{"entity":{"id":"da-donanemab","kind":"drug","name":"Donanemab","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-21","links":[{"label":"FDA Kisunla approval","url":"https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease"}],"tags":["dementia-atlas"],"related":[],"cancers":["alzheimers-disease","mild-cognitive-impairment"],"sections":[],"technologies":[],"targets":["da-target-amyloid-beta"],"drugs":[],"companies":["da-lilly"],"institutions":[],"pathways":[],"terms":["da-term-aria"],"trials":["da-trial-trailblazer-alz2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"US","year":2024,"indication":"Early Alzheimer’s disease with confirmed amyloid"},{"region":"JP","year":2024,"indication":"Early Alzheimer’s disease"},{"region":"UK","year":2024,"indication":"Licensed; funding is a separate decision"},{"region":"EU","year":2025,"indication":"Authorisation and national access may differ"},{"region":"CN","year":2025,"indication":"Access may lag the US label"},{"region":"AU","year":2025,"indication":"Access may lag the US label"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/da-donanemab/","neighbours":{"cancer":[{"id":"alzheimers-disease","kind":"cancer","name":"Alzheimer’s disease","route":"/diagnoses/alzheimers-disease/"},{"id":"mild-cognitive-impairment","kind":"cancer","name":"Mild cognitive impairment","route":"/diagnoses/mild-cognitive-impairment/"}],"target":[{"id":"da-target-amyloid-beta","kind":"target","name":"Amyloid-beta","route":"/targets/da-target-amyloid-beta/"}],"company":[{"id":"da-lilly","kind":"company","name":"Eli Lilly","route":"/companies/da-lilly/"}],"term":[{"id":"da-term-aria","kind":"term","name":"ARIA","route":"/terms/da-term-aria/"}],"trial":[{"id":"da-trial-trailblazer-alz2","kind":"trial","name":"TRAILBLAZER-ALZ 2","route":"/trials/da-trial-trailblazer-alz2/"}],"section":[{"id":"da-front-anti-amyloid","kind":"section","name":"Anti-amyloid treatment","route":"/fronts/da-front-anti-amyloid/"}],"technology":[{"id":"da-tech-anti-amyloid-mab","kind":"technology","name":"Anti-amyloid antibodies","route":"/technologies/da-tech-anti-amyloid-mab/"},{"id":"da-tech-apoe-testing","kind":"technology","name":"ApoE testing","route":"/technologies/da-tech-apoe-testing/"}],"idea":[{"id":"da-idea-inclusive-anti-amyloid-trials","kind":"idea","name":"Antibody trials that enrol mixed and comorbid disease","route":"/ideas/da-idea-inclusive-anti-amyloid-trials/"}],"roadmap":[{"id":"da-roadmap-anti-amyloid","kind":"roadmap","name":"Anti-amyloid medicines","route":"/roadmaps/da-roadmap-anti-amyloid/"}]}}