Pyridazinone compositions and methods for the treatment of muscular conditions

Abstract

Treatments of neuromuscular conditions, activity-induced muscle damage, metabolic myopathies, and movement disorders with compositions comprising 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one (Compound 1), as well as solid forms of Compound 1, and pharmaceutical compositions of Compound 1, and kits of Compound 1, are described herein.

Description

PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601PYRIDAZINONE COMPOSITIONS AND METHODS FOR THE TREATMENT OF MUSCULAR CONDITIONSCROSS-REFERNCE

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 718544, filed November 8, 2024, which is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION

[0002] Skeletal muscle is the largest organ system in the human body, serving two primary purposes. The first is force production to enable muscle contraction, locomotion, and postural maintenance; the second is glucose, fatty acid, and amino acid metabolism. The contraction of skeletal muscle during every-day activity and exercise is naturally connected to muscle stress, breakdown and remodeling which is important for muscle adaptation. In individuals with neuromuscular conditions, such as Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD), Limb-girdle muscular dystrophies (LGMD), and McArdle’s disease, muscle contractions lead to continued rounds of amplified muscle breakdown that the body struggles to repair. Eventually, as patients age, a pathophysiological process emerges that leads to excess inflammation, fibrosis, and fatty deposit accumulation in the muscle, portending a steep decline in physical function and contribution to mortality. One potential treatment to treating such neuromuscular conditions is to administer a compound that reduces skeletal muscle contractions. However, reductions in skeletal contractivity can also lead to muscle weakness and similiary reduce a patient’s physical abilities. There remains a need for treatments that reduce muscle breakdown in patients with neuromuscular conditions while preserving or improving the patient’s muscle strength.SUMMARY OF THE INVENTION

[0003] In an aspect, the present disclosure provides a solid form of 2-((5-fluoropyridin-3-yl)methyl)- 6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form is crystalline. In an aspect, the present disclosure provides a crystalline solid form of 2-((5- fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, and 21.8° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5- fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, whereinPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, and 26.4° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, and 25.1° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, and 22.1° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin- 3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least four or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least six or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In anPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6- (2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X- ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 16.2° ± 0.2° and 21.8° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.8° ± 0.2° and 28.0° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.4° ± 0.2°, 21.3° ± 0.2°, and 27.0° ± 0.2°. In some embodiments, the solid form exhibits one or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, and 11.6° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits the X-ray powder diffraction pattern as shown in Figure 1. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 15.0 °C. In some embodiments, the onset temperature of the endothermic peak is at 117.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram as shown in Figure 2. In some embodiments, the solid form exhibits the thermogravimetric analysis thermogram as shown in Figure 3. In some embodiments, the crystal system is triclinic. In some embodiments, the space group of the unit cell is P-1. In some embodiments, the volume of the unit cell is 802 A3± 100 A3. In some embodiments, the solid form comprises a unit cell with unit cell distances of 6.6 A ± 3.0 A, 9.2 A ± 3.0 A, and 13.4 A ± 3.0 A. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91°, 95°, and 95°. In some embodiments, the solid form is an anhydrate. In some embodiments, the solid form is solid Form 1 of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyri din-3 -yl)methyl)-6-(2-(2, 2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, and 23.6° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2- (2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, and 21.4° ± 0.2°. In an aspect, the present disclosure provides a crystalline solidPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin- 3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, and 23.9° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5- yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, and 33.2° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5- fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ±PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-7466010.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.2° ± 0.2° and 23.6° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 11.7° ± 0.2° and 19.1° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 21.4° ± 0.2°, 18.7° ± 0.2°, and 24.8° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2, 20.5° ± 0.2, and 38.7° ± 0.2. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 12.7° ± 0.2°, 10.7° ± 0.2°, 25.6° ± 0.2°, 28.0° ± 0.2°, 20.0° ± 0.2°, 32.1° ± 0.2°, and 16.4° ± 0.2°. In some embodiments, the solid form exhibits the X-ray powder diffraction pattern as shown in Figure 4. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 15.0 °C. In some embodiments, the onset emperature of the endothermic peak is at 113.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram as shown in Figure 5. In some embodiments, the solid form exhibits the thermogravimetric analysis thermogram as shown in Figure 3. In some embodiments, the solid form is an anhydrate. In some embodiments, the solid form is solid Form 2 of 2-((5-fluoropyridin-3- yl)rnethyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.2°, 6.5° ± 0.2°, and 21.8° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6- (2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, and 25.3° ± 0.2°. In an aspect, the present disclosure provides a crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin- 3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8°PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least four or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least six or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.2°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2° and 21.8° ± 0.2°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 23.8° ± 0.2° and 11.8° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 25.3° ± 0.2°, 28.1° ± 0.2°, and 33.8° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 18.5° ± 0.2°, 22.5° ± 0.2°, and 19.5° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits the X-ray powder diffraction pattern as shown in FigurePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-7466016. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.6 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.3 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 114.0 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 110.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 109.4 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram as shown in Figure 7. In some embodiments, the solid form exhibits the thermogravimetric analysis thermogram as shown in Figure 8. In some embodiments, the solid form is an anhydrate. In some embodiments, the solid form is solid Form 3 of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one. In an aspect, the present disclosure provides a solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form is amorphous. In an aspect, the present disclosure provides a pharmaceutical composition comprising the solid crystalline form, one or more pharmaceutically acceptable excipient(s), and optionally comprising an additional crystalline Form of Compound 1. In an aspect, the present disclosure provides a pharmaceutical composition comprising the solid crystalline form one or more pharmaceutically acceptable excipient(s), and optionally comprising an amorphous Form of Compound 1. In an aspect, the present disclosure provides a pharmaceutical composition comprising the solid form disclosed herein and one or more pharmaceutically acceptable excipient(s). In an aspect, the present disclosure provides a pharmaceutical composition comprising Compound 1 and one or more pharmaceutically acceptable excipient(s). In an aspect, the present disclosure provides a pharmaceutical composition in the form of a solid oral dosage form comprising: (i) Compound(Compound 1) or a pharmaceutically acceptable salt or solvate thereof and (ii) one or more pharmaceutically acceptable excipient(s). In an aspect, the present disclosure provides a pharmaceutical composition in the form of a tablet. In some embodiments, the pharmaceuticalPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 composition comprises between about 1 mg and about 100 mg of Compound 1, or of a pharmaceutically acceptable salt or solvate of Compound 1. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 50 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 40 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 30 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 20 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 15 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 10 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 7.5 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 5.0 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 2.5 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises between about 0.5 mg and about 1.0 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about about 1 mg, 2.5 mg, about 5.0 mg, about 7.5 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about 2.5 mg, about 5.0 mg, about 10 mg, or about 20 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about 2.5 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about 5.0 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about 10 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about 15 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof. In some embodiments, the pharmaceutical composition comprises about 20 mg of Compound 1 or of a pharmaceuticallyPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 acceptable salt or solvate thereof. In some embodiments, Compound 1, or a pharmaceutically acceptable salt or solvate thereof is in the form of microparticles. In some embodiments, the microparticles are obtained from jet milling Compound 1. In some embodiments, the microparticles are obtained from jet milling Compound 1-Form 1. In some embodiments, the average size of the microparticles is between about 1 pm and about 40 pm. In some embodiments, the average size of the microparticles is between about 1 pm and about 30 pm. In some embodiments, the average size of the microparticles is between about 1 pm and about 20 pm. In some embodiments, the average size of the microparticles is between about 1 pm and about 10 pm. In some embodiments, the average size of the microparticles is between about 5 pm and about 40 pm. In some embodiments, the average size of the microparticles is between about 5 pm and about 30 pm. In some embodiments, the average size of the microparticles is between about 5 pm and about 20 pm. In some embodiments, the average size of the microparticles is between about 5 pm and about 10 pm. In some embodiments, the average size of the microparticles is between about 10 pm and about 40 pm. In some embodiments, the average size of the microparticles is between about 10 pm and about30 pm. In some embodiments, the average size of the microparticles is between about 10 pm and about 20 pm. In some embodiments, the average size of the microparticles is less than about 10 pm. In some embodiments, the average size of the microparticles is about 1 pm to to about 10 pm. In some embodiments, the average size of the microparticles is about 1 pm to to about 5 pm. In some embodiments, the average size of the microparticles is about 0.1 pm to to about 2 pm. In some embodiments, the average size of the microparticles is about 0.01 pm to to about 1 pm. In some embodiments, the tablet is made by compression, molding, or extrusion, optionally with one or more pharmaceutically acceptable excipient(s). In some embodiments, the tablet is made by compression.In some embodiments, the tablet is made by molding. In some embodiments, the tablet is made by extrusion. In some embodiments, the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients. In some embodiments, the pharmaceutical composition is stable for at least 1 month at about 25 °C to about 40 °C. In some embodiments, the pharmaceutical composition is stable for at least 3 months at about 25 C. In some embodiments, the pharmaceutical composition is stable for at least 6 months at about 25 C. In some embodiments, the pharmaceutical composition is stable for at least 9 months at about 25 C. In some embodiments, the pharmaceutical composition is stable for at least 12 months at about 25 °C. In some embodiments, the pharmaceutical composition is stable for at least 24 months at about 25 °C. In some embodiments, the pharmaceutical composition is stable for at least 36 months at about 25 °C. In some embodiments, the pharmaceutical composition comprises one or more surfactactant(s), one or more filler(s), one or more binder(s), one or more disintegrant(s), one or more lubricant(s), one or morePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 glidant(s), one or more coloring agent(s), one or more flavoring agent(s), one or more preservative(s), one or more adjustor(s), one or more antiadherent(s), one or more coating agent(s), one or more moisturizing agent(s), or one or more solvent(s). In some embodiments, the pharmaceutical composition comprises one or more filler(s), sweetener(s), binder(s), disintegrant(s), wetting agent(s), lubricant(s), or glidant(s). In some embodiments, the pharmaceutical composition comprises one or more filler(s), sweetener(s), disintegrant(s), lubricant(s), or glidant(s). In some embodiments, the pharmaceutical composition comprises one or more polymer(s). In some embodiments, the pharmaceutical composition comprises one or more filler(s). In some embodiments, the pharmaceutical composition comprises one or more sweetener(s). In some embodiments, the pharmaceutical composition comprises one or more binder(s). In some embodiments, the pharmaceutical composition comprises one or more disinegrant(s). In some embodiments, the pharmaceutical composition comprises one or more wetting agent(s). In some embodiments, the pharmaceutical composition comprises one or more lubricant(s). In some embodiments, the pharmaceutical composition comprises one or more glidant(s). In some embodiments, the pharmaceutical composition comprises microcrystalline cellulose. In some embodiments, the pharmaceutical composition comprises one or more surfactant(s). In some embodiments, the pharmaceutical composition comprises one or more wetting agent(s) independently selected from sodium lauryl sulfate (SLS). In some embodiments, the pharmaceutical composition comprises one or more antioxidant(s). In some embodiments, the pharmaceutical composition comprises one or more di sinti grant(s) independently selected from silicified MCC and croscarmellose sodium. In some embodiments, the pharmaceutical composition comprises a disintigrant independently selected from silicified MCC. In some embodiments, the pharmaceutical composition comprises a disintigrant independently selected from Croscarmellose Sodium. In some embodiments, the pharmaceutical composition comprises one or more filler(s) independently selected from lactose, silicified MCC, microcrystalline cellulose PH-102, microcrystalline cellulose PH-200, and mannitol M100. In some embodiments, the pharmaceutical composition comprises one or more filler(s) independently selected from microcrystalline cellulose PH-102, microcrystalline cellulose PH-200, and mannitol M 100. In some embodiments, the pharmaceutical composition comprises a filler independently selected from lactose. In some embodiments, the pharmaceutical composition comprises a filler independently selected from lactose monohydrate. In some embodiments, the pharmaceutical composition comprises a glidant independently selected from colloidal silicon dioxide. In some embodiments, the pharmaceutical composition comprises a lubricant independently selected from sodium stearyl fumarate (SSF). In some embodiments, the pharmaceutical composition comprises one or more suspending agent(s). In some embodiments, thePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 pharmaceutical composition comprises a suspending agent selected from HPC-EXF. In some embodiments, the pharmaceutical composition comprises one or more emulsifier(s). In some embodiments, the pharmaceutical composition comprises one or more flavoring agent(s). In some embodiments, the pharmaceutical composition comprises one or more preservative(s). In some embodiments, the pharmaceutical composition comprises one or more tonicity adjuster(s). In some embodiments, the pharmaceutical composition comprises one or more coating agent(s). In some embodiments, the pharmaceutical composition comprises one or more nonstick agent(s). In some embodiments, the pharmaceutical composition comprises one or more acid(s) In some embodiments, the pharmaceutical composition comprises one or more base(s). In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 25% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 25% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 20% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 15% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 10% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 9.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 9% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 8.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 8.0% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 7.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 7% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 6.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 6% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 5.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 4.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 4% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 3.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 3% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 2.5% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 2% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 1.5% w / wPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601Compound 1. In some embodiments, the pharmaceutical composition comprises about 6.25% w / w Compound 1. In some embodiments, the pharmaceutical composition comprises about 0.3% w / w to about 2.5% w / w sodium laurel sulfate. In some embodiments, the pharmaceutical composition comprises about 0.8% w / w sodium laurel sulfate. In some embodiments, the pharmaceutical composition comprises about 1.85% w / w sodium laurel sulfate. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 5% w / w hydroxypropyl cellulose. In some embodiments, the pharmaceutical composition comprises about 20% w / w mannitol. In some embodiments, the pharmaceutical composition comprises about 62% w / w microcrystalline cellulose. In some embodiments, the pharmaceutical composition comprises about 2% w / w sucralose. In some embodiments, the pharmaceutical composition comprises about 4% w / w to about 6% w / w croscarmellose sodium. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 2% w / w sodium stearyl fumarate. In some embodiments, the pharmaceutical composition comprises about 1% w / w to about 1.5% w / w colloidal silicon dioxide. In some embodiments, the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 75% w / w to about 90% w / w one or more filler(s), , about 1% w / w to about 3% w / w sweetener, about 2% w / w to about 10% w / w one or more disintegrant(s), about 1% w / w to about 3% w / w one or more lubricant(s), and about 0.5% w / w to about 3% w / w one or more glidant(s). In some embodiments, the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 75% w / w to about 90% w / w one or more filler(s), about 1% w / w to about 3% w / w sweetener, about 2% w / w to about 10% w / w one or more disintegrant(s), about 1% w / w to about 3% w / w one or more lubricant(s), about 0.5% w / w to about 3% w / w one or more glidant(s), and about 4% w / w to about 15% w / w of a film coting. In some embodiments, the pharmaceutical composition comprises about 5% w / w to about 8% w / w Compound 1, about 82% w / w one or more filler(s), about 6% w / w one or more disintegrant(s), about 2% w / w one or more lubricant(s), and about 1.5% w / w one or more glidant(s). In some embodiments, the pharmaceutical composition comprises about 6% w / w Compound 1, about 83% w / w one or more filler(s), about 2% w / w one or more sweetener(s), about 6% w / w one or more disintegrant(s), about 2% w / w one or more lubricant(s), and about 1.5% w / w one or more glidant(s). In some embodiments, the pharmaceutical composition comprises mannitol, microcrystalline cellulose, sucralose, croscarmellose sodium, sodium stearyl fumarate, and colloidal silicon dioxide. In some embodiments, the pharmaceutical composition comprises mannitol, microcrystalline cellulose, sucralose, croscarmellose sodium, sodium stearyl fumarate, colloidal silicon dioxide, and a film coating. In some embodiments, the pharmaceutical composition comprises Compound 1, mannitol, microcrystalline cellulose, sucralose, croscarmellose sodium, sodium stearyl fumarate, colloidalPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 silicon dioxide, and a film coating. In some embodiments, the pharmaceutical composition comprises about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium stearyl fumarate, and about 0.5% w / w to about 3% w / w colloidal silicon dioxide. In some embodiments, the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose,, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium stearyl fumarate, and about 0.5% w / w to about 3% w / w colloidal silicon dioxide. In some embodiments, the pharmaceutical composition comprises about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium stearyl fumarate, about 0.5% w / w to about 3% w / w colloidal silicon dioxide, and about 4% w / w to about 15% w / w of a film coting. In some embodiments, the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium lauryl sulfate, about 1% w / w to about 3% w / w sodium stearyl fumarate, about 0.5% w / w to about 3% w / w colloidal silicon dioxide, and about 4% w / w to about 15% w / w of a film coting. In some embodiments, the pharmaceutical composition comprises about 6% w / w Compound 1, about 65% w / w microcrystalline cellulose, about 20% w / w mannitol, about 2% w / w sucralose, about 6% w / w croscarmellose sodium, about 2% w / w sodium stearyl fumarate, and about 1.5% w / w colloidal silicon dioxide. In some embodiments, the pharmaceutical composition comprises about 6.2% w / w Compound 1, about 61.7% w / w microcrystalline cellulose, about 20.6% w / w mannitol, about 2% w / w sucralose, about 6.0% w / w croscarmellose sodium, about 2% w / w sodium stearyl fumarate, and about 1.5% w / w colloidal silicon dioxide. In an aspect, the present disclosure provides a pharmaceutical composition wherein the Compound 1 is the solid form of any one of the forms disclosed herein.

[0004] In an aspect the present disclosure provides a method of treating human disease the method comprising administering a solid form or a pharmaceutical composition of Compound 1 disclosed herein. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a movement disorder, a neuromuscular condition, or a metabolic myopathy, the method comprising administering to a subject in need thereof a dose of about 1 mg to about 100 mg per dayPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 of Compound, wherein the Compound 1 comprises the solid form of any one of the pharmaceutical composition disclosed herein. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a movement disorder, a neuromuscular condition, or a metabolic myopathy, the method comprising administering to a subject in need thereof a dose of about 1 mg to about 100 mg per day of Compound 1-FormIn some embodiments, the method comprises administering to the subject a dose of about 1 mg to about 50 mg per day of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 2 mg to about 25 mg per day of the compound of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 2 mg to about 15 mg per day of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 2 mg to about 10 mg per day of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 2.5 mg to about 20 mg per day of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 2.5 mg to about 10 mg per day of the compound of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, about 10 mg, about 11 mg, about 12 mg, about 13 mg, about 14 mg, about 15 mg, about 16 mg, about 17 mg, about 18 mg, about 19 mg, about 20 mg, about 21 mg, about 22 mg, about 23 mg, about 24 mg, about 25 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, or about 100 mg per day of Compound 1. In some embodiments, the method comprises administering to the subject a dose of about 1 mg, about 2 mg, about 2.5 mg, about 3.0 mg, about 3.5 mg, about 4.0 mg, about 4.5 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, or about 50 mg of Compound 1, or of a pharmaceutically acceptable salt or solvate thereof. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movementPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to maintain a North Star Ambulatory Assessment (NSAA) score or increase the NSAA score of the subject relative to a pre-treatment NSAA score. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to maintain or improve one or more of the following functional measures of the subject: max elbow flexion strength relative to a pre-treatment max elbow flexion strength; max knee extension strength relative to a pre-treatment max knee extension strength; 10 meter walk / run velocity relative to a pre-treatment 10 meter walk / run velocity; 100 meter timed test velocity relative to a pre-treatment 100 meter timed test velocity; 4-stair climb time velocity relative to a pre-treatment 4-stair climb time velocity; and max-grip strength relative to a pre-treatment max-grip strength value. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to maintain a creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more. In an aspect, the present disclosure provides a method of treating activity -induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to maintain a creatine kinase activity level or increase the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more. In an aspect, the present disclosure provides a method of treating activity- induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to maintain a Dual Energy X-Ray Absorptiometry (DXA) % lean mass of the subject or increase the DXA % lean mass of the subject relative to a pre-treatment DXA % lean mass by 5% or more. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to maintain a Fast Skeletal Muscle Troponin I (TNNI2) concentration of the subject or reduce the TNNI2 concentration of the subject relative to a pre-treatment TNNI2 concentration by 10% or more, and optionally wherein the TNNI2 concentration is inferred from a SOMAscan level. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to decrease protein concentration of one or more muscle injury biomarkers inPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 the subject relative to a pre-treatment protein concentration of the one or more muscle injury biomarkers by 10% or more. In some embodiments, the one or more muscle injury biomarkers comprise ACTN2, MY0M2, MYBPC1, PDLIM3, MYL3, TNNI2, MYL11, CKB, CKM, APOBEC2, ENO3, CA3, KLHL41, ADSS1, CAPN3, HSPB6, TNNT2, MYBPC2, GPDl(a), MUSTN1, FBP2, DUSP29, MYBPH, GPDl(b), THAP4, CHCD10, or a combination thereof. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to decreases protein concentration of one or more pro-inflammatory proteins in the subject relative to a pre-treatment protein concentration of the one or more pro-inflammatory proteins by 10% or more. In some embodiments, the one or more pro-inflammatory proteins comprise CCL22, CCL5, CXCL10, FGG, IFN-y, IL3, PPBP, PF4, or a combination thereof. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to increase protein concentration of one or more anti-inflammatory proteins in the subject relative to a pre-treatment protein concentration of the one or more anti-inflammatory proteins by 10% or more. In some embodiments, the one or more anti-inflammatory proteins comprise IL 10, IL13, IL22, IL37, IL4, or a combination thereof. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to reduce skeletal muscle contraction by 5% to 90% relative to pre-treatment skeletal muscle contraction capacity of said subject. In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject a Compound 1 in an amount sufficient to reduce involuntary muscle contractions by at least 10%. In some embodiments, the neuromuscular condition is selected from Becker Muscular Dystrophy, Duchenne Muscular Dystrophy, and Limb-Girdle Muscular Dystrophy. In some embodiments, the neuromuscular condition is Becker Muscular Dystrophy or Duchenne Muscular Dystrophy. In some embodiments, the movement disorder comprises muscular spasicity. In some embodiments, the muscle spasticity is selected from spasticity associated with multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, or cerebral palsy, or injury, or a traumatic event such as stroke, traumatic brain injury, spinal cord injury, hypoxia, meningitis, encephalitis, phenylketonuria, or amyotrophic lateral sclerosis. In some embodiments, the metabolic myopathy is selected from McArdle's syndrome. In some embodiments, the administering comprises administering a Compound 1 for 2 months or more,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-7466013 months or more, 4 months or more, 5 months or more, 6 months or more, or 7 months or more. In some embodiments, the administering comprises administering a Compound 1 for 4 months or more, 5 months or more, 6 months or more, or 7 months or more, v method of treating activity -induced muscle damage, a neuromuscular condition, a movement disorder, or a metabolic myopathy, the method comprising administering to a subject Compound 1 in an amount sufficient to modulating protein concentration of one or more biomarkers in the subject relative to a pre-treatment protein concentration of the one or more biomarkers by about 5 % or more. In some embodiments, the one or more biomarkers are modulated by 10% or more. In some embodiments, the solid form is administered to a subject in need thereof. In some embodiments, the solid form administered to a subject in need thereof is Form-1. In some embodiments, the pharmaceutical composition is administered to a subject in need thereof.

[0005] In an aspect, the present disclosure provides a kit, comprising an oral pharmaceutical composition and instructions for administration to a subject in need thereof, wherein the oral pharmaceutical composition comprises a compound of Compound 1 and one or more pharmaceutically acceptable excipient(s). In some embodiments, the Compound 1 is the solid form disclosed herein. In an aspect, the present disclosure provides a kit, comprising an oral pharmaceutical composition and instructions for administration to a subject in need thereof, wherein the oral pharmaceutical composition comprises Compound 1 and one or more pharmaceutically acceptable excipient(s).INCORPORATION BY REFERENCE

[0006] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The novel features of the invention are set forth with particularity in the appended claims A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:

[0008] The features of the invention are set forth with particularity in the appended claims. A better understanding of the features of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0009] FIG. 1 Shows the X-ray diffraction pattern of crystalline Form 1.

