	US 12,005,065 B2
	Corticotropin releasing factor receptor antagonists
Alexis Howerton, South San Francisco, CA (US); Hal Gerber, South San Francisco, CA (US); and Michael Huang, South San Francisco, CA (US)
Assigned to Spruce Biosciences, Inc., South San Francisco, CA (US)
Filed by Spruce Biosciences, Inc., South San Francisco, CA (US)
Filed on Apr. 26, 2023, as Appl. No. 18/307,718.
Application 17/586,228 is a division of application No. 17/359,411, filed on Jun. 25, 2021, granted, now 11,351,177, issued on Jun. 7, 2022.
Application 18/307,718 is a continuation of application No. 18/078,649, filed on Dec. 9, 2022.
Application 18/078,649 is a continuation of application No. 17/586,228, filed on Jan. 27, 2022, abandoned.
Application 17/359,411 is a continuation of application No. 17/063,592, filed on Oct. 5, 2020, granted, now 11,344,557, issued on May 31, 2022.
Application 17/063,592 is a continuation of application No. 16/388,620, filed on Apr. 18, 2019, granted, now 10,849,908, issued on Dec. 1, 2020.
Application 16/388,620 is a continuation of application No. PCT/US2018/046760, filed on Aug. 14, 2018.
Claims priority of provisional application 62/545,406, filed on Aug. 14, 2017.
Prior Publication US 2023/0414627 A1, Dec. 28, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/5377 (2006.01); A61K 9/14 (2006.01); A61K 9/48 (2006.01); A61K 31/573 (2006.01); A61P 5/00 (2006.01); A61P 5/24 (2006.01); A61P 5/38 (2006.01); C07D 487/04 (2006.01)

CPC A61K 31/5377 (2013.01) [A61K 9/14 (2013.01); A61K 9/48 (2013.01); A61K 9/4825 (2013.01); A61K 31/573 (2013.01); A61P 5/00 (2018.01); A61P 5/24 (2018.01); A61P 5/38 (2018.01); C07D 487/04 (2013.01)]

21 Claims

1. A method for treating congenital adrenal hyperplasia (CAH) in a human, comprising:

administering to said human a therapeutically-effective amount of a CRF₁receptor antagonist or a pharmaceutically acceptable salt thereof,

wherein said human has received or has been previously determined to receive a first dose of a glucocorticoid, and

administering to said human a second dose of a glucocorticoid, wherein said second dose of a glucocorticoid is reduced compared to said first dose of a glucocorticoid,

wherein an androstenedione (A4) level in said subject is reduced from baseline, or

wherein an adrenocorticotropic hormone (ACTH) level in said subject is reduced from baseline, or

wherein a 17-hydroxyprogesterone (17-OHP) level in said subject is reduced from baseline,

wherein said CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof is administered at a dose between about 50 mg/day and about 200 mg/day, and wherein said CRF1 receptor antagonist is stable for storage for a minimum of six months.