Is Ripretinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Ripretinib, including QINLOCK (Prescription).

Is Ripretinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ripretinib: Qinlock.

Are there safety signals or safety updates for Ripretinib?

US FDA: 1 entry (latest 2025-05-06).

Active substance

Ripretinib

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
QINLOCK	50MG	tablet · oral	DECIPHERA PHARMS	Prescription	15 May 2020

EMA European Union — centrally authorised medicines

Qinlock Deciphera Pharmaceuticals (Netherlands) B.V. · Authorised · authorised 18 Nov 2021 · ATC L01

Therapeutic indication (EMA)

Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
QINLOCK	02500833	50 MG	TABLET · ORAL	DECIPHERA PHARMACEUTICALS. LLC

Safety signals and safety-related labeling changes

US FDA 6 May 2025 QINLOCK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ripretinib →

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.