IP Library Granted Patent US 11,292,783
Granted Patent B2
US 11,292,783 · App. 16/333,849 · Granted Apr 5, 2022

Substituted 1,2,3,4-tetrahydroisoquinolines as kappa opioid antagonists

Inventors: Frank Ivy Carroll (Research Triangle Park, NC); Chad M. Kormos (Research Triangle Park, NC); Pauline W. Ondachi (Research Triangle Park, NC); Scott P. Runyon (Research Triangle Park, NC); Hernan A. Navarro (Research Triangle Park, NC); James B. Thomas (Research Triangle Park, NC); S. Wayne Mascarella (Research Triangle Park, NC)
Assignee: Research Triangle Institute
C07D401/12A61P25/00A61P25/18A61P25/24A61P25/32A61P25/34A61P25/36C07D211/18C07D217/26C07D413/12C07D487/08
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Quick Facts
Patent No.
US 11,292,783
App. No.
16/333,849
Granted
Apr 5, 2022
Kind
B2
Abstract

Potent opioid receptor antagonists of formula (I) and their use as pharmacotherapies for treating depression, anxiety, schizophrenia, eating disorders, and addiction to cocaine, methamphetamine, nicotine, alcohol, and opiates are disclosed. More specifically, the disclosure provides potent and selective kappa opioid receptor antagonist compounds, pharmaceutical compositions of those compounds and uses of those compounds to ameliorate or treat addictions, eating disorders, etc.

Claims (103)

1. A compound of formula I:

or a pharmaceutically acceptable salt or stereoisomer thereof,

wherein:

R 1 is H, C 1-6 alkyl, NHR 9 , N(C 1-8 alkyl)R 9 , N(C 2-8 alkenyl)R 9 , N(C 3-8 cycloalkyl)R 9 , OR 8 , C 3-8 cycloalkyl, C 5-8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, phenyl, or heteroaryl, wherein the heterocycloalkyl or heterocycloalkenyl is optionally substituted with one or more independently selected alkyl substituents;

R 2 is H, C 1-4 alkyl, CH 2 (CH 2 ) n OH, C 3-6 cycloalkyl, or aryl;

R 3 is H or C 1-4 alkyl;

R 4 is O or S;

R 5 is H or C 1-4 alkyl;

R 6 is H or C 1-4 alkyl;

R 7 is halogen, CN, NO 2 , N 3 , CF 3 , CH 2 (CH 2 ) n Y, C(O)NR 8 R 9 , C(O)OR 8 , C(S)NR 8 R 9 , NH 2 , NHC(O)R 8 , NHC(O)OR 8 , OR 8 , or S(O) 2 CF 3 ;

Y is H, CF 3 , C(O)OR 8 , or NR 8 R 9 ;

each R 8 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl;

each R 9 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl; or

R 8 and R 9 , together with the nitrogen atom to which they are attached, form a C 3 -C 8 heterocycloalkyl;

R 10 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl;

R 11 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl; and

each n is independently 0, 1, 2, 3, 4, 5, 6, 7, or 8.

2. The compound of claim 1 , or a stereoisomer thereof, wherein the stereoisomer of the compound is of formula II:

or a pharmaceutically acceptable salt thereof.

3. The compound of claim 1 , or a stereoisomer thereof, wherein the stereoisomer of the compound is of formula III:

or a pharmaceutically acceptable salt thereof.

4. The compound of claim 3 , or a pharmaceutically acceptable salt thereof, wherein R 1 is C 3-8 cycloalkyl.

5. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 1 is NHR 9 , N(C 1-8 alkyl)R 9 , N(C 2-8 alkenyl)R 9 , N(C 3-8 cycloalkyl)R 9 , OH, heterocycloalkyl, heterocycloalkenyl, or heteroaryl.

6. The compound of claim 5 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 1 is heterocycloalkyl, heterocycloalkenyl, or heteroaryl, wherein the heterocycloalkyl, heterocycloalkenyl, or heteroaryl contains at least one nitrogen heteroatom.

7. The compound of claim 6 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 1 is heterocycloalkyl, wherein the heterocycloalkyl contains at least one nitrogen heteroatom.

8. The compound of claim 7 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 1 is a 6-membered heterocycloalkyl, wherein the 6-membered heterocycloalkyl contains at least one nitrogen heteroatom.

9. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 1 is C 2-6 alkyl, C 3-8 cycloalkyl, C 5-8 cycloalkenyl, or phenyl.

10. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 2 is H, C 3-4 alkyl, CH 2 OH, C 3-4 cycloalkyl, or phenyl.

11. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 3 is H or CH 3 .

12. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 4 is O.

13. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:

R 5 is H; or

R 6 is H.

14. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:

R 5 is H; and

R 6 is H.

15. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:

R 3 is H;

R 5 is H; and

R 6 is H.

16. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R 7 is halogen, C(O)NH 2 , or OH.

17. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:

R 10 is H; or

R 11 is H.

18. The compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:

R 10 is H; and

R 11 is H.

19. The compound of claim 1 , or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:

or a pharmaceutically acceptable salt thereof.

20. A pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a therapeutically effective amount of the compound of claim 1 , or a pharmaceutically acceptable salt or stereoisomer thereof.

