Is Elafibranor approved by the US FDA?

Drugs@FDA lists 1 application product line for Elafibranor, including IQIRVO (Prescription).

Is Elafibranor authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Elafibranor: Iqirvo.

Are there safety signals or safety updates for Elafibranor?

US FDA: 1 entry (latest 2026-08-07).

Active substance

Elafibranor

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
IQIRVO	80MG	tablet · oral	IPSEN	Prescription	10 Jun 2024

EMA European Union — centrally authorised medicines

Iqirvo Ipsen Pharma · Authorised · authorised 19 Sep 2024 · ATC A05AX06

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IQIRVO	02557010	80 MG	TABLET · ORAL	IPSEN BIOPHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 7 Aug 2026 IQIRVO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for elafibranor →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.