Is Peginesatide approved by the US FDA?

Drugs@FDA lists 2 application product lines for Peginesatide, including OMONTYS PRESERVATIVE FREE (Discontinued); OMONTYS (Discontinued).

Is Peginesatide authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Peginesatide.

Active substance

Peginesatide

US FDA 2
EMA 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
OMONTYS PRESERVATIVE FREE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML); EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML); EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML); EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML); EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML); EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	solution · intravenous, subcutaneous	TAKEDA PHARMS USA	Discontinued	27 Mar 2012
OMONTYS	EQ 10MG BASE/ML (EQ 10MG BASE/ML); EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	solution · intravenous, subcutaneous	TAKEDA PHARMS USA	Discontinued	27 Mar 2012

EMA European Union — centrally authorised medicines

Omontys Takeda Global Research and Development Centre (Europe) · Application withdrawn · ATC B03XA

Therapeutic indication (EMA)

treatment of symptomatic anaemia associated with chronic kidney disease (CKD)

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.