[0010] FIG. 2 Shows the differential scanning calorimetry of Form 1.

[0011] FIG. 3 Shows the thermogravimetric analysis of Form 1.

[0012] FIG. 4 Shows the X-ray diffraction pattern of crystalline Form 2.

[0013] FIG. 5 Shows the differential scanning calorimetry of Form 2.

[0014] FIG. 6 Shows the X-ray diffraction pattern of crystalline Form 3.

[0015] FIG. 7 Shows the differential scanning calorimetry of Form 3.

[0016] FIG. 8 Shows the thermogravimetric analysis of Form 3.

[0017] FIG. 9 Shows the overlaid XRPD patterns of Forms 1, 2 and 3.

[0018] FIG. 10 Shows the overlaid XRPD patterns of Form 1 scaled up samples.

[0019] FIG. 11 Shows the thermal cycle by DSC of Compound 1 to prepare Form 2.

[0020] FIG. 12 Shows the interconversion studies of Form 1 and Form 2.

[0021] FIG. 13 Shows the interconversion studies of Form 1 and Form 3.

[0022] FIG. 14 Shows the overlaid XRD patterns of Form 1 before and after 92.5% relative humidity.

[0023] FIG. 15 Shows the TGA thermogram of Form 1 after 3 days at 92.5% relative humidity.

[0024] FIG. 16 Shows the overlaid XRPD patterns of the solubility test samples.

[0025] FIG. 17 Shows the photomicrograph of Compound 1-Form 1 single crystals.

[0026] FIG. 18 Shows the Asymmetric unit of Compound 1-Form 1 crystal structure.

[0027] FIG. 19 Shows the overlaid XRPD patterns of single crystal of Compound 1-Form 1 and Form 1.

[0028] FIG. 20 Shows the overlaid XRPD patterns of unmilled Compound 1-Form 1, jet-milled Compound 1, and wet-milled Compound 1.

[0029] FIG. 21 Shows the overlaid DSC and TGA patterns of unmilled Compound 1-Form 1, jet- milled Compound 1, and wet-milled Compound 1.DETAILED DESCRIPTION OF THE INVENTION

[0030] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0031] Described herein, in some aspects, is a method for treating a neuromuscular condition, comprising administering to a subject in need thereof a dose of 1 mg to 40 mg per day of a compound of Formulasome embodiments, the method comprises administering to the subject a dose of 15 mg to 40 mg per day of the compound of Formula (I). In some embodiments, the method comprises administering to the subject a dose of 1 mg, 2 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, or 20 mg per day of the compound of Formula (I). In some embodiments, the method comprises administering to the subject a dose of 10 mg, 15 mg, or 20 mg per day of the compound of Formula (I), when the subject is over 18 years old. In some embodiments, the method comprises administering to the subject a dose of 10 mg, 7.5 mg, 5 mg, 2.5 mg, 2 mg, or 1 mg per day of the compound of Formula (I), when the subject is under 18 years old. In some embodiments, the administering comprises administering of a first dose of said muscle fast myosin (Type II) muscle fast myosin (Type II) inhibitor and one or more subsequent doses of said muscle fast myosin (Type II) muscle fast myosin (Type II) inhibitor, and optionally wherein the one or more subsequent doses are higher than the first dose. In some embodiments, said administering maintains a North Star Ambulatory Assessment (NSAA) score or increase the NSAA score of the subject relative to a pre-treatment NSAA score. In some embodiments, said administering maintains or improves one or more of the following functional measures of the subject: max elbow flexion strength relative to a pre-treatment max elbow flexion strength; max knee extension strength relative to a pre-treatment max knee extension strength; 10 meter walk / run velocity relative to a pre-treatment 10 meter walk / run velocity; 100 meter timed test velocity relative to a pre-treatment 100 meter timed test velocity; 4-stair climb time velocity relative to a pre-treatment 4-stair climb time velocity; and max-grip strength relative to a pre-treatment max-grip strength value. In some embodiments, said administering maintains a creatine kinase activity level or reduces the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more. In some embodiments, said administering maintains a creatine kinase activity level or increases the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more. In some embodiments, said administering maintains a Dual Energy X-ray absorptiometry (DXA) % lean mass of the subject or increase the DXA % lean mass of the subject relative to a pretreatment DXA % lean mass by 5% or more. In some embodiments, said administering maintains aPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601Fast Skeletal Muscle Troponin I (TNNI2) concentration of the subject or reduce the TNNI2 concentration of the subject relative to a pre-treatment TNNI2 concentration by 10% or more, and optionally wherein the TNNI2 concentration is inferred from a SOMAscan level. In some embodiments, said administering decreases protein concentration of one or more muscle injury biomarkers in the subject relative to a pre-treatment protein concentration of the one or more muscle injury biomarkers by 10% or more. In some embodiments, the one or more muscle injury biomarkers comprise ACTN2, MY0M2, MYBPC1, PDLIM3, MYL3, TNNI2, MYL11, CKB, CKM, APOBEC2, ENO3, CA3, KLHL41, ADSS1, CAPN3, HSPB6, TNNT2, MYBPC2, GPDl(a), MUSTN1, FBP2, DUSP29, MYBPH, GPDl(b), THAP4, CHCD10, or a combination thereof. In some embodiments, said administering decreases protein concentration of one or more pro- inflammatory proteins in the subject relative to a pre-treatment protein concentration of the one or more pro-inflammatory proteins by 10% or more. In some embodiments, the one or more pro- inflammatory proteins comprise CCL22, CCL5, CXCL10, FGG, IFN-y, IL3, PPBP, PF4, or a combination thereof. In some embodiments, said administering increases protein concentration of one or more anti-inflammatory proteins in the subject relative to a pre-treatment protein concentration of the one or more anti-inflammatory proteins by 10% or more. In some embodiments, the one or more anti-inflammatory proteins comprise IL 10, IL13, IL22, IL37, IL4, or a combination thereof. In some embodiments, the neuromuscular condition is selected from Becker Muscular Dystrophy, Duchenne Muscular Dystrophy, Limb-Girdle Muscular Dystrophy and McArdle Disease. In some embodiments, the administering comprises administering the compound of Formula (I) for 2 months or more, 3 months or more, 4 months or more, 5 months or more, 6 months or more, or 7 months or more. In some embodiments, prior to said administering the method further comprises selecting a subject for treatment with one or more of characteristics (a)-(g): (a) a creatine kinase activity level is 1000 U / L or greater, 1200 U / L or greater, 1300 U / L or greater; (b) a TNNI2 concentration of 20 ng / mL or greater, 30 ng / mL or great or 40 ng / mL or greater; (c) a dystrophin gene mutation; (d) a pre-treatment NSAA yearly change of -0.1 to -10, or -0.5 to -3; (e) a pretreatment serum creatinine of 1 mg / dL or less, 0.8 mg / dL or less, 0.6 mg / dL or less; (f) a DXA % lean mass of <75%, less than 70%, less than 65%, less than 60%; and (g) a self-reported pain score associated with muscular dystrophy of 1.5 or greater, or 2 or greater.

[0032] In certain aspects, the disclosure provides methods and compositions for treating neuromuscular conditions through selective inhibition of fast-fiber skeletal muscle myosin. In particular, methods of the disclosure may be used in the treatment of DMD, BMD, LGMD, McArdle’s disease, and other neuromuscular conditions. In some embodiments, the methodsPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 described herein include compounds or salts previously described in publications W02020097266, WO2021231615, WO 2023220180, or WO 2024 / 055007.

[0033] In some embodiments, skeletal muscle is mainly composed of two types of fibers, slow- twitch muscle fiber (i.e., type I) and fast-twitch muscle fiber (i.e., type II). In each muscle, the two types of fibers are configured in a mosaic-like arrangement, with differences in fiber type composition in different muscles and at different points in growth and development. Slow-twitch muscle fibers have excellent aerobic energy production ability. Contraction rate of the slow-twitch muscle fiber is low but tolerance to fatigue is high. Slow-twitch muscle fibers typically have a higher concentration of mitochondria and myoglobin than do fast-twitch fibers and are surrounded by more capillaries than are fast-twitch fibers. Slow-twitch fibers contract at a slower rate due to lower myosin ATPase activity and produce less power compared to fast-twitch fibers, but they are able to maintain contractile function over longer-terms, such as in stabilization, postural control, and endurance exercises.

[0034] In some embodiments, fast twitch muscle fibers in humans are further divided into two main fiber types depending on the specific fast skeletal myosin they express (Type Ila, Ilx / d). A third type of fast fiber (Type lib) exists in other mammals but is rarely identified in human muscle. Fast-twitch muscle fibers have excellent anaerobic energy production ability and are able to generate high amounts of tension over a short period of time. Typically, fast-twitch muscle fibers have lower concentrations of mitochondria, myoglobin, and capillaries compared to slow-twitch fibers, and thus can fatigue more quickly. Fast-twitch muscles produce quicker force required for power and resistance activities.

[0035] The proportion of the type I and type II can vary in different individuals. For example, non- athletic individuals can have close to 50% of each muscle fiber types. Power athletes can have a higher ratio of fast-twitch fibers, e.g. ,70-75% type II in sprinters. Endurance athletes can have a higher ratio of slow-twitch fibers, e.g., 70-80% in distance runners. The proportion of the type I and type II fibers can also vary depending on the age of an individual. The proportion of type II fibers, especially the type IIx, can decline as an individual ages, resulting in a loss in lean muscle mass.

[0036] In some embodiments, the contractile action of skeletal muscle leads to muscle damage in subjects with neuromuscular disease, e.g., DMD, and this damage appears to be more prevalent in fast fibers. It has been observed that acute force drop after lengthening injury is greater in predominantly fast type II fiber muscles compared to predominantly slow type I fiber muscles in dystrophy mouse models. It has also been demonstrated that the degree of acute force drop and histological damage in dystrophy mouse models is proportional to peak force development duringPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 lengthening injury. Excessive contraction-induced injuries, which precede the inflammation and irreversible fibrosis that characterizes late-stage DMD pathology.

[0037] In some embodiments, inhibitors of skeletal muscle myosin that are not selective for the type II fibers may lead to excessive inhibition of skeletal muscle contraction including respiratory function and unwanted inhibition of cardiac activity as the heart shares several structural components (such as type I myosin) with type I skeletal muscle fibers. While not wishing to be bound by a particular mechanistic theory, this disclosure provides selective inhibitors of fast-fiber skeletal muscle myosin as a treatment option for Becker muscular dystrophy (BMD), Duchenne muscular dystrophy (DMD), Limb-girdle muscular dystrophies (LGMD), McArdle disease, and other neuromuscular conditions. The targeted inhibition of type II skeletal muscle myosin may reduce skeletal muscle contractions while minimizing the impact on a subject’s daily activities.

[0038] In some embodiments, when healthy muscle is subjected to excessive, unaccustomed exercise, it develops soreness and sustained reductions in strength and range of motion. Proteins also leak from injured muscle fibers into circulation, including creatine kinase (CK), lactate dehydrogenase and myoglobin. These biomarkers are not unique to either fast or slow fibers and so do not provide detail regarding differences in fiber responses to injury. Troponin I (TNNI) is a component of the troponin complex that controls initiation of contraction of muscle by calcium. It is distinct in that there is a different isoform for each type of striated muscle: TNNI1 in slow skeletal muscle, TNNI2 in fast skeletal muscle and TNNI3 in cardiac muscle. Selective enzyme-linked immunosorbent assays (ELISAs) have been used to demonstrate that TNNI2 but not TNNI1 is elevated in circulation after injurious exercise, even under extreme conditions.

[0039] In some embodiments, DMD and BMD are caused by an absence (DMD) or truncation (BMD) of the dystrophin protein5. Dystrophin provides a structural link between the actin cytoskeleton and the basement membrane through the dystrophin-glycoprotein complex. When dystrophin is absent or truncated, contraction of muscle leads to heightened muscle stress and injury with normal use. While the sensitivity to injury is much higher in DMD muscle than in BMD or healthy muscle, fast fibers still appear to be more susceptible than slow fibers, with young DMD patients exhibiting histological evidence of disruption in fast fibers7 and early loss of type IIx fibers. In some embodiments, this disclosure provides selective inhibitors of fast-fiber skeletal muscle myosin as a treatment option for DMD, BMD, McArdle’s disease, or Limb-girdle muscular dystrophies.

[0040] In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a movement disorder, a neuromuscular condition, or a metabolic myopathy, the method comprising administering a compound or salt of any one of Formula (I) to a subject in need thereof.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601In some embodiments, the compound or salt of any one of Formula (I) inhibits skeletal muscle myosin II. In some embodiments, said movement disorder comprises muscle spasticity.Definitions

[0041] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which this invention belongs.

[0042] The phrase “compounds of the invention” refers to Compound 1.

[0043] As used in the specification and claims, the singular form “a”, “an” and “the” includes plural references unless the context clearly dictates otherwise.

[0044] The phrases “parenteral administration” and “administered parenterally” as used herein means modes of administration other than enteral and topical administration, usually by injection, and includes, without limitation, intravenous, intramuscular, intra-arterial, intrathecal, intracapsular, intraorbital, intracardiac, intradermal, intraperitoneal, transtracheal, subcutaneous, subcuticular, intraarticular, subcapsular, subarachnoid, intraspinal and intrasternal injection and infusion.

[0045] The phrase “pharmaceutically acceptable” is employed herein to refer to those compounds, materials, compositions, and / or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio.

[0046] The phrase “pharmaceutically acceptable excipient” or “pharmaceutically acceptable carrier” as used herein includes a pharmaceutically acceptable material, composition, or vehicle, such as a liquid or solid filler, diluent, excipient, solvent, or encapsulating material. Each carrier must be “acceptable” in the sense of being compatible with the other ingredients of the formulation and not injurious to the patient. Some examples of materials which can serve as pharmaceutically acceptable carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol; (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution;(19) ethyl alcohol; (20) phosphate buffer solutions; and (21) other non-toxic compatible substances employed in pharmaceutical formulations.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0047] As used herein, “treatment” or “treating” refers to an approach for obtaining beneficial or desired results with respect to a disease, disorder, or medical condition including but not limited to a therapeutic benefit and / or a prophylactic benefit. A therapeutic benefit can include, for example, the eradication or amelioration of the underlying disorder being treated. Also, a therapeutic benefit can include, for example, the eradication or amelioration of one or more of the physiological symptoms associated with the underlying disorder such that an improvement is observed in the subject, notwithstanding that the subject may still be afflicted with the underlying disorder. In certain embodiments, for prophylactic benefit, the compositions are administered to a subject at risk of developing a particular disease, or to a subject reporting one or more of the physiological symptoms of a disease, even though a diagnosis of this disease may not have been made. Treatment via administration of a compound described herein does not require the involvement of a medical professional.

[0048] The terms “hydrate” and “solvate” are meant to describe crystalline forms, e.g., of Compound 1, that include an amount of water or solvent, e.g., as supported by data derived from differential scanning calorimetry (DSC) experiments, thermogravimetric analysis (TGA) experiments, X-ray diffraction experiments, or the procedure for generating the solid crystalline form. In some embodiments, a solvate crystalline form or hydrate crystalline form comprises at least 1.5%, 1.75%, 2.0%, 2.5%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, 15.0%, or 20.0% of the total weight of the sample as water, solvent, or a combination thereof, as determined by TGA. In some embodiments, a solvate crystalline form or hydrate crystalline form exhibits at least one DSC endotherm onset before or within 30 °C of the boiling point of water or of the solvent(s) used in the generation of the crystalline form. For example, a hydrate crystalline form may have a DSC endotherm onset at 108 °C, with the endotherm peak positioned at 124 °C.

[0049] Crystalline solid forms termed a “solvate,” or “hydrate” are not meant to be limiting. For example, a solvate or hydrate can comprise a combination of water and solvent in the crystalline solid form.

[0050] The terms “type,” “form,” and “pattern” are meant to be used interchangeably and are meant to refer to a particular crystalline material with properties described herein. For example, “crystalline hydrate Type 1 of Compound 1,” “crystalline hydrate Form 1 of Compound 1,” and “XRPD Pattern 1 of Compound 1” refer to the same crystalline matter (e.g., the same crystalline phase of Compound 1).

[0051] The term "about" when referring to a number or a numerical range means that the number or numerical range referred to is an approximation within experimental variability (or within statisticalPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 experimental error), and thus the number or numerical range, in some instances, will vary between 1% and 15% of the stated number or numerical range.

[0052] The term "substantially similar" as used herein means an analytical spectrum, such as XRPD pattern, DSC thermogram, or TGA thermogram, which resembles the reference spectrum to a great degree in both the peak locations and peak intensity.Therapeutic Applications

[0053] Described herein, in some aspects, is a method for treating a neuromuscular condition, comprising administering to a subject in need thereof a dose of 1 mg to 40 mg per day of a compound of Formula (some embodiments, the administering to the sibject comprises a dose of 15 mg to 40 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 15 mg, 20 mg, 25 mg, or 30 mg per day of the compound of Formula (I). In some embodiments, the dose of the compound of Formula (I) comprises about 1 mg per day to about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises about 1 mg per day to about 2 mg per day, about 1 mg per day to about 2.5 mg per day, about 1 mg per day to about 3 mg per day, about 1 mg per day to about 5 mg per day, about 1 mg per day to about 7.5 mg per day, about 1 mg per day to about 10 mg per day, about 1 mg per day to about 12.5 mg per day, about 1 mg per day to about 15 mg per day, about 1 mg per day to about 20 mg per day, about 1 mg per day to about 25 mg per day, about 1 mg per day to about 30 mg per day, about 2 mg per day to about 2.5 mg per day, about 2 mg per day to about 3 mg per day, about 2 mg per day to about 5 mg per day, about 2 mg per day to about7.5 mg per day, about 2 mg per day to about 10 mg per day, about 2 mg per day to about 12.5 mg per day, about 2 mg per day to about 15 mg per day, about 2 mg per day to about 20 mg per day, about 2 mg per day to about 25 mg per day, about 2 mg per day to about 30 mg per day, about 2.5 mg per day to about 3 mg per day, about 2.5 mg per day to about 5 mg per day, about 2.5 mg per day to about 7.5 mg per day, about 2.5 mg per day to about 10 mg per day, about 2.5 mg per day to about12.5 mg per day, about 2.5 mg per day to about 15 mg per day, about 2.5 mg per day to about 20 mg per day, about 2.5 mg per day to about 25 mg per day, about 2.5 mg per day to about 30 mg per day, about 3 mg per day to about 5 mg per day, about 3 mg per day to about 7.5 mg per day, about 3 mgPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 per day to about 10 mg per day, about 3 mg per day to about 12.5 mg per day, about 3 mg per day to about 15 mg per day, about 3 mg per day to about 20 mg per day, about 3 mg per day to about 25 mg per day, about 3 mg per day to about 30 mg per day, about 5 mg per day to about 7.5 mg per day, about 5 mg per day to about 10 mg per day, about 5 mg per day to about 12.5 mg per day, about 5 mg per day to about 15 mg per day, about 5 mg per day to about 20 mg per day, about 5 mg per day to about 25 mg per day, about 5 mg per day to about 30 mg per day, about 7.5 mg per day to about 10 mg per day, about 7.5 mg per day to about 12.5 mg per day, about 7.5 mg per day to about 15 mg per day, about 7.5 mg per day to about 20 mg per day, about 7.5 mg per day to about 25 mg per day, about 7.5 mg per day to about 30 mg per day, about 10 mg per day to about 12.5 mg per day, about 10 mg per day to about 15 mg per day, about 10 mg per day to about 20 mg per day, about 10 mg per day to about 25 mg per day, about 10 mg per day to about 30 mg per day, about 12.5 mg per day to about 15 mg per day, about 12.5 mg per day to about 20 mg per day, about 12.5 mg per day to about 25 mg per day, about 12.5 mg per day to about 30 mg per day, about 15 mg per day to about 20 mg per day, about 15 mg per day to about 25 mg per day, about 15 mg per day to about 30 mg per day, about 20 mg per day to about 25 mg per day, about 20 mg per day to about 30 mg per day, or about 25 mg per day to about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises about 1 mg per day , about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, about 25 mg per day, or about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at least about 1 mg per day , about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, or about 25 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at most about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, about 25 mg per day, or about 30 mg per day.

[0054] In some embodiments, the dose of the compound of Formula (I) comprises at least about 1 mg per day to about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at least about 1 mg per day to about 2 mg per day, about 1 mg per day to about 2.5 mg per day, about 1 mg per day to about 3 mg per day, about 1 mg per day to about 5 mg per day, about 1 mg per day to about 7.5 mg per day, about 1 mg per day to about 10 mg per day, about 1 mg per day to about 12.5 mg per day, about 1 mg per day to about 15 mg per day, about 1 mg per day to about 20 mg per day, about 1 mg per day to about 25 mg per day, about 1 mg per day to about 30 mg per day, about 2 mg per day to about 2.5 mg per day, about 2 mg per day to about 3 mgPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 per day, about 2 mg per day to about 5 mg per day, about 2 mg per day to about 7.5 mg per day, about 2 mg per day to about 10 mg per day, about 2 mg per day to about 12.5 mg per day, about 2 mg per day to about 15 mg per day, about 2 mg per day to about 20 mg per day, about 2 mg per day to about 25 mg per day, about 2 mg per day to about 30 mg per day, about 2.5 mg per day to about 3 mg per day, about 2.5 mg per day to about 5 mg per day, about 2.5 mg per day to about 7.5 mg per day, about 2.5 mg per day to about 10 mg per day, about 2.5 mg per day to about 12.5 mg per day, about 2.5 mg per day to about 15 mg per day, about 2.5 mg per day to about 20 mg per day, about2.5 mg per day to about 25 mg per day, about 2.5 mg per day to about 30 mg per day, about 3 mg per day to about 5 mg per day, about 3 mg per day to about 7.5 mg per day, about 3 mg per day to about 10 mg per day, about 3 mg per day to about 12.5 mg per day, about 3 mg per day to about 15 mg per day, about 3 mg per day to about 20 mg per day, about 3 mg per day to about 25 mg per day, about 3 mg per day to about 30 mg per day, about 5 mg per day to about 7.5 mg per day, about 5 mg per day to about 10 mg per day, about 5 mg per day to about 12.5 mg per day, about 5 mg per day to about 15 mg per day, about 5 mg per day to about 20 mg per day, about 5 mg per day to about 25 mg per day, about 5 mg per day to about 30 mg per day, about 7.5 mg per day to about 10 mg per day, about7.5 mg per day to about 12.5 mg per day, about 7.5 mg per day to about 15 mg per day, about 7.5 mg per day to about 20 mg per day, about 7.5 mg per day to about 25 mg per day, about 7.5 mg per day to about 30 mg per day, about 10 mg per day to about 12.5 mg per day, about 10 mg per day to about 15 mg per day, about 10 mg per day to about 20 mg per day, about 10 mg per day to about 25 mg per day, about 10 mg per day to about 30 mg per day, about 12.5 mg per day to about 15 mg per day, about 12.5 mg per day to about 20 mg per day, about 12.5 mg per day to about 25 mg per day, about12.5 mg per day to about 30 mg per day, about 15 mg per day to about 20 mg per day, about 15 mg per day to about 25 mg per day, about 15 mg per day to about 30 mg per day, about 20 mg per day to about 25 mg per day, about 20 mg per day to about 30 mg per day, or about 25 mg per day to about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at least about 1 mg per day , about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, about 25 mg per day, or about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at least at least about 1 mg per day, about 2 mg per day, about2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, or about 25 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at least at most about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, about 25 mg per day, or about 30 mg per day.

