Is Rilzabrutinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Rilzabrutinib, including WAYRILZ (Prescription).

Is Rilzabrutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rilzabrutinib: Wayrilz.

Active substance

Rilzabrutinib

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
WAYRILZ	400MG	tablet · oral	GENZYME CORP	Prescription	29 Aug 2025

EMA European Union — centrally authorised medicines

Wayrilz Sanofi B.V. · Authorised · authorised 22 Dec 2025

Therapeutic indication (EMA)

Wayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)

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.