Is Donanemab approved by the US FDA?

Drugs@FDA lists 1 application product line for Donanemab, including KISUNLA (Prescription).

Is Donanemab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Donanemab: Kisunla.

Are there safety signals or safety updates for Donanemab?

US FDA: 1 entry (latest 2025-07-01).

Active substance

Donanemab

US FDA 1
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
KISUNLA	350MG/20ML(17.5MG/ML)	injectable · injection	ELI LILLY CO	Prescription	2 Jul 2024

EMA European Union — centrally authorised medicines

Kisunla Eli Lilly Nederland B.V. · Authorised · authorised 24 Sep 2025 · ATC N06DX05

Therapeutic indication (EMA)

Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers with confirmed amyloid pathology (see section 4.4).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KISUNLA	02567725	17.5 MG / ML	SOLUTION · INTRAVENOUS	ELI LILLY CANADA INC

Safety signals and safety-related labeling changes

US FDA 1 Jul 2025 KISUNLA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for donanemab →

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.