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: Europe
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Belgium, Canada, China, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Spain, United States
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Intercept presented P2 Biliary Cirrhosis|Cholangitis results on 2024-05-18 for Obeticholic acid
- Clinical Outcomes Reported - Intercept presented P3 Biliary Cirrhosis|Cholangitis results on 2024-05-20 for Obeticholic acid
- Clinical Outcomes Reported - Intercept presented P2 Cholangitis results on 2023-11-13 for Obeticholic acid
Highest Development Phases
Phase 3: Biliary Atresia|Biliary Cirrhosis|Cholangitis|Liver Cirrhosis
Phase 2: Healthy Volunteers|Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2016-002965-67 |
OCABILE | P2 |
Active, not recruiting |
Non-alcoholic Steatohepatitis|Cholangitis|Hepatitis, Alcoholic |
2018-02-27 |
2022-03-13 |
Treatments |
|
2023-503926-37-00 |
747-308 | P3 |
Not yet recruiting |
Biliary Atresia |
2028-02-29 |
2025-05-02 |
Treatments |
|
NCT05239468 |
NCT05239468 | P2 |
Completed |
Cholangitis|Biliary Cirrhosis|Liver Cirrhosis |
2025-09-01 |
2% |
2025-09-26 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2020-004180-13 |
OCARINA | P2 |
Completed |
Healthy Volunteers |
2025-01-28 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2023-507771-22-01 |
977-311 | P3 |
Not yet recruiting |
Biliary Cirrhosis|Cholangitis |
2029-11-25 |
2025-05-02 |
Treatments |
|
NCT05450887 |
ABDSP2021-III | P3 |
Completed |
Liver Cirrhosis|Biliary Cirrhosis|Cholangitis |
2024-03-18 |
11% |
2024-07-12 |
Primary Completion Date|Primary Endpoints |
CTR20211354 |
CTR20211354 | P3 |
Completed |
Biliary Cirrhosis|Cholangitis |
2023-12-01 |
2025-04-29 |
||
2024-513762-18-00 |
747-213 | P2 |
Active, not recruiting |
Cholangitis|Biliary Cirrhosis |
2025-10-31 |
2025-05-02 |
Treatments |
|
2024-513584-77-00 |
747-214 | P2 |
Active, not recruiting |
Biliary Cirrhosis|Cholangitis |
2025-03-21 |
2025-05-02 |
Treatments |