# Donanemab

Source: https://onco.cc/drugs/da-donanemab/  
OnCo record `da-donanemab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Donanemab is a monthly infused antibody for early Alzheimer’s disease after amyloid confirmation, with the same ARIA monitoring theme as other amyloid antibodies.

## Summary

US approval in 2024 covers mild cognitive impairment or mild dementia due to Alzheimer’s disease after amyloid confirmation. ApoE ε4 changes the ARIA-risk discussion. It is not approved for other dementia subtypes as a disease-modifying treatment.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-21
- Tags: dementia-atlas
- Brand: Kisunla
- Modality: mAb
- Mechanism: Amyloid-beta–directed antibody that reduces plaques. The label allows considering stopping after plaques reach minimal levels on PET.
- Approvals: US 2024: Early Alzheimer’s disease with confirmed amyloid; JP 2024: Early Alzheimer’s disease; UK 2024: Licensed; funding is a separate decision; EU 2025: Authorisation and national access may differ; CN 2025: Access may lag the US label; AU 2025: Access may lag the US label

## Sources

- FDA Kisunla approval: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease

## Connected records

- diagnoses: [Alzheimer’s disease](https://onco.cc/diagnoses/alzheimers-disease/), [Mild cognitive impairment](https://onco.cc/diagnoses/mild-cognitive-impairment/)
- targets: [Amyloid-beta](https://onco.cc/targets/da-target-amyloid-beta/)
- companies: [Eli Lilly](https://onco.cc/companies/da-lilly/)
- terms: [ARIA](https://onco.cc/terms/da-term-aria/)
- trials: [TRAILBLAZER-ALZ 2](https://onco.cc/trials/da-trial-trailblazer-alz2/)
- fronts: [Anti-amyloid treatment](https://onco.cc/fronts/da-front-anti-amyloid/)
- technologies: [Anti-amyloid antibodies](https://onco.cc/technologies/da-tech-anti-amyloid-mab/), [ApoE testing](https://onco.cc/technologies/da-tech-apoe-testing/)
- ideas: [Antibody trials that enrol mixed and comorbid disease](https://onco.cc/ideas/da-idea-inclusive-anti-amyloid-trials/)
- roadmaps: [Anti-amyloid medicines](https://onco.cc/roadmaps/da-roadmap-anti-amyloid/)

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