NDAORALTABLETPriority Review
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
9
Mechanism of Action
Peroxisome Proliferator-activated Receptor Agonists
Pharmacologic Class:
Peroxisome Proliferator-activated Receptor Agonist
Clinical Trials (5)
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Started Apr 2026
350 enrolled
Primary Sclerosing Cholangitis
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
Started Jan 2025
18 enrolled
Primary Biliary Cholangitis
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Started Oct 2024
424 enrolled
Primary Biliary Cholangitis
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Started Jul 2024
69 enrolled
Primary Biliary Cholangitis
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Started Aug 2023
276 enrolled
Primary Biliary Cholangitis (PBC)
Loss of Exclusivity
LOE Date
Mar 30, 2037
134 months away
Patent Expiry
Mar 30, 2037
Exclusivity Expiry
Jun 10, 2031
Company
Ipsen
China - Tianjin