IP Library Granted Patent US 11,440,874
Granted Patent B2
US 11,440,874 · App. 17/067,968 · Granted Sep 13, 2022

Ketamine derivatives and compositions thereof

Inventors: Jia-Ning Xiang (Wuhan, CN); Xuesong Xu (Wuhan, CN); Hao-Wei Shih (New Taipei, TW); Wai-Si Eng (Maple Glen, PA)
Assignee: XWPHARMA LTD.
C07C271/24A61K9/0053A61K31/165A61K31/166C07C211/35C07D213/80C07D305/06C07D309/08C07D317/68C07C271/56C07D207/16C07D207/28C07D211/62
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Quick Facts
Patent No.
US 11,440,874
App. No.
17/067,968
Granted
Sep 13, 2022
Kind
B2
Abstract

Ketamine derivatives and pharmaceutical compositions thereof are disclosed. When administered orally the ketamine derivatives provide increased bioavailability of ketamine in the systemic circulation. The ketamine derivatives can be used to treat neurological diseases, psychological diseases and pain.

Claims (58)

1. A method of treating a psychiatric disease or disorder in a patient comprising administering to a patient in need of such treatment, a therapeutically effective amount of the compound of Formula (1):

or a pharmaceutically acceptable salt thereof, wherein,

R 1 is selected from hydrogen and C 1-3 alkyl; and

R 2 is selected from a moiety of Formula (2) and a moiety of Formula (4):

wherein,

R 3 is selected from hydrogen and C 1-6 alkyl;

R 4 is selected from hydrogen and C 1-3 alkyl;

R 5 is selected from C 1-3 alkyl and —C(═O)—R 10 , wherein R 10 is selected from C 1-6 alkyl and —CF 3 ;

n is 1; and

R 9 is C 1-3 alkyl,

wherein the psychiatric disease or disorder is selected from an alcohol use disorder, an anxiety disorder, an obsessive-compulsive disorder, an opioid use disorder, and a posttraumatic stress disorder.

2. The method of claim 1 , wherein administering comprises orally administering.

3. The method of claim 1 , wherein the compound is the (R)-isomer having the structure of Formula (1a):

4. The method of claim 1 , wherein the compound is the (S)-isomer having the structure of Formula (1b):

5. The method of claim 1 , wherein the compound is selected from:

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl acetylglycinate (3):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl 2-(3-methyloxetan-3-yl)acetate (6):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl acetyl-L-alaninate (7):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl isobutyrylglycinate (19):

(S)-(((1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl 2-(3-methyloxetan-3-yl)acetate (22):

((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl acetyl-L-valinate (32):

(S)-(((1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl isobutyrylglycinate (34):

((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl isobutyryl-L-alaninate (35):

((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl isobutyryl-L-valinate (36):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl N-acetyl-N-methylglycinate (41):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)propyl (2,2,2-trifluoroacetyl)glycinate (49):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl (2,2,2-trifluoroacetyl)-L-alaninate (50):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)-2-methylpropyl (2,2,2-trifluoroacetyl)glycinate (51):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl (2,2,2-trifluoroacetyl)-L-alaninate (53):

1-((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)ethyl acetyl-L-soleucinate (57):

((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl acetyl-L-alloisoleucinate (60): and

or a pharmaceutically acceptable salt of any of the foregoing.

6. The method of claim 1 , wherein,

R 1 is selected from hydrogen and methyl;

R 2 is a moiety of Formula (2);

R 3 is selected from hydrogen and C 1-4 alkyl;

R 4 is selected from hydrogen and methyl; and

R 5 is —C(═O)—R 10 , wherein R 10 is selected from methyl and —CF 3 .

7. The method of claim 1 , wherein,

R 1 is selected from hydrogen and methyl;

R 2 is a moiety of Formula (4); and

R 9 is methyl.

8. The method of claim 1 , wherein, following administration, the compound provides a therapeutically effective amount of (S)-ketamine in the patient's blood for treating the psychiatric disease or disorder.

9. The method of claim 1 , wherein the compound is (S)-(((1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl 2-(3-methyloxetan-3-yl)acetate (22) or a pharmaceutically acceptable salt thereof:

10. The method of claim 1 , wherein the compound is 2-(3-methyloxetan-3-yl)acetoyloxy)methyl (R)-1-(2-chlorophenyl)-2-oxocyclohexylmethylcarbamate (66) or a pharmaceutically acceptable salt thereof:

11. The method of claim 1 , wherein the compound is ((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl dimethyl-L-valinate (39) or a pharmaceutically acceptable salt thereof:

12. The method of claim 1 , wherein the compound has the structure of Formula (1a);

or a pharmaceutically acceptable salt thereof, wherein,

R 1 is hydrogen;

R 2 is a moiety of Formula (2);

R 3 is isopropyl and the carbon atom to which R 3 is bonded is in the (S) configuration; and

each of R 4 and R 5 is methyl.

13. The method of claim 1 , wherein administering comprises administering a pharmaceutical composition comprising the compound of Formula (1) or a pharmaceutically acceptable salt thereof.

14. The method of claim 1 , wherein the psychiatric disease or disorder is an alcohol use disorder.

15. The method of claim 1 , wherein the psychiatric disease or disorder is an obsessive compulsive disorder.

16. The method of claim 1 , wherein the psychiatric disease or disorder is an opioid use disorder.

17. The method of claim 1 , wherein the psychiatric disease or disorder is an anxiety disorder.

18. The method of claim 1 , wherein the psychiatric disease or disorder is a post-traumatic stress disorder.

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 Oct 12, 2020
From: XIANG, JIA-NING; XU, XUESONG; SHIH, HAO-WEI; ENG, WAI-SI
To: XW LABORATORIES INC.
Reel/Frame 054025/0504 →
Continuity (5)
Continuation 16838633 · Apr 2, 2020
Division 16502562 · Jul 3, 2019
Continuation PCTCN2019070912 · Jan 8, 2019
Provisional Application 62615948 · Jan 10, 2018
Related Publication 20210032199A1 · Feb 4, 2021