Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof

Inventors

Copp, James Densmore • Newman, Ann W. • Luong, Anne

Assignees

Akebia Therapeutics Inc

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Publication Number

US-12419877-B2

Patent

Publication Date

2025-09-23

Expiration Date


Abstract

Provided herein are solid forms comprising {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders.

Core Innovation

The document describes crystalline forms of Compound (I), including Forms A, B, and C, characterized through X-ray powder diffraction (XRPD) patterns and analytical techniques. Form B is crystalline and non-hygroscopic but metastable, and converts to Form A. Form A is highly pure and non-hygroscopic, with a melting point of about 175.8 C, while characteristic XRPD peaks define Forms B and C.

The document describes potential therapeutic uses of Compound (I), particularly for anemia, and identifies HIF prolyl hydroxylase in that context. The supplied partial content omits the abstract, summary, and background sections, thereby omitting the background problem being solved. Independent claims cover preparation methods for crystalline Compound (I), with operational details omitted for safety.

Claims Coverage

The two independent claims cover methods for preparing crystalline Compound (I), with each resulting crystalline form identified by a distinct X-ray powder diffraction pattern.

Crystalline compound (I) with the Form B XRPD pattern

The first independent claim covers preparing crystalline Compound (I), wherein the preparation details are [procedural detail omitted for safety]. The resulting crystalline product exhibits an X-ray powder diffraction pattern comprising peaks at 8.6, 15.3, 22.7, and 28.1 0.2 2Θ.

Crystalline compound (I) with the Form C XRPD pattern

The second independent claim covers preparing crystalline Compound (I), wherein the preparation details are [procedural detail omitted for safety]. The resulting crystalline product exhibits an X-ray powder diffraction pattern comprising peaks at 7.2, 17.4, 22.3, 22.4, 28.9, 33.7, and 33.8 0.2 2Θ.

The two independent claims distinguish the crystalline products by their respective X-ray powder diffraction patterns and claim methods for preparing them, with dependent claims addressing form content, purity, and handling details.

Stated Advantages

Form B and Form A are described as non-hygroscopic.

Form A is described as highly pure.

Documented Applications

The document describes potential therapeutic uses of Compound (I), particularly for anemia, in the context of HIF prolyl hydroxylase.

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