KISUNLA donanemab

Drug Class

Amyloid-beta-directed monoclonal antibody

Mechanism

Donanemab is a humanized IgG1 monoclonal antibody directed against N-terminally truncated amyloid-beta (Abeta) peptide, designed to target and clear amyloid plaques in the brains of Alzheimer's disease patients.

Approved Indication

Treatment of early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia stage) with confirmed amyloid pathology.

What This Means For Patients

Kisunla is a disease-modifying monoclonal antibody therapy for early-stage Alzheimer's disease. Administered via monthly intravenous infusion, it selectively targets and clears amyloid-beta plaques in the brain to slow cognitive and functional decline. Following approvals by major global regulators, it is accessible in the Hainan Boao Lecheng pilot zone under special import pathways.

Regulatory Approvals

• FDA — approved (2024) — label
• EMA — approved (2025) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• TRAILBLAZER-ALZ 2 — Sims et al., JAMA 2023 (NCT04437836) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761376s000lbl.pdf
• https://www.lilly.com/news/media-releases-releases/fda-approves-lillys-kisunla-donanemab-azbt-early-symptomatic-alzheimers-disease
• https://www.nmpa.gov.cn/