant in an amount of about 5.0% (w / w); and silica in an amount of about 0.5% (w / w).

[00551] In some respects, the compositions may additionally comprise: Avicel PH101 in an amount of about 3.9% (w / w); sorbitol in an amount of about 10.7% (w / w); croscarmellose sodium in an amount of about 5.0% (w / w); and Aerosil 200 in an amount of about 0.5% (w / w).

[00552] Microcrystalline cellulose may include any microcrystalline cellulose known in the art. In some respects, microcrystalline cellulose may comprise silicified microcrystalline cellulose (SMCC).

[00553] In some aspects, for use in the present invention, the microcrystalline cellulose may be silicified microcrystalline cellulose (SMCC) and may have any particle size. In some aspects, the composition includes silicified microcrystalline cellulose in an amount of about 25% to about 45% (w / w) of the composition. In some aspects, the composition includes silicified microcrystalline cellulose in an amount of about 36.6% (w / w) of the composition.

[00554] The composition may include at least one disintegrant in any suitable amount according to the present Petition 870260065706, dated 03 / 07 / 2026, page 182 / 778 178 / 376 invention. Representative disintegrants for use in the present inve...

Claims

1. Method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, having suitable rheological properties for manufacturing pharmaceutical compositions, characterized in that it comprises the following steps: (a) dissolving the monocyclic peptide compound, or salt or solvate thereof, in a first solvent; (b) adding a first portion of sodium chloride to the mixture obtained in step (a); (c) adding crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) adding a second portion of sodium chloride to the fluid paste obtained in step (c); (e) isolating a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (d) and removing the residual solvent.

2. Method for improving the rheological properties of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, characterized in that it comprises the following steps: (a) dissolving the monocyclic peptide compound, or salt or solvate thereof, in a first solvent; (b) adding a first portion of sodium chloride to the mixture obtained in step (a); (c) adding crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) adding a second portion of sodium chloride to the fluid paste obtained in step (c); (e) isolating a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture obtained in step (d) and removing the residual solvent.

3. Method according to claim 1 or 2, characterized in that: (i) step (a) is carried out at about 25 to about 55 °C; and / or (ii) the first solvent comprises an alkyl alcohol; and / or (iii) the first solvent comprises methanol; and / or (iv) the first solvent comprises methanol and H2O; and / or (v) the first solvent comprises an alkyl alcohol and H2O in a ratio of 9:1 to 5:5 by volume; and / or (vi) the concentration of the monocyclic peptide compound in the mixture obtained in step (a) is 10% to 25% w / v; and / or (vii) the first solvent comprises methanol and H2O in a ratio of 3:1 and 3:2 by volume; and / or (viii) step (a) is carried out at a pH between 5.0 and 6.5; and / or (ix) in step (a), the monocyclic peptide compound, or salt or solvate thereof, is an amorphous or partially amorphous form of the monocyclic peptide compound, or salt or solvate thereof; and / or (x) in step (b), sodium chloride is a 0.1 to 2 M aqueous solution of sodium chloride;and / or (xi) in step (b), 9 to 12 moles, 10 to 11.5 moles or 1.0 to 3.0 molar equivalents, based on the amount of monocyclic peptide compound in step (a), of NaCl are added; and / or (xii) in step (b), sodium chloride is added over a period of time of at least 10 minutes; and / or (xiii) the amount of seeds added is 0.005 to 0.1 molar equivalent based on the amount of monocyclic peptide compound in step (a); and / or (xiv) before step (c), the fluid paste is allowed to age for a period of at least 30 minutes, at a temperature of about 25 °C to about 55 °C; and / or (xv) in step (d), the sodium chloride is an aqueous solution of sodium chloride; and / or (xvi) in step (d), the sodium chloride is a 0.1 M to 2 M aqueous solution of sodium chloride;and / or (xvii) in step (d), at least 2.0 molar equivalents, at least about 3.0 molar equivalents, or at least 4.0 molar equivalents, based on the amount of monocyclic peptide compound in step (a), of NaCl are added; and / or (xviii) in step (d), sodium chloride is added over a period of at least 30 minutes; and / or (xix) the fluid paste obtained in step (d) is allowed to age for a period of at least 1 hour; and / or (xx) the fluid paste obtained in step (d) is allowed to age for a period of at least 1 hour at a temperature between about 25 °C and about 55 °C; and / or (xxi) in step (d), the fluid paste is cooled to a temperature between about 0 °C and about 10 °C; and / or (xxii) in step (d), the fluid paste is cooled to a temperature between about 0 °C and about 10 °C at a rate of less than 1 °C / min; and / or (xxiii) in step (e), the removal of residual solvent is by washing with a second solvent;and / or (xxiv) in step (e), the removal of residual solvent is by washing with a second solvent, wherein the second solvent comprises an alkyl alcohol; and / or Petition 870250070155, dated 06 / 08 / 2025, page 870 / 891 4 / 20 (xxv) in step (e), the removal of residual solvent is by washing with a second solvent, wherein the second solvent comprises 2-propanol; and / or (xxvi) in step (e), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried; and / or (xxvii) the crystalline monocyclic peptide compound obtained in step (f) is in the form of the hydrochloride salt; and / or (xxviii) the method further comprises preparing the monocyclic peptide compound by a Solid Phase Peptide Synthesis; and / or (xxix) the method further comprises preparing the monocyclic peptide compound by a Liquid Phase Peptide Synthesis; and / or (xxx) the amount of monocyclic peptide compound dissolved in step (a) is at least 10 kg.; 4. Method for preparing a crystalline form of a monocyclic peptide compound, or a pharmaceutically acceptable salt or solvate thereof, characterized in that it comprises the following steps: (i) dissolving the monocyclic peptide compound, or salt or solvate thereof, in a first solvent; (ii) adding a second solvent to the mixture obtained in step (i); (iii) optionally cooling the mixture obtained in step (ii); and (iv) isolating the crystalline monocyclic peptide compound, or salt thereof, from the mixture obtained from step (iii) and removing residual solvent.

