Product Description
Bezafibrate is an agonist of peroxisome proliferator-activated receptor alpha (PPARalpha) with antilipidemic activity. Bezafibrate decreases triglyceride levels, increases high density lipoprotein (HDL) cholesterol levels, and decreases total and low density lipoprotein (LDL) cholesterol levels.
Mechanisms of Action: PPAR-a Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Argentina | Austria | Belgium | Brazil | Canada | Chile | China | Colombia | Cyprus | Ecuador | Finland | France | Germany | Hong Kong | Hungary | India | Indonesia | Israel | Italy | Korea | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Pakistan | Peru | Portugal | Romania | Singapore | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | United Kingdom | Venezuela | Vietnam
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, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Spain, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Biliary Cirrhosis|Cholangitis
Phase 2: Liver Cirrhosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| 747-213 | P2 |
Active, not recruiting |
Cholangitis|Biliary Cirrhosis |
2025-10-31 |
2025-05-02 |
Treatments |
|
| NCT05239468 | P2 |
Active, not recruiting |
Cholangitis|Biliary Cirrhosis|Liver Cirrhosis |
2025-10-01 |
12% |
2025-01-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| 747-214 | P2 |
Active, not recruiting |
Cholangitis|Biliary Cirrhosis |
2025-03-21 |
2025-05-02 |
Treatments |
|
| 977-311 | P3 |
Not yet recruiting |
Cholangitis|Biliary Cirrhosis |
2029-11-25 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/30/2025 |
News Article |
Intercept Announces Data to be Presented at Digestive Disease Week 2025 |
|
07/26/2024 |
News Article |
Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis |
|
06/05/2024 |
News Article |
Intercept Presents New Data on the Results of OCA-Bezafibrate Combination Therapy in PBC After Six Months of Treatment in Late-Breaking Poster Presentation at EASL Congress 2024 |
|
05/29/2024 |
News Article |
Intercept Announces New Data to be Presented at the European Association for the Study of the Liver (EASL) Congress 2024 |