Is Trilaciclib approved by the US FDA?

Drugs@FDA lists 1 application product line for Trilaciclib, including COSELA (Prescription).

Is Trilaciclib authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Trilaciclib.

Are there safety signals or safety updates for Trilaciclib?

US FDA: 1 entry (latest 2023-08-03).

Active substance

Trilaciclib

US FDA 1
EMA 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
COSELA	EQ 300MG BASE/VIAL	powder · intravenous	PHARMACOSMOS	Prescription	12 Feb 2021

EMA European Union — centrally authorised medicines

Zinmyleo Pharmacosmos A/S · Application withdrawn · ATC V03AF12

Therapeutic indication (EMA)

Prevention of chemotherapy-induced myelosuppression when administered prior to platinum/etoposide- or topotecan-containing regimens for extensive-stage small cell lung cancer (ES-SCLC).

Safety signals and safety-related labeling changes

US FDA 3 Aug 2023 COSELA — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for trilaciclib →

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.