5. Method according to claim 4, characterized in that: (i) step (i) is carried out at a temperature of about 25 °C to about 55 °C; and / or (ii) the first solvent comprises an alkyl alcohol; and / or (iii) the first solvent comprises methanol; and / or (iv) the first solvent comprises methanol and H2O; and / or (v) the concentration of the monocyclic peptide compound in the mixture obtained in step (i) is 5% w / v to 20% w / v; and / or (vi) the first solvent comprises methanol and H2O in a ratio of 9:1 to 5:5 by volume; and / or (vii) in step (ii), the second solvent is added over a period of at least 1 hour; and / or (viii) in step (ii), the ratio of the first solvent to the second solvent is 3:1 to 1:3 by volume; and / or (ix) the second solvent comprises H2O; and / or (x) in step (iii), the mixture obtained in step (ii) is cooled to a temperature between about 0 °C and about 10 °C;and / or (xi) in step (iii), the mixture obtained in step (ii) is cooled to a temperature between about 0 °C and about 10 °C at a rate of less than 1 °C / min; and / or (xii) before step (iii) and after the addition of the second solvent, the temperature of the mixture is maintained for a period of time of at least 1 hour; and / or (xiii) after step (iii), the temperature is maintained for a period of time of at least 30 minutes; and / or (xiv) after step (iii), the mixture is heated to a temperature of about 25 to about 55 °C and then cooled to a temperature between about 0 °C and about 10 °C; and / or (xv) in step (iv), the removal of residual solvent is by washing with a third solvent, wherein the third solvent comprises an alkyl alcohol; and / or (xvi) in step (iv), the removal of residual solvent is by Petition 870250070155, dated 06 / 08 / 2025, p. 872 / 891 6 / 20 washing with a third solvent, where the third solvent comprises 2-propanol;and / or (xvii) in step (iv), the crystalline monocyclic peptide compound is isolated by filtration; and / or (xviii) in step (iv), the crystalline monocyclic peptide compound is washed with a solvent, optionally wherein the solvent is alkyl alcohol or water, preferably wherein the crystalline monocyclic peptide compound is isolated and dried, optionally wherein the crystalline monocyclic peptide compound is dried with a dynamic drying step, wherein the dynamic drying step comprises agitating the crystalline monocyclic peptide compound, further optionally wherein the dynamic drying step further comprises heating, exposure to vacuum or exposure to nitrogen gas; and / or (xix) in step (iv), the crystalline monocyclic peptide compound is isolated by filtration and then washed and dried at a temperature below 20 °C under vacuum; and / or (xx) the monocyclic peptide compound is in the form of the hydrochloride salt.

