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 not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2024) — Sources
• EMA — Approved (2025) — Sources
• NMPA — Approved (2024) — Sources

Pivotal Clinical Evidence

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

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/