Is Mirdametinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Mirdametinib, including GOMEKLI (Prescription); GOMEKLI (Prescription).

Is Mirdametinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mirdametinib: Ezmekly.

Active substance

Mirdametinib

US FDA 2
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
GOMEKLI	1MG; 3MG; 4MG	tablet, for suspension · oral	SPRINGWORKS	Prescription	11 Feb 2025
GOMEKLI	1MG; 2MG	capsule · oral	SPRINGWORKS	Prescription	11 Feb 2025

EMA European Union — centrally authorised medicines

Ezmekly Merck Europe B.V. · Authorised · authorised 17 Jul 2025 · ATC L01EE

Therapeutic indication (EMA)

Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.

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.