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Elafibranor

Alternative Names: elafibranor, gft505
Latest Update: 2024-10-02
Latest Update Note: Clinical Trial Update

Product Description

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: LOOS I0 59120
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Elafibranor

Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, France, Germany, Italy, Korea, New Zealand, Poland, Portugal, Romania, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States

Active Clinical Trial Count: 12

Highest Development Phases

Phase 3: Biliary Cirrhosis|Cholangitis|Liver Cirrhosis

Phase 2: Cholangitis, Sclerosing

Phase 1: Healthy Volunteers

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
CLIN-60190-454

P3

Unknown Status

Cholangitis|Biliary Cirrhosis

2030-10-30

ELFIDENCE

P3

Recruiting

Liver Cirrhosis|Cholangitis|Biliary Cirrhosis

2029-05-01

2019-004941-34

P3

Active, not recruiting

Biliary Cirrhosis|Cholangitis

2028-01-09

GFT505B-319-1

P3

Unknown Status

Cholangitis|Biliary Cirrhosis

2027-12-01

Recent News Events

Date

Type

Title

09/23/2024

News Article

 Ipsen's Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease

08/29/2024

News Article

 Ipsen's Iqirvo Shows Strong Start in Primary Biliary Cholangitis, Now Faces Rivalry from Gilead's Livdelzi

07/26/2024

News Article

 Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases

06/10/2024

News Article

 Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis

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.

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