Donanemab History and Updates

58 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-04Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Donanemab since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2025

Label revisionKisunla (Donanemab) Label Receives Boxed Warning for ARIA Risk· Dec 30, 2025
Results postedDonanemab Titration Regimen Reduces ARIA-E in Early Alzheimer's Disease· Nov 14, 2025
FDA approval (supplemental)Donanemab Supplemental Application for Efficacy Approved by FDA· Jul 1, 2025
Results postedDonanemab Follow-On Study Validates Remote Assessments in Alzheimer's· Jun 13, 2025

Upcoming & expected milestones

Trial startedJun 30, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07167966

Alzheimer's Tau Platform: Regimen A - AADvac1

Trial startedAug 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT06911944

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

Primary completionNov 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05026866

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Primary completionMay 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05508789

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Primary completionAug 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07167966

Alzheimer's Tau Platform: Regimen A - AADvac1

Primary completionAug 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07589595

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

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT06911944

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

Primary completionSep 30, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07602582

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Primary completionApr 30, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT07571161

Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

Primary completionJun 1, 2030· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT06996730

A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment o

Primary completionFeb 28, 2033· ClinicalTrials.gov

Primary completion: NCT06566170

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Al

Past events

2026

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07589595

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

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07602582

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Trial registeredMay 22, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07602582

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Trial registeredMay 15, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07589595

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

Trial registeredMay 6, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07571161

Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

Trial startedApr 30, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07571161

Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

Trial startedJan 15, 2026· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT06996730

A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment o

2025

Label revisionDec 30, 2025· FDA

Boxed warning present on label on Kisunla label (effective 2025-12-30)

WARNING: AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and

Results postedNov 14, 2025· ClinicalTrials.gov

Trial results posted: NCT05738486

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Trial registeredSep 11, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07167966

Alzheimer's Tau Platform: Regimen A - AADvac1

FDA approval (supplemental)Jul 1, 2025· FDA

FDA approved supplemental application for Kisunla (donanemab-azbt) — Efficacy (BLA 761248 S-4)

Sponsor: ELI LILLY CO. Class: Efficacy.

Results postedJun 13, 2025· ClinicalTrials.gov

Trial results posted: NCT04640077

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Trial registeredMay 30, 2025· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT06996730

A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment o

Trial registeredApr 4, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06911944

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

2024

Trial startedOct 7, 2024· ClinicalTrials.gov

Trial started: NCT06566170

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Al

Results postedOct 4, 2024· ClinicalTrials.gov

Trial results posted: NCT05567159

A Study of Donanemab (LY3002813) in Healthy Participants

Results postedOct 4, 2024· ClinicalTrials.gov

Trial results posted: NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Trial registeredAug 22, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06566170

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Al

FDA approvalJul 2, 2024· FDA

FDA approved Kisunla (donanemab-azbt) (BLA 761248)

Sponsor: ELI LILLY CO. Class: Type 1 - New Molecular Entity and Type 4 - New Combination.

Results postedMay 20, 2024· ClinicalTrials.gov

Trial results posted: NCT04437511

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Primary completionMay 16, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05738486

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Primary completionFeb 27, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04640077

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

2023

Results postedNov 2, 2023· ClinicalTrials.gov

Trial results posted: NCT05108922

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Primary completionJul 14, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05567159

A Study of Donanemab (LY3002813) in Healthy Participants

Primary completionApr 14, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04437511

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Trial startedFeb 28, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05738486

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Trial registeredFeb 22, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05738486

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Primary completionJan 5, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

2022

Trial startedOct 10, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05508789

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Trial registeredOct 5, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05567159

A Study of Donanemab (LY3002813) in Healthy Participants

Trial startedOct 4, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05567159

A Study of Donanemab (LY3002813) in Healthy Participants

Trial startedSep 14, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Trial registeredSep 9, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Primary completionSep 9, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT05108922

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Trial registeredAug 19, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05508789

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Results postedFeb 15, 2022· ClinicalTrials.gov

Trial results posted: NCT03367403

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

2021

Trial startedNov 16, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05108922

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Trial registeredNov 5, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05108922

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Trial registeredAug 30, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05026866

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Trial startedAug 27, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05026866

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

2020

Primary completionDec 4, 2020· ClinicalTrials.gov

Phase 2 primary completion: NCT03367403

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Trial startedNov 23, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04640077

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Trial registeredNov 23, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04640077

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Trial startedJun 19, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04437511

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Trial registeredJun 18, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04437511

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

2017

Trial startedDec 18, 2017· ClinicalTrials.gov

Phase 2 trial started: NCT03367403

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Trial registeredDec 8, 2017· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03367403

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.