Is Daprodustat approved by the US FDA?

Drugs@FDA lists 1 application product line for Daprodustat, including JESDUVROQ (Discontinued).

Is Daprodustat authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Daprodustat.

Active substance

Daprodustat

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
JESDUVROQ	1MG; 2MG; 4MG; 6MG; 8MG	tablet · oral	GLAXOSMITHKLINE	Discontinued	1 Feb 2023

EMA European Union — centrally authorised medicines

Jesduvroq GlaxoSmithKline Trading Services Limited · Application withdrawn · ATC B03XA

Therapeutic indication (EMA)

Treatment of anaemia associated with chronic kidney disease (CKD) in adults.

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.