6. Method according to any one of claims 1 to 3, characterized in that: (i) seeds of crystalline monocyclic peptide compound are obtained by the method as defined in claim 4 or 5; and / or (ii) the method further comprises the following steps: (f) dissolving the hydrochloride salt obtained in step (e) in aqueous hydrochloric acid; (g) adding a buffer solution to the mixture obtained in step (f) over a period of at least 10 hours;(e) and (h) isolating a crystalline monocyclic peptide compound Petition 870250070155, dated 06 / 08 / 2025, page 873 / 891 7 / 20 in the form of the free base from the mixture obtained in step (g), optionally wherein, in step (f), the amount of hydrochloric acid added is 1 to 2 molar equivalents, further optionally wherein the buffer solution is a phosphate buffer having a pH between pH 7 and pH 9, further optionally wherein the method further comprises: (i) dissolving the crystalline free base of the monocyclic peptide compound in a second solvent; (j) adding a solution comprising a counterion to the mixture obtained in step (i); (k) adding an antisolvent; (l) isolating the crystalline salt of the monocyclic peptide compound from the mixture obtained from step (k), preferably wherein: (a) the second solvent comprises methanol and / or water; and / or (b) the antisolvent is selected from the group consisting of tert-butyl methyl ether (TBME), acetonitrile and isopropanol (IPA);and / or (c) the solution comprising a contraion is a solution comprising a contraion selected from the group consisting of fumarate, glutarate, glycolate, mesylate, sulfate and citrate.; 7. Method according to any one of claims 1 to 6, characterized in that: (i) the monocyclic peptide compound is an inhibitor of the interleukin-23 receptor (IL-23R); and / or (ii) the method further comprises passing the isolated crystalline monocyclic peptide through a suitable sieve; and / or (iii) the crystalline monocyclic peptide compound is isolated and then dried with a dynamic drying step, wherein the dynamic drying step comprises agitating the crystalline monocyclic peptide compound, optionally wherein the dynamic drying step further comprises heating, exposure to vacuum or exposure to nitrogen gas; and / or Petition 870250070155, dated 06 / 08 / 2025, p.874 / 891 8 / 20 (iv) the crystalline monocyclic peptide compound is a crystalline solid distinguished by a Dv10 in the range of about 1 μm to 30 μm; about 2 μm to 20 μm; or about 3 μm to 10 μm; and / or (v) the crystalline monocyclic peptide compound is a crystalline solid distinguished by a Dv50 in the range of about 3 μm to 80 μm; about 5 μm to 60 μm; or about 10 μm to 40 μm; and / or (vi) the crystalline monocyclic peptide compound is a crystalline solid distinguished by a Dv90 in the range of about 10 μm to 110 μm; about 20 μm to 100 μm; or about 30 μm to 90 μm; and / or (vii) the crystalline monocyclic peptide compound is a crystalline solid that has a particle size distribution range calculated to be about 1 to 3.

8. Pharmaceutical tablet, characterized in that it comprises a crystalline form of a monocyclic peptide compound prepared by the method as defined in any of the preceding claims, and a pharmaceutical excipient.

