How many clinical trials are studying Donanemab?

5 recruiting trials in our tracked data involve Donanemab.

What conditions is Donanemab being studied for?

In our tracked recruiting trials, Donanemab is being studied in trials for Alzheimer's disease, Alzheimer Disease, Alzheimers Disease.

Donanemab: clinical trials recruiting now

Q: Is Donanemab FDA-approved?

Yes. According to the FDA drug label available through openFDA, Donanemab is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Donanemab appears in the FDA drug-label database. Marketed as Kisunla.
Boxed warning: The FDA label for Donanemab carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. ( 1 )

FDA label via openFDA

Phase breakdown

Phase 2 2 Phase 3 3 Not applicable 1

Conditions being studied

Condition	Trials
Alzheimer's disease · Donanemab for Alzheimer's disease	5
Alzheimer Disease · Donanemab for Alzheimer Disease	3
Alzheimers Disease	1
Amyloid	1
Autosomal Dominant Alzheimers Disease	1
Cognitive Dysfunction	1
Dementia	1
Early Onset Alzheimer Disease	1
Lewy Body Disease	1
Plaque, Amyloid	1
Synucleinopathies	1

Recruiting trials involving Donanemab

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
NCT06566170 · Phase: Not specified · Ages: 60 Years and older · Sex: All (male and female) · 1 location
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
NCT07602582 · Phase: Phase 3 · Ages: 55 Years and older · Sex: All (male and female) · 59 locations
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
NCT07589595 · Phase: Phase 2 · Ages: 55 Years to 85 Years · Sex: All (male and female) · 72 locations
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
NCT06996730 · Phase: Phase 2, Phase 3 · Ages: 25 Years to 65 Years · Sex: All (male and female) · 1 location
Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
NCT07571161 · Phase: Phase 3 · Ages: 55 Years to 80 Years · Sex: All (male and female) · 30 locations

Common questions

Is Donanemab FDA-approved?

Yes, marketed as Kisunla. Its FDA label carries a boxed warning.

How many recruiting trials involve Donanemab?

5 recruiting trials across 11 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.