Also known as: Kisunla
Donanemab is a humanized monoclonal antibody marketed as Kisunla for Alzheimer's disease treatment in early symptomatic stages. It targets amyloid beta and is administered intravenously. The drug received U.S. approval in July 2024 and later EU authorization in 2025.
A review of more than 200 studies linked up to a third of dementia cases to diseases outside the brain. Trials and broader evidence also support multi-domain prevention strategies.
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
A new Cochrane review said anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit, but many researchers said the analysis has major limitations. Newer evidence on lecanemab and donanemab and broader drug development efforts continue to shape the field.
A review of 17 studies involving 20,342 patients found anti-amyloid Alzheimer’s drugs had “trivial” effects after 18 months and increased the risk of brain swelling and bleeding. A separate PET study suggested ARIA-E may mark brain regions with greater amyloid plaque reduction.
NICE has upheld appeals to review its guidance on Alzheimer's drugs lecanemab and donanemab, sending the decision back to committee. The manufacturers argued NICE failed to account for the treatments' wider impact on unpaid carers. This comes amid broader challenges in neurodegenerative disease research following recent high-profile clinical trial failures.
Eli Lilly's weight-loss drug Mounjaro fueled sevenfold sales growth in Brazil and doubled sales in India within months of launch, as the company commits $1 billion to make India a global export hub for its supply chain.
Blood-based biomarkers including brain-derived tau and amyloid-beta are enabling earlier Alzheimer's disease diagnosis through non-invasive testing, though confirmatory imaging remains necessary before treatment initiation.
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025, with successful phase 3 trials for cancer drug Jaypirca, next-gen obesity medicine retatrutide, and oral GLP-1 orforglipron, while Alzheimer's drug Kisunla showed cognitive decline benefits.
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025 and acquired Orna Therapeutics for $2.4 billion to develop circular RNA therapies for autoimmune diseases.
Eli Lilly acquired Orna Therapeutics for $2.4 billion and announced multiple partnerships while investing in AI drug discovery infrastructure, including building the industry's largest AI supercomputer to boost clinical trial success rates.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07602582 |
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). |
NOT_YET_RECRUITING | PHASE3 |
| NCT07589595 |
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07571161 |
Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease |
NOT_YET_RECRUITING | PHASE3 |
| NCT07167966 |
Alzheimer's Tau Platform: Regimen A - AADvac1 |
NOT_YET_RECRUITING | PHASE2 |
| NCT06996730 |
A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT06911944 |
Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation |
NOT_YET_RECRUITING | PHASE4 |
| NCT06566170 |
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease |
RECRUITING | |
| NCT05738486 |
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05567159 |
A Study of Donanemab (LY3002813) in Healthy Participants |
COMPLETED | PHASE1 |
| NCT05533411 |
A Study of Donanemab (LY3002813) in Healthy Chinese Participants |
COMPLETED | PHASE1 |