9. Method according to any one of claims 1 to 7, characterized in that: (i) the monocyclic peptide compound comprises an amino acid sequence of formula (I'): X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-X15-X16 (I') wherein X3 is absent or is any amino acid; X4 is Abu, Cys, (D)Cys, alpha-MeCys, (D)Pen, Pen or Pen(sulfoxide); X5 é Cit, Glu, Gly, Gly substituída, Leu, Ile, beta-Ala, Ala, Lys, Asn, Pro, Ser, alfa-MeGln, alfa-MeLys, alfa-MeLeu, alfa-MeAsn, Lys(Ac), alfa-MeLys(Ac), Dab(Ac), Dap(Ac), homo-Lys(Ac), Gln ou Asp; X6 is Thr, Aib, Asp, Dab, Gly, Pro, Ser, alpha-MeGln, alpha Petition 870250070155, of 06 / 08 / 2025, p. 875 / 891 9 / 20 MeLys, alpha-MeLeu, alpha-MeAsn, alpha-MeThr, alpha-MeSer or Val; X7 is substituted or unsubstituted Trp;X8 é Gln, alfa-MeLys, alfa-MeLeu, alfa-MeLys(Ac), betahomoGln, Cit, Glu, Phe, Phe substituída, Tyr, Asn, Thr, Val, Aib, alfaMeGln, alfa-MeAsn, Lys(Ac), Dab(Ac), Dap(Ac), homo-Lys(Ac), 1-Nal, 2-Nal, Lys(b-Ala), Lys(Gly), Lys(Benzyl, Ac), Lys(butyl, Ac), Lys(isobutyl,Ac), Lys(propyl,Ac) or Trp; X9 is Abu, Cys, (D)Cys, alpha-MeCys, (D)Pen, Pen or Pen(sulfoxide); X10 is Tyr, or substituted Tyr, unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; and X11 is substituted or unsubstituted 2-Nal, Phe(2-Me), Phe(3-Me), Phe(4-Me), Phe(3,4-dimethoxy), 2Quin, 3Quin, 1-Nal, unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, hydroxy or alkoxy; X12 é 4-amino-4-carboxitetra-hidropirano (THP), Acvc, alfaMeLys, alfa-MeLeu, alfa-MeArg, alfa-MePhe, alfa-MeLeu, alfa-MeLys, alfa-MeAsn, alfa-MeTyr, Ala, ciclo-hexilAla, Lys ou Aib; X13 is any amino acid;X14 is any amino acid; and X15 is substituted or unsubstituted Ala, Arg, Asn, Asp, Cys, Glu, Gln, Gly, His, (D)His, Ile, Lue, (D)Lue, Lys, (D)Lys, Met, 2Pal, 3Pal or 4Pal, Phe, Pro, 5-Pyal, 2Quin, 3Quin, Ser, Thr, Trp, Tyr, Val; X16 is absent or is any amino acid; and wherein X4 and X9 form a disulfide bond or a thioether bond; and / or (ii) the peptide compound comprises an amino acid sequence of formula (IIa), (IIb), (IIc) or (IId): Petition 870250070155, dated 06 / 08 / 2025, p. 876 / 891 10 / 20 X3-X4-X5-X6-X7-X8-X9-[Phe]-X11-X12-X13-X14-X15-X16 (IIb), or Trp replaced by cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl, or substituted or unsubstituted heteroaryl;where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is unsubstituted 2-Nal; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X3 to X16 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an Abu-Cys or Abu-Pen thioether linkage;and / or (iii) the peptide compound comprises an amino acid sequence of the formula (IIa), (IIb), (IIc) or (IId): X3-X4-X5-X6-X7-X8-X9-[Phe]-X11-X12-X13-X14-X15-X16 (IIb), or X3-X4-X5-X6-X7-X8-X9-X10-X11-X12-X13-X14-[Pal]-X16 (IId) where Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl or substituted or unsubstituted heteroaryl; where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is unsubstituted 2-Nal; Petition 870250070155, dated 06 / 08 / 2025, p. 877 / 891 11 / 20 where Pal is 2Pal, 3Pal or 4Pal; where X16 is Sarc; and, unless otherwise indicated, X3 to X15 are as described for formula (I');and the peptide compound is cyclized via a Pen-Pen disulfide bond; or the peptide compound is cyclized via an AbuCys or Abu-Pen thioether bond; and / or (iv) the peptide compound comprises an amino acid sequence of the formula (IIIa), (IIIb), (IIIc), (IIId), (IIIe) or (IIIf): X4-X5-X6-[Trp]-X8-X9-X10-[2-Nal]-X12-X13-X14-X15-X16 (IIIb), X4-X5-X6-X7-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-X15-X16 (II Id), X4-X5-X6-X7-X8-X9-[Phe]-X11-X12-X13-X14-[Pal]-X16 (IIIe) or X4-X5-X6-X7-X8-X9-X10-[2-Nal]-X12-X13-X14-[Pal]-X16 (IIIf); wherein Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl or substituted or unsubstituted heteroaryl;where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is unsubstituted 2-Nal; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X4 to X16 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an Abu-Cys or Abu-Pen thioether linkage;and / or (v) the peptide compound comprises an amino acid sequence of formula (IVa), (IVb), (IVc) or (IVd): X4-X5-X6-[Trp]-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-X15-X16 (IVa), Petition 870250070155, dated 06 / 08 / 2025, p. 878 / 891 12 / 20 X4-X5-X6-[Trp]-X8-X9-[Phe]-X11-X12-X13-X14-[Pal]-X16 (IVb), X4-X5-X6-X7-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-[Pal]-X16 (IVc) or X4-X5-X6-[Trp]-X8-X9-X10-[2-Nal]-X12-X13-X14-[Pal]-X16 (IVd) where Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl or substituted or unsubstituted heteroaryl; where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is unsubstituted 2-Nal; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X4 to X16 are as described for formula (I');and the peptide compound is cyclized via a Pen-Pen disulfide linkage; or the peptide compound is cyclized via an Abu-Cys or Abu-Pen thioether linkage; and / or (vi) the peptide compound comprises an amino acid sequence of formula (IVe): X4-X5-X6-[Trp]-X8-X9-[Phe]-[2-Nal]-X12-X13-X14-[Pal]-X16 (IVe) where Trp is unsubstituted Trp or Trp substituted with cyano, halo, alkyl, haloalkyl, alkoxy, substituted or unsubstituted aryl or substituted or unsubstituted heteroaryl; where Phe is unsubstituted Phe or Phe substituted with halo, alkyl, haloalkyl, hydroxy, alkoxy, cyano, cycloalkyl, carboxy, carboxamide, 2-aminoethoxy or 2-acetylaminoethoxy; where 2-Nal is unsubstituted 2-Nal; where Pal is 2Pal, 3Pal or 4Pal; where, unless otherwise indicated, X4 to X16 are as described for formula (I'); and the peptide compound is cyclized via a Pen-Pen disulfide bond;or the peptide compound is cyclized via an Abu-Cys or Abu-Pen thioether linkage; and / or (vii) X4 is Pen and X9 is Pen, and the linkage is a disulfide linkage; and / or (viii) X5 is Asn; and / or (ix) X6 is Thr; and / or (x) X8 is Lys(Ac); and / or (xi) X12 is 4-amino-4-carboxytetrahydropyran (THP); and / or (xii) X13 is Glu; and / or (xiii) X14 is Asn; and / or (xiv) X16 is Sarc; and / or (xv) the monocyclic peptide compound is a compound that has the structure: a pharmaceutically acceptable salt thereof.; 10. Method for the preparation of a crystalline form of the hydrochloride salt of a monocyclic peptide compound, characterized in that it is a compound having the structure: Petition 870250070155, dated 06 / 08 / 2025, page 880 / 891 14 / 20 wherein the method comprises the following steps: (a) dissolving the monocyclic peptide compound comprising a hydrochloride salt of the monocyclic peptide compound in a first solvent; (b) adding a first portion of sodium chloride to the mixture obtained in step (a); (c) adding crystalline hydrochloride salt seeds of the monocyclic peptide compound to the mixture obtained in step (b) to obtain a fluid paste; (d) adding a second portion of sodium chloride to the fluid paste obtained in step (c); (e) Isolate a crystalline monocyclic peptide compound in the form of the hydrochloride salt from the mixture and remove residual solvent.