[0055] In some embodiments, the dose of the compound of Formula (I) comprises at most about 1 mg per day to about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at most about 1 mg per day to about 2 mg per day, about 1 mg per day to about 2.5 mg per day, about 1 mg per day to about 3 mg per day, about 1 mg per day to about 5 mg per day, about 1 mg per day to about 7.5 mg per day, about 1 mg per day to about 10 mg per day, about 1 mg per day to about 12.5 mg per day, about 1 mg per day to about 15 mg per day, about 1 mg per day to about 20 mg per day, about 1 mg per day to about 25 mg per day, about 1 mg per day to about 30 mg per day, about 2 mg per day to about 2.5 mg per day, about 2 mg per day to about 3 mg per day, about 2 mg per day to about 5 mg per day, about 2 mg per day to about 7.5 mg per day, about 2 mg per day to about 10 mg per day, about 2 mg per day to about 12.5 mg per day, about 2 mg per day to about 15 mg per day, about 2 mg per day to about 20 mg per day, about 2 mg per day to about 25 mg per day, about 2 mg per day to about 30 mg per day, about 2.5 mg per day to about 3 mg per day, about 2.5 mg per day to about 5 mg per day, about 2.5 mg per day to about 7.5 mg per day, about 2.5 mg per day to about 10 mg per day, about 2.5 mg per day to about 12.5 mg per day, about 2.5 mg per day to about 15 mg per day, about 2.5 mg per day to about 20 mg per day, about2.5 mg per day to about 25 mg per day, about 2.5 mg per day to about 30 mg per day, about 3 mg per day to about 5 mg per day, about 3 mg per day to about 7.5 mg per day, about 3 mg per day to about 10 mg per day, about 3 mg per day to about 12.5 mg per day, about 3 mg per day to about 15 mg per day, about 3 mg per day to about 20 mg per day, about 3 mg per day to about 25 mg per day, about 3 mg per day to about 30 mg per day, about 5 mg per day to about 7.5 mg per day, about 5 mg per day to about 10 mg per day, about 5 mg per day to about 12.5 mg per day, about 5 mg per day to about 15 mg per day, about 5 mg per day to about 20 mg per day, about 5 mg per day to about 25 mg per day, about 5 mg per day to about 30 mg per day, about 7.5 mg per day to about 10 mg per day, about7.5 mg per day to about 12.5 mg per day, about 7.5 mg per day to about 15 mg per day, about 7.5 mg per day to about 20 mg per day, about 7.5 mg per day to about 25 mg per day, about 7.5 mg per day to about 30 mg per day, about 10 mg per day to about 12.5 mg per day, about 10 mg per day to about 15 mg per day, about 10 mg per day to about 20 mg per day, about 10 mg per day to about 25 mg per day, about 10 mg per day to about 30 mg per day, about 12.5 mg per day to about 15 mg per day, about 12.5 mg per day to about 20 mg per day, about 12.5 mg per day to about 25 mg per day, about12.5 mg per day to about 30 mg per day, about 15 mg per day to about 20 mg per day, about 15 mg per day to about 25 mg per day, about 15 mg per day to about 30 mg per day, about 20 mg per day to about 25 mg per day, about 20 mg per day to about 30 mg per day, or about 25 mg per day to aboutPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-74660130 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at most about 1 mg per day , about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, about 25 mg per day, or about 30 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at most at least about 1 mg per day , about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, or about 25 mg per day. In some embodiments, the dose of the compound of Formula (I) comprises at most at most about 2 mg per day, about 2.5 mg per day, about 3 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 20 mg per day, about 25 mg per day, or about 30 mg per day.

[0056] In some embodiments, the administering to the subject comprises a dose of 20 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 1 mg to 20 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprise a dose of 1 mg, 2 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, or 20 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 1 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 2 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 2.5 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 5 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 7.5 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 10 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 15 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 20 mg per day of the compound of Formula (I).

[0057] In some embodiments, the subject being treated by the compound of Formula (I) is over 18 years old. In some embodiments, the administering to the subject comprises a dose of 10 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 15 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 20 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 10 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 7.5 mg per day of the compound of Formula (I). In some embodiments, the administering to the subjectPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 comprises a dose of 5 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 2.5 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 2 mg per day of the compound of Formula (I). In some embodiments, the administering to the subject comprises a dose of 1 mg per day of the compound of Formula (I). In some embodiments, the administering comprises administering of a first dose of said muscle fast myosin (Type II) muscle fast myosin (Type II) inhibitor and one or more subsequent doses of said muscle fast myosin (Type II)muscle fast myosin (Type II) inhibitor, and optionally wherein the one or more subsequent doses are higher than the first dose. In some embodiments, said administering maintains a North Star Ambulatory Assessment (NSAA) score or increase the NSAA score of the subject relative to a pre-treatment NSAA score. In some embodiments, said administering maintains or improves one or more of the following functional measures of the subject: max elbow flexion strength relative to a pre-treatment max elbow flexion strength; max knee extension strength relative to a pre-treatment max knee extension strength; 10 meter walk / run velocity relative to a pre-treatment 10 meter walk / run velocity; 100 meter timed test velocity relative to a pre-treatment 100 meter timed test velocity; 4-stair climb time velocity relative to a pre-treatment 4-stair climb time velocity; and max-grip strength relative to a pre-treatment max-grip strength value. In some embodiments, said administering maintains a creatine kinase activity level or reduces the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more. In some embodiments, said administering maintains a creatine kinase activity level or increases the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more. In some embodiments, said administering maintains a Dual Energy X-ray absorptiometry (DXA) % lean mass of the subject or increase the DXA % lean mass of the subject relative to a pre-treatment DXA % lean mass by 5% or more. In some embodiments, said administering maintains a Fast Skeletal Muscle Troponin I (TNNI2) concentration of the subject or reduce the TNNI2 concentration of the subject relative to a pre-treatment TNNI2 concentration by 10% or more, and optionally wherein the TNNI2 concentration is inferred from a SOMAscan level. In some embodiments, said administering decreases protein concentration of one or more muscle injury biomarkers in the subject relative to a pre-treatment protein concentration of the one or more muscle injury biomarkers by 10% or more. In some embodiments, the one or more muscle injury biomarkers comprise ACTN2, MY0M2, MYBPC1, PDLIM3, MYL3, TNNI2, MYL11, CKB, CKM, APOBEC2, ENO3, CA3, KLHL41, ADSS1, CAPN3, HSPB6, TNNT2, MYBPC2, GPDl(a), MUSTN1, FBP2, DUSP29, MYBPH, GPDl(b), THAP4, CHCD10, or a combination thereof. In some embodiments, said administering decreases protein concentration of one or more pro-inflammatory proteins in the subject relative to aPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 pre-treatment protein concentration of the one or more pro-inflammatory proteins by 10% or more. In some embodiments, the one or more pro-inflammatory proteins comprise CCL22, CCL5, CXCL10, FGG, IFN-y, IL3, PPBP, PF4, or a combination thereof. In some embodiments, said administering increases protein concentration of one or more anti-inflammatory proteins in the subject relative to a pre-treatment protein concentration of the one or more anti-inflammatory proteins by 10% or more. In some embodiments, the one or more anti-inflammatory proteins comprise IL10, IL13, IL22, IL37, IL4, or a combination thereof. In some embodiments, the neuromuscular condition is selected from Becker Muscular Dystrophy, Duchenne Muscular Dystrophy, Limb-Girdle Muscular Dystrophy and McArdle Disease. In some embodiments, the administering comprises administering the compound of Formula (I) for 2 months or more, 3 months or more, 4 months or more, 5 months or more, 6 months or more, or 7 months or more. In some embodiments, prior to said administering, the method further comprises selecting a subject for treatment with one or more of characteristics (a)-(g): (a) a creatine kinase activity level is 1000 U / L or greater, 1200 U / L or greater, 1300 U / L or greater; (b) a TNNI2 concentration of 20 ng / mL or greater, 30 ng / mL or great or 40 ng / mL or greater; (c) a dystrophin gene mutation; (d) a pretreatment NSAA yearly change of -0.1 to -10, or -0.5 to -3; (e) a pre-treatment serum creatinine of 1 mg / dL or less, 0.8 mg / dL or less, 0.6 mg / dL or less; (f) a DXA % lean mass of <75%, less than 70%, less than 65%, less than 60%; and (g) a self-reported pain score associated with muscular dystrophy of 1.5 or greater, or 2 or greater.

[0058] The methods described herein are useful for the treatment of neuromuscular conditions. In some embodiments, the methods comprise administering a composition comprising a muscle fast myosin (Type II) muscle fast myosin (Type II) inhibitor and one or more pharmaceutically acceptable carriers, diluents, excipients, stabilizers, dispersing agents, suspending agents, and / or thickening agents. In some embodiments, the muscle fast myosin (Type II) muscle fast myosin (Type II) inhibitor is a compound described in W02020097266, WO2021231615, WO 2023220180, or WO 2024 / 055007. In some embodiments, the muscle fast myosin (Type II) muscle fast myosin (Type II) inhibitor is described in W02020097266. In some embodiments, the muscle myosin inhibitor is depicted as Formula (also referred to as Compound 1.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0059] Methods of administration of Compound 1 or another muscle fast myosin (Type II)muscle fast myosin (Type II) inhibitor may be used for the treatment of neuromuscular conditions and movement disorders. Examples of neuromuscular conditions include but are not limited to Duchenne Muscular Dystrophy, Becker muscular dystrophy, myotonic dystrophy 1, myotonic dystrophy 2, facioscapulohumeral muscular dystrophy, oculopharyngeal muscular dystrophy, limb girdle muscular dystrophies, tendinitis, and carpal tunnel syndrome. Examples of movement disorders include but are not limited to muscle spasticity disorders, spasticity associated with multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, or cerebral palsy, or injury or a traumatic event such as stroke, traumatic brain injury, spinal cord injury, hypoxia, meningitis, encephalitis, phenylketonuria, or amyotrophic lateral sclerosis. Also included are other conditions that may respond to the inhibition of skeletal myosin II, skeletal troponin C, skeletal troponin I, skeletal tropomyosin, skeletal troponin T, skeletal regulatory light chains, skeletal myosin binding protein C or skeletal actin. In some embodiments, neuromuscular conditions and movement disorders are selected from muscular dystrophies and myopathies. In some embodiments, muscular dystrophies are diseases that cause progressive weakness and loss of muscle mass where abnormal genes (mutations) interfere with the production of proteins needed to form healthy muscle. In some embodiments, muscular dystrophies are selected from Becker muscular dystrophy (BMD), Congenital muscular dystrophies (CMD), Duchenne muscular dystrophy (DMD), Emery-Dreifuss muscular dystrophy (EDMD), Facioscapulohumeral muscular dystrophy (FSHD), Limb-girdle muscular dystrophies (LGMD), Myotonic dystrophy (DM), and Oculopharyngeal muscular dystrophy (OPMD). In some embodiments, Congenital muscular dystrophies (CMD) is selected from Bethlem CMD, Fukuyama CMD, Muscle-eye-brain diseases (MEBs), Rigid spine syndromes, Ullrich CMD, and Walker- Warburg syndromes (WWS). In some embodiments, myopathies are diseases of muscle that are not caused by nerve disorders. Myopathies cause the muscles to become weak or shrunken (atrophied). In some embodiments, myopathies are selected from congenital myopathies, distal myopathies, endocrine myopathies, inflammatory myopathies, metabolic myopathies, myofibrillar myopathies (MFM), scapuloperoneal myopathy, and cardiomyopathies. In some embodiments, congenital myopathies are selected from cap myopathies, centronuclear myopathies, congenital myopathies with fiber type disproportion, core myopathies, central core disease, multiminicore myopathies, myosin storage myopathies, myotubular myopathy, and nemaline myopathies. In some embodiments, distal myopathies are selected from, GNE myopathy / Nonaka myopathy / hereditary inclusion-body myopathy (HIBM), Laing distal myopathy, Markesbery-Griggs late-onset distal myopathy, Miyoshi myopathy, Udd myopathy / tibial muscular dystrophy, VCP myopathy / IBMPFD, vocal cord and pharyngeal distal myopathy, and welander distal myopathy. In some embodiments, endocrinePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 myopathies are selected from, hyperthyroid myopathy, and hypothyroid myopathy. In some embodiments, inflammatory myopathies are selected from, dermatomyositis, inclusion-body myositis, and polymyositis. In some embodiments, metabolic myopathies are selected from, von Gierke’s disease, Anderson disease, Fanconi -Bickel syndrome, aldolase A deficiency, acid maltase deficiency (Pompe disease), carnitine deficiency, carnitine palmitoyltransferase deficiency, debrancher enzyme deficiency (Cori disease, Forbes disease), lactate dehydrogenase deficiency, myoadenylate deaminase deficiency, phosphofructokinase deficiency (Tarui disease), phosphoglycerate kinase deficiency, phosphoglycerate mutase deficiency (e.g., glycogen storage disease X), and phosphorylase deficiency (McArdle disease). In some embodiments, cardiomyopathies are selected from intrinsic cardiomyopathies and extrinsic cardiomyopathies. In some embodiments, intrinsic cardiomyopathies are selected from genetic myopathies and acquired myopathies. In some embodiments, genetic myopathies are selected from Hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy (ARVC), LV non-compaction, ion channelopathies, dilated cardiomyopathy (DCM), and restrictive cardiomyopathy (RCM). In some embodiments, acquired myopathies are selected from stress cardiomyopathy, myocarditis, eosinophilic myocarditis, and ischemic cardiomyopathy. In some embodiments, extrinsic cardiomyopathies are selected from metabolic cardiomyopathies, endomyocardial cardiomyopathies, endocrine cardiomyopathies, and cardiofacial cardiomyopathies. In some embodiments, metabolic cardiomyopathies are selected from Fabry's disease and hemochromatosis. In some embodiments, endomyocardial cardiomyopathies are selected from endomyocardial fibrosis and Hypereosinophilic syndrome. In some embodiments, endocrine cardiomyopathies are selected from diabetes mellitus, hyperthyroidism, and acromegaly. In some embodiments, the Cardiofacial cardiomyopathy is Noonan syndrome.

[0060] In an aspect, the present disclosure provides a method of treating activity-induced muscle damage, a movement disorder, a neuromuscular condition, or a metabolic myopathy, the method comprising administering a composition comprising a compound or salt of Formula (I) to a subject in need thereof. In some embodiments, the composition comprising a compound or salt of Formula (I) inhibits skeletal muscle myosin II. In some embodiments, said movement disorder comprises muscle spasticity. In some embodiments, said muscle spasticity may be selected from spasticity associated with multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, or cerebral palsy, or injury, or a traumatic event such as stroke, traumatic brain injury, spinal cord injury, hypoxia, meningitis, encephalitis, phenylketonuria, or amyotrophic lateral sclerosis.

[0061] Methods of administration of a composition comprising a compound or salt of Formula (I)discussed herein may be used for inhibiting muscle myosin II. In some embodiments, thePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 composition comprising a compound or salt of Formula (I)may be used to treat activity-induced muscle damage. In some embodiments, the composition comprising a compound or salt of Formula (I)may be used to treat neuromuscular conditions or movement disorders (which may comprise spasticity).

[0062] Methods of administration of a composition comprising a compound or salt of Formula (I) discussed herein may be used for the treatment of activity-induced muscle damage, neuromuscular conditions, movement disorders, or metabolic myopathies. In some embodiments, activity-induced muscle damage, neuromuscular conditions, movement disorders, or metabolic myopathies are treated through administration of a skeletal inhibitor. Examples of neuromuscular conditions include but are not limited to Duchenne Muscular Dystrophy, Becker muscular dystrophy, myotonic dystrophy 1, myotonic dystrophy 2, facioscapulohumeral muscular dystrophy, oculopharyngeal muscular dystrophy, limb girdle muscular dystrophies, tendinitis and carpal tunnel syndrome. Examples of movement disorders include but are not limited to muscle spasticity disorders, spasticity associated with multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, or cerebral palsy, or injury or a traumatic event such as stroke, traumatic brain injury, spinal cord injury, hypoxia, meningitis, encephalitis, phenylketonuria, or amyotrophic lateral sclerosis. Also included are other conditions that may respond to the inhibition of skeletal myosin II, skeletal troponin C, skeletal troponin I, skeletal tropomyosin, skeletal troponin T, skeletal regulatory light chains, skeletal myosin binding protein C or skeletal actin. In some embodiments, neuromuscular conditions and movement disorders are selected from muscular dystrophies and myopathies. In some embodiments, muscular dystrophies are diseases that cause progressive weakness and loss of muscle mass where abnormal genes (mutations) interfere with the production of proteins needed to form healthy muscle. In some embodiments, muscular dystrophies are selected from Becker muscular dystrophy (BMD), Congenital muscular dystrophies (CMD), Duchenne muscular dystrophy (DMD), Emery -Dreifuss muscular dystrophy (EDMD), Facioscapulohumeral muscular dystrophy (FSHD), Limb-girdle muscular dystrophies (LGMD), Myotonic dystrophy (DM), and Oculopharyngeal muscular dystrophy (OPMD). In some embodiments, Congenital muscular dystrophies (CMD) is selected from Bethlem CMD, Fukuyama CMD, Muscle-eye-brain diseases (MEBs), Rigid spine syndromes, Ullrich CMD, and Walker-Warburg syndromes (WWS). In some embodiments, myopathies are diseases of muscle that are not caused by nerve disorders. Myopathies cause the muscles to become weak or shrunken (atrophied). In some embodiments, myopathies are selected from congenital myopathies, distal myopathies, endocrine myopathies, inflammatory myopathies, metabolic myopathies, myofibrillar myopathies (MFM), scapuloperoneal myopathy, and cardiomyopathies. In some embodiments, congenital myopathies are selected from cap myopathies, centronuclearPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 myopathies, congenital myopathies with fiber type disproportion, core myopathies, central core disease, multiminicore myopathies, myosin storage myopathies, myotubular myopathy, and nemaline myopathies. In some embodiments, distal myopathies are selected from, gne myopathy / Nonaka myopathy / hereditary inclusion-body myopathy (HIBM), laing distal myopathy, Markesbery-Griggs late-onset distal myopathy, Miyoshi myopathy, Udd myopathy / tibial muscular dystrophy, VCP myopathy / IBMPFD, vocal cord and pharyngeal distal myopathy, and Welander distal myopathy. In some embodiments, endocrine myopathies are selected from, hyperthyroid myopathy, and hypothyroid myopathy. In some embodiments, inflammatory myopathies are selected from, dermatomyositis, inclusion-body myositis, and polymyositis. In some embodiments, metabolic myopathies are selected from, von Gierke’s disease, Anderson disease, Fanconi -Bickel syndrome, aldolase A deficiency, acid maltase deficiency (Pompe disease), carnitine deficiency, carnitine palmitoyltransferase deficiency, debrancher enzyme deficiency (Cori disease, Forbes disease), lactate dehydrogenase deficiency, myoadenylate deaminase deficiency, phosphofructokinase deficiency (Tarui disease), phosphoglycerate kinase deficiency, phosphoglycerate mutase deficiency (Her’s disease), and phosphorylase deficiency (e.g., McArdle’s disease). In some embodiments, metabolic myopathies are selected from McArdle’s disease. In some embodiments, cardiomyopathies are selected from intrinsic cardiomyopathies and extrinsic cardiomyopathies. In some embodiments, intrinsic cardiomyopathies are selected from genetic myopathies and acquired myopathies. In some embodiments, genetic myopathies are selected from Hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy (ARVC), LV non-compaction, ion channelopathies, dilated cardiomyopathy (DCM), and restrictive cardiomyopathy (RCM). In some embodiments, acquired myopathies are selected from stress cardiomyopathy, myocarditis, eosinophilic myocarditis, and ischemic cardiomyopathy. In some embodiments, extrinsic cardiomyopathies are selected from metabolic cardiomyopathies, endomyocardial cardiomyopathies, endocrine cardiomyopathies, and cardiofacial cardiomyopathies. In some embodiments, metabolic cardiomyopathies are selected from Fabry's disease and hemochromatosis. In some embodiments, endomyocardial cardiomyopathies are selected from endomyocardial fibrosis and Hypereosinophilic syndrome. In some embodiments, endocrine cardiomyopathies are selected from diabetes mellitus, hyperthyroidism, and acromegaly. In some embodiments, the Cardiofacial cardiomyopathy is Noonan syndrome. In some embodiments, the disease (e.g., activity-induced muscle damage, neuromuscular condition, movement disorder, or metabolic myopathy) comprises muscle wasting. In some embodiments, the muscle wasting comprises Cachexia. In some embodiments, the Cachexia is associated with one or more cancer(s). In some embodiments, the one or more cancer(s) is selected from renal cell carcinoma. In some embodiments, the muscle wasting arises from inactivity. In some embodiments, the muscle wastingPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 comprises acute quadriplegic myopathy. In some embodiments, the muscle wasting arises from a reaction against anesthetics. In some embodiments, the muscle wasting comprises rhabdomyolysis. In some embodiments, the muscle wasting comprises Compartment syndrome. In some embodiments, the disease comprises muscle pain. In some embodiments, the disease comprises back pain. In some embodiments, the disease comprises lower-back pain. In some embodiments, the disease comprises chronic back pain. In some embodiments, the disease comprises insomnia. In some embodiments, the disease is insomnia. In some embodiments, the compound or salt is administered in a low dose. In some embodiments, the disease is insomnia, and the compound or salt is administered in a low dose. In some embodiments, the subject in need thereof experiences enhanced strength and enhanced fatiguability. In some embodiments, the subject in need thereof does not experience muscle leakiness.

[0063] In some aspects, methods of treating neuromuscular conditions or movement disorders may comprise administering a composition comprising a compound or salt of Formula (I) to inhibit skeletal muscle contraction. In some embodiments, the composition comprising a compound or salt of Formula (I) does not significantly inhibit cardiac muscle contraction. In some embodiments, cardiac muscle contraction is inhibited by 20% or less. In some embodiments, cardiac muscle contraction is inhibited by 15% or less. In some embodiments, cardiac muscle contraction is inhibited by 10% or less. In some embodiments, cardiac muscle contraction is inhibited by 9% or less. In some embodiments, cardiac muscle contraction is inhibited by 8% or less. In some embodiments, cardiac muscle contraction is inhibited by 7% or less. In some embodiments, cardiac muscle contraction is inhibited by 6% or less. In some embodiments, cardiac muscle contraction is inhibited by 5% or less. In some embodiments, cardiac muscle contraction is inhibited by 4% or less. In some embodiments, cardiac muscle contraction is inhibited by 3% or less. In some embodiments, cardiac muscle contraction is inhibited by 2% or less. In some embodiments, cardiac muscle contraction is inhibited by 1% or less.

[0064] A subject’s activities of daily life (ADL) or habitual physical activity may be monitored prior to and following the treatment with the composition comprising a compound or salt of Formula (I). ADL or habitual physical activity is subject-dependent and may range from simple walking to extensive exercise depending on the subject’s ability and routine. Treatment options and dosages of the skeletal muscle contraction inhibitors discussed herein may be personalized to a subject such that the ADL and habitual physical activity remains unchanged.

[0065] In some aspects, methods of treating neuromuscular conditions or movement disorders may comprise administering a composition comprising a compound or salt of Formula (I) to inhibit skeletal muscle contraction. The composition comprising a compound or salt of Formula (I)may bePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 given in an amount relative to the amount needed to reduce skeletal muscle contraction by 50%. The composition comprising a compound or salt of Formula (I)may be administered in an amount less than the amount needed to reduce skeletal muscle contraction by 50% relative to pre-treatment skeletal muscle contraction capacity of the subject. The composition comprising a compound or salt of Formula (I)may be administered in an amount that reduces skeletal muscle contraction by 5% to 45% relative to pre-treatment skeletal muscle contraction capacity of said subject. In some cases, the composition comprising a compound or salt of Formula (I)may be administered in an amount that reduces skeletal muscle contraction by less than 10%, less than 15%, less than 20%, less than 25%, less than 30%, less than 35%, less than 40%, less than 45% or even less than 50% relative to pretreatment skeletal muscle contraction capacity of said subject. In certain embodiments, the composition comprising a compound or salt of Formula (I)may be administered in an amount that reduces skeletal muscle contraction from 1% to 50% relative to pre-treatment skeletal muscle contraction capacity of said subject.

