donanemab
Trade name: Kisunla
mAbapprovedFast Track FDABreakthrough Therapy FDA
Approved
Jul 2, 2024
Clinical trial activity
13 trials · 8 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
7
Phase 3
5
Phase 4
1
Earliest trial started May 3, 2013 (NCT01837641)
Timeline
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 4
- Amyloid beta-Peptides · Phase 4
- Brain Diseases · Phase 3
- Central Nervous System Diseases · Phase 3
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 3
- Dementia · Phase 3
- Down Syndrome · Phase 4
- Healthy Volunteers · Phase 1
- Mental Disorders · Phase 3
- Nervous System Diseases · Phase 3
- Neurocognitive Disorders · Phase 3
- Neurodegenerative Diseases · Phase 3
- Tauopathies · Phase 3
Mechanism of action
- Beta amyloid A4 proteinDISRUPTING AGENT
Beta amyloid A4 protein disrupting agent
Specifically binds the N-terminal pyroglutamate for of beta-amyloid.
Approval history
- approvedPriority reviewFast trackBreakthroughJul 2, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4297245 ↗
Also known as
- ly3002813
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06911944 | Phase 4 | Aug 1, 2026 | Alzheimer's Clinical Trial Consortium (ACTC), Alzheimer's Therapeutic Research Institute, Eli Lilly, National Institute on Aging (NIA), University of Southern California |
| NCT06996730 | Phase 2/Phase 3 (Phase 3) | Jan 15, 2026 | Harvard University, National Institute on Aging (NIA), Universidad de Antioquia, University of Arizona |
| NCT05738486 | Phase 3 | Feb 28, 2023 | Eli Lilly |
| NCT05508789 | Phase 3 | Oct 10, 2022 | Eli Lilly |
| NCT05567159 | Phase 1 | Oct 4, 2022 | Eli Lilly |
| NCT05533411 | Phase 1 | Sep 14, 2022 | Eli Lilly |
| NCT05108922 | Phase 3 | Nov 16, 2021 | Eli Lilly |
| NCT05026866 | Phase 3 | Aug 27, 2021 | Eli Lilly |
| NCT04640077 | Phase 2 | Nov 23, 2020 | Eli Lilly |
| NCT04437511 | Phase 2 | Jun 22, 2020 | Eli Lilly |
| NCT03367403 | Phase 2 | Dec 18, 2017 | Eli Lilly |
| NCT02624778 | Phase 1 | Dec 1, 2015 | Eli Lilly |
| NCT01837641 | Phase 1 | May 3, 2013 | Eli Lilly |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 12 | 11 | 4 | 2013 |
| National Institute on Aging (NIA) | Government | 2 | 0 | 2 | 2026 |
| Alzheimer's Clinical Trial Consortium (ACTC) | Academic/Hospital | 1 | 0 | 1 | 2026 |
| Alzheimer's Therapeutic Research Institute | Academic/Hospital | 1 | 0 | 1 | 2026 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2026 |
| Universidad de Antioquia | Academic/Hospital | 1 | 0 | 1 | 2026 |
| University of Arizona | Academic/Hospital | 1 | 1 | 1 | 2026 |
| University of Southern California | Academic/Hospital | 1 | 1 | 1 | 2026 |
8 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eli Lilly | For profit | NDA | Jul 2, 2024 |