Product Description
Obeticholic acid is in a class of medications called farnesoid X receptor agonists. It works by decreasing the production of bile in the liver and increasing the removal of bile from the liver.
Mechanisms of Action: FXR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Biliary Cirrhosis|Cholangitis *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Canada | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | India | Ireland | Israel | Italy | Latvia | Lebanon | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Alfasigma S.p.a
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, China, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Spain, United States
Active Clinical Trial Count: 12
Highest Development Phases
Phase 3: Biliary Atresia|Biliary Cirrhosis|Cholangitis|Liver Cirrhosis
Phase 2: Healthy Volunteers|Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 977-311 | P3 |
Unknown Status |
Cholangitis|Biliary Cirrhosis |
2029-11-25 |
|
| 747-308 | P3 |
Unknown Status |
Biliary Atresia |
2028-02-29 |
|
| 747-213 | P2 |
Unknown Status |
Biliary Cirrhosis|Cholangitis |
2025-10-31 |
|
| - | P2 |
Active, not recruiting |
Biliary Cirrhosis|Cholangitis |
2025-10-20 |