[0066] In some aspects, methods of treating neuromuscular conditions or movement disorders may comprise administering a composition comprising a compound or salt of Formula (I)to inhibit type I skeletal muscle contraction. The inhibitor of type I skeletal muscle contraction may be given in an amount relative to the amount needed to reduce type I skeletal muscle contraction by 20%. The inhibitor of type I skeletal muscle contraction may be administered in an amount less than the amount needed to reduce type I skeletal muscle contraction by 20% relative to pre-treatment type I skeletal muscle contraction capacity of the subject. The inhibitor of type I skeletal muscle contraction may be administered in an amount that reduces type I skeletal muscle contraction by 0.01% to 20% relative to pre-treatment type I skeletal muscle contraction capacity of said subject. In some cases, the inhibitor may be administered in an amount that reduces type I skeletal muscle contraction by less than 0.01%, less than 0.1%, less than 0.5%, less than 1%, less than 5%, less than 10%, less than 15% or less than 20% relative to pre-treatment type I skeletal muscle contraction capacity of said subject. In certain embodiments, the inhibitor may be administered in an amount that reduces type I skeletal muscle contraction from 0.01% to 20% relative to pre-treatment type I skeletal muscle contraction capacity of said subject.

[0067] In some aspects, methods of treating neuromuscular conditions or movement disorders may comprise administering Compound 1 or a salt thereof to inhibit type II skeletal muscle contraction. The inhibitor of type II skeletal muscle contraction may be given in an amount relative to the amount needed to reduce type II skeletal muscle contraction by 90%. The inhibitor of type II skeletal muscle contraction may be administered in an amount less than the amount needed to reduce type II skeletal muscle contraction by 90% relative to pre-treatment type II skeletal muscle contraction capacity ofPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 the subject. The inhibitor of type II skeletal muscle contraction may be administered in an amount that reduces type II skeletal muscle contraction by 5% to 75% relative to pre-treatment type II skeletal muscle contraction capacity of said subject. In some cases, the inhibitor may be administered in an amount that reduces type II skeletal muscle contraction by less than 10%, less than 15%, less than 20%, less than 25%, less than 30%, less than 35%, less than 40%, less than 45%, less than 50%, less than 55%, less than 60%, less than 65%, less than 70%, less than 75%, less than 80%, less than 85% or even less than 90% relative to pre-treatment type II skeletal muscle contraction capacity of said subject. In certain embodiments, the inhibitor may be administered in an amount that reduces type II skeletal muscle contraction by from 1% to 50% relative to pre-treatment type II skeletal muscle contraction capacity of said subject.

[0068] In some aspects, methods of treating contraction-induced injury in skeletal muscle fiber may comprise administering the composition comprising a compound or salt of Formula (I)to inhibit skeletal muscle contraction and / or skeletal muscle fast myosin (Type Iljmuscle fast myosin (Type II). In certain embodiments, the inhibitor does not appreciably inhibit cardiac muscle contraction.

[0069] In some aspects, methods of treating metabolic myopathies, e.g. McArdle’s syndrome, may comprise administering a composition comprising a compound or salt of Formula (I).

[0070] In certain embodiments, the contraction-induced injury in skeletal muscle fiber is from involuntary skeletal muscle contraction. The involuntary skeletal muscle contraction may be associated with a neuromuscular condition or spasticity-associated condition. In certain embodiments, the contraction-induced injury in skeletal muscle fiber may be from voluntary skeletal muscle contraction, e.g., physical exercise.

[0071] In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject modulates one or more biomarkers associated with muscle contraction. Examples of biomarkers include but are not limited to creatinine, creatine kinase (CK), Troponin T (TnT), Troponin C (TnC), Troponin I (Tnl), pyruvate kinase (PK), lactate dehydrogenase (LDH), myoglobin, isoforms of Tnl (such as cardiac, slow skeletal, fast skeletal muscles) and inflammatory markers (IL-1, IL-6, IL-4, TNF-a). Biomarkers may also include measures of muscle inflammation for example, edema. The level of biomarkers described herein may increase after the administration of the inhibitor relative to pre-treatment level of the biomarkers. Alternatively, the level of biomarkers may decrease after the administration of the inhibitor relative to pre-treatment level of the biomarkers. The modulation of one or more biomarkers with an inhibitor described herein may indicate treatment of a neuromuscular condition such as those described herein.

[0072] In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I) or a salt thereof to a subject decreases one or more muscle injury biomarkers (e.g.,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 one or more of the muscle injury proteins shown in FIG. 14D). Examples of the one or more muscle injury biomarkers can include ACTN2, MY0M2, MYBPC1, PDLIM3, MYL3, TNNI2, MYL11, CKB, CKM, APOBEC2, ENO3, CA3, KLHL41, ADSS1, CAPN3, HSPB6, TNNT2, MYBPC2, GPDl(a), MUSTN1, FBP2, DUSP29, MYBPH, GPDl(b), THAP4, CHCD10, or a combination thereof. In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject decreases one or more muscle injury biomarkers during short-term treatment (e.g., 1-2 months of treatment with Compound 1). In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I) to a subject decreases one or more muscle injury biomarkers during mid-term treatment (e.g., 3-4 months of treatment with Compound 1). In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject decreases one or more muscle injury biomarkers during long-term treatment (e.g., 6-12 months of treatment with Compound 1).

[0073] In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject decreases one or more pro-inflammatory proteins (e.g., one or more of the pro-inflammatory proteins shown in FIG. 14G or FIG. 14H). Examples of the one or more pro- inflammatory proteins can include CCL22, CCL5, CXCL10, FGG, IFN-y, IL3, PPBP, PF4, or a combination thereof. In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I) to a subject decreases one or more pro-inflammatory proteins during short-term treatment (e.g., 1-2 months of treatment with Compound 1). In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject decreases one or more pro-inflammatory proteins during mid-term treatment (e.g., 3-4 months of treatment with Compound 1). In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I) to a subject decreases one or more pro-inflammatory proteins during long-term treatment (e.g., 6-12 months of treatment with Compound 1).

[0074] In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject increases one or more anti-inflammatory proteins (e.g., one or more of the anti-inflammatory proteins shown in FIG. 14G or FIG. 14H). Examples of the one or more antiinflammatory proteins can include IL 10, IL 13, IL22, IL37, IL4, or a combination thereof. In certain embodiments, the administration of Compound 1 or a salt thereof to a subject increases one or more anti-inflammatory proteins during short-term treatment (e.g., 1-2 months of treatment with Compound 1). In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I) to a subject increases one or more anti-inflammatory proteins during mid-term treatment (e.g., 3-4 months of treatment with Compound 1). In certain embodiments, the administration of the composition comprising a compound or salt of Formula (I)to a subject increasesPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 one or more anti-inflammatory proteins during long-term treatment (e.g., 6-12 months of treatment with Compound 1).

[0075] Levels of CK in a subject increase when the subject is active as compared to when the subject is inactive (e.g., sleeping) and therefore CK is a potential metric for evaluating skeletal muscle breakdown caused by skeletal muscle contraction. In certain embodiments, the composition comprising a compound or salt of Formula (I) may be administered to a subject prior to mild, moderate, or strenuous activity to reduce or prevent skeletal muscle breakdown from the activity. Moderate to strenuous activity may be dependent on a subject’s abilities and may include physical exercise that increases the heart rate by at least 20% or more, such as about 50% or more relative to the subject’s resting heart rate. Examples of moderate to strenuous activity include walking, running, weightlifting, biking, swimming, hiking, etc.

[0076] In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, the creatine kinase activity level of the subject is evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the evaluation is performed 1 month or more, 2 months or more, 3 months or more, 4 months or more, 6 months or more, 8 months or more, 12 months or more, 24 months or more, 18 months or more, or 24 months or more. In some embodiments, the creatine kinase activity level of the subject is evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the evaluation is performed 1 month or more, 2 months or more, 3 months or more, 4 months or more, 6 months or more, 8 months or more, 12 months or more, 24 months or more, 18 months or more, or 24 months or more following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, said administering comprises administering of a first dose of said muscle fast myosin (Type II) inhibitor and one or more subsequent doses of said muscle fast myosin (Type II) inhibitor. In some embodiments, the one or more subsequent doses are higher than the first dose. In some embodiments, the one or more subsequent doses are lower than the first dose. In some embodiments, the one or more subsequent doses are determined based on the level of creatine kinase activity evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the one or more subsequent doses are determined based on the level of creatine kinase activity evaluated following a previous dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the pre-treatment creatine kinasePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 activity level is evaluated within 1 month prior to the first dose of said muscle fast myosin (Type II) inhibitor to the subj ect.

[0077] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered prior to, during, or after moderate or strenuous activity to reduce or prevent skeletal muscle breakdown from the activity. Compound 1 or a salt thereof may reduce the subject’s level of CK relative to the untreated subject performing the same activity. The level of CK may be measured in the peripheral blood of the subject during or after the activity. The administration of an inhibitor described herein may reduce the level of CK by 5% to 90% in an active subject relative to the untreated subject performing the same activity, thereby reducing, or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may modulate the level of CK by about 5% to about 90% relative to the untreated subject performing the same activity, thereby reducing, or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may reduce the level of CK by at least about 5% relative to the untreated subject performing the same activity thereby reducing or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may modulate the level of CK by at most about 90% relative to the untreated subject performing the same activity. The administration of an inhibitor described herein may reduce the level of CK by about 5% to about 15%, about 5% to about 25%, about 5% to about 35%, about 5% to about 45%, about 5% to about 55%, about 5% to about 65%, about 5% to about 75%, about 5% to about 85%, about 5% to about 90%, about 15% to about 25%, about 15% to about 35%, about 15% to about 45%, about 15% to about 55%, about 15% to about 65%, about 15% to about 75%, about 15% to about 85%, about 15% to about 90%, about 25% to about 35%, about 25% to about 45%, about 25% to about 55%, about 25% to about 65%, about 25% to about 75%, about 25% to about 85%, about 25% to about 90%, about 35% to about 45%, about 35% to about 55%, about 35% to about 65%, about 35% to about 75%, about 35% to about 85%, about 35% to about 90%, about 45% to about 55%, about 45% to about 65%, about 45% to about 75%, about 45% to about 85%, about 45% to about 90%, about 55% to about 65%, about 55% to about 75%, about 55% to about 85%, about 55% to about 90%, about 65% to about 75%, about 65% to about 85%, about 65% to about 90%, about 75% to about 85%, about 75% to about 90%, or about 85% to about 90% relative to the untreated subject performing the same activity, thereby reducing or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may modulate the level of CK by about 5%, about 15%, about 25%, about 35%, about 45%, about 55%, about 65%, about 75%, about 85%, or about 90% relative to the untreated subject performing the same activity, thereby reducing, or preventing skeletal muscle breakdown from the activity.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0078] The treatment of muscle fast myosin (Type II) inhibitor, such as Compound 1, that lasts for varying durations may reduce the creatine kinase activity level of the subject. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 1 month to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 2 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pretreatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 3 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 4 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 5 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 6 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 7 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 8 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 9 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatinePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 10 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 11 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 12 months to maintain the creatine kinase activity level or reduce the creatine kinase activity level of the subject relative to a pre-treatment creatine kinase activity level by 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more.

[0079] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient to maintain or increase the lean mass of a subject as determined by Dual Energy x-Ray absorptiometry (DXA) %. In some embodiments, the lean mass of the subject is increased by 5% or more, 10% or more, 15% or more, 20% or more, 30% or more, 40% or more, or 50% or more. In some embodiments, the lean mass of the subject is evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the evaluation is performed 1 month or more, 2 months or more, 3 months or more, 4 months or more, 6 months or more, 8 months or more, 12 months or more, 24 months or more, 18 months or more, or 24 months or more following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, said administering comprises administering of a first dose of said muscle fast myosin (Type II) inhibitor and one or more subsequent doses of said muscle fast myosin (Type II) inhibitor. In some embodiments, the one or more subsequent doses are higher than the first dose. In some embodiments, the one or more subsequent doses are lower than the first dose. In some embodiments, the one or more subsequent doses are determined based on the level of lean mass evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the one or more subsequent doses are determined based on the level of lean mass evaluated following one or more previous doses of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the pre-treatment lean mass level is evaluated within 1 month prior to the first dose of said muscle fast myosin (Type II) inhibitor to the subject.

[0080] The administration of a composition comprising a compound or salt of Formula (I)to a subject may modulate the levels of circulating fast skeletal muscle Troponin I (fS-Tnl or TNNI2). The level of fS-Tnl may be measured in the peripheral blood. The level of fS-Tnl in the peripheralPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 blood may increase after the administration of the inhibitor relative to pre-treatment level of fS-Tnl for the subject. Alternatively, the level of fS-Tnl in the peripheral blood may decrease after the administration of the inhibitor relative to pre-treatment level of fS-Tnl for the subject. The administration of an inhibitor described herein may modulate the level of fS-Tnl by 5% to 90% relative to pre-treatment level of fS-Tnl for the subject. In some cases, the level of fS-Tnl may be modulated by at least about 5% relative to pre-treatment level of fS-Tnl of the subject. In some cases, the level of fS-Tnl may be modulated by at most about 90% relative to pre-treatment level of fS-Tnl of the subject. In some cases, the level of fS-Tnl may be modulated by about 5% to about 15%, about 5% to about 25%, about 5% to about 35%, about 5% to about 45%, about 5% to about 55%, about 5% to about 65%, about 5% to about 75%, about 5% to about 85%, about 5% to about 90%, about 15% to about 25%, about 15% to about 35%, about 15% to about 45%, about 15% to about 55%, about 15% to about 65%, about 15% to about 75%, about 15% to about 85%, about 15% to about 90%, about 25% to about 35%, about 25% to about 45%, about 25% to about 55%, about 25% to about 65%, about 25% to about 75%, about 25% to about 85%, about 25% to about 90%, about 35% to about 45%, about 35% to about 55%, about 35% to about 65%, about 35% to about 75%, about 35% to about 85%, about 35% to about 90%, about 45% to about 55%, about 45% to about 65%, about 45% to about 75%, about 45% to about 85%, about 45% to about 90%, about 55% to about 65%, about 55% to about 75%, about 55% to about 85%, about 55% to about 90%, about 65% to about 75%, about 65% to about 85%, about 65% to about 90%, about 75% to about 85%, about 75% to about 90%, or about 85% to about 90% relative to pre-treatment level of fS-Tnl of the subject. In some cases, the level of fS-Tnl may be modulated by about 5%, about 15%, about 25%, about 35%, about 45%, about 55%, about 65%, about 75%, about 85%, or about 90% relative to pretreatment level of fS-Tnl of the subject.

[0081] Isoforms of troponin may be measured in a subject prior to and following the administration of the composition comprising a compound or salt of Formula (I). Inhibition of skeletal muscle contraction may not inhibit some isoforms of troponin, such as cardiac troponin I (cTnl) or slow skeletal troponin I (ssTnl). In some cases, the inhibition of skeletal muscle contraction may not appreciably inhibit cTnl or ssTnl. As used herein with regard to cTnl or ssTnl, the phrase not appreciably refers to the cTnl or ssTnl reduced by less than 10%, less than 8%, less than 6%, less than 4%, less than 2%, less than 1%, less than 0.5% or even less than 0.1% relative to the cTnl or ssTnl prior to the administration of the inhibitor.

[0082] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject relative to a pre-treatment TNNI2 concentration. In some embodiments, the TNNI2 of thePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 subject is reduced by 5% or more, 10%, 15%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or more. In some embodiments, the TNNI2 of the subject is evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the evaluation is performed 1 month or more, 2 months or more, 3 months or more, 4 months or more, 6 months or more, 8 months or more, 12 months or more, 24 months or more, 18 months or more, or 24 months or more following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, said administering comprises administering of a first dose of said muscle fast myosin (Type II) inhibitor and one or more subsequent doses of said muscle fast myosin (Type II) inhibitor. In some embodiments, the one or more subsequent doses are higher than the first dose. In some embodiments, the one or more subsequent doses are lower than the first dose. In some embodiments, the one or more subsequent doses are determined based on the level of TNNI2 evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the one or more subsequent doses are determined based on the level of TNNI2 evaluated following one or more previous doses of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the pre-treatment TNNI2 level is evaluated within 1 month prior to the first dose of said muscle fast myosin (Type II) inhibitor to the subject.

[0083] The treatment of muscle fast myosin (Type II) inhibitor, such as Compound 1, that lasts for varying durations may reduce the TNNI2 level of the subject. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 1 month to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 2 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 3 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 4 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to thePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 subject for 5 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 6 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 7 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 8 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 9 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 10 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 11 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject for 12 months to maintain the TNNI2 level or reduce the TNNI2 level of the subject relative to a pre-treatment TNNI2 level by 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more.

[0084] Elevated levels of serum myoglobin may be found in patients with several types of neuromuscular conditions, so myoglobin may be a potential metric for evaluating progress of the neuromuscular conditions. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to maintain the myoglobin levelPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 or reduce the myoglobin level of the subject relative to a pre-treatment myoglobin level by 5% or more, by 10% or more, by 15% or more, 20% or more, by 25% or more, 30% or more, by 35% or more, 40% or more, by 45% or more, or 50% or more. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to maintain the myoglobin level or reduce the myoglobin level of the subject relative to a pre-treatment myoglobin level by about 5% to about 15%, about 5% to about 25%, about 5% to about 35%, about 5% to about 45%, about 5% to about 55%, about 5% to about 65%, about 5% to about 75%, about 5% to about 85%, about 5% to about 90%, about 15% to about 25%, about 15% to about 35%, about 15% to about 45%, about 15% to about 55%, about 15% to about 65%, about 15% to about 75%, about 15% to about 85%, about 15% to about 90%, about 25% to about 35%, about 25% to about 45%, about 25% to about 55%, about 25% to about 65%, about 25% to about 75%, about 25% to about 85%, about 25% to about 90%, about 35% to about 45%, about 35% to about 55%, about 35% to about 65%, about 35% to about 75%, about 35% to about 85%, about 35% to about 90%, about 45% to about 55%, about 45% to about 65%, about 45% to about 75%, about 45% to about 85%, about 45% to about 90%, about 55% to about 65%, about 55% to about 75%, about 55% to about 85%, about 55% to about 90%, about 65% to about 75%, about 65% to about 85%, about 65% to about 90%, about 75% to about 85%, about 75% to about 90%, or about 85% to about 90%. In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to maintain the myoglobin level or reduce the myoglobin level of the subject relative to a pre-treatment myoglobin level by about 5%, about 15%, about 25%, about 35%, about 45%, about 55%, about 65%, about 75%, about 85%, or about 90%.

[0085] In some embodiments, the myoglobin level of the subject is evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the evaluation is performed 1 month or more, 2 months or more, 3 months or more, 4 months or more, 6 months or more, 8 months or more, 12 months or more, 24 months or more, 18 months or more, or 24 months or more following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, said administering comprises administering of a first dose of said muscle fast myosin (Type II) inhibitor and one or more subsequent doses of said muscle fast myosin (Type II) inhibitor. In some embodiments, the one or more subsequent doses are higher than the first dose. In some embodiments, the one or more subsequent doses are lower than the first dose. In some embodiments, the one or more subsequent doses are determined based on the level of myoglobin evaluated following the first dose of said muscle fast myosin (Type II) inhibitor to the subject. In some embodiments, the one or more subsequent doses are determined based on the level of myoglobin evaluated following one or more previous dose of said muscle fast myosin (Type II) inhibitor to thePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 subject. In some embodiments, the pre-treatment myoglobin level is evaluated within 1 month prior to the first dose of said muscle fast myosin (Type II) inhibitor to the subject.

[0086] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered prior to, during, or after moderate or strenuous activity to reduce or prevent skeletal muscle breakdown from the activity. Compound 1 or a salt thereof may reduce the subject’s level of myoglobin relative to the untreated subject performing the same activity. The level of myoglobin may be measured in the peripheral blood of the subject during or after the activity. The administration of an inhibitor described herein may reduce the level of myoglobin by 5% to 90% in an active subject relative to the untreated subject performing the same activity, thereby reducing, or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may modulate the level of myoglobin by about 5% to about 90% relative to the untreated subject performing the same activity, thereby reducing, or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may reduce the level of myoglobin by at least about 5% relative to the untreated subject performing the same activity thereby reducing or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may modulate the level of myoglobin by at most about 90% relative to the untreated subject performing the same activity. The administration of an inhibitor described herein may reduce the level of myoglobin by about 5% to about 15%, about 5% to about 25%, about 5% to about 35%, about 5% to about 45%, about 5% to about 55%, about 5% to about 65%, about 5% to about 75%, about 5% to about 85%, about 5% to about 90%, about 15% to about 25%, about 15% to about 35%, about 15% to about 45%, about 15% to about 55%, about 15% to about 65%, about 15% to about 75%, about 15% to about 85%, about 15% to about 90%, about 25% to about 35%, about 25% to about 45%, about 25% to about 55%, about 25% to about 65%, about 25% to about 75%, about 25% to about 85%, about 25% to about 90%, about 35% to about 45%, about 35% to about 55%, about 35% to about 65%, about 35% to about 75%, about 35% to about 85%, about 35% to about 90%, about 45% to about 55%, about 45% to about 65%, about 45% to about 75%, about 45% to about 85%, about 45% to about 90%, about 55% to about 65%, about 55% to about 75%, about 55% to about 85%, about 55% to about 90%, about 65% to about 75%, about 65% to about 85%, about 65% to about 90%, about 75% to about 85%, about 75% to about 90%, or about 85% to about 90% relative to the untreated subject performing the same activity, thereby reducing or preventing skeletal muscle breakdown from the activity. The administration of an inhibitor described herein may modulate the level of myoglobin by about 5%, about 15%, about 25%, about 35%, about 45%, about 55%, about 65%, about 75%, about 85%, or about 90% relative to the untreated subject performing the same activity, thereby reducing, or preventing skeletal muscle breakdown from the activity.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0087] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject relative to a pre-treatment TNNI2 concentration. In some embodiments, the TNNI2 concentration is reduced by 120 ng / mL or more, 100 ng / mL or more, 80 ng / mL or more, 65 ng / mL or more, 50 ng / mL or more, 45 ng / mL or more, 40 ng / mL or more, 35 ng / mL or more, 30 ng / mL or more, 25 ng / mL or more, 20 ng / mL or more, 15 ng / mL or more, 10 ng / mL or more, 5 ng / mL or more. In some embodiments, the TNNI2 concentration is reduced by between about 5 to 120 ng / mL, between about 10 to 120 ng / mL, between about 20 to 100 ng / mL, 5 to 50 ng / mL, between about 5 to 45 ng / mL, between about 5 to 40 ng / mL, between about 5 to 35 ng / mL, between about 5 to 30 ng / mL, between about 5 to 25 ng / mL, between about 5 to 20 ng / mL, between about 5 to 15 ng / mL, between about 5 to 10 ng / mL, between about 10 to 40 ng / mL, between about 20 to 40 ng / mL, between about 25 to 35 ng / mL, between about 15 to 35 ng / mL, between about 10 to 20 ng / mL, between about 40 to 50 ng / mL, or between about 20 to 35 ng / mL.

