Drugs / Donanemab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Alzheimer disease 5 milestones | |||||
| Refused (EMA) | EU (EMA) | — | Alzheimer disease | 2025-03-28 | “issued an opinion that does not recommend Eli Lilly and Company’s (NYSE:LLY) donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease.” lilly.com ↗ |
| Rejected (CRL) | US (FDA) | — | Alzheimer disease | 2023-01-19 | “the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab” lilly.com ↗ |
| Filed | US (FDA) | — | Alzheimer disease | 2022-08-04 | “The U.S. Food and Drug Administration (FDA) accepted, with Priority Review designation, donanemab for Alzheimer's disease for review under the accelerated approval pathway.” lilly.com ↗ |
| Filed | US (FDA) | — | Alzheimer disease | 2021-10-26 | “The company initiated rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer's disease.” lilly.com ↗ “submissions of donanemab for traditional approval to the FDA and EMA” lilly.com ↗ |
| Filed | EU (EMA) | — | Alzheimer disease | — | “submissions of donanemab for traditional approval to the FDA and EMA” lilly.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Kisunla | — | 2025-09-24 | europa.eu ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 1 | NCT01837641 | May 2013 → Aug 2016 | Alzheimer disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06996730 | Jul 2026 → Jun 2030 expected | early-onset autosomal dominant Alzheimer disease | Banner Health | Recruiting | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07838155 | Oct 2026 → Jul 2030 expected | Alzheimer disease | Eli Lilly and Company | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06911944 | Aug 2026 → Dec 2028 expected | Alzheimer disease, trisomy 21 | Michael Rafii, MD, PhD | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2025-09-25 | Eli Lilly and Company | Regulatory Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), in adults with mild cognitive impairment as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers. |
| 2025-07-30 | Eli Lilly and Company | Results Lilly's Kisunla (donanemab-azbt) showed growing benefit over three years in early symptomatic Alzheimer's disease lilly.com ↗
Findings from the TRAILBLAZER-ALZ 2 long-term extension study highlight Kisunla continued to demonstrate slowing of decline, with most participants having completed treatment |
| 2025-07-25 | Eli Lilly and Company | Regulatory Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers. |
| 2025-07-09 | Eli Lilly and Company | Regulatory FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease lilly.com ↗
the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt) |
| 2025-05-21 | Eli Lilly and Company | Regulatory Lilly's Kisunla (donanemab) receives marketing authorization in Australia for the treatment of early symptomatic Alzheimer's disease lilly.com ↗
Kisunla is the first amyloid-targeting therapy for people with Alzheimer's registered in Australia and the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. |
| 2025-03-28 | Eli Lilly and Company | Regulatory Lilly’s statement about the CHMP opinion issued for donanemab lilly.com ↗
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an opinion that does not recommend Eli Lilly and Company’s (NYSE:LLY) donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease. |
| 2024-12-17 | Eli Lilly and Company | Regulatory Lilly's Kisunla™ (donanemab-azbt) Approved in China for the Treatment of Early Symptomatic Alzheimer's Disease lilly.com ↗
China is the fourth major market in which Kisunla has been approved for use, following approvals in the United States, Japan and Great Britain. |
| 2024-10-29 | Eli Lilly and Company | Results Modified Titration of Donanemab Demonstrated Reduction of ARIA-E in Early Symptomatic Alzheimer's Disease Patients in Phase 3b study lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease (AD). |
| 2024-10-23 | Eli Lilly and Company | Regulatory Lilly's Kisunla™ (donanemab-azbt) Receives Marketing Authorization in Great Britain for the Treatment of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease in Adult Patients Who Are Apolipoprotein E Ε4 Heterozygotes or Non-Carriers lilly.com ↗
Great Britain is the third major market where donanemab has received approval |
| 2024-09-24 | Eli Lilly and Company | Regulatory Lilly's Kisunla™ (donanemab-azbt) Approved in Japan for the Treatment of Early Symptomatic Alzheimer's Disease lilly.com ↗
Japan is the second major market in which Kisunla has been approved for use. |
| 2024-07-02 | Eli Lilly and Company | Regulatory Lilly's Kisunla™ (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease lilly.com ↗ |
| 2024-03-08 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab lilly.com ↗
The date of the advisory committee meeting for donanemab has yet to be set by the FDA, and, as a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024. |
| 2023-07-17 | Eli Lilly and Company | Results Results from Lilly's Landmark Phase 3 Trial of Donanemab Presented at Alzheimer's Association Conference and Published in JAMA lilly.com ↗
Eli Lilly and Company (NYSE: LLY) presented full results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease (AD). |
| 2023-05-03 | Eli Lilly and Company | Results Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease. |
| 2023-01-19 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab lilly.com ↗ |
| 2022-11-30 | Eli Lilly and Company | Results Lilly Shares Positive Donanemab Data in First Active Comparator Study in Early Symptomatic Alzheimer's Disease lilly.com ↗
Brain amyloid clearance (<24.1 Centiloids) was achieved in 37.9% of donanemab-treated participants compared with 1.6% of Aduhelm® (aducanumab-avwa)-treated patients at 6 months |
| 2021-07-29 | Eli Lilly and Company | Results Lilly releases donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline lilly.com ↗
In the first, greater amyloid plaque changes following donanemab treatment was highly associated with less cognitive decline and participants with greater plaque clearance at 24 weeks of treatment showed less tau progression. |
| 2021-06-24 | Eli Lilly and Company | Regulatory Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease lilly.com ↗
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company's (NYSE: LLY) investigational antibody therapy for Alzheimer's disease (AD). |
| 2021-03-13 | Eli Lilly and Company | Results Lilly's donanemab slowed Alzheimer's disease progression in Phase 2 trial: full data presented at AD/PD™ 2021 and published in NEJM lilly.com ↗
Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer's disease. |
| 2021-03-09 | Eli Lilly and Company | Results Data from Lilly at International Conference on Alzheimer's & Parkinson Diseases 2021™ (AD/PD™ 2021) to Showcase Clinical Advances in Alzheimer's Disease Research lilly.com ↗
donanemab treatment resulted in significant slowing of decline in a composite measure of cognition and daily function in people with early symptomatic Alzheimer's disease (AD) compared to placebo. |
| 2021-01-12 | Carrier Biomed (Suzhou) Co., Ltd | Results 礼来阿尔茨海默病药物Donanemab二期临床达主要终点 carrierbiomed.com ↗
在综合阿尔茨海默病分级量表(iADRS)中，donanemab满足了从基线到76周变化的主要终点，相对于安慰剂，减缓了32%的下降，具有统计学意义。 |
| 2021-01-11 | Eli Lilly and Company | Results Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial lilly.com ↗
Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. |
All press releases naming this drug 24 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Donanemab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07167966 ↗ |
| 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 ↗ |
| 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 ↗ |