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Drug

Donanemab

Approved · EMA
Late-stage development

Also known as Kisunla, IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS APP (AMYLOID BETA A4 PRECURSOR PROTEIN) A BETA 3-PYROGLUTAMYL PEPTIDES, A.BETA. 3 (3-X)), HUMANIZED MONOCLONAL ANTIBODYGAMMA1 HEAVY CHAIN HUMANIZED (1-444) (VH (HOMO SAPIENS IGHV1-3*01 (84.7%)-(IGHD)-IGHJ4*01 (.

RxNorm2687966UNII1ADB65P1KK
10
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1

Clinical trial2026-07-09Results expected Q3 2028 · ClinicalTrials.gov

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Clinical trial2026-07-07Results expected Q3 2028 · ClinicalTrials.gov

A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Clinical trial2026-07-07Results expected Q2 2030 · ClinicalTrials.gov

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

Clinical trial2026-07-07Results expected Q3 2029 · ClinicalTrials.gov

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

Clinical trial2026-06-18Results posted · ClinicalTrials.gov

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Clinical trial2026-06-03Results expected Q2 2028 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 4 Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Donanemab in Adults With Down Syndrome

Clinical trial2026-05-15Results expected Q4 2028 · ClinicalTrials.gov

Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease

Clinical trial2026-03-19Results posted · ClinicalTrials.gov

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Clinical trial2026-01-21Results expected Q4 2027 · ClinicalTrials.gov

Approval: Kisunla (EMA)

Regulatory2025-09-24EMA

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

Clinical trial2025-08-29Results posted · ClinicalTrials.gov

A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

Clinical trial2025-08-03Results expected Q2 2030 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Donanemab
Aliases & brands
KisunlaIMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS APP (AMYLOID BETA A4 PRECURSOR PROTEIN) A BETA 3-PYROGLUTAMYL PEPTIDES, A.BETA. 3 (3-X)), HUMANIZED MONOCLONAL ANTIBODYGAMMA1 HEAVY CHAIN HUMANIZED (1-444) (VH (HOMO SAPIENS IGHV1-3*01 (84.7%)-(IGHD)-IGHJ4*01 (
RxNorm CUI
2687966
UNII
1ADB65P1KK
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-09-24
Latest approval
2025-09-24
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-09-24Approval
Approval: Kisunla (EMA)
Indication: Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic… Show full indication

Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers with confirmed amyloid pathology (see section 4.4). 

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

15 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
15
registered trials across all phases
LATEST COMPLETION 2024
10
Active studies
6
Recruiting
9
Late-stage (III+)
5
Completed
PHASE DISTRIBUTIONn = 15
Phase 12Phase 24Phase 2 / 31Phase 37Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Double-Blind, Placebo-Controlled, Phase 4 Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Donanemab in Adults With Down Syndrome

Not yet recruitingPH IVMichael Rafii, MD, PhDn=602028

A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

Not yet recruitingPH II/IIIBanner Healthn=2402030

A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

RecruitingPH IIIEli Lilly and Companyn=1402030

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

RecruitingPH IIIEli Lilly and Companyn=5502029

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

Active, not recruitingPH IIIKey trialEli Lilly and Companyn=1,7362028

Recent completions

Trials that read out recently, adding to the completed evidence base.

Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments

CompletedPH IIEli Lilly and Companyn=952024

A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease

CompletedPH IIIEli Lilly and Companyn=1482023

A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants

CompletedPH IEli Lilly and Companyn=422023

A Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese Participants

CompletedPH IEli Lilly and Companyn=362023

Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease

CompletedPH IIEli Lilly and Companyn=2722021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.