Substituted fatty acids for treating non-alcoholic steatohepatitis
The present disclosure relates to a method of preventing and/or treating non-alcoholic steatohepatitis in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a compound of Formula (II): wherein R 1 , R2, R3, X and Y are as defined in the specification; or a pharmaceutically acceptable salt, solvate, or solvate of such a salt. More particularly, the present disclosure relates to a method of preventing and/or treating non-alcoholic steatohepatitis in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a compound of Formula (I): wherein R2, R 3 , and X, are as defined in the specification; or a pharmaceutically acceptable salt, solvate, or solvate of such a salt. Further, the present invention relates to a compound of Formula (I) for preventing and/or treating non-alcoholic steatohepatitis, wherein R 2 , R 3 and X are as defined in the specification; or a pharmaceutically acceptable salt, solvate, or solvate of such a salt.
1. A method for treating non-alcoholic steatohepatitis in a subject, comprising administering to the subject in need thereof a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a pharmaceutically effective amount of a compound of Formula (I):
or a pharmaceutically acceptable salt or enantiomer thereof,
wherein:
R 2 is H, C 1 -C 6 alkyl, or C 3 -C 6 cycloalkyl;
R 3 is H, C 1 -C 6 alkyl, or C 3 -C 6 cycloalkyl; and
X is C(O)OH or C(O)OC 1 -C 6 alkyl;
with the proviso that R 2 and R 3 are not simultaneously H.
2. The method according to claim 1 , wherein X is C(O)OH.
3. The method according to claim 1 , wherein X is C(O)OC 1 -C 6 alkyl.
4. The method according to claim 1 , wherein X is C(O)OCH 3 , C(O)OCH 2 CH 3 , C(O)OCH(CH 3 ) 2 , C(O)O(CH 2 ) 3 CH 3 , or C(O)OC(CH 3 ) 3 .
5. The method according to claim 1 , wherein:
R 2 is H, CH 3 , CH 2 CH 3 , CH 2 CH 2 CH 3 , or CH(CH 3 ) 2 ; and
R 3 is H, CH 3 , CH 2 CH 3 , CH 2 CH 2 CH 3 , or CH(CH 3 ) 2 .
6. The method according to claim 1 , wherein:
R 2 is CH 2 CH 3 ; and
R 3 is CH 2 CH 3 .
7. The method according to claim 1 , wherein:
R 2 is CH 2 CH 3 ;
R 3 is CH 2 CH 3 ; and
X is C(O)OH.
8. The method according to claim 1 , wherein the compound of Formula (I) is the (R)-enantiomer.
9. The method according to claim 1 , wherein the compound of Formula (I) is the (S)-enantiomer.
10. The method according to claim 1 , wherein the method comprises administering a pharmaceutical composition comprising from 5 mg to 2 g of the compound of Formula (I).
11. The method according to claim 1 , wherein the method comprises administering a pharmaceutical composition comprising from 200 mg to 800 mg of the compound of Formula (I).
12. The method according to claim 1 , wherein the method comprises administering the pharmaceutical composition once daily.
13. The method according to claim 1 , wherein the pharmaceutical composition is formulated for oral administration.
14. The method according to claim 13 , wherein the pharmaceutical composition is formulated as a capsule or a tablet.
15. The method according to claim 1 , wherein the pharmaceutical composition comprises at least one pharmaceutically acceptable excipient selected from the group consisting of a binder and a diluent, or a combination thereof.
16. The method according to claim 1 , wherein the pharmaceutical composition further comprises an antioxidant.
17. The method according to claim 16 , wherein the antioxidant is selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, and tocopherol, or a mixture thereof.
18. A method for treating non-alcoholic steatohepatitis in a subject, comprising administering to the subject in need thereof a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a pharmaceutically effective amount of the compound:
or a pharmaceutically acceptable salt thereof.
19. The method according to claim 18 , wherein the method comprises administering a pharmaceutical composition comprising from 200 mg to 800 mg of the compound.
20. A method for reducing hepatic inflammation in a subject having non-alcoholic steatohepatitis, comprising administering to the subject in need thereof a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a pharmaceutically effective amount of a compound of Formula (I):
or a pharmaceutically acceptable salt or enantiomer thereof,
wherein:
R 2 is H, C 1 -C 6 alkyl, or C 3 -C 6 cycloalkyl;
R 3 is H, C 1 -C 6 alkyl, or C 3 -C 6 cycloalkyl; and
X is C(O)OH or C(O)OC 1 -C 6 alkyl;
with the proviso that R 2 and R 3 are not simultaneously H.