Drugs / Lecanemab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Leqembi | — | 2025-04-15 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05045716 | Sep → Dec 2021 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02094729 | Sep 2013 → Mar 2015 | Alzheimer disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01230853 | Aug 2010 → Oct 2012 | Alzheimer disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01767311 | Dec 2012 → Dec 2024 | Alzheimer disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06384573 | Jun 2024 → Jun 2030 expected | familial Alzheimer disease | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04468659 | Jul 2020 → Dec 2028 expected | Alzheimer disease | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03887455 | Mar 2019 → Jun 2029 expected | Alzheimer disease | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07688460 | Jul 2026 → Mar 2029 expected | Alzheimer disease | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | No outcome recorded |
| Phase 4 | NCT07604896 | Jan 2026 → Dec 2027 expected | Alzheimer disease | First Affiliated Hospital of Wenzhou Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT07034222 | Feb 2024 → Jan 2026 overdue | Alzheimer disease | Ruijin Hospital | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07544953 | May 2026 → Jun 2030 expected | Parkinson disease | Yonsei University | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05469009 Background | Jul 2022 → Jul 2029 expected | Alzheimer disease type 1, cognitive impairment with or without cerebellar ataxia | Ali Rezai | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07212062 Comparator | Dec 2025 → Apr 2028 expected | Alzheimer disease | Neurology Office of South Florida | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06602258 Background | Sep 2024 → Dec 2026 expected | Alzheimer disease | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05269394 Background | Dec 2021 → Apr 2028 expected | early-onset autosomal dominant Alzheimer disease | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01760005 Background | Dec 2012 → Apr 2028 expected | familial Alzheimer disease | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06530732 Background | Jul 2024 → Jun 2026 overdue | Alzheimer disease | Zhejiang Provincial People's Hospital | Recruiting | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lecanemab | “Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)” NCT01230853 ↗15“efficacy and safety of lecanemab (10 mg/kg administered every two weeks)” NCT07034222 ↗ |
| Known as | BAN2401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02094729 ↗ |
| Known as | Lecanemab irmb | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833321 ↗ |
| Known as | Leqembi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833321 ↗ |
| Action | Inhibit | “Amyloid-beta A4 protein inhibitor” CHEMBL3833321 ↗ |
| Modality | Monoclonal antibody | “Lecanemab (BAN2401), an IgG1 monoclonal antibody” PMID 33865446 ↗ Apr 2021 |
| Route | Intravenous | “Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)” NCT01230853 ↗ |
| Target | APP | “Amyloid-beta A4 protein inhibitor” CHEMBL3833321 ↗ |