[0088] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject to about 1 ng / mL to about 50 ng / mL. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject to about 1 ng / mL to about 3 ng / mL, about 1 ng / mL to about 5 ng / mL, about 1 ng / mL to about 8 ng / mL, about 1 ng / mL to about 10 ng / mL, about 1 ng / mL to about 15 ng / mL, about 1 ng / mL to about 20 ng / mL, about 1 ng / mL to about 25 ng / mL, about 1 ng / mL to about 30 ng / mL, about 1 ng / mL to about 35 ng / mL, about 1 ng / mL to about 40 ng / mL, about 1 ng / mL to about 50 ng / mL, about 3 ng / mL to about 5 ng / mL, about 3 ng / mL to about 8 ng / mL, about 3 ng / mL to about 10 ng / mL, about 3 ng / mL to about 15 ng / mL, about 3 ng / mL to about 20 ng / mL, about 3 ng / mL to about 25 ng / mL, about 3 ng / mL to about 30 ng / mL, about 3 ng / mL to about 35 ng / mL, about 3 ng / mL to about 40 ng / mL, about 3 ng / mL to about 50 ng / mL, about 5 ng / mL to about 8 ng / mL, about 5 ng / mL to about 10 ng / mL, about 5 ng / mL to about 15 ng / mL, about 5 ng / mL to about 20 ng / mL, about 5 ng / mL to about 25 ng / mL, about 5 ng / mL to about 30 ng / mL, about 5 ng / mL to about 35 ng / mL, about 5 ng / mL to about 40 ng / mL, about 5 ng / mL to about 50 ng / mL, about 8 ng / mL to about 10 ng / mL, about 8 ng / mL to about 15 ng / mL, about 8 ng / mL to about 20 ng / mL, about 8 ng / mL to about 25 ng / mL, about 8 ng / mL to about 30 ng / mL, about 8 ng / mL to about 35 ng / mL, about 8 ng / mL to about 40 ng / mL, about 8 ng / mL to about 50 ng / mL, about 10 ng / mL to about 15 ng / mL, about 10 ng / mL to about 20 ng / mL, about 10 ng / mL to about 25 ng / mL, about 10 ng / mL to about 30 ng / mL, about 10 ng / mL to about 35 ng / mL, about 10 ng / mL to about 40 ng / mL, about 10 ng / mL to about 50 ng / mL, about 15 ng / mL to about 20PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 ng / mL, about 15 ng / mL to about 25 ng / mL, about 15 ng / mL to about 30 ng / mL, about 15 ng / mL to about 35 ng / mL, about 15 ng / mL to about 40 ng / mL, about 15 ng / mL to about 50 ng / mL, about 20 ng / mL to about 25 ng / mL, about 20 ng / mL to about 30 ng / mL, about 20 ng / mL to about 35 ng / mL, about 20 ng / mL to about 40 ng / mL, about 20 ng / mL to about 50 ng / mL, about 25 ng / mL to about 30 ng / mL, about 25 ng / mL to about 35 ng / mL, about 25 ng / mL to about 40 ng / mL, about 25 ng / mL to about 50 ng / mL, about 30 ng / mL to about 35 ng / mL, about 30 ng / mL to about 40 ng / mL, about 30 ng / mL to about 50 ng / mL, about 35 ng / mL to about 40 ng / mL, about 35 ng / mL to about 50 ng / mL, or about 40 ng / mL to about 50 ng / mL. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject to about 1 ng / mL, about 3 ng / mL, about 5 ng / mL, about 8 ng / mL, about 10 ng / mL, about 15 ng / mL, about 20 ng / mL, about 25 ng / mL, about 30 ng / mL, about 35 ng / mL, about 40 ng / mL, or about 50 ng / mL. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject to at least about 1 ng / mL, about 3 ng / mL, about 5 ng / mL, about 8 ng / mL, about 10 ng / mL, about 15 ng / mL, about 20 ng / mL, about 25 ng / mL, about 30 ng / mL, about 35 ng / mL, or about 40 ng / mL. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the TNNI2 concentration of the subject to at most about 3 ng / mL, about 5 ng / mL, about 8 ng / mL, about 10 ng / mL, about 15 ng / mL, about 20 ng / mL, about 25 ng / mL, about 30 ng / mL, about 35 ng / mL, about 40 ng / mL, or about 50 ng / mL.

[0089] In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to reduce serum creatine kinase (CK) levels by 10 U / L or more, 20 U / L or more, 30 U / L or more, 40 U / L or more, 50 U / L or more, 60 U / L or more, 70 U / L or more, 80 U / L or more, 90 U / L or more, 100 U / L or more, 200 U / L or more, 300 U / L or more, 400 U / L or more, 500 U / L or more, 600 U / L or more, 700 U / L or more, 800 U / L or more, 900 U / L or more, 1000 U / L or more, 1100 U / L or more, 1200 U / L or more, 1300 U / L or more, 1400 U / L or more, 1500 U / L or more. In some embodiments, CK levels are reduced by between about 500 U / L and 1500 U / L, about 800 U / L and 1400 U / L, about 1000 U / L and 1300 U / L, or about 1100 U / L and 1300 U / L.

[0090] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the serum creatine kinase (CK) levels of the subject to about 400 U / L to about 1,500 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the serum creatine kinase (CK) levels of the subject to about 400 U / L toPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 about 500 U / L, about 400 U / L to about 600 U / L, about 400 U / L to about 700 U / L, about 400 U / L to about 800 U / L, about 400 U / L to about 900 U / L, about 400 U / L to about 1,000 U / L, about 400 U / L to about 1,100 U / L, about 400 U / L to about 1,200 U / L, about 400 U / L to about 1,300 U / L, about 400 U / L to about 1,400 U / L, about 400 U / L to about 1,500 U / L, about 500 U / L to about 600 U / L, about 500 U / L to about 700 U / L, about 500 U / L to about 800 U / L, about 500 U / L to about 900 U / L, about 500 U / L to about 1,000 U / L, about 500 U / L to about 1,100 U / L, about 500 U / L to about 1,200 U / L, about 500 U / L to about 1,300 U / L, about 500 U / L to about 1,400 U / L, about 500 U / L to about 1,500 U / L, about 600 U / L to about 700 U / L, about 600 U / L to about 800 U / L, about 600 U / L to about 900 U / L, about 600 U / L to about 1,000 U / L, about 600 U / L to about 1,100 U / L, about 600 U / L to about 1,200 U / L, about 600 U / L to about 1,300 U / L, about 600 U / L to about 1,400 U / L, about 600 U / L to about 1,500 U / L, about 700 U / L to about 800 U / L, about 700 U / L to about 900 U / L, about 700 U / L to about 1,000 U / L, about 700 U / L to about 1,100 U / L, about 700 U / L to about 1,200 U / L, about 700 U / L to about 1,300 U / L, about 700 U / L to about 1,400 U / L, about 700 U / L to about 1,500 U / L, about 800 U / L to about 900 U / L, about 800 U / L to about 1,000 U / L, about 800 U / L to about 1,100 U / L, about 800 U / L to about 1,200 U / L, about 800 U / L to about 1,300 U / L, about 800 U / L to about 1,400 U / L, about 800 U / L to about 1,500 U / L, about 900 U / L to about 1,000 U / L, about 900 U / L to about 1,100 U / L, about 900 U / L to about 1,200 U / L, about 900 U / L to about 1,300 U / L, about 900 U / L to about 1,400 U / L, about 900 U / L to about 1,500 U / L, about 1,000 U / L to about 1,100 U / L, about 1,000 U / L to about 1,200 U / L, about 1,000 U / L to about 1,300 U / L, about 1,000 U / L to about 1,400 U / L, about 1,000 U / L to about 1,500 U / L, about 1,100 U / L to about 1,200 U / L, about 1,100 U / L to about 1,300 U / L, about 1,100 U / L to about 1,400 U / L, about 1,100 U / L to about 1,500 U / L, about 1,200 U / L to about 1,300 U / L, about 1,200 U / L to about 1,400 U / L, about 1,200 U / L to about 1,500 U / L, about 1,300 U / L to about 1,400 U / L, about 1,300 U / L to about 1,500 U / L, or about 1,400 U / L to about 1,500 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the serum creatine kinase (CK) levels of the subject to about 400 U / L, about 500 U / L, about 600 U / L, about 700 U / L, about 800 U / L, about 900 U / L, about 1,000 U / L, about 1,100 U / L, about 1,200 U / L, about 1,300 U / L, about 1,400 U / L, or about 1,500 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the serum creatine kinase (CK) levels of the subject to at least about 400 U / L, about 500 U / L, about 600 U / L, about 700 U / L, about 800 U / L, about 900 U / L, about 1,000 U / L, about 1,100 U / L, about 1,200 U / L, about 1,300 U / L, or about 1,400 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce the serum creatine kinase (CK) levels of the subject to at mostPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 about 500 U / L, about 600 U / L, about 700 U / L, about 800 U / L, about 900 U / L, about 1,000 U / L, about 1,100 U / L, about 1,200 U / L, about 1,300 U / L, about 1,400 U / L, or about 1,500 U / L.

[0091] In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to reduce myoglobin levels by 10 ng / mL or more, 20 ng / mL or more, 30 ng / mL or more, 40 ng / mL or more, 50 ng / mL or more, 60 ng / mL or more, 70 ng / mL or more, 80 ng / mL or more, 90 ng / mL or more, 100 ng / mL or more, 200 ng / mL or more, 300 ng / mL or more, 400 ng / mL or more, 500 ng / mL or more, 600 ng / mL or more, 700 ng / mL or more, 800 ng / mL or more, 900 ng / mL or more, 1000 ng / mL or more.

[0092] In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce myoglobin levels of the subject to about 100 U / L to about 400 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce myoglobin levels of the subject to about 100 U / L to about 150 U / L, about 100 U / L to about 200 U / L, about 100 U / L to about 250 U / L, about 100 U / L to about 300 U / L, about 100 U / L to about350 U / L, about 100 U / L to about 400 U / L, about 150 U / L to about 200 U / L, about 150 U / L to about250 U / L, about 150 U / L to about 300 U / L, about 150 U / L to about 350 U / L, about 150 U / L to about400 U / L, about 200 U / L to about 250 U / L, about 200 U / L to about 300 U / L, about 200 U / L to about350 U / L, about 200 U / L to about 400 U / L, about 250 U / L to about 300 U / L, about 250 U / L to about350 U / L, about 250 U / L to about 400 U / L, about 300 U / L to about 350 U / L, about 300 U / L to about400 U / L, or about 350 U / L to about 400 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce myoglobin levels of the subject to about 100 U / L, about 150 U / L, about 200 U / L, about 250 U / L, about 300 U / L, about 350 U / L, or about 400 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce myoglobin levels of the subject to at least about 100 U / L, about 150 U / L, about 200 U / L, about 250 U / L, about 300 U / L, or about 350 U / L. In certain embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1 or a salt thereof, is administered in an amount sufficient maintain or reduce myoglobin levels of the subject to at most about 150 U / L, about 200 U / L, about 250 U / L, about 300 U / L, about 350 U / L, or about 400 U / L.

[0093] In some embodiments, a muscle fast myosin (Type II) inhibitor, such as Compound 1, is administered to the subject in an amount sufficient to increase serum creatinine levels by 1 mg / dL or more, 0.8 mg / dL or more, 0.6 mg / dL or more, 0.5 mg / dL or more, 0.4 mg / dL or more, 0.3 mg / dL or more, 0.2 mg / dL or more, or 0.1 mg / dL or more.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0094] The administration of a composition comprising a compound or salt of Formula (I)may reduce involuntary muscle contractions. Involuntary muscle contractions may be reduced by 20% to 90% relative to involuntary muscle contractions prior to the administration of the inhibitor. In some cases, involuntary muscle contractions may be reduced by at least about 20% relative to pretreatment involuntary muscle contractions. In some cases, involuntary muscle contractions may be reduced by at most about 90% relative to pre-treatment involuntary muscle contractions. In some cases, involuntary muscle contractions may be reduced by about 20% to about 25%, about 20% to about 30%, about 20% to about 40%, about 20% to about 50%, about 20% to about 70%, about 20% to about 75%, about 20% to about 80%, about 20% to about 85%, about 20% to about 90%, about 25% to about 30%, about 25% to about 40%, about 25% to about 50%, about 25% to about 70%, about 25% to about 75%, about 25% to about 80%, about 25% to about 85%, about 25% to about 90%, about 30% to about 40%, about 30% to about 50%, about 30% to about 70%, about 30% to about 75%, about 30% to about 80%, about 30% to about 85%, about 30% to about 90%, about 40% to about 50%, about 40% to about 70%, about 40% to about 75%, about 40% to about 80%, about 40% to about 85%, about 40% to about 90%, about 50% to about 70%, about 50% to about 75%, about 50% to about 80%, about 50% to about 85%, about 50% to about 90%, about 70% to about 75%, about 70% to about 80%, about 70% to about 85%, about 70% to about 90%, about 75% to about 80%, about 75% to about 85%, about 75% to about 90%, about 80% to about 85%, about 80% to about 90%, or about 85% to about 90% relative to pre-treatment involuntary muscle contractions. In some cases, involuntary muscle contractions may be reduced by about 20%, about 25%, about 30%, about 40%, about 50%, about 70%, about 75%, about 80%, about 85%, or about 90% relative to pre-treatment involuntary muscle contractions.

[0095] The composition comprising a compound or salt of Formula (I)may be used to improve activities of daily living (ADL) or habitual physical activity in a subject as mature, functional undamaged muscle may be restored. Examples of ADL or habitual activities include but are not limited to stair climb, time to get up, timed chair rise, habitual walk speed, North Star Ambulatory Assessment (NSAA), incremental / endurance shuttle walk and 6 minute walk distance tests. ADL or habitual physical activity levels or capacity may be measured prior to and following the administration of a skeletal muscle inhibitor. Inhibition of skeletal muscle contraction may not affect ADL or habitual physical activity. In some cases, the inhibition of skeletal muscle contraction may not appreciably affect ADL or habitual physical activity. As used herein with regard to ADL or habitual physical activity, the phrase not appreciably refers to the level of ADL or habitual activity reduced by less than 20%, less than 15%, less than 10%, less than 8%, less than 6%, less than 4%,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 less than 2%, less than 1%, less than 0.5% or even less than 0.1% relative to the ADL or habitual activity prior to the administration of the inhibitor.

[0096] In some embodiments, the administration of the composition comprising a compound or salt of Formula (I)affect ADL or habitual physical activity of the subject. In some embodiments, the North Star Ambulatory Assessment is used to evaluate the progression of a neuromuscular disease in the subject over time. On average there is an estimated average yearly decrease of -1.22 for patients 10 to 32 years if age. In some embodiments, administration of the composition comprising a compound or salt of Formula (I)slows the rate at which the neuromuscular disease progresses as determined by NSAA scores. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than -1.22. In some embodiments, administration of the composition comprising a compound or salt of Formula (I)increases the average yearly NSAA score to greater than -1. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than -0.5. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than -0.4. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than -0.3. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than -0.2. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than -0.1. In some embodiments, administration of Compound 1 or a salt increases the average yearly NSAA score to greater than 0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 0.1. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 0.2. In some embodiments, administration of the composition comprising a compound or salt of Formula (I)increases the average yearly NSAA score to greater than 0.3. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 0.4. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 0.5. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 1.0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 2.0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I)PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 increases the average yearly NSAA score to greater than 3.0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 4.0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 5.0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average yearly NSAA score to greater than 10.0. In some embodiments, administration of the composition comprising a compound or salt of Formula (I) increases the average monthly NSAA score to at least -0.1, 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 2.0, 3.0, 4.0, 5.0, or 10.0.

[0097] In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to about 10. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to 2. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to 1.5. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to 1. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to 0.5. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to 0. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2 to -0.5. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1. to 2. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -0.5 to 2. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about 0 to 5. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1. to 5. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -0.5 to 4. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about 0 to 3. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about 2 to 10. In some embodiments, administration of a muscle fast myosin (Type II) inhibitor increases the NSAA score of the patient to greater than about -1.2, about -1, about -0.75, about -0.5, about -0.25, about 0, about 0.25, about 0.5, about 0.75, about 1, about 1.5, or about 2, about 3, about 4, about 5, about 6, about 7, about 8, or about 10.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0098] In some embodiments, the NSAA score of a patient increases following the administration of a muscle myosin inhibitor, such as Compound 1. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 1 month to about 24 months. In some embodiments, the NSAA score of a patient increases following the administration of a muscle myosin inhibitor, such as Compound 1. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 2 month to about 12 months. In some embodiments, the NSAA score of a patient increases following the administration of a muscle myosin inhibitor, such as Compound 1. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 4 month to about 12 months. In some embodiments, the NSAA score of a patient increases following the administration of a muscle myosin inhibitor, such as Compound 1. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 6 month to about 18 months. In some embodiments, the NSAA score of a patient increases following the administration of a muscle myosin inhibitor, such as Compound 1. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 2 month to about 6 months. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 10 months, about 12 months, about 18 months, or about 24 months. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for at least about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 10 months, about 12 months, or about 18 months. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for at most about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 10 months, about 12 months, about 18 months, or about 24 months.

[0099] Administering to a subject a muscle fast myosin (Type II) inhibitor, such as Compound 1, in an amount sufficient to maintain or improve one or more functional measures of the subject. In some embodiments, functional measures are selected from 100 meter timed test velocity relative to a pretreatment 100 meter timed test velocity; 4-stair climb time velocity relative to a pre-treatment 4-stair climb time velocity; 10 meter walk / run velocity relative to a pre-treatment 10 meter walk / run velocity; max elbow flexion strength relative to a pre-treatment max elbow flexion strength; max knee extension strength relative to a pre-treatment max knee extension strength; and max-grip strength relative to a pre-treatment max-grip strength value. In some embodiments, functional measures include evaluation of the patients ability to: perform Gower’s maneuver, walk, stand up from a chair, stand on one leg, climb a box with a leg step, descend a box with a leg step, sit down, rise from the floor, lift head, stand on heels, jump with two feet, hop with on foot, or run.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0100] In some embodiments, the muscle fast myosin (Type II) inhibitor is administered in an amount sufficient to maintain the one or more functional measures of the subject relative to the pretreatment value. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered in an amount sufficient to improve the one or more functional measures of the subject relative to the pre-treatment value. In some embodiments, the one or more functional measures is maintained to within 20%, 30%, 40%, or 50% of the pre-treatment value. In some embodiments, the one or more functional measures are maintained for 2 months or more, for 4 months or more, for 6 months or more, for 8 months or more, for 12 months or more, for 18 months or more, for 24 months or more, or for 36 months or more.

[0101] Skeletal muscle contraction or force in a subject may be measured prior to and following the administration of the composition comprising a compound or salt of Formula (I) thereof. Such measurements may be performed to generate a dose response curve for Compound 1 or a salt thereof. Dosage of Compound 1 or a salt thereof may be adjusted by about 5% to 50% relative to a dose that reduces type II skeletal muscle contraction by 90%. In some cases, dosage of the skeletal muscle contraction inhibitor may be adjusted by at least about 5% relative to a dose that reduces type II skeletal muscle contraction by 90%. In some cases, dosage of the skeletal muscle contraction inhibitor may be adjusted by at most about 50% relative to a dose that reduces type II skeletal muscle contraction by 90%. In some cases, dosage of the skeletal muscle contraction inhibitor may be adjusted by about 5 % to about 10 %, about 5 % to about 15 %, about 5 % to about 20 %, about 5 % to about 25 %, about 5 % to about 30 %, about 5 % to about 35 %, about 5 % to about 40 %, about 5 % to about 50 %, about 10 % to about 15 %, about 10 % to about 20 %, about 10 % to about 25 %, about 10 % to about 30 %, about 10 % to about 35 %, about 10 % to about 40 %, about 10 % to about 50 %, about 15 % to about 20 %, about 15 % to about 25 %, about 15 % to about 30 %, about 15 % to about 35 %, about 15 % to about 40 %, about 15 % to about 50 %, about 20 % to about 25 %, about 20 % to about 30 %, about 20 % to about 35 %, about 20 % to about 40 %, about 20 % to about 50 %, about 25 % to about 30 %, about 25 % to about 35 %, about 25 % to about 40 %, about 25 % to about 50 %, about 30 % to about 35 %, about 30 % to about 40 %, about 30 % to about 50 %, about 35 % to about 40 %, about 35 % to about 50 %, or about 40 % to about 50 % relative to a dose that reduces type II skeletal muscle contraction by 90%. In some cases, dosage of the skeletal muscle contraction inhibitor may be adjusted by about 10%, about 12%, about 15%, about 18%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45% or about 50% relative to a dose that reduces type II skeletal muscle contraction by 90%. Skeletal muscle contraction may be measured by a muscle force test after nerve stimulation using surface electrodes (e.g., foot plantar flexion after peroneal nerve stimulation in the leg), isolated limb assay, heart rate monitor or anPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 activity monitor or equivalents thereof prior to and following the administration of a skeletal muscle contraction inhibitor.

[0102] Tidal volume in lung in a subject may be measured prior to and following the administration of the composition comprising a compound or salt of Formula (I) . Administration may not inhibit tidal volume in a lung. In some cases, administration may not appreciably inhibit tidal volume in a lung. In certain embodiments with regard to tidal lung volume in a lung, the phrase not appreciably refers to the tidal volume in a lung reduced by less than 10%, less than 8%, less than 6%, less than 4%, less than 2%, less than 1%, less than 0.5% or less than 0.1% relative to the tidal volume in a lung prior to the administration of the inhibitor. Tidal volume in a lung in a subject may be measured using forced volume in one second test (FEV1) or forced vital capacity test (FVC) or equivalent tests thereof.

[0103] Smooth muscle contraction in a subject may be measured prior to and following the administration of a skeletal muscle contraction inhibitor. Inhibition of skeletal muscle contraction may not inhibit smooth muscle contraction. In some cases, the inhibition of skeletal muscle contraction may not appreciably inhibit smooth muscle contraction. As used herein with regard to smooth muscle contraction, the phrase not appreciably refers to the smooth muscle contraction reduced by less than 10%, less than 8%, less than 6%, less than 4%, less than 2%, less than 1%, less than 0.5% or even less than 0.1% relative to the smooth muscle contraction prior to the administration of the inhibitor. Smooth muscle contraction in a subject may be evaluated by measuring a subject’s blood pressure.

[0104] Neuromuscular coupling in a subject may be measured prior to and following the administration of the composition comprising a compound or salt of Formula (I). Inhibition of skeletal muscle contraction, with an inhibitor described herein, may not impair nerve conduction, neurotransmitter release or electrical depolarization of skeletal muscle in a subject. In some cases, the inhibition of skeletal muscle contraction may not appreciably impair neuromuscular coupling in a subject. As used herein with regard to neuromuscular coupling, the phrase not appreciably refers to a level of neuromuscular coupling in the subject reduced by less than 10%, less than 8%, less than 6%, less than 4%, less than 2%, less than 1%, less than 0.5% or less than 0.1% relative to the level of neuromuscular coupling in the subject prior to the administration of the inhibitor. Neuromuscular coupling in a subject may be evaluated by measuring nerve induced electrical depolarization of skeletal muscle by the recording of electrical activity produced by skeletal muscles after electrical or voluntary stimulation with electromyography (EMG) using surface or needle electrodes.

[0105] Pain may be associated with the neuromuscular condition disclosed herein. Therefore, disclosed here is a method of reducing a pain associated with a neuromuscular condition, comprisingPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 administering to a subject in need thereof a muscle fast myosin (Type II) inhibitor. In some embodiments, the pain is diffused. In some embodiments, the pain is in a spine of the subject. In some embodiments, the pain in in calves of the subject. In some embodiments, the pain is associated with Becker muscular dystrophy (BMD), Duchenne muscular dystrophy (DMD), Limb-girdle muscular dystrophies (LGMD), McArdle disease, and other neuromuscular conditions.

