drug · small molecule
elafibranor
Marketedupdated 3mo agoby Ipsen SA🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for cholangitis and biliary liver cirrhosis and 7 investigational indications.
targets
Peroxisome proliferator-activated receptor alphaPeroxisome proliferator-activated receptor delta
all catalysts(0)
nothing on the calendar yet
Trials studying elafibranor
- phase3A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
- phase3A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
- phase3A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
- phase3Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
- phase3A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
- phase2A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
- phase1A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
- phase1Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 10, 2029
~2.8 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (8)
- Mar 30, 2037method-of-use (U-3955)US 11185519
- Mar 30, 2037method-of-use (U-1854)US 11331292
- Mar 30, 2037method-of-use (U-1854)US 11850223
- Mar 30, 2037method-of-use (U-3955)US 11857523
- Mar 30, 2037method-of-use (U-1854)US 12233038
- Mar 30, 2037method-of-use (U-1854)US 12295927
- Mar 30, 2037method-of-use (U-1854)US 12295928
- Mar 30, 2037method-of-use (U-1854)US 12310935
FDA exclusivities (2)
- Jun 10, 2031ODE-486Orphan Drug (7y)4.8y
- Jun 10, 2029NCENew Chemical Entity (5y)2.8y
News(1)
- ‘It’s making a difference’: Madrigal CEO talks strategy behind MASH shopping spreeNot content with navigating Rezdiffra’s trajectory to blockbuster territory, Madrigal Pharmaceuticals has spent 2026 shopping for a range of drugs that the company hopes could work alongside its me…fiercebiotech · 11d ago
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