Methods for treating hepatitis C

1. A compound of Formula (I):

wherein:

X is:

-cyano;

Y is:

-aryl substituted with one or more of the following:

—C 1 to C 6 alkoxy, substituted with:

—C 1 to C 6 alkoxy,

-hydroxy,

-one or more halogen substituents,

-5 or 6 membered heterocycle, optionally substituted with:

—C 1 to C 6 alkyl, or

-hydroxy,

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents, —NR i SO 2 R x , where R x is C 1 to C 6 alkyl and R i is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—NR J COR k , where R k is:

—C 1 to C 6 alkyl,

-hydrogen, or

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents, and R j is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—N═N + ═N − , or

—COR 1 , where R 1 is 5 or 6 membered heterocycle optionally substituted with hydroxy,

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents,

—C 1 to C 6 alkyl substituted with:

—NHSO 2 R x , where R x is as defined above, or

—NR x SO 2 R x , where R x , is as defined above,

—C 1 to C 6 haloalkoxy,

-hydroxy,

—COOR x , where R x is as defined above,

—COR m , where R m is:

-amino optionally substituted with:

(i) -cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl, or

(ii) one or more C 1 to C 6 alkyl substituents, where the C 1 to C 6 alkyl substituents are optionally substituted with:

 -hydroxy

 -5 or 6 membered heterocycle,

 -amino optionally substituted with one or more C 1 to C 6 alkyl substituents,

 —C 1 to C 6 alkoxy,

-3 to 7 membered heterocycle, optionally substituted with C 1 to C 6 alkyl, optionally substituted with di-C 1 to C 6 alkyl-amino,

—NHR n , where R n is:

—CH 2 CONH 2 , or

-aryl optionally substituted with:

 —C 1 to C 6 alkyl,

 -one or more halogen substituents,

 -nitro, or

 -one or more C 1 to C 6 alkoxy substituents,

—NR o ,COR p , where R p is:

—C 1 to C 6 alkyl optionally substituted with:

-halogen,

—C 1 to C 6 alkoxy, or

-aryl,

-cyclopropyl,

-cyclobutyl,

-cyclopentyl,

-cyclohexyl,

-5 or 6 membered heterocycle,

-aryl, optionally substituted with halogen,

-5 or 6 membered heteroaryl optionally substituted with one or more C 1 to C 6 alkyl substituents,

-hydrogen,

and where R o is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—NR q CONR q R r , where R q is:

-hydrogen,

—C 1 to C 6 alkyl,

—C 1 to C 6 haloalkyl,

—C 1 to C 6 haloalkoxy, or

—COR x , where R x is as defined above,

and where R r is:

-aryl optionally substituted with:

—C 1 to C 6 alkyl,

—C 1 to C 6 haloalkyl,

—OR s , where R s is aryl, or

—COOR x , where R x is as defined above,

—C 1 to C 6 alkyl optionally substituted with one or more of the following:

-halogen,

—C 2 to C 6 alkenyl,

-aryl, or

—COOR, where R x is as defined above,

—COOR x , where R x is as defined above,

-cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl,

—NR t COOR u , where R u is:

—C 1 to C 12 alkyl, optionally substituted with:

-aryl optionally substituted with C 1 to C 6 alkyl or C 1 to C 6 alkoxy,

—C 2 to C 6 alkenyl,

—C 1 to C 6 alkoxy,

—C 2 to C 6 alkynyl,

-halogen,

-5 or 6 membered heterocycle,

-cyclopropyl,

-cyclobutyl,

-cyclopentyl, or

-cyclohexyl,

-aryl, optionally substituted with:

—C 1 to C 6 alkoxy,

-halogen, or

—C 1 to C 6 alkyl,

-5 or 6 membered heterocycle,

-cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl, wherein cyclopropyl, cyclobutyl, cyclopentyl or cyclohexyl are optionally substituted with one or more C 1 to C 6 alkyl substituents,

and R t is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—NR v SO 2 R w , where R v is:

-hydrogen,

—COR x , where R x , is as defined above, or

—C 1 to C 6 alkyl, optionally substituted with:

-halogen,

—COR x , where R x is as defined above,

—OCOR x , where R x is as defined above,

-hydroxyl, or

—C 1 to C 6 alkoxy,

and where R w is:

—C 1 to C 6 alkyl optionally substituted with:

-halogen,

—C 1 to C 6 haloalkyl,

-aryl, or

-5 or 6 membered heterocycle,

-cyclopropyl,

-cyclobutyl,

-cyclopentyl,

-cyclohexyl,

—C 2 to C 6 alkenyl,

—C 1 to C 6 alkyl- or di-C 1 to C 6 alkyl-amino optionally substituted with halogen,

