Iqirvo
Iqirvo ingredients
| Active ingredient | Strength |
|---|---|
| Elafibranor | 80 mg/1 |
What Iqirvo is used for
The FDA lists the approved uses on the official label (below). In the EU, elafibranor is approved as Iqirvo for:
Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Iqirvo
- Generic name
- Elafibranor
- Made by
- Ipsen Biopharmaceuticals, Inc.
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Peroxisome Proliferator-activated Receptor Agonist
- FDA approval
- New drug application (NDA) NDA218860
- On the US market since
- 2024
Official information
- Iqirvo prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Elafibranor)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Iqirvo?
Iqirvo (Elafibranor) is a specialist medicine made by Ipsen Biopharmaceuticals, Inc., approved by the US FDA.
What are the ingredients of Iqirvo?
Iqirvo contains Elafibranor (80 mg/1).
Is Iqirvo approved in Europe?
The same active substance is approved in the EU as Iqirvo.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA