Is Vimseltinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Vimseltinib, including ROMVIMZA (Prescription).

Is Vimseltinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vimseltinib: Romvimza.

Active substance

Vimseltinib

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
ROMVIMZA	14MG; 20MG; 30MG	capsule · oral	DECIPHERA PHARMS	Prescription	14 Feb 2025

EMA European Union — centrally authorised medicines

Romvimza Deciphera Pharmaceuticals (Netherlands) B.V. · Authorised · authorised 17 Sep 2025 · ATC L01EX

Therapeutic indication (EMA)

Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

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.