-5 or 6 membered heterocycle, or

-5 or 6 membered heteroaryl optionally substituted with:

—C 1 to C 6 alkyl,

-5 or 6 membered heterocycle, or

 optionally substituted with C 1 to C 6 alkyl, where R y is C 1 to C 6 alkyl or hydrogen,

where R x , is hydrogen or C 1 to C 6 alkyl, optionally substituted with aryl,

—SR x , where R x is as defined above,

—SO 2 R aa , where R aa is:

—C 1 to C 6 alkyl,

-amino,

—C 1 to C 6 alkyl- or di-C 1 to C 6 alkyl-amino optionally substituted with hydroxy

or —COOR x , where R x is as defined above,

-5 or 6 membered heteroaryl,

-cyclopropylamino, cyclobutylamino, cyclopentylamino, or cyclohexylamino,

-aryl, or

—NHR bb , where R bb is:

—C(═S)NH 2 , or

—PO(OR x ) 2 , where R x is as defined above;

Z is:

-hydrogen;

—C 1 to C 6 alkyl optionally substituted with:

—C 1 to C 6 alkoxy,

-one or more halogen substituents, or

-aryl;

—C 2 to C 6 alkenyl;

-aryl optionally substituted with C 1 to C 6 alkoxy or one or more C 1 to C 6 alkyl substituents;

—COOR x , where R x is as defined above;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl;

-cyclohexyl;

-cyclopropylmethyl;

-cyclobutylmethyl; or

-cyclopentylmethyl;

R is hydrogen, halogen or C 1 to C 6 alkoxy;

R 1 is:

-hydrogen;

-hydroxy;

-halogen;

—C 1 to C 6 haloalkyl;

-nitro;

-5 or 6 membered heteroaryl;

-5 or 6 membered heterocycle;

—C 1 to C 6 alkoxy optionally substituted with:

-one or more halogen substituents,

-aryl, or

-5 or 6 membered heterocycle;

-aryl optionally substituted with C 1 to C 6 alkoxy;

—COR x , where R x is as defined above;

—C 1 to C 6 alkyl optionally substituted with di-C 1 to C 6 alkyl-amino or 5 or 6 membered heterocycle;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl; or -cyclohexyl;

and wherein when R 2 is unsubstituted methoxy, then R 1 is hydrogen;

R 2 is:

-nitro;

-hydrogen;

-halogen;

-hydroxy;

—C 1 to C 6 alkyl, optionally substituted with one or more halogen substituents;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl;

-cyclohexyl;

-amino;

—C 1 to C 6 alkoxy optionally substituted with:

-one or more halogen substituents,

—OCOR X , where R x is as defined above,

-di-C 1 to C 6 alkyl-amino optionally substituted with C 1 to C 6 alkoxy,

-5 or 6 membered heterocycle optionally substituted with C 1 to C 6 alkyl,

-5 or 6 membered heteroaryl, or -aryl;

—COOR x , where R x is as defined above;

—C 1 to C 6 haloalkyl;

-amide optionally substituted with:

-hydroxy, or

-aryl;

-5 or 6 membered heteroaryl;

—OCOR x , where R x is as defined above;

—NHCOR jj , where R jj is:

—C 1 to C 6 alkoxy, or

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents;

—OR kk , where R kk is 5 to 6 membered heteroaryl;

—NHSO 2 R x , where R x is as defined above;

—NHSO 2 cyclopropyl;

—NHSO 2 cyclobutyl;

—NHSO 2 cyclopentyl; or

—NHSO 2 cyclohexyl;

and wherein when R 1 is unsubstituted methoxy, then R 2 is hydrogen; and

R 3 is:

-hydrogen; or

—CH 2 OCOR x , where R x is as defined above;

or a pharmaceutically acceptable salt thereof.