11. Method according to claim 10, characterized in that it further comprises preparing the crude monocyclic peptide compound by a Liquid Phase Peptide Synthesis.

12. Method for the preparation of a crystalline form of the hydrochloride salt of a monocyclic peptide compound, Petition 870250070155, dated 06 / 08 / 2025, pp. 881 / 891 15 / 20 characterized in that it is a compound that has the structure: wherein the method comprises the following steps: (a) mixing the monocyclic peptide compound in a first solvent; (b) heating the mixture between 30 and 40 °C; (c) adding a second solvent to the solution obtained in step (b); (d) cooling the mixture between 20 and 30 °C; (e) adding seeds of the crystalline monocyclic peptide compound to the mixture obtained in step (d); (f) stirring the mixture at 20 to 30 °C for 1 to 3 hours; (g) cooling the mixture to 5 °C and stirring for 2 to 4 hours; (h) Heat the mixture to 22 °C and stir for 2 to 4 hours; (i) Cool the mixture to 5 °C and stir for 8 to 10 hours; (j) Isolate a crystalline monocyclic peptide compound from the mixture and remove residual solvent.

13. Method according to claim 12, characterized in that the monocyclic peptide compound Petition 870250070155, dated 06 / 08 / 2025, pp. 882 / 891 16 / 20 has been obtained by a Liquid Phase Peptide Synthesis.

14. Method for the preparation of a crystalline form of the hydrochloride salt of a monocyclic peptide compound, characterized in that it is a compound having the structure: nh2, wherein the method comprises the following steps: (a) mixing the crude monocyclic peptide compound in a first solvent; (b) heating the mixture to 30 to 50 °C; (c) filtering the suspension obtained in step (b) to obtain a solution; (d) cooling the solution obtained in step (c) to 10 to 20 °C; (e) adding seeds of crystalline monocyclic peptide compound to the mixture obtained in step (d) to obtain a mixture; (f) stirring the mixture for 1 to 2 hours; (g) adding a second solvent to the mixture obtained in step (f); (h) cooling the mixture to 0 °C for 3 to 5 hours; (i) stirring the mixture at 0 to 5 °C for 12 to 18 hours; (j) isolate a crystalline monocyclic peptide compound from the mixture and remove residual solvent.

15. Method according to claim 14, characterized in that it further comprises preparing the crude monocyclic peptide compound by a Liquid Phase Peptide Synthesis.

