Granted Patent
B2
US 12,337,003 · App. 17/700,317 · Granted Jun 24, 2025
Pharmaceutical compositions for combination therapy
Assignee:
Intercept Pharmaceuticals, Inc.
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Abstract
The present invention relates to a pharmaceutical composition comprising a combination of an FXR agonist and at least one lipid lowering agent (e.g., PPAR-alpha agonist, PPAR-delta agonist, PPAR-alpha and delta dual agonist, and/or statin). Also disclosed is use of the combination for the treatment or prevention of a FXR mediated disease or condition, such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), portal hypertension, bile acid diarrhea, NAFLD (nonalcoholic fatty liver disease), NASH (non-alcohol-induced steatohepatitis), and other chronic liver diseases. The combination of the present invention is useful for the treatment or prevention of conditions related to elevated lipid and liver enzyme levels. The present invention also relates to packs or kits including the pharmaceutical combination.
Claims (22)
1. A pharmaceutical composition comprising a combination of a compound of formula (1):
or a pharmaceutically acceptable salt or amino acid conjugate thereof, and bezafibrate; and optionally one or more pharmaceutically acceptable carriers, wherein bezafibrate is in an amount of 80-400 mg; and
wherein the compound of formula (1) or pharmaceutically acceptable salt or amino acid conjugate thereof is in an amount of about 5 mg or about 10 mg.
2. A pharmaceutical composition comprising a combination of therapeutic agents consisting of a compound of formula (1):
or a pharmaceutically acceptable salt or amino acid conjugate thereof, and bezafibrate; wherein the pharmaceutical composition further optionally comprises one or more pharmaceutically acceptable carriers, wherein bezafibrate is in an amount of 80-400 mg; and
wherein the compound of formula (1) or pharmaceutically acceptable salt or amino acid conjugate thereof is in an amount of about 5 mg or about 10 mg.
3. The pharmaceutical composition of claim 2 , wherein bezafibrate is in an amount of 100-300 mg.
4. The pharmaceutical composition of claim 2 , wherein bezafibrate is in an amount of 100 mg.
5. The pharmaceutical composition of claim 2 , wherein bezafibrate is in an amount of 200 mg.
6. The pharmaceutical composition of claim 2 , wherein bezafibrate is in an amount of 400 mg.
7. The pharmaceutical composition of claim 2 , wherein the composition is a single unit dosage form.
8. The pharmaceutical composition of claim 7 , wherein the single unit dosage form is a tablet or capsule.
9. The pharmaceutical composition of claim 1 , wherein bezafibrate is in an amount of 100-300 mg.
10. The pharmaceutical composition of claim 1 , wherein bezafibrate is in an amount of 100 mg.
11. The pharmaceutical composition of claim 1 , wherein bezafibrate is in an amount of 200 mg.
12. The pharmaceutical composition of claim 1 , wherein bezafibrate is in an amount of 400 mg.
13. The pharmaceutical composition of claim 1 , wherein the composition is a single unit dosage form.
14. The pharmaceutical composition of claim 13 , wherein the single unit dosage form is a tablet or capsule.
15. The pharmaceutical composition of claim 2 , wherein the compound of formula (1) or pharmaceutically acceptable salt or amino acid conjugate thereof is in an amount of about 5 mg and bezafibrate is in an amount of 400 mg.
16. The pharmaceutical composition of claim 15 , wherein the composition is a single unit dosage form.
17. The pharmaceutical composition of claim 16 , wherein the single unit dosage form is a tablet or capsule.
18. The pharmaceutical composition of claim 17 , wherein the single unit dosage form is a tablet.
Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 12, 2026
From: INTERCEPT PHARMACEUTICALS, INC.
To: ALFASIGMA S.P.A
Reel/Frame 075044/0679 →
RELEASE OF SECURITY INTEREST
Recorded Jan 4, 2024
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 066662/0210 →
SECURITY INTEREST
Recorded Apr 27, 2022
From: INTERCEPT PHARMACEUTICALS, INC.
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 059749/0019 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 24, 2022
From: PRUZANSKI, MARK; ADORINI, LUCIANO
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 059387/0380 →
Continuity (3)
Continuation
15548537
Provisional Application
62113134
· Feb 6, 2015
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