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 1h ago · 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. It is indicated for treating non-alcoholic steatohepatitis (NASH), a progressive liver disease characterized by inflammation and fibrosis. The drug works by activating PPAR receptors to reduce hepatic inflammation, improve lipid metabolism, and slow disease progression.
Growth10.8 years to LOE
Early-stage commercial growth phase with market establishment underway; team expansion likely as sales infrastructure builds and market uptake accelerates.
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 Aug 2026
3 enrolled
Pregnancy Related
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Started May 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.