16. Method for the preparation of a crystalline form of the acetate salt of a monocyclic peptide compound, characterized in that it is a compound having the structure: h2n nh2, wherein the method comprises the following steps: (a) dissolving the monocyclic peptide compound comprising a hydrochloride salt of the monocyclic peptide compound in a first solvent; (b) percolating the mixture obtained in step (a) through an anion exchange resin of acetate form; (c) washing the resin with a second solvent; (d) filtering the resulting mixture; (e) freezing the solution obtained in step (d); (f) lyophilizing the solid obtained in step (e) to isolate a dry solid.

17. Method according to claim 16, Petition 870250070155, dated 06 / 08 / 2025, pp. 884 / 891 18 / 20 characterized in that it further comprises preparing the crude monocyclic peptide compound by a Liquid Phase Peptide Synthesis.

18. Crystalline form of a monocyclic peptide compound, or pharmaceutically acceptable salt thereof, characterized in that it is prepared by the method as defined in any one of claims 8 to 17.

19. Method according to any one of claims 8 to 18, characterized in that: (i) the method further comprises passing the isolated crystalline monocyclic peptide through a suitable sieve; and / or (ii) the crystalline monocyclic peptide compound is isolated and then dried with a dynamic drying step, wherein the dynamic drying step comprises agitating the crystalline monocyclic peptide compound, optionally wherein the dynamic drying step further comprises heating, exposure to vacuum or exposure to nitrogen gas; and / or (iii) the crystalline monocyclic peptide compound is a crystalline solid distinguished by a Dv10 in the range of about 1 pm to 30 pm; about 2 pm to 20 pm; or about 3 pm to 10 pm; and / or (iv) the crystalline monocyclic peptide compound is a crystalline solid distinguished by a Dv50 in the range of about 3 pm to 80 pm; about 5 pm to 60 pm; or about 10 pm to 40 pm;and / or (v) the crystalline monocyclic peptide compound is a crystalline solid distinguished by a Dv90 in the range of about 10 pm to 110 pm; about 20 pm to 100 pm; or about 30 pm to 90 pm; and / or (vi) the crystalline monocyclic peptide compound is a crystalline solid that has a particle size distribution range calculated to be about 1 to 3.

20. Pharmaceutical tablet, characterized by the fact that Petition 870250070155, dated 06 / 08 / 2025, pages 885 / 891 19 / 20, comprises a crystalline form of a monocyclic peptide compound prepared by the method as defined in any one of claims 8 to 19, and a pharmaceutical excipient.

21. Method, according to any one of claims 3, 5 and 10, characterized in that the crystalline monocyclic peptide compound is in the form of a hydrochloride salt hydrate having a water content of about 5%.

22. Use of a compound, as defined in any of the preceding claims, characterized in that it is in the preparation of a composition and / or a product and / or a medicament for: (i) treating an individual suffering from a condition or indication associated with IL-21 or IL-23R (e.g., activation of the IL-23 or IL-23R signaling pathway); and / or (ii) treating autoimmune inflammatory diseases and related disorders.

23. Invention, characterized by the fact that it is in any form of its embodiment or in any applicable category of claim, for example, product or process or use, or any other type of claim encompassed by the matter initially described, disclosed or illustrated in the patent application, including: Composition comprising a compound as defined in any of the above claims or as defined in this patent application, or a pharmaceutically acceptable salt thereof; and an excipient; and / or Single or separate composition comprising a compound as defined in any of the above claims or as defined in this patent application, or a pharmaceutically acceptable salt thereof; and an excipient; and one or more additional agents;Petition 870250070155, dated 06 / 08 / 2025, pp. 886 / 891 20 / 20 and / or Combination of a compound, as defined in any of the above claims or as defined in this patent application, or a pharmaceutically acceptable salt thereof, with one or more additional agents; and / or Use of a compound as defined in any of the above claims or as defined in this patent application, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament, composition, combination and / or product to prevent, improve or treat a disorder, disease or health condition;and / or Use of a compound, as defined in any of the claims above or as defined in this patent application, or a pharmaceutically acceptable salt thereof, with one or more additional agents for the preparation of a single or separate medicament, single or separate composition, single or separate combination and / or single or separate product to prevent, improve or treat a disorder, disease or health condition; and / or Use of a compound, as defined in any of the claims above or as defined in this patent application, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament, composition, combination and / or product, in combination with one or more additional agents, to prevent, improve or treat a disorder, disease or health condition.

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