Is Imetelstat approved by the US FDA?

Drugs@FDA lists 1 application product line for Imetelstat, including RYTELO (Prescription).

Is Imetelstat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Imetelstat: Rytelo.

Active substance

Imetelstat

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
RYTELO	EQ 47MG BASE/VIAL; EQ 188MG BASE/VIAL	powder · intravenous	GERON	Prescription	6 Jun 2024

EMA European Union — centrally authorised medicines

Rytelo Geron Netherlands B.V. · Authorised · authorised 7 Mar 2025 · ATC L01XX80

Therapeutic indication (EMA)

Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

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.