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  1. pharmadog
  2. ›drugs
  3. ›Iqirvo
drug · small molecule
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elafibranor

Marketedupdated 3mo ago
by Ipsen SA🔗 ChEMBL
Approved
community 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)active not recruitingn=18
  • phase3A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.completedn=92
  • phase3A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitisrecruitingn=350
  • phase3Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)active not recruitingn=161
  • phase3A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitisrecruitingn=276
  • phase2A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.active not recruitingn=68
  • phase1A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tabletcompletedn=34
  • phase1Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participantscompletedn=48
more trials →

Patent cliff

source: FDA Orange Book
first 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 spree
    Not 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
brand
Iqirvo
trade names
Iqirvo
generic
elafibranor
MOA
Peroxisome proliferator-activated receptor alpha agonist; Peroxisome proliferator-activated receptor delta agonist
indication
Primary Sclerosing Cholangitis
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 43m ago
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