IP Library Granted Patent US 12,343,319
Granted Patent B2
US 12,343,319 · App. 18/652,721 · Granted Jul 1, 2025

Compositions and methods for treatment of diseases and disorders

Inventors: Carrie Bowen (Encinitas, CA); Glenn F. Short (Encinitas, CA); Thomas Cameron Robertson (Encinitas, CA)
Assignee: Atai Therapeutics, Inc.
A61K31/137A61P25/20A61P25/24
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Quick Facts
Patent No.
US 12,343,319
App. No.
18/652,721
Granted
Jul 1, 2025
Kind
B2
Abstract

Provided herein are compounds of Formula (I), Formula (I-A), Formula (I-B), or pharmaceutically acceptable salt thereof, wherein R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11, R12, R13, R14 are defined herein. Also provided herein are pharmaceutical compositions comprising a compound of Formula (I), Formula (I-A), Formula (I-B) or pharmaceutically acceptable salt thereof, and methods of using a compound of Formula (I), Formula (I-A), Formula (I-B) or pharmaceutically acceptable salt thereof. The current invention reports compounds to reduce REM sleep and/or non-REM sleep in a subject which can be effective in treating diseases or disorder where sleep is dysregulated. The methods of the disclosure include methods of treating sleep dysfunction, sleep disorder, stress related disorders, neuropsychiatric diseases, neurological conditions and/or neurodevelopmental disorders, using the compound of Formula (I), Formula (I-A), and/or Formula (I-B).

Claims (24)

1. A method of treating a sleep dysfunction or a sleep disorder in a subject comprising administering to the subject a compound of Formula (I):

or a pharmaceutically acceptable salt thereof; wherein

R 1 is independently at each position hydrogen, C 1 -C 6 alkyl, or C 1 -C 6 haloalkyl;

R 2 , R 3 and R 7 are independently hydrogen, heterocycle, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, halogen, cyano, OR 1 , S(O)(=NH)R 1 , S(O) 2 R 1 , S(O)R 1 or SR 1 , wherein at least one of R 2 and R 3 is hydrogen;

R 4 , R 5 and R 6 are independently hydrogen, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, halogen, cyano, OR 1 , SR 1 , (C═O)(R 14 ), O(C═O)(R 14 ), NO 2 , or NH(C═O)(R 14 ), wherein R 14 is C 1 -C 6 alkyl, OH, or OC 1 -C 6 alkyl;

R 8 and R 9 are independently hydrogen, C 1 -C 6 alkyl, C 1 -C 4 alkyl, C 3 -C 6 cycloalkyl, C 3 -C 10 cycloalkyl, CH 2 OH, or CH 2 O—C 1 -C 4 alkyl;

R 10 and R 11 are independently hydrogen, halogen, C 1 -C 6 alkyl, OH, C 1 -C 4 alkyl, C 3 -C 6 cycloalkyl, or CH 2 O—C 1 -C 4 alkyl;

R 12 is hydrogen, CH 2 OH, CH 2 O—C 1 -C 9 alkyl, C 3 -C 10 cycloalkyl, CH 2 OH, or CH 2 O—C 1 -C 4 alkyl; and

R 13 is hydrogen, C 1 -C 9 alkyl, C 3 -C 10 cycloalkyl, CH 2 OH, or CH 2 O—C 1 -C 4 alkyl,

thereby treating the sleep dysfunction or the sleep disorder in the subject.

2. The method of claim 1 , wherein the sleep dysfunction or sleep disorder is a hypersomnia or a circadian rhythm sleep disorder.

3. The method of claim 2 , wherein the hypersomnia is narcolepsy, long sleeper disorder, Kleine-Levine Syndrome, or a combination thereof.

4. The method of claim 3 , wherein the hypersomnia is narcolepsy.

5. The method of claim 3 , wherein the hypersomnia is long sleeper disorder.

6. The method of claim 3 , wherein the hypersomnia is Kleine-Levine Syndrome.

7. The method of claim 2 , wherein the circadian rhythm sleep disorder is delayed sleep-wake phase disorder, advanced sleep-wake phase disorder, a non-24 sleep wake rhythm, or a combination thereof.

8. The method of claim 7 , wherein the circadian rhythm sleep disorder is delayed sleep-wake phase disorder.

9. The method of claim 7 , wherein the circadian rhythm sleep disorder is advanced sleep-wake phase disorder.

10. The method of claim 7 , wherein the circadian rhythm sleep disorder is a non-24 sleep wake rhythm.

11. The method of claim 1 , wherein the compound is

or a pharmaceutically acceptable salt thereof.

12. The method of claim 1 , wherein the compound is:

or a pharmaceutically acceptable salt thereof.

13. The method of claim 1 , wherein the administering comprises sublingual, intracutaneous, subcutaneous, intramuscular, intraperitoneal, intravenous, intraarterial, intradermal, transdermal, oral, buccal, or nasal route of administration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 14, 2024
From: BOWEN, CARRIE; SHORT, GLENN F.; ROBERTSON, THOMAS CAMERON
To: ATAI THERAPEUTICS INC.
Reel/Frame 067411/0284 →
Continuity (4)
Provisional Application 63567737 · Mar 20, 2024
Provisional Application 63545825 · Oct 26, 2023
Provisional Application 63463202 · May 1, 2023
Related Publication 20240366531A1 · Nov 7, 2024
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