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imlunestrant

Inluriyo · ATC code L02BA

Also known as: İmlunestrant

Key facts
Active substance
imlunestrant
Drug class
Estrogen antagonist
ATC code
L02BA
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Inluriyo 200 mg film-coated tablets
Marketing authorisation holder
Eli Lilly Nederland B.V.
Information as of
2026-10-29

Key facts

Imlunestrant (Inluriyo) is an oral selective oestrogen receptor degrader used to treat ER-positive, HER2-negative advanced breast cancer with an activating ESR1 mutation.

What it is used for

  • Monotherapy for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation, progressing after prior endocrine-based treatment.
  • In pre- or perimenopausal women and in men, combined with an LHRH agonist.
  • The ESR1 mutation is detected in tumour or plasma specimens with a validated test.

Dosing

  • 400 mg (two 200 mg tablets) once daily in the fasted state, as long as there is clinical benefit.
  • Dose reductions in steps of 200 mg; discontinue if 200 mg once daily is not tolerated. Adjustments for raised liver enzymes and other reactions see the full text.
  • Moderate or severe hepatic impairment: 200 mg once daily; caution in severe renal impairment.
  • Strong CYP3A inhibitors: reduce the dose by 200 mg; strong CYP3A inducers: increase by 200 mg, if the combination cannot be avoided.
  • A missed dose can be taken up to 6 hours late; otherwise skip it.

Contraindications

  • Lactation.
  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Take fasted, as higher exposures may occur with food.
  • Monitor ALT and AST during treatment.
  • Verify pregnancy status before starting.

Side effects

  • Most common: ALT increased (34.3 %), AST increased (33.2 %), fatigue (25.7 %), diarrhoea (22.5 %), nausea (20.1 %) and vomiting (9.0 %).
  • Others: decreased appetite, headache, hot flush, cough, venous thromboembolism.

Interactions

  • Avoid strong CYP3A inducers (e.g. carbamazepine) and strong CYP3A inhibitors (e.g. itraconazole).
  • Caution with sensitive CYP2D6 substrates and P-gp substrates (e.g. digoxin).
  • Omeprazole has no clinically meaningful effect.

Pregnancy and breastfeeding

  • Highly effective contraception for females and males during treatment and for at least 1 week after the last dose.
  • Contraindicated during lactation.

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)

  • InluriyoEli Lilly Nederland B.V. · EMEA/H/C/006184

Source: European Medicines Agency (EMA), product information

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

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

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Inluriyo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/inluriyo-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L02BA.

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.