Is Aficamten approved by the US FDA?

Drugs@FDA lists 1 application product line for Aficamten, including MYQORZO (Prescription).

Is Aficamten authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Aficamten: Myqorzo.

Active substance

Aficamten

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
MYQORZO	5MG; 10MG; 15MG; 20MG	tablet · oral	CYTOKINETICS	Prescription	19 Dec 2025

EMA European Union — centrally authorised medicines

Myqorzo Cytokinetics (Ireland) Limited · Authorised · authorised 12 Feb 2026

Therapeutic indication (EMA)

Myqorzo is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.

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.