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Eisai Co., Ltd. is a Japanese pharmaceutical company headquartered in Tokyo, specializing in oncology, neurology, and specialty care. Founded in 1941, Eisai is a key player in [Alzheimer's disease](/diseases/alzheimers-disease) research, having co-developed [lecanemab](/entities/lecanemab) (Leqembi) with Biogen — the first amyloid-targeting antibody to receive full FDA approval. [@eisai]
Eisai Co., Ltd. is a Japanese pharmaceutical company headquartered in Tokyo, specializing in oncology, neurology, and specialty care. Founded in 1941, Eisai is a key player in [Alzheimer's disease](/diseases/alzheimers-disease) research, having co-developed [lecanemab](/entities/lecanemab) (Leqembi) with Biogen — the first amyloid-targeting antibody to receive full FDA approval. [@eisai]
Target: Protofibrils of amyloid-beta ( soluble oligomers)
Approval: FDA accelerated approval January 2023, full approval July 2023
Developer: Jointly developed with Biogen
Status: Marketed in US, Japan, China, South Korea, Taiwan, Israel
Clinical Trial: [Clarity AD (NCT04437511)](https://clinicaltrials.gov/show/NCT04437511)
Efficacy: 27% slowing of clinical decline (CDR-SB) in Clarity AD; 31% slower decline in amyloid-related imaging abnormalities (ARIA)
Sales: ~$18M in Q3 2024 (early launch phase) [@lecanemab-q3-2024]
Leqembi Mechanism of Action:
Leqembi binds to protofibrils — the soluble, toxic oligomeric forms of amyloid-beta that are believed to be primary drivers of synaptic dysfunction and cognitive decline in AD. By selectively targeting protofibrils rather than monomeric Aβ or plaque, Leqembi reduces both soluble toxic species and existing amyloid plaques.
Pipeline Programs
| Drug | Mechanism | Phase | Indication | |------|-----------|-------|------------| | Lecanemab (Leqembi) | Anti-amyloid β protofibril mAb | Approved | Early AD | | E2814 | Anti-tau mAb (Mosaic) | Phase 1/2 | AD (DIAN-TU) | | E2027 | PDE9 inhibitor | Phase 2 | AD | | E2028 | Tau aggregation inhibitor | Phase 1 | AD |
E2814 (Anti-tau Monoclonal Antibody)
Mechanism: Anti-tau monoclonal antibody designed to bind multiple phospho-tau epitopes
Target: Pathological phosphorylated tau in brain
Phase: Phase 1/2 being evaluated in DIAN-TU trial (Dominantly Inherited Alzheimer Network Trials Unit)
Rationale: Complement amyloid-targeting with tau-focused approach; prevent spread of tau pathology across brain regions
Unique Feature: "Mosaic" design targets multiple tau epitopes for broader coverage
Research: First-in-human study published showing safety and target engagement [@e2814-phase1]
DIAN-TU Study Context: The DIAN-TU platform tests therapies in individuals with autosomal dominant AD mutations, allowing for earlier intervention before symptom onset. E2814 is being evaluated alongside other anti-amyloid and anti-tau candidates.
E2027 (PDE9 Inhibitor)
Mechanism: Phosphodiesterase 9 (PDE9) inhibitor
Target: cGMP signaling pathway in neurons
Phase: Phase 2
Rationale: Enhance synaptic plasticity and memory function by increasing cGMP levels
Rationale Basis: PDE9 is enriched in brain regions affected by AD and is involved in NMDA receptor-mediated signaling
E2028 (Tau Aggregation Inhibitor)
Mechanism: Small molecule inhibitor of tau aggregation
Target: Pathological tau protein aggregation
Phase: Phase 1
Rationale: Prevent formation of neurofibrillary tangles (NFTs)
Elenbecestat (E2609 - Discontinued)
Mechanism: BACE (Beta-Secretase) inhibitor
Target: [BACE1](/entities/bace1) enzyme
Status: Discontinued Phase 2/3 (2021)
Reason: Safety concerns (liver toxicity, cognitive worsening in some patients)
Lesson: Taught the field about risks of aggressive amyloid reduction
Parkinson's Disease Pipeline
Eisai has limited [Parkinson's disease](/diseases/parkinsons-disease) programs. The company focuses primarily on Alzheimer's disease. No significant PD candidates in current pipeline.
[AC Immune](/companies/ac-immune) — Tau vaccines and antibodies
[BioArctic](/companies/bioarctic) — Swedish biotech with AD pipeline
References
[Eisai Corporate Website](https://www.eisai.com)
[Leqembi FDA Approval](https://www.fda.gov/drugs/news-events-human-drug-alerts/fda-approves-leqembi-lecanemab-amyloid-reducing-therapy-alzheimers-disease)
[Clarity AD Trial Results](https://doi.org/10.1056/NEJMoa2212948)