2. A compound of Formula (I):

wherein:

X is:

-cyano;

Y is:

Z is:

-hydrogen;

—C 1 to C 6 alkyl optionally substituted with:

—C 1 to C 6 alkoxy,

-one or more halogen substituents, or

-aryl;

—C 2 to C 6 alkenyl;

-aryl optionally substituted with C 1 to C 6 alkoxy or one or more C 1 to C 6 alkyl substituents;

—COOR x , where R x is as defined above;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl;

-cyclohexyl;

-cyclopropylmethyl;

-cyclobutylmethyl; or

-cyclopentylmethyl;

R is hydrogen, halogen or C 1 to C 6 alkoxy;

R 1 is:

-hydrogen;

-hydroxy;

-halogen;

—C 1 to C 6 haloalkyl;

-nitro;

-5 or 6 membered heteroaryl;

-5 or 6 membered heterocycle;

—C 1 to C 6 alkoxy optionally substituted with:

-one or more halogen substituents,

-aryl, or

-5 or 6 membered heterocycle;

-aryl optionally substituted with C 1 to C 6 alkoxy;

—COR x , where R x is as defined above;

—C 1 to C 6 alkyl optionally substituted with di-C 1 to C 6 alkyl-amino or 5 or 6 membered heterocycle;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl; or

-cyclohexyl;

R 2 is:

-nitro;

-hydrogen;

-halogen;

-hydroxy;

—C 1 to C 6 alkyl, optionally substituted with one or more halogen substituents;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl;

-cyclohexyl;

-amino;

—C 1 to C 6 alkoxy optionally substituted with:

-one or more halogen substituents,

—OCOR X , where R x is as defined above,

-di-C 1 to C 6 alkyl-amino optionally substituted with C 1 to C 6 alkoxy,

-5 or 6 membered heterocycle optionally substituted with C 1 to C 6 alkyl,

-5 or 6 membered heteroaryl, or

-aryl;

—COOR x , where R x is as defined above;

—C 1 to C 6 haloalkyl;

-amide optionally substituted with:

-hydroxy, or

-aryl;

-5 or 6 membered heteroaryl;

—OCOR x , where R x is as defined above;

—NHCOR jj , where R jj is:

—C 1 to C 6 alkoxy, or

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents;

—OR kk , where R kk is 5 to 6 membered heteroaryl;

—NHSO 2 R x , where R x is as defined above;

—NHSO 2 cyclopropyl;

—NHSO 2 cyclobutyl;

—NHSO 2 cyclopentyl; or

—NHSO 2 cyclohexyl; and

R 3 is:

-hydrogen; or

—CH 2 OCOR x , where R x is as defined above;

or a pharmaceutically acceptable salt thereof.

3. The compound of claim 1 , wherein Z is selected from the group consisting of -cyclopropyl; -cyclobutyl; -cyclopentyl; -cyclohexyl; -cyclopropylmethyl;

-cyclobutylmethyl; -cyclopentylmethyl; -hydrogen; —C 1 to C 6 alkyl optionally substituted with:

—C 1 to C 6 alkoxy, -one or more halogen substituents, or -aryl; —C 2 to C 6 alkenyl; and -aryl optionally substituted with C 1 to C 6 alkoxy.

4. The compound of claim 1 , wherein R is hydrogen.

5. The compound of claim 1 , wherein R 1 is selected from the group consisting of -cyclopropyl; -cyclobutyl; -cyclopentyl; -cyclohexyl; -hydrogen; -halogen; -nitro; -5 or 6 membered heterocycle; —C 1 to C 6 alkoxy optionally substituted with: -aryl; -aryl optionally substituted with C 1 to C 6 alkoxy.

6. The compound of claim 1 , wherein R 2 is selected from the group consisting of -nitro; -hydrogen; -halogen; -hydroxy; —C 1 to C 6 alkyl, optionally substituted with one or more halogen substituents; -cyclopropyl; -cyclobutyl; -cyclopentyl; -cyclohexyl; —C 1 to C 6 alkoxy optionally substituted with: -one or more halogen substituents, —OCOR x , where R x is as defined above, -di-C 1 to C 6 alkyl-amino optionally substituted with C 1 to C 6 alkoxy, -5 or 6 membered heterocycle optionally substituted with C 1 to C 6 alkyl, or -5 or 6 membered heteroaryl; -amide; —NHSO 2 R x , where R x is as defined above; —NHSO 2 cyclopropyl; —NHSO 2 cyclobutyl; —NHSO 2 cyclopentyl; or —NHSO 2 cyclohexyl.

7. The compound of claim 1 , wherein R 3 is hydrogen.

8. A compound selected from the group consisting of:

or a pharmaceutically acceptable salt thereof.