[0106] In some embodiments, a muscle fast myosin (Type II) inhibitor is administered to a subject exhibiting a dystrophin gene mutation selected from del 45-48, del 45-47, del 48, del x-51, del 45- 55, and del 48-49.

[0107] In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma PK value of 500 ng / mL or higher, 1,000 ng / mL or higher, 1,200 ng / mL or higher, 1,400 ng / mL or higher, 1,800 ng / mL or higher, 2,000 ng / mL or higher, 2,200 ng / mL or higher, 2,300 ng / mL or higher, 2,400 ng / mL or higher, 2,500 ng / mL or higher, 2,800 ng / mL or higher, 3,000 ng / mL or higher, or 4,000 ng / mL or higher. In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma PK value of between about 500 ng / mL and 4,000 ng / mL, between about 500 ng / mL and 4,000 ng / mL, between about 1,000 ng / mL and 3,000 ng / mL, between about 1,300 ng / mL and 2,800 ng / mL, between about 1,400 ng / mL and 2,600 ng / mL, between about 2,000 ng / mL and 2,600 ng / mL, or between about 2,200 ng / mL and 2,400 ng / mL.

[0108] In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma concentration of about 10 ng / mL to about 200 ng / mL. In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma concentration of about 10 ng / mL to about 20 ng / mL, about 10 ng / mL to about 30 ng / mL, about 10 ng / mL to about 40 ng / mL, about 10 ng / mL to about 50 ng / mL, about 10 ng / mL to about 60 ng / mL, about 10 ng / mL to about 70 ng / mL, about 10 ng / mL to about 80 ng / mL, about 10 ng / mL to about 90 ng / mL, about 10 ng / mL to about 100 ng / mL, about 10 ng / mL to about 150 ng / mL, about 10 ng / mL to about 200 ng / mL, about 20 ng / mL to about 30 ng / mL, about 20 ng / mL to about 40 ng / mL, about 20 ng / mL to about 50 ng / mL, about 20 ng / mL to about 60 ng / mL, about 20 ng / mL to about 70 ng / mL, about 20 ng / mL to about 80 ng / mL, about 20 ng / mL to about 90 ng / mL, about 20 ng / mL to about 100 ng / mL, about 20 ng / mL to about 150 ng / mL, about 20 ng / mL to about 200 ng / mL, about 30 ng / mL to about 40 ng / mL, about 30 ng / mL to about 50 ng / mL, about 30 ng / mL to about 60 ng / mL, about 30 ng / mL to about 70 ng / mL, about 30 ng / mL to about 80 ng / mL, about 30 ng / mL to about 90 ng / mL, about 30 ng / mL to about 100 ng / mL, about 30 ng / mL to about 150 ng / mL, about 30 ng / mL to about 200 ng / mL, about 40 ng / mL to about 50 ng / mL, about 40 ng / mL to about 60 ng / mL, about 40 ng / mL to about 70 ng / mL, about 40 ng / mL to about 80 ng / mL, about 40 ng / mL to about 90 ng / mL, about 40 ng / mL to about 100 ng / mL, about 40 ng / mL to about 150 ng / mL, about 40 ng / mL to about 200PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 ng / mL, about 50 ng / mL to about 60 ng / mL, about 50 ng / mL to about 70 ng / mL, about 50 ng / mL to about 80 ng / mL, about 50 ng / mL to about 90 ng / mL, about 50 ng / mL to about 100 ng / mL, about 50 ng / mL to about 150 ng / mL, about 50 ng / mL to about 200 ng / mL, about 60 ng / mL to about 70 ng / mL, about 60 ng / mL to about 80 ng / mL, about 60 ng / mL to about 90 ng / mL, about 60 ng / mL to about 100 ng / mL, about 60 ng / mL to about 150 ng / mL, about 60 ng / mL to about 200 ng / mL, about 70 ng / mL to about 80 ng / mL, about 70 ng / mL to about 90 ng / mL, about 70 ng / mL to about 100 ng / mL, about 70 ng / mL to about 150 ng / mL, about 70 ng / mL to about 200 ng / mL, about 80 ng / mL to about 90 ng / mL, about 80 ng / mL to about 100 ng / mL, about 80 ng / mL to about 150 ng / mL, about 80 ng / mL to about 200 ng / mL, about 90 ng / mL to about 100 ng / mL, about 90 ng / mL to about 150 ng / mL, about 90 ng / mL to about 200 ng / mL, about 100 ng / mL to about 150 ng / mL, about 100 ng / mL to about 200 ng / mL, or about 150 ng / mL to about 200 ng / mL. In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma concentration of about 10 ng / mL, about 20 ng / mL, about 30 ng / mL, about 40 ng / mL, about 50 ng / mL, about 60 ng / mL, about 70 ng / mL, about 80 ng / mL, about 90 ng / mL, about 100 ng / mL, about 150 ng / mL, or about 200 ng / mL. In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma concentration of at least about 10 ng / mL, about 20 ng / mL, about 30 ng / mL, about 40 ng / mL, about 50 ng / mL, about 60 ng / mL, about 70 ng / mL, about 80 ng / mL, about 90 ng / mL, about 100 ng / mL, or about 150 ng / mL. In some embodiments, Compound 1 is administered to a subject in a sufficient quantity to maintain a plasma concentration of at most about 20 ng / mL, about 30 ng / mL, about 40 ng / mL, about 50 ng / mL, about 60 ng / mL, about 70 ng / mL, about 80 ng / mL, about 90 ng / mL, about 100 ng / mL, about 150 ng / mL, or about 200 ng / mL.

[0109] The muscle fast myosin (Type II) inhibitor may be administered for varying duration. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 months. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered for more than 1 month, more than 2 months, more than 3 months, more than 4 months, more than 5 months, more than 6 months, more than 7 months, more than 8 months, more than 9 months, more than 10 months, more than 11 months, or more than 12 months.

[0110] In some embodiments, Compound 1 is administered. In some embodiments, Compound 1 is administered in a daily dose of about 1 mg to about 10 mg. In some embodiments, Compound 1 is administered in a daily dose of about 1 mg to about 2 mg, about 1 mg to about 2.5 mg, about 1 mg to about 3 mg, about 1 mg to about 4 mg, about 1 mg to about 5 mg, about 1 mg to about 6 mg, about 1 mg to about 7 mg, about 1 mg to about 7.5 mg, about 1 mg to about 8 mg, about 1 mg to about 9 mg, about 1 mg to about 10 mg, about 2 mg to about 2.5 mg, about 2 mg to about 3 mg, about 2 mg to about 4 mg, about 2 mg to about 5 mg, about 2 mg to about 6 mg, about 2 mg to about 7 mg, about 2PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 mg to about 7.5 mg, about 2 mg to about 8 mg, about 2 mg to about 9 mg, about 2 mg to about 10 mg, about 2.5 mg to about 3 mg, about 2.5 mg to about 4 mg, about 2.5 mg to about 5 mg, about 2.5 mg to about 6 mg, about 2.5 mg to about 7 mg, about 2.5 mg to about 7.5 mg, about 2.5 mg to about 8 mg, about 2.5 mg to about 9 mg, about 2.5 mg to about 10 mg, about 3 mg to about 4 mg, about 3 mg to about 5 mg, about 3 mg to about 6 mg, about 3 mg to about 7 mg, about 3 mg to about 7.5 mg, about 3 mg to about 8 mg, about 3 mg to about 9 mg, about 3 mg to about 10 mg, about 4 mg to about 5 mg, about 4 mg to about 6 mg, about 4 mg to about 7 mg, about 4 mg to about 7.5 mg, about 4 mg to about 8 mg, about 4 mg to about 9 mg, about 4 mg to about 10 mg, about 5 mg to about 6 mg, about 5 mg to about 7 mg, about 5 mg to about 7.5 mg, about 5 mg to about 8 mg, about 5 mg to about 9 mg, about 5 mg to about 10 mg, about 6 mg to about 7 mg, about 6 mg to about 7.5 mg, about 6 mg to about 8 mg, about 6 mg to about 9 mg, about 6 mg to about 10 mg, about 7 mg to about 7.5 mg, about 7 mg to about 8 mg, about 7 mg to about 9 mg, about 7 mg to about 10 mg, about 7.5 mg to about 8 mg, about 7.5 mg to about 9 mg, about 7.5 mg to about 10 mg, about 8 mg to about 9 mg, about 8 mg to about 10 mg, or about 9 mg to about 10 mg. In some embodiments, Compound 1 is administered in a daily dose of about 1 mg, about 2 mg, about 2.5 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 7.5 mg, about 8 mg, about 9 mg, or about 10 mg. In some embodiments, Compound 1 is administered in a daily dose of at least about 1 mg, about 2 mg, about 2.5 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 7.5 mg, about 8 mg, or about 9 mg. In some embodiments, Compound 1 is administered in a daily dose of at most about 2 mg, about 2.5 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about7.5 mg, about 8 mg, about 9 mg, or about 10 mg. In some embodiments, Compound 1 is administered in a daily dose of about 2.5 mg to about 20 mg. In some embodiments, Compound 1 is administered in a daily dose of about 2.5 mg to about 5 mg, about 2.5 mg to about 7.5 mg, about 2.5 mg to about 10 mg, about 2.5 mg to about 12.5 mg, about 2.5 mg to about 15 mg, about 2.5 mg to about 17.5 mg, about 2.5 mg to about 20 mg, about 5 mg to about 7.5 mg, about 5 mg to about 10 mg, about 5 mg to about 12.5 mg, about 5 mg to about 15 mg, about 5 mg to about 17.5 mg, about 5 mg to about 20 mg, about 7.5 mg to about 10 mg, about 7.5 mg to about 12.5 mg, about 7.5 mg to about 15 mg, about 7.5 mg to about 17.5 mg, about 7.5 mg to about 20 mg, about 10 mg to about12.5 mg, about 10 mg to about 15 mg, about 10 mg to about 17.5 mg, about 10 mg to about 20 mg, about 12.5 mg to about 15 mg, about 12.5 mg to about 17.5 mg, about 12.5 mg to about 20 mg, about 15 mg to about 17.5 mg, about 15 mg to about 20 mg, or about 17.5 mg to about 20 mg. In some embodiments, Compound 1 is administered in a daily dose of about 2.5 mg, about 5 mg, about 7.5 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg. In some embodiments, Compound 1 is administered in a daily dose of at least about 2.5 mg, about 5 mg,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 about 7.5 mg, about 10 mg, about 12.5 mg, about 15 mg, or about 17.5 mg. In some embodiments, Compound 1 is administered in a daily dose of at most about 5 mg, about 7.5 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg.[oni] In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a constant dosage throughout the whole treatment. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a constant dosage throughout about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 months. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a constant dosage for more than 1 month, more than 2 months, more than 3 months, more than 4 months, more than 5 months, more than 6 months, more than 7 months, more than 8 months, more than 9 months, more than 10 months, more than 11 months, or more than 12 months. In some embodiments, the constant dosage is more than Img / day, more than 2.5mg / day, more than 5mg / day, more than lOmg / day, more than 15mg / day, more than 20mg / day, more than 25mg / day, more than 30mg / day, more than 35mg / day, or more than 40mg / day. In some embodiments, the constant dosage is less than Img / day, less than 2.5mg / day, less than 5mg / day, less than lOmg / day, less than 15mg / day, less than 20mg / day, less than 25mg / day, less than 30mg / day, less than 35mg / day, less than 40mg / day, less than 45mg / day, less than 50mg / day, less than 55mg / day, or less than 60mg / day. In some embodiments, the constant dosage is about Img / day, 2mg / day, 2.5mg / day, 3mg / day, 4mg / day, 5mg / day, 6mg / day, 7mg / day, 7.5mg / day, 8mg / day, 9mg / day, lOmg / day, 1 Img / day, 12mg / day, 12.5mg / day, 13mg / day, 14mg / day, 15mg / day, 16mg / day, 17mg / day, 17,5mg / day, 18mg / day, 19mg / day,or 20mg / day. In some preferred embodiments, the constant dosage is about lOmg / day.

[0112] In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage throughout the whole treatment. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage throughout about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 months. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage for more than 1 month, more than 2 months, more than 3 months, more than 4 months, more than 5 months, more than 6 months, more than 7 months, more than 8 months, more than 9 months, more than 10 months, more than 11 months, or more than 12 months. In specific embodiments, the muscle fast myosin (Type II) inhibitor is administered at a deescalating dosage throughout the treatment. In specific embodiments, the muscle fast myosin (Type II) inhibitor is administered at an escalating dosage throughout the treatment. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at xmg / day, followed by (x+5)mg / day, further followed by (x+5 times 2)mg / day, further followed by (x+5 times 3)mg / day, further followed by (x+5 times 4)mg / day, lastly followed by (x+5 times y)mg / day where x can be a number between 1-100, 5-100,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-7466015-50, 5-20, or 5-10, and y can be a number between 1-10. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at xmg / day, followed by (x+5)mg / day, and further followed by (x+10)mg / day, where x can be between 1-100, 5-100, 5-50, 5-20, or 5-10. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at lOmg / day, followed by 15mg / day, and further followed by 20mg / day.

[0113] In some embodiments where the muscle fast myosin (Type II) inhibitor is administered at a varying dosage throughout the treatment, the varying dosage lasts for about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 months. In some specific embodiments, the muscle fast myosin (Type II) inhibitor is administered at lOmg / day for 1stand 2ndmonth, followed by 15mg / day from 3rdmonth to 6thmonth, and further followed by 20mg / day from 7thmonth to 12thmonth.

[0114] The muscle fast myosin (Type II) inhibitor may be administered at a varying dosage which is determined in real time based on one or more biomarkers and / or the plasma concentration of the muscle fast myosin (Type II) inhibitor in the subject. In some embodiments, the varying dosage is determined by whether it is sufficient to reduce one or more biomarkers (e.g., creatine kinase, lactate dehydrogenase, myoglobin, TNNI2). In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a plasma concentration of said muscle fast myosin (Type II) inhibitor in the subject in an optimal range. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a plasma concentration of said muscle fast myosin (Type II) inhibitor in the subject to be between 5ng / ml to 200ng / ml, between lOng / ml to 200ng / ml, between lOng / ml to 150ng / ml, between lOng / ml to 140ng / ml, between lOng / ml to 130ng / ml, between lOng / ml to 120ng / ml, between lOng / ml to HOng / ml, between lOng / ml to lOOng / ml, between lOng / ml to 80ng / ml, between 20ng / ml to 70ng / ml, between 40ng / ml to 60ng / ml, between 40ng / ml to lOOng / ml, between 20ng / ml to 200ng / ml, between 20ng / ml to 150ng / ml, between 20ng / ml to 140ng / ml, between 20ng / ml to 130ng / ml, between 20ng / ml to 120ng / ml, between 20ng / ml to 1 lOng / ml, between 20ng / ml to lOOng / ml, between 30ng / ml to 200ng / ml, between 30ng / ml to 150ng / ml, between 30ng / ml to 140ng / ml, between 30ng / ml to 130ng / ml, between 30ng / ml to 120ng / ml, between 30ng / ml to HOng / ml, between 30ng / ml to lOOng / ml, between 40ng / ml to 200ng / ml, between 40ng / ml to 150ng / ml, between 40ng / ml to 140ng / ml, between 40ng / ml to 130ng / ml, between 40ng / ml to 120ng / ml, between 40ng / ml to1 lOng / ml, or between 40ng / ml to lOOng / ml. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a plasma concentration of said muscle fast myosin (Type II) inhibitor in the subject to be between lOng / ml to lOOng / ml, between lOng / ml to lOOng / ml, between lOng / ml to lOOng / ml, 20ng / ml to lOOng / ml, or 30ng / ml to lOOng / ml. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage toPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 maintain a plasma concentration of said muscle fast myosin (Type II) inhibitor in the subject to be more than lOng / ml, more than 15ng / ml, more than 20ng / ml, more than 25ng / ml, more than 30ng / ml, more than 35ng / ml, or more than 40ng / ml. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a plasma concentration of said muscle fast myosin (Type II) inhibitor in the subject to be less than 70ng / ml, less than 60ng / ml, less than 50ng / ml, less than 40ng / ml, or less than 30ng / ml. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a plasma concentration of said muscle fast myosin (Type II) inhibitor in the subject to be between 15ng / ml to 70ng / ml, between 15ng / ml to 60ng / ml, between 15ng / ml to 50ng / ml, between 15ng / ml to 40ng / ml, between 15ng / ml to 30ng / ml, between 15ng / ml to 20ng / ml, between 20ng / ml to 70ng / ml, between 25ng / ml to 70ng / ml, between 30ng / ml to 70ng / ml, between 35ng / ml to 70ng / ml, between 40ng / ml to 70ng / ml, between 45ng / ml to 70ng / ml, between 50ng / ml to 70ng / ml, between 55ng / ml to 70ng / ml, between 60ng / ml to 70ng / ml, or between 65ng / ml to 70ng / ml.

[0115] In some embodiments, the muscle fast myosin (Type II) inhibitor is enriched in muscles. Accordingly, in some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a muscle concentration of said muscle fast myosin (Type II) inhibitor in the subject to be more than 500 ng / g, more than 600 ng / g, more than 700 ng / g, more than 800 ng / g, more than 900 ng / g, more than 1000 ng / g, more than 1100 ng / g, more than 1200 ng / g, more than 1300 ng / g, more than 1400 ng / g, more than 1500 ng / g, more than 2000 ng / g, or more than 3000 ng / g. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a muscle concentration of said muscle fast myosin (Type II) inhibitor in the subject to be less than 10000 ng / g, less than 9000 ng / g, less than 8000 ng / g, less than 7000 ng / g, less than 6000 ng / g, less than 5000 ng / g, less than 4000 ng / g, or less than 3000 ng / g. In some embodiments, the muscle fast myosin (Type II) inhibitor is administered at a varying dosage to maintain a muscle concentration of said muscle fast myosin (Type II) inhibitor in the subject to be between 1000 ng / g to 4000 ng / g, between 1000 ng / g to 3000 ng / g, between 1000 ng / g to 2000 ng / g, between 2000 ng / g to 4000 ng / g, between 2000 ng / g to 4000 ng / g, or between 3000 ng / g to 4000 ng / g.

[0116] The compositions and methods described herein may be considered useful as pharmaceutical compositions for administration to a subject in need thereof. Pharmaceutical compositions may comprise a muscle fast myosin (Type II) inhibitor and one or more pharmaceutically acceptable carriers, diluents, excipients, stabilizers, dispersing agents, suspending agents, and / or thickening agents. In some embodiments, the muscle fast myosin (Type II) inhibitor is a compound or salt thereof described in W02020097266, WO2021231615, WO 2023220180, or WO 2024 / 055007. InPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 some embodiments, the muscle fast myosin (Type II) inhibitor is described in W02020097266. In some embodiments, the muscle myosin inhibitor is the compound of Formula (I):, also referred to as Compound 1.

[0117] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may be formulated using one or more physiologically-acceptable carriers comprising excipients and auxiliaries. Formulation may be modified depending upon the route of administration chosen. Pharmaceutical compositions comprising a compound, salt or conjugate may be manufactured, for example, by lyophilizing the compound, salt or conjugate, mixing, dissolving, emulsifying, encapsulating, or entrapping the conjugate. The pharmaceutical compositions may also include the compounds, salts or conjugates in a free-base form or pharmaceutically-acceptable salt form.

[0118] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may include formulating any of the compounds, salts, or conjugates with one or more inert, pharmaceutically-acceptable excipients or carriers to form a solid, semi-solid, or liquid composition. Solid compositions may include, for example, powders, tablets, dispersible granules, and capsules, and in some aspects, the solid compositions further contain nontoxic, auxiliary substances, for example wetting or emulsifying agents, pH buffering agents, and other pharmaceutically-acceptable additives. Alternatively, the compounds, salts or conjugates may be lyophilized or in powder form for re-constitution with a suitable vehicle, e.g., sterile pyrogen-free water, before use.

[0119] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may comprise at least one active ingredient (e.g., a compound, salt or conjugate and other agents). The active ingredients may be entrapped in microcapsules prepared, for example, by coacervation techniques or by interfacial polymerization (e.g., hydroxymethylcellulose or gelatin microcapsules and poly-(methylmethacylate) microcapsules, respectively), in colloidal drug-delivery systems (e.g., liposomes, albumin microspheres, microemulsions, nano-particles and nanocapsules) or in macroemulsions.

[0120] The compositions and formulations may be sterilized. Sterilization may be accomplished by filtration through sterile filtration.

[0121] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may be formulated for administration as an injection. Non-limiting examples of formulations for injectionPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 may include a sterile suspension, solution, or emulsion in oily or aqueous vehicles. Suitable oily vehicles may include, but are not limited to, lipophilic solvents or vehicles such as fatty oils or synthetic fatty acid esters, or liposomes. Aqueous injection suspensions may contain substances which increase the viscosity of the suspension. The suspension may also contain suitable stabilizers. Injections may be formulated for bolus injection or continuous infusion. Alternatively, the compositions may be lyophilized or in powder form for reconstitution with a suitable vehicle, e.g., sterile pyrogen-free water, before use.

[0122] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may be formulated in a unit dosage injectable form (e.g., solution, suspension, emulsion) in association with a pharmaceutically acceptable parenteral vehicle. Such vehicles may be inherently non-toxic, and non-therapeutic. Vehicles may be water, saline, Ringer’s solution, dextrose solution, and 5% human serum albumin. Non-aqueous vehicles such as fixed oils and ethyl oleate may also be used. Liposomes may be used as carriers. The vehicle may contain minor amounts of additives such as substances that enhance isotonicity and chemical stability (e.g., buffers and preservatives).

[0123] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may be formulated for oral delivery to a subject in need. In one embodiment a composition is formulated so as to deliver one or more pharmaceutically active agents to a subject through a mucosa layer in the mouth or esophagus. In another embodiment the composition is formulated to deliver one or more pharmaceutically active agents to a subject through a mucosa layer in the stomach and / or intestines.

[0124] In one embodiment compositions comprising a muscle fast myosin (Type II) inhibitor may include modified release dosage forms. Suitable modified release dosage vehicles include, but are not limited to, hydrophilic or hydrophobic matrix devices, water-soluble separating layer coatings, enteric coatings, osmotic devices, multi-particulate devices, and combinations thereof. The compositions may also comprise non-release controlling excipients.

[0125] In another embodiment compositions comprising a muscle fast myosin (Type II) inhibitor may be provided in enteric coated dosage forms. These enteric coated dosage forms can also comprise non-release controlling excipients. In one embodiment the compositions are in the form of enteric-coated granules, as controlled-release capsules for oral administration. The compositions can further comprise cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, pyridazine, lactose, mannitol, or sodium lauryl sulfate. In another embodiment the compositions are in the form of enteric-coated pellets, as controlled-release capsules for oral administration. The compositions can further comprise glycerol monostearate 40-50, hydroxypropyl cellulose, pyridazine, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, or triethyl citrate.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0126] In another embodiment the compositions comprising a muscle fast myosin (Type II) inhibitor are enteric-coated controlled-release tablets for oral administration. The compositions can further comprise carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, pyridazine phthalate, magnesium stearate, mannitol, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide, or yellow ferric oxide.

