US 12,433,882 B2
Treatments for amyotrophic lateral sclerosis using dazucorilant
Grace Mann, Menlo Park, CA (US); Iulia Cristina Tudor, Menlo Park, CA (US); William Guyer, Menlo Park, CA (US); Hazel Hunt, West Sussex (GB); and Joseph Custodio, Menlo Park, CA (US)
Assigned to Corcept Therapeutics Incorporated, Redwood City, CA (US)
Filed by Corcept Therapeutics Incorporated, Menlo Park, CA (US)
Filed on Oct. 27, 2023, as Appl. No. 18/496,134.
Claims priority of provisional application 63/525,044, filed on Jul. 5, 2023.
Claims priority of provisional application 63/453,989, filed on Mar. 22, 2023.
Claims priority of provisional application 63/427,305, filed on Nov. 22, 2022.
Claims priority of provisional application 63/420,409, filed on Oct. 28, 2022.
Prior Publication US 2024/0156806 A1, May 16, 2024
Int. Cl. A61K 31/4738 (2006.01); A61K 31/4152 (2006.01); A61K 31/428 (2006.01); A61P 25/28 (2006.01)
CPC A61K 31/4738 (2013.01) [A61K 31/4152 (2013.01); A61K 31/428 (2013.01); A61P 25/28 (2018.01)] 16 Claims
 
1. A method of treating a subject suffering from amyotrophic lateral sclerosis (ALS) by providing said patient with greater dazucorilant exposure than the fasted dazucorilant exposure for treating ALS, the method comprising administering to the subject, by oral administration with food, an effective amount of 150 milligrams (mg) or 300 mg of dazucorilant, (R)-(1-(4-fluorophenyl)-6-((4-(trifluoromethyl)phenyl) sulfonyl)-4, 4a, 5,6,7,8-hexahydro-1-H-pyrazolo [3,4-g]isoquinolin-4a-yl) (pyridin-2-yl) methanone:

OG Complex Work Unit Chemistry
formulated in a LFCS Type IV lipid formulation in a softgel capsule containing dazucorilant, thereby increasing dazucorilant exposure by about 1.3-fold to about 1.7-fold as compared to the dazucorilant exposure of said effective amount of dazucorilant when administered without food to a fasted subject, effective to provide the patient with greater dazucorilant exposure than the fasted dazucorilant exposure for treating said ALS in the patient.