Is Cangrelor approved by the US FDA?

Drugs@FDA lists 3 application product lines for Cangrelor, including KENGREAL (Prescription); CANGRELOR (Prescription); CANGRELOR (Prescription).

Is Cangrelor authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cangrelor: Kengrexal.

Are there safety signals or safety updates for Cangrelor?

US FDA: 1 entry (latest 2019-10-23).

Active substance

Cangrelor

US FDA 3
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
KENGREAL	50MG/VIAL	powder · intravenous	CHIESI	Prescription	22 Jun 2015
CANGRELOR	50MG/VIAL	powder · intravenous	GLAND	Prescription	11 Aug 2025
CANGRELOR	50MG/VIAL	powder · intravenous	MSN	Prescription	4 Jun 2026

EMA European Union — centrally authorised medicines

Kengrexal Chiesi Farmaceutici S.p.A. · Authorised · authorised 23 Mar 2015 · ATC B01

Therapeutic indication (EMA)

Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KENGREXAL	02534622	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	CHIESI FARMACEUTICI S.P.A.

Safety signals and safety-related labeling changes

US FDA 23 Oct 2019 KENGREAL — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations

All safety entries for cangrelor →

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.