Also known as: Leqembi
Lecanemab-irmb is an amyloid beta-directed monoclonal antibody marketed as Leqembi for Alzheimer's disease. It is used in early-stage disease settings such as mild cognitive impairment or mild dementia due to Alzheimer's pathology. The FDA first approved Leqembi on January 6, 2023.
A review of more than 200 studies linked up to a third of dementia cases to diseases outside the brain. Trials and broader evidence also support multi-domain prevention strategies.
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
A new Cochrane review said anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit, but many researchers said the analysis has major limitations. Newer evidence on lecanemab and donanemab and broader drug development efforts continue to shape the field.
A review of 17 studies involving 20,342 patients found anti-amyloid Alzheimer’s drugs had “trivial” effects after 18 months and increased the risk of brain swelling and bleeding. A separate PET study suggested ARIA-E may mark brain regions with greater amyloid plaque reduction.
NICE has upheld appeals to review its guidance on Alzheimer's drugs lecanemab and donanemab, sending the decision back to committee. The manufacturers argued NICE failed to account for the treatments' wider impact on unpaid carers. This comes amid broader challenges in neurodegenerative disease research following recent high-profile clinical trial failures.
Canada's Drug Agency issued a draft recommendation against public drug plan coverage for lecanemab, an Alzheimer's treatment conditionally approved by Health Canada in October 2025, citing cost concerns despite the drug's ability to slow cognitive decline.
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
Researchers at Washington University in St. Louis have adapted CAR-T immunotherapy to target aggregated amyloid-beta in mice, with transient CAR expression clearing brain plaques. The approach uses CD4+ T cells engineered with receptors based on lecanemab antibody sequences.
BioArctic reported net revenues of SEK 184.0 M for Q4 2025, driven by Leqembi royalties and Novartis partnership income. Leqembi received multiple regulatory approvals and submissions across global markets during the quarter.
Blood-based biomarkers including brain-derived tau and amyloid-beta are enabling earlier Alzheimer's disease diagnosis through non-invasive testing, though confirmatory imaging remains necessary before treatment initiation.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07544953 |
Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology |
NOT_YET_RECRUITING | NA |
| NCT06602258 |
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06530732 |
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study) |
RECRUITING | PHASE3 |
| NCT06384573 |
DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06285448 |
Feasibility of Lecanemab Registry and Clinical Outcome Measures |
ENROLLING_BY_INVITATION | |
| NCT05925621 |
Cognitive Neurology Unit Clinical Registry |
RECRUITING | |
| NCT05533801 |
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants |
COMPLETED | PHASE1 |
| NCT05469009 |
Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy |
ACTIVE_NOT_RECRUITING | EARLY_PHASE1 |
| NCT05269394 |
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU) |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT05045716 |
A Study of Subcutaneous Lecanemab in Healthy Participants |
COMPLETED | PHASE1 |
