LECANEMAB
Trade name: Leqembi
mAbapprovedFast Track FDABreakthrough Therapy FDA
Approved
Jan 6, 2023
Clinical trial activity
15 trials · 14 clinical orgs · 2 marketing orgs
Phase 1
6
Phase 2
7
Phase 3
5
Phase 4
1
Earliest trial started Aug 1, 2010 (NCT01230853)
Timeline
2010s
2020s
- Jan 6, 2023
Sarepta Therapeutics — Earliest FDA Approval
- Jan 6, 2023
Eisai — Marketing Organization
- Jan 6, 2023
Sarepta Therapeutics — NDA Secondary Org
- Jan 6, 2023
Sarepta Therapeutics — NDA Organization
Indications
Approved for
Mechanism of action
- Beta amyloid A4 proteinINHIBITOR
APP inhibitor
selectively binds soluble amyloid ß (Aß) protofibrils
Approval history
- approvedPriority reviewAcceleratedFast trackBreakthroughJan 6, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL3833321 ↗
Also known as
- ban2401
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07212062 | Phase 2 | Dec 1, 2025 | Bristol-Myers Squibb, Neurology Office of South Florida |
| NCT06992804 | Early Phase 1 (Phase 1) | May 28, 2025 | Capital Medical University |
| NCT06701149 | Phase 1 | Nov 28, 2024 | Jinan University, Simcere Pharmaceutical Co., Ltd |
| NCT06602258 | Phase 2 | Sep 30, 2024 | Eisai |
| NCT06530732 | Phase 3 | Aug 1, 2024 | Zhejiang University |
| NCT06384573 | Phase 3 | Jun 10, 2024 | Alzheimer's Association, Eisai, Washington University in St. Louis |
| NCT07034222 | Phase 4 | Feb 1, 2024 | Jiao Tong University |
| NCT05533801 | Phase 1 | Sep 6, 2022 | Eisai |
| NCT05269394 | Phase 2/Phase 3 (Phase 3) | Dec 22, 2021 | Accelerating Medicines Partnership, Alzheimer's Association, Eisai, National Institute on Aging (NIA), Washington University in St. Louis |
| NCT05045716 | Phase 1 | Sep 7, 2021 | Eisai |
| NCT04468659 | Phase 3 | Jul 13, 2020 | Alzheimer's Clinical Trial Consortium (ACTC), Biogen, Eisai, National Institute on Aging (NIA) |
| NCT03887455 | Phase 3 | Mar 29, 2019 | Biogen, Eisai |
| NCT02094729 | Phase 1 | Sep 1, 2013 | Eisai |
| NCT01767311 | Phase 2 | Dec 1, 2012 | Eisai |
| NCT01230853 | Phase 1 | Aug 1, 2010 | Eisai |
Showing 15 of 15 trials
Page 1 / 1
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eisai | For profit | 10 | 8 | 3 | 2010 |
| Alzheimer's Association | Academic/Hospital | 2 | 0 | 1 | 2021 |
| Biogen | For profit | 2 | 0 | 1 | 2019 |
| National Institute on Aging (NIA) | Government | 2 | 0 | 1 | 2020 |
| Washington University in St. Louis | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Accelerating Medicines Partnership | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Alzheimer's Clinical Trial Consortium (ACTC) | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2025 |
| Capital Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Jiao Tong University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Jinan University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Neurology Office of South Florida | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Simcere Pharmaceutical Co., Ltd | For profit | 1 | 1 | 1 | 2024 |
| Zhejiang University | Academic/Hospital | 1 | 1 | 1 | 2024 |
14 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eisai | For profit | MKTG | Jan 6, 2023 |
| Sarepta Therapeutics | For profit | NDA2 | Jan 6, 2023 |
| Sarepta Therapeutics | For profit | NDA | Jan 6, 2023 |