Product Description
Elafibranor is an orally available peroxisome proliferator-activated receptor agonist that is used in combination with ursodeoxycholic acid to treat primary biliary cholangitis. Elafibranor therapy is associated with rare instances of worsening of liver enzymes during therapy but has not been convincingly linked to episodes of clinically apparent liver injury with jaundice. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK605979/)
Mechanisms of Action: PPAR-d Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Priority Review - Cholestatic Liver Disease *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Genfit
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Korea, Mexico, New Zealand, Poland, Portugal, Romania, South Africa, South Korea, Spain, Switzerland, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 13
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Ipsen presented P3 Cholangitis results on 2025-11-07 for Elafibranor
- Clinical Outcomes Reported - Ipsen presented P3 Cholangitis results on 2025-05-07 for Elafibranor
- Clinical Outcomes Reported - Ipsen presented P3 Cholangitis results on 2024-06-05 for Elafibranor
Highest Development Phases
Phase 3: Biliary Cirrhosis|Cholangitis|Liver Cirrhosis
Phase 2: Cholangitis, Sclerosing
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06730061 |
ELONSEN | P3 |
Recruiting |
Biliary Cirrhosis|Liver Cirrhosis|Cholangitis |
2026-03-19 |
27% |
2025-02-01 |
|
2022-002695-37 |
2022-002695-37 | P2 |
Active, not recruiting |
Cholangitis, Sclerosing |
2026-03-10 |
12% |
||
2024-511370-72-00 |
CLIN-60190-453 | P2 |
Not yet recruiting |
Cholangitis, Sclerosing |
2026-07-26 |
2025-05-02 |
Treatments |
|
NCT05627362 |
ELMWOOD | P2 |
Active, not recruiting |
Cholangitis, Sclerosing |
2026-08-28 |
12% |
2024-11-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
jRCT2011240053 |
jRCT2011240053 | P3 |
Recruiting |
Cholangitis|Biliary Cirrhosis |
2032-06-30 |
|||
2023-505251-43-00 |
CLIN-60190-454 | P3 |
Recruiting |
Cholangitis|Biliary Cirrhosis |
2029-05-31 |
23% |
2025-05-02 |
Treatments |
NCT06016842 |
ELFIDENCE | P3 |
Recruiting |
Liver Cirrhosis|Biliary Cirrhosis|Cholangitis |
2029-05-31 |
23% |
2024-11-01 |
|
2024-512232-30-00 |
GFT505B-319-1 | P3 |
Active, not recruiting |
Cholangitis|Biliary Cirrhosis |
2027-12-01 |
2025-05-02 |
Treatments |
|
2024-510695-20-00 |
CLIN-60190-463 | P3 |
Recruiting |
Cholangitis|Biliary Cirrhosis |
2026-12-01 |
23% |
2025-05-02 |
Treatments |
NCT06383403 |
ELSPIRE | P3 |
Active, not recruiting |
Liver Cirrhosis|Cholangitis|Biliary Cirrhosis |
2026-06-26 |
23% |
2025-12-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2022-001883-91 |
2022-001883-91 | P1 |
Completed |
Cholangitis|Biliary Cirrhosis |
2023-01-07 |
69% |
2025-05-06 |
Treatments |
NCT04526665 |
ELATIVE | P3 |
Active, not recruiting |
Biliary Cirrhosis|Liver Cirrhosis |
2023-06-01 |
23% |
2025-08-27 |
|
NCT05543369 |
CLIN-60190-450 | P1 |
Completed |
Healthy Volunteers |
2023-03-10 |
69% |
2023-05-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/07/2026 |
News Article |
GENFIT Announces 2026 Financial Calendar |
|
11/27/2025 |
News Article |
GENFIT Announces Appointment of new Chief Medical Officer |
|
11/20/2025 |
News Article |
GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market |
|
11/20/2025 |
News Article |
GENFIT Reports Third Quarter 2025 Financial Information and Provides a Corporate Update |
|
05/10/2024 |
PubMed |
Resmetirom, the long-awaited first treatment for metabolic dysfunction-associated steatohepatitis and liver fibrosis? |
|
03/11/2024 |
PubMed |
Different Coactivator Recruitment to Human PPARα/δ/γ Ligand-Binding Domains by Eight PPAR Agonists to Treat Nonalcoholic Fatty Liver Disease. |
|
01/29/2024 |
PubMed |
Elafibranor emerged as a potential chemotherapeutic drug for non-muscle invasive bladder cancer. |