Drugs / Donanemab

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Kisunla 2025-09-24 europa.eu

Trials 17 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT05567159 Oct 2022 → Jul 2023 Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT05533411 Sep 2022 → Jan 2023 Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02624778 Dec 2015 → Aug 2019 Alzheimer disease Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01837641 May 2013 → Aug 2016 Alzheimer disease Eli Lilly and Company Completed No outcome recorded
Phase 24 trials
Phase 2 NCT07167966 Nov 2026 → Aug 2028 expected Alzheimer disease Paul S. Aisen Enrolling by invitation No outcome recorded
Phase 2 NCT07589595 May 2026 → Aug 2028 expected Lewy body dementia, amyloidosis Eli Lilly and Company Recruiting No outcome recorded
Phase 2 NCT04640077 Nov 2020 → Feb 2024 Alzheimer disease, brain disorder Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT03367403 Dec 2017 → Dec 2020 Alzheimer disease Eli Lilly and Company Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06996730 Jan 2026 → Jun 2030 expected early-onset autosomal dominant Alzheimer disease Banner Health Not yet recruiting No outcome recorded
Phase 37 trials
Phase 3 NCT07602582 May 2026 → Sep 2029 expected Alzheimer disease, senile plaque formation Eli Lilly and Company Recruiting No outcome recorded
Phase 3 NCT07571161 Apr 2026 → Apr 2030 expected Alzheimer disease Eli Lilly and Company Recruiting No outcome recorded
Phase 3 NCT05738486 Feb 2023 → May 2024 overdue Alzheimer disease, mental disorder Eli Lilly and Company Active not recruiting No outcome recorded
Phase 3 NCT05508789 Oct 2022 → May 2028 expected Alzheimer disease, mental disorder Eli Lilly and Company Active not recruiting No outcome recorded
Phase 3 NCT05108922 Nov 2021 → Sep 2022 Alzheimer disease Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT05026866 Aug 2021 → Nov 2027 expected Alzheimer disease Eli Lilly and Company Active not recruiting No outcome recorded
Phase 3 NCT04437511 Jun 2020 → Apr 2023 overdue Alzheimer disease Eli Lilly and Company Active not recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT06911944 Aug 2026 → Dec 2028 expected Alzheimer disease, trisomy 21 Michael Rafii, MD, PhD Not yet recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited text
Known as donanemab ClinicalTrials.gov intervention name — accepted as the source's own label NCT04640077
14

NCT05108922

NCT07602582

NCT05567159

NCT06996730

NCT07167966

NCT05533411

NCT05738486

NCT07589595

NCT03367403

NCT06911944

NCT05508789

NCT04437511

NCT07571161

NCT05026866

Known as Donanemab-azbt ChEMBL registry synonym — accepted as the source's own label CHEMBL4297245
Known as Kisunla ChEMBL registry synonym — accepted as the source's own label CHEMBL4297245
Known as LY3002813 “A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)” NCT07589595
2

NCT01837641

NCT02624778

Modality Monoclonal antibody “Donanemab, a monoclonal antibody targeting the insoluble form of β-amyloid found in plaques” PMID 42128444 May 2026
Route Intravenous “Administered IV” NCT01837641
Target APP “Amyloid-beta A4 protein disrupting agent” CHEMBL4297245