Donanemab

Intervention Approved 2024

3 papers1 finding

C, W, M, H: cells, worms or flies, mice, humans. Dark: independent labs found the same change there. Light: one lab or one study. Outline: nothing yet.

Labs are independent when their papers share no last author and no institution.

Against: findings that point the other way from most findings on the same outcome.

On aging: the drug’s trials ARN judged to be about aging, of every trial that tests it for any use.

No results posted: trials that ended more than a year ago with no results on ClinicalTrials.gov and no paper in ARN’s record.

Company ties: findings with an author at a company, or from a paper whose competing-interests statement declares ties to one.

1 on aging of 16 trials

14 of 16 trials sponsored by its developers

Human trial1
In silico1

Outcomes

Amyloid plaques

downin silico1

1 study

Donanemab decreases amyloid plaques in silico (median serum over 15 μg/mL (95% CI 8.54─18.0)).
“Following donanemab treatment in early symptomatic AD participants with mean age of 73.2 years and 71% APOE4 carriers, amyloid reduction was associated with maintaining median serum donanemab concentrations over 15 μg/mL”
In silicoearly symptomatic AD participants (71% APOE4 carriers)brainmedian serum donanemab concentrations over 15 μg/mL (95% confidence interval 8.54─18.0)
Donanemab physiologically based pharmacokinetic model coupled with natural life cycle model for amyloid plaque aggregation to predict target CSF and ISF concentrations associated with amyloid plaque reduction
AAIC 2025 abstract25 Dec 2025

Trials

1 on aging of 16

On aging

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Phase 2Recruiting

Approved

FDA Kisunla
2 Jul 2024Dementia, Alzheimer's Disease, mild cognitive impairment
EMA Kisunla
24 Sep 2025Alzheimer Disease, Cognitive Dysfunction, Dementia, mild cognitive impairment, amyloid pathology