9. A pharmaceutical composition comprising a compound of claim 1 or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

10. A pharmaceutical composition comprising a compound of claim 2 or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

11. A pharmaceutical composition comprising a compound of claim 8 or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

12. A compound of Formula (I):

wherein:

X is:

-cyano;

Y is:

-aryl substituted with one or more of the following:

—C 1 to C 6 alkoxy, optionally substituted with:

—C 1 to C 6 alkoxy,

-hydroxy,

-one or more halogen substituents,

-5 or 6 membered heterocycle, optionally substituted with:

—C 1 to C 6 alkyl, or

-hydroxy,

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents,

—NR i SO 2 R x , where R x is C 1 to C 6 alkyl and R i is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—NR j COR k , where R k is:

—C 1 to C 6 alkyl,

-hydrogen, or

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents, and R j is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—N═N═ + ═N − , or

—COR 1 , where R 1 is 5 or 6 membered heterocycle optionally substituted with hydroxy,

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents,

-nitro,

—C 1 to C 6 alkyl, optionally substituted with:

—NHSO 2 R x , where R x is as defined above, or

—NR x SO 2 R x , where R x is as defined above,

—C 1 to C 6 haloalkoxy,

-halogen,

-hydroxy,

—COOR x , where R x is as defined above,

—COR m , where R m is:

-amino optionally substituted with:

(i) -cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl, or

(ii) one or more C 1 to C 6 alkyl substituents, where the C 1 to C 6 alkyl substituents are optionally substituted with: -hydroxy

 -5 or 6 membered heterocycle,

 -amino optionally substituted with one or more C 1 to C 6 alkyl substituents,

—C 1 to C 6 alkoxy,

-3 to 7 membered heterocycle, optionally substituted with C 1 to C 6 alkyl, optionally substituted with di-C 1 to C 6 alkyl-amino,

—NHR n , where R n is:

—CH 2 CONH 2 , or

-aryl optionally substituted with:

—C 1 to C 6 alkyl,

 -one or more halogen substituents,

 -nitro, or

 -one or more C 1 to C 6 alkoxy substituents,

—NR o COR p , where R p is:

—C 1 to C 6 alkyl optionally substituted with:

-halogen,

—C 1 to C 6 alkoxy, or

-aryl,

-cyclopropyl,

-cyclobutyl,

-cyclopentyl,

-cyclohexyl,

-5 or 6 membered heterocycle,

-aryl, optionally substituted with halogen,

-5 or 6 membered heteroaryl optionally substituted with one or more C 1 to C 6 alkyl substituents,

-hydrogen,

and where R o is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—NR q CONR q R r where R q is:

-hydrogen,

—C 1 to C 6 alkyl,

—C 1 to C 6 haloalkyl,

—C 1 to C 6 haloalkoxy, or

—COR x , where R x is as defined above,

and where R r , is:

-aryl optionally substituted with:

—C 1 to C 6 alkyl,

—C 1 to C 6 haloalkyl,

—OR s , where R s is aryl, or

—COOR x , where R x is as defined above,

—C 1 to C 6 alkyl optionally substituted with one or more of the following:

-halogen,

—C 2 to C 6 alkenyl,

-aryl, or

—COOR x , where R x is as defined above,

—COOR x , where R x is as defined above,

-cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl,

—NR t COOR u , where R u , is:

—C 1 to C 12 alkyl, optionally substituted with:

-aryl optionally substituted with C 1 to C 6 alkyl or C 1 to C 6 alkoxy,

—C 2 to C 6 alkenyl,

—C 1 to C 6 alkoxy,

—C 2 to C 6 alkynyl,

-halogen,

-5 or 6 membered heterocycle,

-cyclopropyl,

-cyclobutyl,

-cyclopentyl, or

-cyclohexyl,

-aryl, optionally substituted with:

—C 1 to C 6 alkoxy,

-halogen, or

—C 1 to C 6 alkyl,

-5 or 6 membered heterocycle,

-cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl, wherein cyclopropyl, cyclobutyl, cyclopentyl or cyclohexyl are optionally substituted with one or more C 1 to C 6 alkyl substituents,

and R t is:

-hydrogen,

—C 1 to C 6 alkyl,

—COR x , where R x is as defined above,

—C 1 to C 6 haloalkyl, or

—C 1 to C 6 haloalkoxy,

—NR v SO 2 R w , where R v is:

-hydrogen,

—COR x , where R x is as defined above, or

—C 1 to C 6 alkyl, optionally substituted with:

-halogen,

—COR x , where R x is as defined above,

—OCOR x , where R x is as defined above,

-hydroxyl, or

—C 1 to C 6 alkoxy,

and where R w is:

—C 1 to C 6 alkyl optionally substituted with:

-halogen,

—C 1 to C 6 haloalkyl,

-aryl, or

-5 or 6 membered heterocycle,

-cyclopropyl,

-cyclobutyl,

-cyclopentyl,

-cyclohexyl,

—C 2 to C 6 alkenyl,

—C 1 to C 6 alkyl- or di-C 1 to C 6 alkyl-amino optionally substituted with halogen,

-5 or 6 membered heterocycle, or

-5 or 6 membered heteroaryl optionally substituted with:

—C 1 to C 6 alkyl,

-5 or 6 membered heterocycle, or

 optionally substituted with C 1 to C 6 alkyl, where R y is C 1 to C 6 alkyl or hydrogen,

where R z , is hydrogen or C 1 to C 6 alkyl, optionally substituted with aryl,

—SR x , where R x is as defined above,

—SO 2 R aa , where R aa is:

—C 1 to C 6 alkyl,

-amino,

—C 1 to C 6 alkyl- or di-C 1 to C 6 alkyl-amino optionally substituted with hydroxy or —COOR x , where R x is as defined above,

-5 or 6 membered heteroaryl,

-cyclopropylamino, cyclobutylamino, cyclopentylamino, or cyclohexylamino, -aryl, or

—NHR bb , where R bb is:

—C(═S)NH 2 , or

—PO(OR x ) 2 , where R x is as defined above;

Z is:

—C 1 to C 6 alkyl optionally substituted with:

—C 1 to C 6 alkoxy,

-one or more halogen substituents, or

-aryl;

—C 2 to C 6 alkenyl;

-aryl optionally substituted with C 1 to C 6 alkoxy or one or more C 1 to C 6 alkyl substituents;

—COOR x , where R x is as defined above;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl;

-cyclohexyl;

-cyclopropylmethyl;

-cyclobutylmethyl; or -cyclopentylmethyl;

R is hydrogen, halogen or C 1 to C 6 alkoxy;

R 1 is:

-hydrogen;

-hydroxy;

-halogen;

—C 1 to C 6 haloalkyl;

-nitro;

-5 or 6 membered heteroaryl;

-5 or 6 membered heterocycle;

—C 1 to C 6 alkoxy optionally substituted with:

-one or more halogen substituents,

-aryl, or

-5 or 6 membered heterocycle;

-aryl optionally substituted with C 1 to C 6 alkoxy;

—COR, where R x is as defined above;

—C 1 to C 6 alkyl optionally substituted with di-C 1 to C 6 alkyl-amino or 5 or 6 membered heterocycle;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl; or

-cyclohexyl;

and wherein when R 2 is unsubstituted methoxy, then R 1 is hydrogen;

R 2 is:

-nitro;

-hydrogen;

-halogen;

-hydroxy;

—C 1 to C 6 alkyl, optionally substituted with one or more halogen substituents;

-cyclopropyl;

-cyclobutyl;

-cyclopentyl;

-cyclohexyl;

-amino;

—C 1 to C 6 alkoxy optionally substituted with:

-one or more halogen substituents,

—OCOR x , where R x is as defined above,

-di-C 1 to C 6 alkyl-amino optionally substituted with C 1 to C 6 alkoxy,

-5 or 6 membered heterocycle optionally substituted with C 1 to C 6 alkyl,

-5 or 6 membered heteroaryl, or

-aryl;

—COOR x , where R x is as defined above;

—C 1 to C 6 haloalkyl;

-amide optionally substituted with:

-hydroxy, or

-aryl;

-5 or 6 membered heteroaryl;

—OCOR x , where R x is as defined above;

—NHCOR jj , where R jj is:

—C 1 to C 6 alkoxy, or

-amino optionally substituted with one or more C 1 to C 6 alkyl substituents;

—OR kk , where R kk is 5 to 6 membered heteroaryl;

—NHSO 2 R x , where R x is as defined above;

—NHSO 2 cyclopropyl;

—NHSO 2 cyclobutyl;

—NHSO 2 cyclopentyl; or —NHSO 2 cyclohexyl;

and wherein when R 1 is unsubstituted methoxy, then R 2 is hydrogen; and

R 3 is:

-hydrogen; or

—CH 2 OCOR x , where R x is as defined above;

or a pharmaceutically acceptable salt thereof.

13. The compound of claim 12 , wherein

Y is:

-aryl substituted with one or more of the following:

—C 1 to C 6 alkoxy

-nitro,

—C 1 to C 6 alkyl

-halogen;

and

Z is:

—C 1 to C 6 alkyl optionally substituted with:

—C 1 to C 6 alkoxy,

-one or more halogen substituents, or

-aryl.

14. A pharmaceutical composition comprising a compound of claim 12 or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.