[0127] Sustained release compositions comprising a muscle fast myosin (Type II) inhibitor may also be prepared. Examples of sustained-release preparations may include semipermeable matrices of solid hydrophobic polymers that may contain the compound, salt or conjugate, and these matrices may be in the form of shaped articles (e.g., films or microcapsules). Examples of sustained-release matrices may include polyesters, hydrogels (e.g., poly(2-hydroxyethyl-methacrylate), or poly(vinyl alcohol)), polylactides, copolymers of L-glutamic acid and y ethyl-L-glutamate, non-degradable ethylene-vinyl acetate, degradable lactic acid-glycolic acid copolymers such as the LUPRON DEPO™ (i.e., injectable microspheres composed of lactic acid-glycolic acid copolymer and leuprolide acetate), and poly-D-(-)-3 -hydroxybutyric acid.

[0128] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may be prepared for storage by mixing a compound, salt or conjugate with a pharmaceutically acceptable carrier, excipient, and / or a stabilizer. This formulation may be a lyophilized formulation or an aqueous solution. Acceptable carriers, excipients, and / or stabilizers may be nontoxic to recipients at the dosages and concentrations used. Acceptable carriers, excipients, and / or stabilizers may include buffers such as phosphate, citrate, and other organic acids; antioxidants including ascorbic acid and methionine; preservatives, polypeptides; proteins, such as serum albumin or gelatin; hydrophilic polymers; amino acids; monosaccharides, disaccharides, and other carbohydrates including glucose, mannose, or dextrin; chelating agents such as EDTA; sugars such as sucrose, mannitol, trehalose or sorbitol; salt-forming counter-ions such as sodium; metal complexes; and / or non-ionic surfactants or polyethylene glycol. Examples of saccharides comprise comprise glucose (e.g., dextrose), arabinose, mannitol, fructose (e.g., levulose), allulose, or galactose, sucrose, sucralose, trehalose, maltose, lactose, cellobiose, chitobiose, isomaltose, cellulose and its derivatives such as sodium carboxymethyl cellulose, ethyl cellulose, or methyl cellulose.

[0129] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor can further comprise calcium stearate, crospovidone, hydroxypropyl methylcellulose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate.

[0130] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor can be provided in a dosage form that has at least one component that can facilitate the immediate release ofPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 an active agent, and at least one component that can facilitate the controlled release of an active agent. In a further embodiment the dosage form can be capable of giving a discontinuous release of the compound in the form of at least two consecutive pulses separated in time from 0.1 up to 24 hours. The compositions can comprise one or more release controlling and non-release controlling excipients, such as those excipients suitable for a disruptable semi-permeable membrane and as swellable substances.

[0131] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor are provided in a dosage form for oral administration to a subject, which comprise one or more pharmaceutically acceptable excipients or carriers, enclosed in an intermediate reactive layer comprising a gastric juice-resistant polymeric layered material partially neutralized with alkali and having cation exchange capacity and a gastric juice-resistant outer layer.

[0132] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor provided herein can be in unit-dosage forms or multiple-dosage forms. Unit-dosage forms, as used herein, refer to physically discrete units suitable for administration to human or non-human animal subjects and packaged individually. Each unit-dose can contain a predetermined quantity of an active ingredient(s) sufficient to produce the desired therapeutic effect, in association with the required pharmaceutical carriers or excipients. Examples of unit-dosage forms include, but are not limited to, ampoules, syringes, and individually packaged tablets and capsules. In some embodiments, unitdosage forms may be administered in fractions or multiples thereof. A multiple-dosage form is a plurality of identical unit-dosage forms packaged in a single container, which can be administered in segregated unit-dosage form. Examples of multiple-dosage forms include, but are not limited to, vials, bottles of tablets or capsules, or bottles of pints or gallons. In another embodiment the multiple dosage forms comprise different pharmaceutically active agents.

[0133] Pharmaceutical compositions comprising a muscle fast myosin (Type II) inhibitor may also be formulated as a modified release dosage form, including immediate-, delayed-, extended-, prolonged-, sustained-, pulsatile-, controlled-, extended, accelerated- and fast-, targeted-, programmed-release, and gastric retention dosage forms. These dosage forms can be prepared according to known methods and techniques (see, Remington: The Science and Practice of Pharmacy, supra; Modified-Release Drug Delivery Technology, Rathbone et al., Eds., Drugs and the Pharmaceutical Science, Marcel Dekker, Inc.: New York, N.Y., 2002; Vol. 126, which are herein incorporated by reference in their entirety).Solid FormsCrystalline FormsPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0134] In an aspect, the present disclosure provides solid forms of Compound 1 :(Compound 1).

[0135] In an aspect, the present disclosure provides crystalline Compound 1 of Form 1, 2, or 3.

[0136] In an aspect, the present disclosure provides crystalline Compound 1 of Form 1. In an aspect, the present disclosure provides crystalline Compound 1 of Form 2. In an aspect, the present disclosure provides crystalline Compound 1 of Form 3.

[0137] In one embodiment, the crystalline Forms are characterized by the interlattice plane intervals determined by a X-ray powder diffraction (e.g., XRPD) pattern. The spectrum of XRPD can be represented by a diagram plotting the intensity of the peaks versus the location of the peaks, i.e., diffraction angle 20 (two-theta) in degrees. The characteristic peaks of a given XRPD can be selected according to the peak locations and their relative intensity to conveniently distinguish this crystalline structure from others.

[0138] Measurements of XRPD peak locations (e.g., angles) and / or intensity for a given crystalline form of the same compound can vary within a margin of error. The values of degree 20 may allow error margins. Typically, the error margins can be represented by "±". For example, the degree 20 = "8.716° ± 0.3°" denotes a range from 8.716° + 0.3° (i.e., 9.016°) to 8.716° - 0.3° (i.e., 8.416). In some embodiments, the margin of error for a 20 peak in an XRPD can be ± 0.5°; ± 0.4°; ± 0.3°; ± 0.2°; ± 0.1°; ± 0.05°; or less; or more. In some embodiments, calibration techniques applied to the instruments, human operational variation, and etc. influence the margin of error.

[0139] Additional details of the methods and equipment used for the XRPD analysis are described in the Examples section.

[0140] Unless otherwise specified, all 20 values reported correspond to 20 values as measured by x- ray powder diffraction using an X-ray wavelength of 1.54060 A.

[0141] In some embodiments, the crystalline forms are characterized by Differential Scanning Calorimetry (DSC) and Therm ogravimetric Analysis (TGA). The DSC thermogram can be expressed by a diagram plotting the normalized heat flow (e.g., in units of Watts / gram ("W / g")) versus the measured sample temperature in degree C. The DSC thermogram can be evaluated for extrapolated onset and end (e.g., outset) temperatures, peak temperature, and heat of fusion. The single maximum value of a DSV thermogram can be used as the characteristic peak to distinguish one crystalline formPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 from another crystalline form. The TGA thermogram can be expressed by a diagram plotting the weight loss percentage (%) versus the measured sample temperature in degree C.

[0142] Measurements of the DSC and TGA thermograms for a given crystalline form of the same compound can vary within a margin of error. The values of a single maximum value, expressed in degree C, allow appropriate error margins. Typically, the error margins are represented by "±". For example, the single maximum value of "53.1 °C ± 10.0 °C" denotes a range from 53.09 °C + 10.0 °C, (i.e., 63.1 °C) to about 53.1 °C - 10.0 °C (i.e., 43.1 °C). In some embodiments, the margin of error for any of the DSC or TGA measurements (e.g., onset temperature, endotherm, or temperature of TGA weight loss) described herein can depend on sample preparation techniques, crystallization conditions, calibration techniques applied to the instruments, human operational variations, and etc. In some embodiments, the margin of error for a single maximum value can be ± 20 °C, ± 15 °C, ± 10.0 °C; ± 7.5 °C; ± 5.0 °C; ± 2.5 °C; ± 2 °C; ± 1.5 °C; ± 1 °C; ± 0.5 °C; or less; or more for any of the DSC or TGA measurements (e.g., onset temperature, endotherm, or temperature of TGA weight loss) described herein. In some embodiments, the margin of error for the extent of weight loss can depend on sample preparation techniques, crystallization conditions, calibration techniques applied to the instruments, human operational variations, and etc. In some embodiments, the margin of error for the extent of weight loss can be ± 1.0%, ± 0.9%, ± 0.8%, ± 0.7%, ± 0.6%, ± 0.5%, ± 0.4%, ± 0.3%, ± 0.2%, ± 0.1%, ± 0.05%, or less or more. In some embodiments, the percentage of weight loss expressed is a weight percentage (e.g., prepresenting the percentage of weight lost relative to the weight of the initial sample).

[0143] In some embodiments, the present disclosure provides a solid form of Compound 1.Form 1 of Compound 1(Form 1 of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin- 3(2H)-one)

[0144] In some embodiments, the present disclosure provides crystalline anhydrate Form 1 of Compound 1. In some embodiments, Form 1 exhibits an XRPD of that in Fig. 1. In some embodiments, Form 1 exhibits an DSC and TGA of that in Fig. 2 and Figure 3.

[0145] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.3°.

[0146] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid formPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.3°, 16.2° ± 0.3°, and 21.8° ± 0.3°.

[0147] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, and 26.4° ± 0.3°.

[0148] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, and 25.1° ± 0.3°.

[0149] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, and 22.1° ± 0.3°.

[0150] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.3°,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-74660116.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.3°, 16.2° ± 0.3°, 21.8° ± 0.3°, 20.8° ± 0.3°, 28.0° ± 0.3°, 26.4° ± 0.3°, 21.3° ± 0.3°, 27.0° ± 0.3°, 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, 11.6° ± 0.3°, 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°.

[0151] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.3°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 16.2° ± 0.3° and 21.8° ± 0.3°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.8° ± 0.3° and 28.0° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.4° ± 0.3°, 21.3° ± 0.3°, and 27.0° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 19.7° ± 0.3°, 25.1° ± 0.3°, 20.0° ± 0.3°, and 11.6° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 13.0° ± 0.3°, 22.1° ± 0.3°, and 23.3° ± 0.3°.

[0152] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.2°.

[0153] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, and 21.8° ± 0.2°.

[0154] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, and 26.4° ± 0.2°.

[0155] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, and 25.1° ± 0.2°.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0156] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, and 22.1° ± 0.2°.

[0157] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

[0158] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 16.2° ± 0.2° and 21.8° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powderPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 diffraction pattern reflection at a 20 value of 20.8° ± 0.2° and 28.0° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.4° ± 0.2°, 21.3° ± 0.2°, and 27.0° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, and 11.6° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

[0159] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.1°.

[0160] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.1°, 16.2° ± 0.1°, and 21.8° ± 0.1°.

[0161] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, and 26.4° ± 0.1°.

[0162] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, and 25.1° ± 0.1°.

[0163] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, and 22.1° ± 0.1°.

[0164] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°. In some embodiments, the solid form exhibits at least three or morePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5° ± 0.1°, 16.2° ± 0.1°, 21.8° ± 0.1°, 20.8° ± 0.1°, 28.0° ± 0.1°, 26.4° ± 0.1°, 21.3° ± 0.1°, 27.0° ± 0.1°, 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, 11.6° ± 0.1°, 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°.

[0165] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.1°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 16.2° ± 0.1° and 21.8° ± 0.1°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.8° ± 0.1° and 28.0° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.4° ± 0.1°, 21.3° ± 0.1°, and 27.0° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 19.7° ± 0.1°, 25.1° ± 0.1°, 20.0° ± 0.1°, and 11.6° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 13.0° ± 0.1°, 22.1° ± 0.1°, and 23.3° ± 0.1°.

[0166] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6. 5°.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0167] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5°, 16.2°, and 21.8°.

[0168] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, and 26.4°.

[0169] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, and 25.1°.

[0170] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, and 22.1°.

[0171] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, 22.1°, and 23.3. In some embodiments, the solid form exhibits at least three or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, 22.1°, and 23.3.In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, 22.1°, and 23.3. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, 22.1°, and 23.3. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, 22.1°, and 23.3. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.5°, 16.2°, 21.8°, 20.8°, 28.0°, 26.4°, 21.3°, 27.0°, 19.7°, 25.1°, 20.0°, 11.6°, 13.0°, 22.1°, and 23.3°.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0172] In some embodiments, crystalline anhydrate Form 1 exhibits at least one of the X-ray powder diffraction pattern reflections in Table 1. In some embodiments, Form 1 is an anhydrate.Table 1. Peaks from the X-ray powder diffractogram of crystalline anhydrate Form 1 of Compound1 above 2% relative intensity

[0173] In some embodiments, the solid form exhibits the XRPD pattern as shown in Figure 1. In some embodiments, the solid form exhibits an XRPD pattern substantially similar to that shown in Figure 1.

[0174] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °CPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at118.5 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at118.5 °C ± 1.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at118.5 °C.

[0175] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 20.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at117.8 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at117.8 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 1 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at117.8 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C.

[0176] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram as shown in Figure 2. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram substantially similar to that shown in Figure 2.

[0177] In some embodiments, the solid form exhibits the thermogravimetric analysis thermogram as shown in Figure 3. In some embodiments, the solid form exhibits a thermogravimetric analysis thermogram substantially similar to that shown in Figure 3. In some embodiments, the solid form exhibits about 0% weight loss upon thermogravimetric analysis.

[0178] In some embodiments, the solid form is a triclinic crystal system. In some embodiments, the solid form comprises a unit cell of space group P-1. In some embodiments, the solid form comprises a unit cell of volume 802 A3± 100 A3. In some embodiments, the solid form comprises a unit cellPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 with unit cell distances of 6.6 A ± 3.0 A, 9.2 A ± 3.0 A, and 13.4 A ± 3.0 A. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91° ± 3°, 95° ± 3.0°, and 95° ± 3°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91° ± 3°, 95° ± 3.0°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91°, 95° ± 3.0°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91°, 95° ± 2.0°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91°, 95° ± 1.0°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91°, 95° ± 0.5°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of about 91°, 95°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91°, 95°, and 95°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91° ± 3.0°, 95° ± 3.0°, and 95° ± 3.0°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91° ± 2°, 95° ± 2.0°, and 95° ± 2°. In some embodiments, the solid form comprises a unit cell with unit cell angles of 91° ± 2.0°, 95° ± 2.0°, and 95° ± 2.0°. In some embodiments, the solid form comprises a unit cell with two unit cell angles of about 91°. In some embodiments, the solid form comprises a unit cell with two unit cell angles of 91°. In some embodiments, the solid form comprises a unit cell with one unit cell angle of 95° ± 3.0°, 95° ± 2.0°, 95° ± 1.0°, or 95° ± 0.5°, or about 95°, or 95°.

[0179] In some embodiments, the solid form is crystalline. In some embodiments, the solid form is an anhydrate.

[0180] In some embodiments, the solid form is solid Form 1 of 2-((5-fluoropyridin-3-yl)methyl)-6- (2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one.

[0181] In some embodiments, the solid form is crystalline and obtained from methanol, ethanol, isopropanol, isobutanol, toluene, water, acetonitrile, heptane, acetone, tert-butyl methyl ether, 2- butanone, ethyl acetate, isopropyl acetate, tetrahydrofuran, or any combination thereof. In some embodiments, the solid form is crystalline and obtained from isopropanol and water. In some embodiments, the solid form is crystalline and obtained from 100% isopropanol. In some embodiments, the solid form is crystalline and obtained from 1 :9 methokwater. In some embodiments, the solid form is crystalline and obtained by cooling crystallization. In some embodiments, the solid form is crystalline and obtained by dehydration / desolvation by thermal cycle (heating to to 80 ° C or 114 ° C). In some embodiments, the solid form is crystalline and obtained by cooling crystallization. In some embodiments, the solid form is crystalline and obtained by slurry. In some embodiments, the solid form is crystalline and obtained by anti-solvent addition. In some embodiments, the solid form is crystalline and obtained by inter-conversion.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0182] In some embodiments, the present disclosure provides a pharmaceutical composition comprising any solid form described herein (e.g., Form 1 of Compound 1) and one or more pharmaceutically acceptable excipient(s). In some embodiments, the present disclosure provides a composition comprising Form 1 of Compound 1. In some embodiments, the present disclosure provides a composition comprising Form 1 and optionally one or more other Forms of Compound 1. In some embodiments, the amount of other crystalline or amorphous forms in the composition comprising Form 1 is 10% (w / w) or less. In some embodiments, the amount of other crystalline or amorphous forms in the composition comprising Form 1 is 5% (w / w) or less. In some embodiments, the amount of other crystalline or amorphous forms in the composition comprising Form 1 is 1% (w / w) or less. In some embodiments, provided is a composition comprising solid Form 1 of Compound 1 in 97% chemical purity or more. In some embodiments, provided is a composition comprising solid Form 1 of Compound 1 in 98% chemical purity or more. In some embodiments, provided is a composition comprising solid Form 1 of Compound 1 in 99% chemical purity or more. In some embodiments, provided is a composition comprising solid Form 1 of Compound 1 in 99.5% chemical purity or more.

[0183] In some embodiments, provided herein is a crystalline Form of Compound 1, wherein the Crystalline Form has at least one of the following properties: (i) an XRPD pattern substantially the same as that shown in Figure 1; (ii) at least two XRPD pattern reflection(s) at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°; (iii) a TGA similar to the one set forth in Figure 3; (iv) DSC substantially similar to the one set forth in Figure 2; (v) a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 15.0 °C; no weight loss at 150 °C ± 10.0 °C as determined by thermogravimetric analysis; a triclinic crystal system; a -1 unit cell; a unit cell volume of 802 A3± 100 A3; a unit cell with unit cell distances of 18.3 A ± 3.0 A, 4.8 A ± 3.0 A, and 22.0 A ± 3.0 A; or a unit cell with unit cell angles of 91° ± 3.0, 95° ± 3.0°, and 95° ± 3.0.Form 2 of Compound 1(Form 2 of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin- 3(2H)-one)

[0184] In some embodiments, the present disclosure provides crystalline anhydrate Form 2 of Compound 1. In some embodiments, Form 2 exhibits an XRPD of that in Figure 4. In some embodiments, Form 2 exhibits a DSC of that in Figure 5.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0185] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.3°.

[0186] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.3°, 20.2° ± 0.3°, and 23.6° ± 0.3°.

[0187] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, and 21.4° ± 0.3°.

[0188] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, and 23.9° ± 0.3°.

[0189] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, and 33.2° ± 0.3°.

[0190] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°.

[0191] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°,PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-74660123.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.3°, 20.2° ± 0.3°, 23.6° ± 0.3°, 11.7° ± 0.3°, 19.1° ± 0.3°, 21.4° ± 0.3°, 18.7° ± 0.3°, 24.8° ± 0.3°, 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3°, and 20.5° ± 0.3°.

[0192] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.3°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.2° ± 0.3° and 23.6° ± 0.3°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 11.7° ± 0.3° and 19.1° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 21.4° ± 0.3°, 18.7° ± 0.3°, and 24.8° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.1° ± 0.3°, 22.0° ± 0.3°, 23.9° ± 0.3°, 33.2° ± 0.3, 20.5° ± 0.3, and 38.7° ± 0.3. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 12.7° ± 0.3°, 10.7° ± 0.3°, 25.6° ± 0.3°, 28.0° ± 0.3°, 20.0° ± 0.3°, 32.1° ± 0.3°, and 16.4° ± 0.3°.

[0193] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.2°.

[0194] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid formPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, and 23.6° ± 0.2°.

[0195] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, and 21.4° ± 0.2°.

[0196] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, and 23.9° ± 0.2°.

[0197] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, and 33.2° ± 0.2°.

[0198] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°.

[0199] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction patternPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.2°, 20.2° ± 0.2°, 23.6° ± 0.2°, 11.7° ± 0.2°, 19.1° ± 0.2°, 21.4° ± 0.2°, 18.7° ± 0.2°, 24.8° ± 0.2°, 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2°, and 20.5° ± 0.2°.

[0200] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.2° ± 0.2° and 23.6° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 11.7° ± 0.2° and 19.1° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 21.4° ± 0.2°, 18.7° ± 0.2°, and 24.8° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.1° ± 0.2°, 22.0° ± 0.2°, 23.9° ± 0.2°, 33.2° ± 0.2, 20.5° ± 0.2, and 38.7° ± 0.2. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 12.7° ± 0.2°, 10.7° ± 0.2°, 25.6° ± 0.2°, 28.0° ± 0.2°, 20.0° ± 0.2°, 32.1° ± 0.2°, and 16.4° ± 0.2°.

[0201] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.1°.

[0202] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.1°, 20.2° ± 0.1°, and 23.6° ± 0.1°.

[0203] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, and 21.4° ± 0.1°.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0204] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, and 23.9° ± 0.1°.

[0205] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, and 33.2° ± 0.1°.

[0206] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°.

[0207] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°. In some embodiments, the solid formPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3° ± 0.1°, 20.2° ± 0.1°, 23.6° ± 0.1°, 11.7° ± 0.1°, 19.1° ± 0.1°, 21.4° ± 0.1°, 18.7° ± 0.1°, 24.8° ± 0.1°, 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1°, and 20.5° ± 0.1°.

[0208] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3° ± 0.1°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.2° ± 0.1° and 23.6° ± 0.1°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 11.7° ± 0.1° and 19.1° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 21.4° ± 0.1°, 18.7° ± 0.1°, and 24.8° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.1° ± 0.1°, 22.0° ± 0.1°, 23.9° ± 0.1°, 33.2° ± 0.1, 20.5° ± 0.1, and 38.7° ± 0.1. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 12.7° ± 0.1°, 10.7° ± 0.1°, 25.6° ± 0.1°, 28.0° ± 0.1°, 20.0° ± 0.1°, 32.1° ± 0.1°, and 16.4° ± 0.1°.

[0209] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3°.

[0210] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3°, 20.2°, and 23.6°.

[0211] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflections at 20 values of 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, and 21.4°.

[0212] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, and 23.9°.

[0213] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid formPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, and 33.2°.

[0214] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyridin-3- yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°.

[0215] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°. In some embodiments, the solid form exhibits at least six or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 6.3°, 20.2°, 23.6°, 11.7°, 19.1°, 21.4°, 18.7°, 24.8°, 26.1°, 22.0°, 23.9°, 33.2°, and 20.5°.

[0216] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 6.3°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.2° and 23.6°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 11.7° and 19.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 21.4°, 18.7°, and 24.8°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.1°, 22.0°, 23.9°, 33.2° ± 0.1, 20.5° ± 0.1, and 38.7° ± 0.1. In some embodiments, the solid form exhibits one or more X-ray powder diffractionPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 pattern reflection(s) at 20 value(s) independently selected from 12.7°, 10.7°, 25.6°, 28.0°, 20.0°, 32.1°, and 16.4°.

[0217] In some embodiments, crystalline anhydrate Form 2 exhibits at least one of the X-ray powder diffraction pattern reflections in Table 2. In some embodiments, Form 2 is an anhydrate.Table 2. Peaks from the X-ray powder diffractogram of crystalline anhydrate Form 2 of Compound1 above 3.3% relative intensityPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0218] In some embodiments, the solid form exhibits the XRPD pattern as shown in Figure 4. In some embodiments, the solid form exhibits an XRPD pattern substantially similar to that shown in Figure 4.

[0219] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 1.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.25 °C.

[0220] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 113.8 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 113.8 °C ± 20.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 113.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at113.8 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 113.8 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at113.8 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 113.8 °C ± 1 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at113.8 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 113.8 °C.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0221] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram as shown in Figure 5. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram substantially similar to that shown in Figure 5.

[0222] In some embodiments, the solid form exhibits about 0% weight loss upon thermogravimetric analysis.

[0223] In some embodiments, the solid form is crystalline. In some embodiments, the solid form is an anhydrate.

[0224] In some embodiments, the solid form is solid Form 2 of 2-((5-fluoropyridin-3-yl)methyl)-6- (2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one.

[0225] In some embodiments, the solid form is crystalline and obtained through thermal cycle. In some embodiments, the solid form is crystalline and obtained as an anhydrate through thermal cycle by equilibration at 25 °C, followed by heating 10 °C / min to 150 °C, equilibration at -40 °C, and heating 10 °C / min to 200 °C.

