Is Glasdegib approved by the US FDA?

Drugs@FDA lists 1 application product line for Glasdegib, including DAURISMO (Prescription).

Is Glasdegib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Glasdegib: Daurismo.

Are there safety signals or safety updates for Glasdegib?

US FDA: 1 entry (latest 2023-03-27).

Active substance

Glasdegib

US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
DAURISMO	EQ 25MG BASE; EQ 100MG BASE	tablet · oral	PFIZER	Prescription	21 Nov 2018

EMA European Union — centrally authorised medicines

Daurismo Pfizer Europe MA EEIG · Authorised · authorised 26 Jun 2020 · ATC L01XX63

Therapeutic indication (EMA)

Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DAURISMO	02498472	25 MG	TABLET · ORAL	PFIZER CANADA ULC
DAURISMO	02498480	100 MG	TABLET · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 27 Mar 2023 DAURISMO — 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 glasdegib →

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.