NDAORALTABLETPriority Review
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
7/8 — Comprehensive
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 8h ago · AI intelligence enriched 1mo 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 on June 10, 2024. It is indicated for the treatment of non-alcoholic steatohepatitis (NASH), a progressive liver disease characterized by inflammation and fibrosis. The drug works by activating PPAR-α and PPAR-δ pathways to reduce hepatic inflammation and improve metabolic function.
Growth17.3 years to LOE
Early-stage commercial growth phase with minimal competitive pressure; team expansion likely as market adoption increases.
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 (19)
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Started Nov 2026
50 enrolled
Primary Biliary Cholangitis (PBC)
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
Started Jul 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
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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.