NDAORALTABLETPriority Review
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
6/8 — Strong
Priority Review
IQIRVO (elafibranor) by Ipsen is peroxisome proliferator-activated receptor agonists [moa]. Approved for peroxisome proliferator-activated receptor agonist [epc]. First approved in 2024.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IQIRVO (elafibranor) is an oral small-molecule peroxisome proliferator-activated receptor (PPAR) agonist approved by the FDA in June 2024 for primary biliary cholangitis (PBC). It works by activating PPAR receptors to reduce inflammation and fibrosis in the liver. Patients with PBC, a rare autoimmune liver disease, represent the treatment population.
Growth10.9 years to LOE
Early-stage growth product with significant patent protection through 2037; expect expansion of commercial team as market penetration increases and indication pipeline develops.
Mechanism of Action
Peroxisome Proliferator-activated Receptor Agonists
Pharmacologic Class:
Peroxisome Proliferator-activated Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
Started Apr 2026
3 enrolled
Pregnancy Related
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.