Granted Patent
B2
US 12,569,491 · App. 19/043,275 · Granted Mar 10, 2026
Methods for treating testicular and ovarian adrenal rest tumors
Assignee:
SPRUCE BIOSCIENCES, INC.
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Abstract
Provided herein are compounds and pharmaceutical compositions for the prevention and treatment of testicular adrenal rest tumors (TART) or ovarian adrenal rest tumors (OART).
Claims (25)
1 . A method of treating an endocrine disorder associated with corticotropin-releasing factor type-1 (CRF 1 ) activity, comprising administering to a subject in need thereof a small molecule CRF 1 antagonist, or a pharmaceutically acceptable salt thereof, wherein the small molecule CRF 1 antagonist is:
or a pharmaceutically acceptable salt thereof,
wherein the small molecule CRF 1 antagonist is administered to the subject twice per day, and
wherein the subject is in the fed state,
wherein the endocrine disorder associated with CRF 1 activity is a testicular adrenal rest tumor (TART) or an ovarian adrenal rest tumor (OART).
2 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is:
or a pharmaceutically acceptable salt thereof.
3 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is:
or a pharmaceutically acceptable salt thereof.
4 . The method of claim 1 , wherein the subject has congenital adrenal hyperplasia (CAH).
5 . The method of claim 1 , wherein the subject is receiving a glucocorticoid in conjunction with the administering of the small molecule CRF 1 antagonist.
6 . The method of claim 5 , wherein the glucocorticoid comprises beclomethasone, betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or triamcinolone, or a combination thereof.
7 . The method of claim 6 , wherein the glucocorticoid is hydrocortisone.
8 . The method of claim 1 , wherein the subject is an adolescent.
9 . The method of claim 1 , wherein the subject is at least 18 years old.
10 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is administered at a dose of about 10 mg/day to about 400 mg/day to the subject.
11 . The method of claim 10 , wherein the small molecule CRF 1 antagonist is administered at a dose of about 50 mg.
12 . The method of claim 10 , wherein the small molecule CRF 1 antagonist is administered at a dose of about 100 mg.
13 . The method of claim 10 , wherein the small molecule CRF 1 antagonist is administered at a dose of about 200 mg.
14 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is administered at a dose of about 400 mg.
15 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is administered orally.
16 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is formulated as a capsule or tablet.
17 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is administered less than about 6 hours before sleep.
18 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is administered less than about 3 hours before sleep.
19 . The method of claim 1 , wherein the small molecule CRF 1 antagonist is administered in the evening.
Assignments (2)
SECURITY INTEREST
Recorded Jan 12, 2026
From: SPRUCE BIOSCIENCES, INC.
To: AVENUE CAPITAL MANAGEMENT II, L.P.
Reel/Frame 073442/0864 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 13, 2025
From: HOWERTON, ALEXIS; GERBER, HAL
To: SPRUCE BIOSCIENCES, INC.
Reel/Frame 072013/0129 →
Continuity (7)
Continuation
PCTUS2019029486
· Apr 26, 2019
Provisional Application
62822815
· Mar 23, 2019
Provisional Application
62663951
· Apr 27, 2018
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