IP Library Granted Patent US 8,546,365
Granted Patent B2
US 8,546,365 · App. 13/082,261 · Granted Oct 1, 2013

Bile acid derivatives as FXR ligands for the prevention or treatment of FXR-mediated diseases or conditions

Inventors: Roberto Pellicciari (Perugia, IT); Stefano Fiorucci (Perugia, IT); Mark Pruzanski (New York, NY)
Assignee: Intercept Pharmaceuticals, Inc.
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Quick Facts
Patent No.
US 8,546,365
App. No.
13/082,261
Granted
Oct 1, 2013
Kind
B2
Abstract

The present invention relates to compounds of formula (I): wherein R is hydrogen or alpha-hydroxy, the hydroxyl group in position 7 is in the alpha or beta position; and pharmaceutically acceptable salts, solvates or amino acid conjugates thereof.

Claims (33)

1. A method for the treatment of a chronic liver disease selected from primary biliary cirrhosis, primary sclerosing cholangitis, nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis (NASH) in a mammal comprising administering to the mammal suffering from the chronic liver disease a therapeutically effective amount of a compound of formula (I):

(I) or a pharmaceutically acceptable salt or amino acid conjugate thereof,

wherein R is hydrogen or alpha-hydroxy, and

the hydroxy group in the 7 position is in the alpha or beta position.

2. The method of claim 1 , wherein the pharmaceutically acceptable salt is

3. The method of claim 1 , wherein the pharmaceutically acceptable salt is

4. A method for the treatment of a gastrointestinal disease selected from inflammatory bowel disease, irritable bowel syndrome, bacterial overgrowth, and malabsorption comprising administering to the mammal suffering from the gasterointestinal disease a therapeutically effective amount of a compound of formula (I):

(I) or a pharmaceutically acceptable salt or amino acid conjugate thereof,

wherein R is hydrogen or alpha-hydroxy, and

the hydroxy group in the 7 position is in the alpha or beta position.

5. The method of claim 4 , wherein the inflammatory bowel disease is selected from Crohn's disease and ulcerative colitis.

6. The method of claim 4 , wherein the pharmaceutically acceptable salt is

7. The method of claim 4 , wherein the pharmaceutically acceptable salt is

8. A method for the treatment of a renal disease selected from diabetic nephropathy, focal segmental glomerulosclerosis (FSGS), and chronic glomerulonephritis comprising administering to the mammal suffering from the renal disease a therapeutically effective amount of a compound of formula (I):

(I) or a pharmaceutically acceptable salt or amino acid conjugate thereof,

wherein R is hydrogen or alpha-hydroxy, and

the hydroxy group in the 7 position is in the alpha or beta position.

9. The method of claim 8 , wherein the renal disease is diabetic nephropathy.

10. The method of claim 8 , wherein the pharmaceutically acceptable salt is

11. The method of claim 8 , wherein the pharmaceutically acceptable salt is

12. A method for the treatment of a cardiovascular disease selected from atherosclerosis, arteriosclerosis, dyslipidemia, hypercholesterolemia, and hypertriglyceridemia comprising administering to the mammal suffering from the cardiovascular disease a therapeutically effective amount of a compound of formula (I):

(I) or a pharmaceutically acceptable salt or amino acid conjugate thereof,

wherein R is hydrogen or alpha-hydroxy, and

the hydroxy group in the 7 position is in the alpha or beta position.

13. The method of claim 12 , wherein the cardiovascular disease is selected from hypertriglyceridemia, hypercholesterolemia, and atherosclerosis.

14. The method of claim 12 , wherein the pharmaceutically acceptable salt is

15. The method of claim 12 , wherein the pharmaceutically acceptable salt is

16. A method for the treatment of metabolic disease selected from insulin resistance, Type I and Type II diabetes, and obesity comprising administering to the mammal suffering from the metabolic disease a therapeutically effective amount of a compound of formula (I):

(I) or a pharmaceutically acceptable salt or amino acid conjugate thereof,

wherein R is hydrogen or alpha-hydroxy, and

the hydroxy group in the 7 position is in the alpha or beta position.

17. The method of claim 16 , wherein the pharmaceutically acceptable salt is

18. The method of claim 16 , wherein the pharmaceutically acceptable salt is

Assignments (9)
RELEASE OF SECURITY INTEREST Recorded Jan 4, 2024
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 066662/0210 →
CHANGE OF ADDRESS Recorded Aug 22, 2022
From: INTERCEPT PHARMACEUTICALS, INC.
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 061297/0856 →
SECURITY INTEREST Recorded Aug 18, 2021
From: INTERCEPT PHARMACEUTICALS, INC.
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 057650/0772 →
NOTICE OF JOINT OWNERSHIP CLAIM Recorded Mar 23, 2017
From: FIORUCCI, STEFANO, DR.
To: FIORUCCI, STEFANO, DR.
Reel/Frame 042072/0643 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYANCE TYPE PREVIOUSLY RECORDED ON REEL 030555 FRAME 0115. ASSIGNOR(S) HEREBY CONFIRMS THE CONVEYANCE TYPE FROM CHANGE OF NAME TO CHANGE OF ADDRESS OF ASSIGNEE. Recorded Jun 14, 2013
From: INTERCEPT PHARMACEUTICALS, INC.
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 030611/0610 →
SPONSORED RESEARCH AGREEMENT Recorded Jun 4, 2013
From: FIORUCCI, STEFANO
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 030555/0065 →
AMENDED AND RESTATED SPONSORED RESEARCH AGREEMENT Recorded Jun 4, 2013
From: FIORUCCI, STEFANO
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 030555/0093 →
CHANGE OF NAME Recorded Jun 4, 2013
From: INTERCEPT PHARMACEUTICALS, INC.
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 030555/0115 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2013
From: PELLICCIARI, ROBERTO; PRUZANSKI, MARK
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 030542/0373 →
Continuity (3)
Continuation 11819517 · Jun 27, 2007
Provisional Application 60816635 · Jun 27, 2006
Related Publication 20120283234A1 · Nov 8, 2012