Trial Profile

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 27 May 2025

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At a glance

Drugs Donanemab (Primary)
Indications Alzheimer's disease
Focus Registrational; Therapeutic Use
Acronyms TRAILBLAZER-ALZ 2
Sponsors Eli Lilly and Company

Most Recent Events

21 May 2025 According to an Eli Lilly and Company media release, the company announced that based on data from TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies, Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease.
24 Dec 2024 Planned End Date changed from 22 Aug 2025 to 1 Aug 2025.
17 Dec 2024 Results presented in an Eli Lilly and Company media release.

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