21. A method for treating anxiety, depression, an eating disorder, or schizophrenia in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of a compound of formula I:

or a pharmaceutically acceptable salt or stereoisomer thereof,

wherein:

R 1 is H, C 1-6 alkyl, NHR 9 , N(C 1-8 alkyl)R 9 , N(C 2-8 alkenyl)R 9 , N(C 3-8 cycloalkyl)R 9 , OR 8 , C 3-8 cycloalkyl, C 5-8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, phenyl, or heteroaryl, wherein the heterocycloalkyl or heterocycloalkenyl is optionally substituted with one or more independently selected alkyl substituents;

R 2 is H, C 1-4 alkyl, CH 2 (CH 2 ) n OH, C 3-6 cycloalkyl, or aryl;

R 3 is H or C 1-4 alkyl;

R 4 is O or S;

R 5 is H or C 1-4 alkyl;

R 6 is H or C 1-4 alkyl;

R 7 is halogen, CN, NO 2 , N 3 , CF 3 , CH 2 (CH 2 ) n Y, C(O)NR 8 R 9 , C(O)OR 8 , C(S)NR 8 R 9 , NH 2 , NHC(O)R 8 , NHC(O)OR 8 , OR 8 , or S(O) 2 CF 3 ;

Y is H, CF 3 , C(O)OR 8 , or NR 8 R 9 ;

each R 8 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl;

each R 9 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl; or

R 8 and R 9 , together with the nitrogen atom to which they are attached, form a C 3 -C 8 heterocycloalkyl;

R 10 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl;

R 11 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl; and

each n is independently 0, 1, 2, 3, 4, 5, 6, 7, or 8.

22. A method for treating substance abuse addiction in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of a compound of formula I:

or a pharmaceutically acceptable salt or stereoisomer thereof,

wherein:

R 1 is H, C 1-6 alkyl, NHR 9 , N(C 1-8 alkyl)R 9 , N(C 2-8 alkenyl)R 9 , N(C 3-8 cycloalkyl)R 9 , OR 8 , C 3-8 cycloalkyl, C 5-8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, phenyl, or heteroaryl, wherein the heterocycloalkyl or heterocycloalkenyl is optionally substituted with one or more independently selected alkyl substituents;

R 2 is H, C 1-4 alkyl, CH 2 (CH 2 ) n OH, C 3-6 cycloalkyl, or aryl;

R 3 is H or C 1-4 alkyl;

R 4 is O or S;

R 5 is H or C 1-4 alkyl;

R 6 is H or C 1-4 alkyl;

R 7 is halogen, CN, NO 2 , N 3 , CF 3 , CH 2 (CH 2 ) n Y, C(O)NR 8 R 9 , C(O)OR 8 , C(S)NR 8 R 9 , NH 2 , NHC(O)R 8 , NHC(O)OR 8 , OR 8 , or S(O) 2 CF 3 ;

Y is H, CF 3 , C(O)OR 8 , or NR 8 R 9 ;

each R 8 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl;

each R 9 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl; or

R 8 and R 9 , together with the nitrogen atom to which they are attached, form a C 3 -C 8 heterocycloalkyl;

R 10 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl;

R 11 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl; and

each n is independently 0, 1, 2, 3, 4, 5, 6, 7, or 8.

23. The method of claim 22 , wherein the substance abuse addiction is selected from the group consisting of alcohol addiction, cocaine addiction, methamphetamine addiction, nicotine addiction, and opioid addiction.

24. A compound of formula I:

or a pharmaceutically acceptable salt or stereoisomer thereof,

wherein:

R 1 is H, C 1-6 alkyl, NHR 9 , N(C 1-8 alkyl)R 9 , N(C 2-8 alkenyl)R 9 , N(C 3-8 cycloalkyl)R 9 , OR 8 , C 3-8 cycloalkyl, C 5-8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, phenyl, or heteroaryl, wherein the heterocycloalkyl or heterocycloalkenyl is optionally substituted with one or more independently selected alkyl substituents;

R 2 is H, C 1-4 alkyl, CH 2 (CH 2 ) n OH, C 3-6 cycloalkyl, or aryl;

R 3 is H or C 1-4 alkyl;

R 4 is O or S;

R 5 is H or C 1-4 alkyl;

R 6 is H or C 1-4 alkyl;

R 7 is halogen, CN, NO 2 , N 3 , CF 3 , CH 2 (CH 2 ) n Y, C(O)NR 8 R 9 , C(O)OR 8 , C(S)NR 8 R 9 , NH 2 , NHC(O)R 8 , NHC(O)OR 8 , OR 8 , or S(O) 2 CF 3 ;

Y is H, CF 3 , C(O)OR 8 , or NR 8 R 9 ;

each R 8 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl;

each R 9 is independently H, C 1-8 alkyl, C 2-8 alkenyl, or C 3-8 cycloalkyl;

R 10 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl;

R 11 is H, C 1-8 alkyl, C 3-8 alkynyl, OC 1-8 alkyl, or C 3-8 cycloalkyl; and

each n is independently 0, 1, 2, 3, 4, 5, 6, 7, or 8.

25. A compound, or a stereoisomer thereof, wherein the stereoisomer of the compound is selected from the group consisting of:

or a pharmaceutically acceptable salt thereof.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jan 31, 2023
From: RESEARCH TRIANGLE INSTITUTE
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 062559/0357 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 15, 2019
From: CARROLL, FRANK IVY; KORMOS, CHAD M.; ONDACHI, PAULINE W.; RUNYON, SCOTT P.; NAVARRO, HERNAN A.; THOMAS, JAMES B.; MASCARELLA, S. WAYNE
To: RESEARCH TRIANGLE INSTITUTE
Reel/Frame 048612/0508 →
Continuity (2)
Provisional Application 62395750 · Sep 16, 2016
Related Publication 20190263781A1 · Aug 29, 2019