[0226] In some embodiments, the present disclosure provides a pharmaceutical composition comprising any solid form described herein (e.g., Form 2 of Compound 1) and one or more pharmaceutically acceptable excipient(s).Form 3 of Compound 1(Form 3 of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin- 3(2H)-one)

[0227] In some embodiments, the present disclosure provides crystalline anhydrate Form 3 of Compound 1. In some embodiments, Form 3 exhibits an XRPD of that in Fig. 6. In some embodiments, Form 3 exhibits an DSC and TGA of that in Figure 7 and Figure 8, respectively.

[0228] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.3°.

[0229] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.3°, 6.5° ± 0.3°, and 21.8° ± 0.3°.

[0230] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, and 25.3° ± 0.3°.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0231] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.3°, 6.5° ± 0.3°, 21.8° ± 0.3°, 23.8° ± 0.3°, 11.8° ± 0.3°, 25.3° ± 0.3°, 28.1° ± 0.3°, 33.8° ± 0.3°, 18.5° ± 0.3°, 22.5° ± 0.3°, 19.5° ± 0.3°, 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.3°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.3° and 21.8° ± 0.3°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 23.8° ± 0.3° and 11.8° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 25.3° ± 0.3°, 28.1° ± 0.3°, and 33.8° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independentlyPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 selected from 18.5° ± 0.3°, 22.5° ± 0.3°, and 19.5° ± 0.3°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 16.7° ± 0.3°, 39.7° ± 0.3°, 13.0° ± 0.3°, and 16.2° ± 0.3°.

[0232] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.2°.

[0233] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.2°, 6.5° ± 0.2°, and 21.8° ± 0.2°.

[0234] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, and 25.3° ± 0.2°.

[0235] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least six or more X-PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.2°, 6.5° ± 0.2°, 21.8° ± 0.2°, 23.8° ± 0.2°, 11.8° ± 0.2°, 25.3° ± 0.2°, 28.1° ± 0.2°, 33.8° ± 0.2°, 18.5° ± 0.2°, 22.5° ± 0.2°, 19.5° ± 0.2°, 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.2°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2° and 21.8° ± 0.2°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 23.8° ± 0.2° and 11.8° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 25.3° ± 0.2°, 28.1° ± 0.2°, and 33.8° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 18.5° ± 0.2°, 22.5° ± 0.2°, and 19.5° ± 0.2°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 16.7° ± 0.2°, 39.7° ± 0.2°, 13.0° ± 0.2°, and 16.2° ± 0.2°.

[0236] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.1°.

[0237] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.1°, 6.5° ± 0.1°, and 21.8° ± 0.1°.

[0238] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, and 25.3° ± 0.1°.

[0239] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, thePCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3° ± 0.1°, 6.5° ± 0.1°, 21.8° ± 0.1°, 23.8° ± 0.1°, 11.8° ± 0.1°, 25.3° ± 0.1°, 28.1° ± 0.1°, 33.8° ± 0.1°, 18.5° ± 0.1°, 22.5° ± 0.1°, 19.5° ± 0.1°, 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3° ± 0.1°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.1° and 21.8° ± 0.1°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 23.8° ± 0.1° and 11.8° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 25.3° ± 0.1°, 28.1° ± 0.1°, and 33.8° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 18.5° ± 0.1°, 22.5° ± 0.1°, and 19.5° ± 0.1°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 16.7° ± 0.1°, 39.7° ± 0.1°, 13.0° ± 0.1°, and 16.2° ± 0.1°.PCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0240] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3°.

[0241] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3°, 6.5°, and 21.8°.

[0242] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, and 25.3°.

[0243] In an aspect, the present disclosure provides crystalline solid form of 2-((5-fluoropyri din-3 - yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits at least two or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits at least three or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits at least four or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits at least five or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits at least six or more X- ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits at least seven or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 20.3°, 6.5°, 21.8°, 23.8°, 11.8°, 25.3°, 28.1°, 33.8°, 18.5°, 22.5°, 19.5°, 16.7°, 39.7°, 13.0°, and 16.2°. In some embodiments, the solid form exhibits an X-ray powder diffraction pattern reflection at a 20 value of 20.3°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° and 21.8°. In some embodiments, the solid form exhibits X-ray powder diffraction pattern reflections at 20 valuesPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601 of 23.8° and 11.8°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 25.3°, 28.1°, and 33.8°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 18.5°, 22.5°, and 19.5°. In some embodiments, the solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 16.7°, 39.7°, 13.0°, and 16.2°.

[0244] In some embodiments, crystalline anhydrate Form 3 exhibits at least one of the X-ray powder diffraction pattern reflections in Table 3. In some embodiments, Form 3 is an anhydrate.Table 3. Peaks from the X-ray powder diffractogram of crystalline anhydrate Form 3 of Compound1 above 2% relative intensityPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601

[0245] In some embodiments, the solid form exhibits the XRPD pattern as shown in Figure 6. In some embodiments, the solid form exhibits an XRPD pattern substantially similar to that shown in Figure 6.

[0246] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.6 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.6 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.6 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at118.6 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.6 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at118.6 °C ± 1.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.6 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at118.6 °C.

[0247] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °CPCT / US25 / 54654 07 November 2025 (07.11.2025)WSGR Ref. No.: 52600-746601± 20.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at117.8 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at117.8 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C ± 1 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at117.8 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 117.8 °C.

[0248] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.3 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.3 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.3 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at115.3 °C ± 5.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.3 °C ± 2.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at115.3 °C ± 1.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 115.3 °C ± 0.5 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at115.3 °C.

[0249] In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 114.0 °C ± 25.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 114.0 °C ± 20.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 114.0 °C ± 15.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 114.0 °C ± 10.0 °C. In some embodiments, the solid form exhibits a differential scanning calorimetry thermogram comprising an onset temperature at 114.0 °C ± 5.0 °C. In some embodiments, the solid form ex...

Claims

WSGR Ref. No.: 52600-746601CLAIMSWHAT IS CLAIMED IS:

1. A solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5- yl)pyridazin-3(2H)-one, wherein the solid form is crystalline.

2. A crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the solid form exhibits an X- ray powder diffraction pattern reflection at a 20 value of 6.5° ± 0.2°.

3. A crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the crystalline solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, and 21.8° ± 0.2°.

4. A crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the crystalline solid form exhibits X-ray powder diffraction pattern reflections at 20 values of 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, and 26.4° ± 0.2°.

5. A crystalline solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2- trifluoroethoxy)pyrimidin-5-yl)pyridazin-3(2H)-one, wherein the crystalline solid form exhibits at least two or more X-ray powder diffraction pattern reflections at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

6. The crystalline solid form of claim 5, wherein the crystalline solid form exhibits at least three or more X-ray powder diffraction pattern reflections at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

7. The crystalline solid form of claim 5 or 6, wherein the crystalline solid form exhibits at least four or more X-ray powder diffraction pattern reflections at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

8. The crystalline solid form of any one of claims 1-7, wherein the crystalline solid form exhibits at least five or more X-ray powder diffraction pattern reflections at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°,WSGR Ref. No.: 52600-74660126.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

9. The crystalline solid form of any one of claims 1-8, wherein the crystalline solid form exhibits at least six or more X-ray powder diffraction pattern reflections at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

10. The crystalline solid form of any one of claims 1-9, wherein the crystalline solid form exhibits at least seven or more X-ray powder diffraction pattern reflections at 20 values independently selected from 6.5° ± 0.2°, 16.2° ± 0.2°, 21.8° ± 0.2°, 20.8° ± 0.2°, 28.0° ± 0.2°, 26.4° ± 0.2°, 21.3° ± 0.2°, 27.0° ± 0.2°, 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, 11.6° ± 0.2°, 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

11. The crystalline solid form of any one of claims 1 or 3-10, wherein the crystalline solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 16.2° ± 0.2° and 21.8° ± 0.2°.

12. The crystalline solid form of any one of claims 1 or 4-11, wherein the crystalline solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 values independently selected from 20.8° ± 0.2° and 28.0° ± 0.2°.

13. The crystalline solid form of any one of claims 11-12, wherein the crystalline solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 26.4° ± 0.2°, 21.3° ± 0.2°, and 27.0° ± 0.2°.

14. The crystalline solid form of any one of claims 11-13, wherein the crystalline solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 19.7° ± 0.2°, 25.1° ± 0.2°, 20.0° ± 0.2°, and 11.6° ± 0.2°.

15. The crystalline solid form of any one of claims 11-14, wherein the crystalline solid form exhibits one or more X-ray powder diffraction pattern reflection(s) at 20 value(s) independently selected from 13.0° ± 0.2°, 22.1° ± 0.2°, and 23.3° ± 0.2°.

16. The crystalline solid form of any one of claims 1-15, wherein the crystalline solid form exhibits the X-ray powder diffraction pattern as shown in Figure 1.

17. The crystalline solid form of any one of claims 1-16, wherein the crystalline solid form exhibits a differential scanning calorimetry thermogram comprising an endothermic peak at 118.5 °C ± 15.0 °C.

18. The crystalline solid form of claim 17, wherein the onset temperature of the endothermic peak is at 117.8 °C ± 15.0 °C.WSGR Ref. No.: 52600-74660119. The crystalline solid form of any one of claims 1-18, wherein the solid form exhibits a differential scanning calorimetry thermogram as shown in Figure 2.

20. The crystalline solid form of any one of claims 1-19, wherein the crystalline solid form exhibits the thermogravimetric analysis thermogram as shown in Figure 3.

21. The crystalline solid form of any one of claims 1-20, wherein the crystal system is triclinic or the space group of the unit cell is P-1.

22. The crystalline solid form of claim 21, wherein the volume of the unit cell is 802 A3± 100 A3, or the crystalline solid form comprises a unit cell with unit cell distances of 6.6 A ± 3.0 A, 9.2 A ± 3.0 A, and 13.4 A ± 3.0 A, or the crystalline solid form comprises a unit cell with unit cell angles of 91°, 95°, and 95°.

23. The crystalline solid form of any one of claims 1 to 22, wherein the crystalline solid form is an anhydrate.

24. The crystalline solid form of any one of claims 1 to 23, wherein the crystalline solid form is solid Form 1 of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5- yl)pyridazin-3(2H)-one.

25. A solid form of 2-((5-fluoropyridin-3-yl)methyl)-6-(2-(2,2,2-trifluoroethoxy)pyrimidin-5- yl)pyridazin-3(2H)-one, wherein the solid form is amorphous.

26. A pharmaceutical composition comprising the solid form of any one of claims 1 to 25 and one or more pharmaceutically acceptable excipient(s).

27. The pharmaceutical composition of claim 25 further comprising an additional crystalline Form of Compound 1 or the amorphous Form of Compound 1.

28. A pharmaceutical composition comprising Compound 1 and one or more pharmaceutically acceptable excipient(s).

29. The pharmaceutical composition of any one of claims 25-28, wherein the pharmaceutical composition is in a solid oral dosage form comprising: (i) Compound(Compound 1) or a pharmaceutically acceptable salt or solvate thereof and (ii) one or more pharmaceutically acceptable excipient(s).

30. The pharmaceutical composition of any one of claims 25-29 in the form of a tablet.WSGR Ref. No.: 52600-74660131. The pharmaceutical composition of claim any one of claims 25-30, wherein the pharmaceutical composition comprises from about 0.5 mg to about 100 mg of Compound 1, or of a pharmaceutically acceptable salt or solvate of Compound 1, optionally wherein the pharmaceutical composition comprises from about 0.5 mg to about 100 mg of Compound 1.

32. The pharmaceutical composition of any one of claims 25-31, wherein the pharmaceutical composition comprises from about 0.5 mg to about 50 mg of Compound 1 or of a pharmaceutically acceptable salt or solvate thereof, optionally wherein the pharmaceutical composition comprises from about 0.5 mg to about 50 mg of Compound 1.

33. The pharmaceutical composition of any one of claims 25-32, wherein the pharmaceutical composition comprises from about 0.5 mg to about 20 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof, optionally wherein the pharmaceutical composition comprises from about 0.5 mg to about 20 mg of Compound 1.

34. The pharmaceutical composition of claim 33, wherein the pharmaceutical composition comprises about 2.5 mg, about 5.0 mg, about 7.5 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.

35. The pharmaceutical composition of claim 34, wherein the pharmaceutical composition comprises about 5 mg, about 10 mg, or about 15 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.

36. The pharmaceutical composition of claim 34, wherein the pharmaceutical composition comprises about 2.5 mg of Compound 1.

37. The pharmaceutical composition of claim 35, wherein the pharmaceutical composition comprises about 5 mg of Compound 1.

38. The pharmaceutical composition of claim 35, wherein the pharmaceutical composition comprises about 10 mg of Compound 1.

39. The pharmaceutical composition of claim 35, wherein the pharmaceutical composition comprises about 15 mg of Compound 1.

40. The pharmaceutical composition of any one of claims 25-39, wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof is in the form of microparticles.

41. The pharmaceutical composition of any one of claims 25-40, wherein the Compound 1 is jet- milled.

42. The pharmaceutical composition of any one of claims claim 25-41, wherein the average size of the microparticles is from about 1 pm to about 40 pm.WSGR Ref. No.: 52600-74660143. The pharmaceutical composition of claim 42, wherein the average size of the microparticles is from about 1 pm to about 20 pm.

44. The pharmaceutical composition of any one of claims 25-41, wherein the average size of the microparticles is less than about 10 pm.

45. The pharmaceutical composition of any one of claims 25-44, wherein the pharmaceutical composition is stable for at least 1 month at about 25 °C to about 40 °C.

46. The pharmaceutical composition of any one of claims 25-45, wherein the pharmaceutical composition is stable for at least 3 months at about 25 °C.

47. The pharmaceutical composition of any one of claims 25-46, wherein the pharmaceutical composition comprises one or more surfactactant(s), one or more filler(s), one or more binder(s), one or more disintegrant(s), one or more lubricant(s), one or more glidant(s), one or more coloring agent(s), one or more flavoring agent(s), one or more preservative(s), one or more adjustor(s), one or more antiadherent(s), one or more coating agent(s), one or more moisturizing agent(s), or one or more solvent(s).

48. The pharmaceutical composition of any one of claims 25-47, wherein the pharmaceutical composition comprises one or more filler(s), sweetener(s), disintegrant(s), lubricant(s), glidant(s), or coating agent(s).

49. The pharmaceutical composition of any one of claims 25-48, wherein the pharmaceutical composition comprises one or more filler(s), sweetener(s), disintegrant(s), lubricant(s), and glidant(s).

50. The pharmaceutical composition of any one of claims 25-49, wherein the pharmaceutical composition comprises microcrystalline cellulose (MCC), optionally wherein the microcrystalline cellulose (MCC) is MCC PH-102 or MCC PH-200, optionally wherein the microcrystalline cellulose (MCC) is silicified MCC.

51. The pharmaceutical composition of any one of claims 25-50, wherein the pharmaceutical composition comprises sucralose.

52. The pharmaceutical composition of any one of claims 25-51, wherein the pharmaceutical composition comprises croscarmellose sodium.

53. The pharmaceutical composition of any one of claims 25-52, wherein the pharmaceutical composition comprises mannitol, optionally wherein the mannitol is mannitol M 100.

54. The pharmaceutical composition of any one of claims 25-53, wherein the pharmaceutical composition comprises silicon dioxide, optionally wherein the silicon dioxide is colloidal silicon dioxide.WSGR Ref. No.: 52600-74660155. The pharmaceutical composition of any one of claims 25-54, wherein the pharmaceutical composition comprises sodium stearyl fumarate (SSF).

56. The pharmaceutical composition of any one of claims 42-55, wherein the pharmaceutical composition comprises about 1% w / w to about 25% w / w Compound 1.

57. The pharmaceutical composition of any one of claims 25-56, wherein the pharmaceutical composition comprises about 1% w / w to about 10% w / w Compound 1.

58. The pharmaceutical composition of any one of claims 25-57, wherein the pharmaceutical composition comprises about 6.25% w / w Compound 1.

59. The pharmaceutical composition of any one of claims 25-58, wherein: the pharmaceutical composition comprises about 40% w / w to about 80% w / w microcrystalline cellulose; or the pharmaceutical composition comprises about 1% w / w to about 5% w / w sucralose; or the pharmaceutical composition comprises about 1% w / w to about 10% w / w croscarmellose sodium; or the pharmaceutical composition comprises about 0.1% w / w to about 5% w / w sodium stearyl fumarate; or the pharmaceutical composition comprises about 0.1% w / w to about 5% w / w colloidal silicon dioxide.

60. The pharmaceutical composition of any one of claims 25-59, wherein the pharmaceutical composition comprises: about 1% w / w to about 20% w / w Compound 1, about 15% w / w to about 98% w / w one or more filler(s), about 0.2% w / w to about 35% w / w one or more disintegrant(s), about 0.1% w / w to about 10% w / w one or more lubricant(s), and about 0.05% w / w to about 10% w / w one or more glidant(s).

61. The pharmaceutical composition of any one of claims 25-60, wherein the pharmaceutical composition comprises: about 2.5% w / w to about 15% w / w Compound 1, about 50% w / w to about 95% w / w one or more filler(s), about 0.2% w / w to about 10% w / w one or more disintegrant(s), about 0.5% w / w to about 5% w / w one or more lubricant(s), and about 0.25% w / w to about 5% w / w one or more glidant(s).WSGR Ref. No.: 52600-74660162. The pharmaceutical composition of any one of claims 25-61, wherein the pharmaceutical composition comprises: about 2.5% w / w to about 15% w / w Compound 1, about 50% w / w to about 95% w / w one or more filler(s), about 0.01% w / w to about 10% w / w one or more sweetener(s) about 0.2% w / w to about 10% w / w one or more disintegrant(s), about 0.5% w / w to about 5% w / w one or more lubricant(s), and about 0.25% w / w to about 5% w / w one or more glidant(s).

63. The pharmaceutical composition of any one of claims 25-62, wherein the pharmaceutical composition comprises: about 5% w / w to about 10% w / w Compound 1, about 75% w / w to about 90% w / w one or more filler(s), about 1% w / w to about 3% w / w one or more sweetener(s), about 2% w / w to about 10% w / w one or more disintegrant(s), about 1% w / w to about 3% w / w one or more lubricant(s), and about 0.5% w / w to about 3% w / w one or more glidant(s).

64. The pharmaceutical composition of any one of claims 25-63, wherein the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 75% w / w to about 90% w / w one or more filler(s), about 1% w / w to about 3% w / w one or more sweetener(s), about 2% w / w to about 10% w / w one or more disintegrant(s), about 1% w / w to about 3% w / w one or more lubricant(s), about 0.5% w / w to about 3% w / w one or more glidant(s), and about 4% w / w to about 15% w / w of a film coting.

65. The pharmaceutical composition of any one of claims 25-64, wherein the pharmaceutical composition comprises about 5% w / w to about 8% w / w Compound 1, about 82% w / w one or more filler(s), about 6% w / w one or more disintegrant(s), about 2% w / w one or more lubricant(s), and about 1.5% w / w one or more glidant(s).

66. The pharmaceutical composition of any one of claims 25-65, wherein the pharmaceutical composition comprisesWSGR Ref. No.: 52600-746601 about 6% w / w Compound 1, about 83% w / w one or more filler(s), about 2% w / w one or more sweetener(s), about 6% w / w one or more disintegrant(s), about 2% w / w one or more lubricant(s), and about 1.5% w / w one or more glidant(s).

67. The pharmaceutical composition of any one of claims 25-66, wherein the pharmaceutical composition comprises mannitol, microcrystalline cellulose, sucralose, croscarmellose sodium, sodium stearyl fumarate, or colloidal silicon dioxide.

68. The pharmaceutical composition of any one of claims 25-67, wherein the pharmaceutical composition comprises: about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium stearyl fumarate, and about 0.5% w / w to about 3% w / w colloidal silicon dioxide.

69. The pharmaceutical composition of any one of claims 25-68, wherein the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium stearyl fumarate, and about 0.5% w / w to about 3% w / w colloidal silicon dioxide.

70. The pharmaceutical composition of any one of claims 25-69, wherein the pharmaceutical composition comprises about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium stearyl fumarate, about 0.5% w / w to about 3% w / w colloidal silicon dioxide, andWSGR Ref. No.: 52600-746601 about 4% w / w to about 15% w / w of a film coting.

71. The pharmaceutical composition of any one of claims 25-70, wherein the pharmaceutical composition comprises about 5% w / w to about 10% w / w Compound 1, about 60% w / w to about 70% w / w microcrystalline cellulose, about 20% w / w to about 25% w / w mannitol, about 1% w / w to about 3% w / w sucralose, about 2% w / w to about 10% w / w croscarmellose sodium, about 1% w / w to about 3% w / w sodium lauryl sulfate, about 1% w / w to about 3% w / w sodium stearyl fumarate, about 0.5% w / w to about 3% w / w colloidal silicon dioxide, and72. about 4% w / w to about 15% w / w of a film coting. The pharmaceutical composition of any one of claims 25-71, wherein the pharmaceutical composition comprises about 6% w / w Compound 1, about 65% w / w microcrystalline cellulose, about 20% w / w mannitol, about 2% w / w sucralose, about 6% w / w croscarmellose sodium, about 2% w / w sodium stearyl fumarate, and about 1.5% w / w colloidal silicon dioxide.

73. The pharmaceutical composition of any one of claims 25-72, wherein the pharmaceutical composition comprises about 6.2% w / w Compound 1, about 61.7% w / w microcrystalline cellulose, about 20.6% w / w mannitol, about 2% w / w sucralose, about 6.0% w / w croscarmellose sodium, about 2% w / w sodium stearyl fumarate, and about 1.5% w / w colloidal silicon dioxide.

74. The pharmaceutical composition of any one of claims 25-73 wherein the Compound 1 comprises the solid form of any one of claims 1-24, optionally wherein the Compound 1 consists essentially of the solid form of any one of claims 1-24, optionally wherein the Compound 1 is solid form of any one of claims 1-24.WSGR Ref. No.: 52600-74660175. A method of treating activity-induced muscle damage, a movement disorder, a neuromuscular condition, or a metabolic myopathy, the method comprising administering to a subject in need thereof a dose of about 1 mg to about 100 mg per day of Compound 1 :, wherein the Compound 1 comprises the solid form of any one of claims1-24 or the pharmaceutical composition of anyone of claims 25-74.

76. The method of claim 75, comprising administering to the subject a dose of about 2.5 mg to about 20 mg per day of Compound 1.

77. The method of claim 76, comprising administering to the subject a dose of about 2.5 mg per day, about 5 mg per day, about 7.5 mg per day, about 10 mg per day, about 12.5 mg per day, about 15 mg per day, about 17.5 mg per day, or about 20 mg per day of the compound of Compound 1, optionally wherein the dose is administered in about 5 mg per day, about 10 mg per day, or about 15 mg per day.

78. The method of claim 77, comprising administering to the subject a dose of about 5 mg per day.

79. The method of claim 77, comprising administering to the subject a dose of about 10 mg per day.

80. The method of claim 77, comprising administering to the subject a dose of about 15 mg per day.

81. The method of any of claims 75-80, wherein the method is for treating Becker Muscular Dystrophy, Duchenne Muscular Dystrophy, Limb-Girdle Muscular Dystrophy, or McArdle’s syndrome.

82. A kit, comprising an oral pharmaceutical composition and instructions for administration to a subject in need thereof, wherein the oral pharmaceutical composition comprises the solid form of any one of claims 1 to 24 or the pharmaceutical composition of anyone of claims 25- 74, optionally wherein the kit is used in the method of any one of claims 75-81.

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