Donanemab (Kisunla)

Donanemab is a humanized IgG1 monoclonal antibody. It targets a specific, pyroglutamate-modified end of amyloid-beta (called N3pG). That target appears almost only in established plaques. In the phase 3 TRAILBLAZER-ALZ 2 trial, it slowed clinical decline by 22 to 36% over 76 weeks, in early symptomatic Alzheimer's. The decline was measured on two standard scales (iADRS and CDR-SB). The effect was larger in people with low-to-medium tau. One practical feature: you can stop treatment once a PET scan shows the amyloid is cleared. The FDA approved donanemab on 2 July 2024. The European Medicines Agency first refused it on 27 March 2025. But it recommended approval after re-examination on 24 July 2025. The European Commission then granted marketing authorization on 24 September 2025. That approval is restricted to APOE epsilon-4 non-carriers and heterozygotes. A brain side effect (ARIA-E) hit roughly 24% of treated participants in the trial. On 9 July 2025, the FDA approved an updated label with a slower titration schedule, which lowered ARIA-E rates. The UK's MHRA approved donanemab on 23 October 2024. (NICE then issued a final non-recommendation on 19 June 2025.) And Japan's PMDA approved it on 24 September 2024.

Last reviewed: June 22, 2026

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