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Donanemab · Kisunla, LY-3002813

Monoclonal antibody · Antagonist of N-truncated pyroglutamate amyloid beta · developed by Eli Lilly Co

Approved FDA, Jul 2024

LLY Developer

1 Registered trials

What is Donanemab?

Donanemab-azbt is a humanized IgG1 monoclonal antibody that binds insoluble N-truncated pyroglutamate amyloid beta, reducing amyloid beta plaques in the brain.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Kisunla, LY-3002813
Drug type: Monoclonal antibody
Targets: N-truncated pyroglutamate amyloid beta
Mechanism: Antagonist of N-truncated pyroglutamate amyloid beta
Pathways: amyloid beta plaque clearance
Therapy area: Neurology
Developer: Eli Lilly Co (LLY)
FDA status: Approved as Kisunla (July 2, 2024), BLA761248 · FDA label
UNII: 1ADB65P1KK

✅ FDA-approved uses

Alzheimer's disease

From the indications section of the FDA label (version of Dec 30, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07589595	Phase 2	Cognitive Dysfunction	Recruiting	LLY

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

AmyloidCognitive DysfunctionLewy Body DiseaseSynucleinopathies

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Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the LLY page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z