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elafibranor

Iqirvo · ATC code A05AX06

Key facts
Active substance
elafibranor
ATC code
A05AX06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Iqirvo 80 mg film-coated tablets
Marketing authorisation holder
Ipsen Pharma
Information as of
2026-10-29

Key facts

Elafibranor (Iqirvo) is a PPAR agonist used to treat primary biliary cholangitis (PBC) in adults.

What it is used for

  • Primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA.
  • As monotherapy in patients unable to tolerate UDCA.

Dosing

  • Recommended dose: 80 mg once daily by mouth.
  • Missed dose: do not take it; take the next dose at the scheduled time; no double dose.
  • No dose adjustment in patients older than 65 years, in renal impairment, or in mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
  • Not recommended in severe hepatic impairment (Child-Pugh C). No relevant use in children and adolescents.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Known or suspected pregnancy, and women of childbearing age not using effective contraception.

Important warnings

  • Increases in liver tests (transaminases, bilirubin): assess liver function before starting and thereafter as per routine management; investigate increases and consider interruption.
  • Elevated creatine phosphokinase (CPK) and muscle injury: check CPK before starting; consider periodic measurements, especially with concomitant statins.
  • Embryo-foetal toxicity: animal data suggest congenital malformations and reduced foetal survival; check pregnancy status before starting.

Side effects

  • Most common (more than 10%): abdominal pain, diarrhoea, nausea and vomiting (11.1% each), mostly mild to moderate, early in treatment, tending to resolve within days to a few weeks.
  • Others: headache, constipation, cholelithiasis, pruritic rash, myalgia, increased CPK and creatinine.
  • Most common reason for discontinuation: blood CPK increased (3.7%).

Interactions

  • Elafibranor may be a mild CYP3A4 inducer and decreased ethinylestradiol exposure (AUC by 35%); hormonal contraception may fail – use non-hormonal contraception or add a barrier method.
  • No change in warfarin exposure or INR; no clinically meaningful change with simvastatin or atorvastatin.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; discontinue if pregnancy occurs.
  • Effective contraception during treatment and for at least 3 weeks after the final dose.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • IqirvoIpsen Pharma · EMEA/H/C/006231

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Iqirvo
Liechtenstein
Iqirvo
Norway
Iqirvo

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Iqirvo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/iqirvo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.