Overview
Lecanemab is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ), which are implicated in the pathophysiology of Alzheimer’s disease. Lecanemab works to reduce Aβ plaques and prevent Aβ deposition in the brain with high selectivity to Aβ protofibrils. In clinical trials, it significantly reduced brain Aβ plaques compared to placebo. On January 6, 2023, lecanemab was granted accelerated approval by the FDA for the treatment of Alzheimer’s Disease. It was granted full FDA approval on July 6, 2023.
Indication
Lecanemab is indicated for the treatment of Alzheimer’s disease. Treatment with lecanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Associated Conditions
- Alzheimer's Disease (AD)
Research Report
A Comprehensive Clinical and Pharmacological Review of Lecanemab (Leqembi) for the Treatment of Early Alzheimer's Disease
Executive Summary
Lecanemab, marketed as Leqembi, represents a significant, albeit complex, advancement in the therapeutic landscape for Alzheimer's disease (AD). As a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, its development is predicated on the amyloid cascade hypothesis, but with a refined focus. Lecanemab's novel mechanism involves high-affinity, selective binding to soluble amyloid-beta (Aβ) protofibrils, the species increasingly considered to be the most neurotoxic. This targeted action is designed to neutralize these toxic oligomers, prevent their aggregation into insoluble plaques, and facilitate their clearance from the brain.
The pivotal Phase 3 Clarity AD trial provided the foundational evidence for Lecanemab's approval, demonstrating a statistically significant slowing of cognitive and functional decline in patients with early AD. Over 18 months, treatment resulted in a 27% reduction in the rate of decline on the primary endpoint, the Clinical Dementia Rating-Sum of Boxes (CDR-SB), compared to placebo. This clinical benefit was corroborated by robust biomarker evidence, including a profound reduction in brain amyloid plaque burden and favorable changes in downstream markers of tau pathology.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/10/08 | Not Applicable | Not yet recruiting | Neurology Office of South Florida | ||
2025/09/03 | N/A | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/12/19 | N/A | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/09/19 | Phase 2 | Active, not recruiting | |||
2024/07/31 | Phase 3 | Recruiting | |||
2024/04/25 | Phase 3 | Recruiting | |||
2024/02/29 | N/A | ENROLLING_BY_INVITATION | |||
2023/06/29 | N/A | Recruiting | |||
2022/09/09 | Phase 1 | Completed | |||
2022/07/21 | Early Phase 1 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eisai Inc. | 62856-212 | INTRAVENOUS | 100 mg in 1 mL | 9/26/2023 | |
| Eisai Inc. | 62856-215 | INTRAVENOUS | 100 mg in 1 mL | 9/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/15/2025 | ||
Authorised | 4/15/2025 | ||
Authorised | 4/15/2025 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LEQEMBI CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML | SIN17228P | INFUSION, SOLUTION CONCENTRATE | 100 mg/ml | 5/2/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LEQEMBI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/5ML | N/A | N/A | N/A | 7/3/2024 | |
| LEQEMBI CONCENTRATE FOR SOLUTION FOR INFUSION 200MG/2ML | N/A | N/A | N/A | 7/3/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LEQEMBI 100 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1241891001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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