IP Library Granted Patent US 10,941,107
Granted Patent B2
US 10,941,107 · App. 16/988,027 · Granted Mar 9, 2021

Prodrugs of gamma-hydroxybutyric acid, compositions and uses thereof

Inventors: Jia-Ning Xiang (Wuhan, CN); Xuesong Xu (Wuhan, CN); Xuan Zhang (Wuhan, CN)
Assignee: XW LABORATORIES INC.
C07C69/78C07B59/001C07C69/22C07C69/24C07C69/28C07C69/34C07C69/608C07C69/612C07C69/618C07C69/738C07C69/74C07C69/76C07C69/96C07C229/08C07C229/34C07C229/36C07C233/47C07C255/57C07C271/22C07C271/34C07C317/14C07C317/44C07D207/12C07D207/16C07D211/44C07D211/46C07D213/79C07D213/80C07D277/30C07D277/56C07D307/68C07D309/12C07D317/64C07D333/38C07C2601/06C07C2601/08C07C2601/14C07C2601/16
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Quick Facts
Patent No.
US 10,941,107
App. No.
16/988,027
Granted
Mar 9, 2021
Kind
B2
Abstract

Provided are prodrugs of gamma-hydroxybutyric acid as well as compositions and uses thereof.

Claims (33)

1. A compound having the structure of Formula (1D):

or a pharmaceutically acceptable salt thereof, wherein,

R 2 is —(CR 6 R 7 ) m —, wherein,

m is an integer from 1 to 6; and

each of R 6 and R 7 is independently selected from hydrogen and C 1-3 alkyl; and

R 3 is selected from C 5-8 aryl, C 3-8 heterocycloalkyl, C 5-8 heteroaryl, substituted C 1-12 alkyl, substituted C 5-8 aryl, substituted C 3-8 heterocycloalkyl, and substituted C 5-8 heteroaryl, wherein each of the one or more substituent groups is independently selected from halogen, C 1-6 alkyl, C 1-6 alkoxy, and —NR 2 , wherein each R is independently selected from hydrogen, C 1-6 alkyl, and C 1-6 alkylcarbonyl.

2. The compound of claim 1 , wherein each of R 6 and R 7 is hydrogen.

3. The compound of claim 1 , wherein R 2 is —(CH 2 ) 3 —.

4. The compound of claim 1 , wherein R 3 is substituted C 1-12 alkyl.

5. The compound of claim 1 , wherein R 3 is amino-substituted C 1-12 alkyl.

6. The compound of claim 1 , wherein R 3 is amino-substituted C 5 alkyl.

7. The compound of claim 1 , wherein,

R 2 is —(CH 2 ) 3 —; and

R 3 is amino-substituted C 5 alkyl.

8. A pharmaceutical composition comprising the compound of claim 1 or a pharmaceutically acceptable salt thereof.

9. The pharmaceutical composition of claim 8 , wherein the pharmaceutical composition comprises a therapeutically effective amount of the compound of claim 1 or a pharmaceutically acceptable salt thereof for treating a disease in a patient, wherein the disease is selected from narcolepsy, cataplexy, excessive daytime sleepiness, fibromyalgia, chronic fatigue, and tardive dyskinesia.

10. The pharmaceutical composition of claim 8 , wherein the pharmaceutical composition is an oral formulation.

11. The pharmaceutical composition of claim 8 , wherein the pharmaceutical composition comprises a sustained release oral formulation.

12. The pharmaceutical composition of claim 8 , wherein the pharmaceutical composition comprises a delayed release oral formulation.

13. The pharmaceutical composition of claim 8 , wherein the pharmaceutical composition comprises a quick release oral formulation.

14. The pharmaceutical composition of claim 8 , wherein the pharmaceutical composition comprises an oral dosage form.

15. A method of treating a disease in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of the compound of claim 1 or a pharmaceutically acceptable salt thereof to the patient, wherein the disease is selected from narcolepsy, cataplexy, excessive daytime sleepiness, fibromyalgia, chronic fatigue, and tardive dyskinesia.

16. The method of claim 15 , wherein the disease is cataplexy associated with narcolepsy.

17. The method of claim 15 , wherein the disease is excessive daytime sleepiness associated with narcolepsy.

18. The method of claim 15 , wherein the disease is excessive daytime sleepiness in a patient with Parkinson's disease.

19. The method of claim 15 , wherein the disease is chronic fatigue in a patient with Parkinson's disease.

20. The method of claim 15 , wherein administering comprises orally administering.

21. A method of treating a disease in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of the pharmaceutical composition of claim 8 to the patient, wherein the disease is selected from narcolepsy, cataplexy, excessive daytime sleepiness, fibromyalgia, chronic fatigue, and tardive dyskinesia.

22. The method of claim 21 , wherein the disease is cataplexy associated with narcolepsy.

23. The method of claim 21 , wherein the disease is excessive daytime sleepiness associated with narcolepsy.

24. The method of claim 21 , wherein the disease is excessive daytime sleepiness in a patient with Parkinson's disease.

25. The method of claim 21 , wherein the disease is chronic fatigue in a patient with Parkinson's disease.

26. The method of claim 21 , wherein administering comprises orally administering.

Assignments (2)
CHANGE OF NAME Recorded May 4, 2021
From: XW LABORATORIES INC.
To: XWPHARMA LTD.
Reel/Frame 056177/0619 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2020
From: XIANG, JIA-NING; XU, XUESONG; ZHANG, XUAN
To: XW LABORATORIES INC.
Reel/Frame 053435/0471 →
Priority Claims (2)
WO PCT/CN2015/090326 · Sep 23, 2015 · international
CN 201610782104.1 · Aug 31, 2016 · national
Continuity (5)
Continuation 16831086 · Mar 26, 2020
Continuation 16601908 · Oct 15, 2019
Continuation 16275165 · Feb 13, 2019
Continuation 15762559
Related Publication 20200369598A1 · Nov 26, 2020
Cited By (13)
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