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Drug

Lecanemab

Approved · FDA / EMA
ClassAmyloid-beta A4 protein inhibitorEmerging researchLate-stage development

Also known as Leqembi.

2
Research papers
10
Active clinical trials
Amyloid-beta precursor protein
Primary target
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease

Clinical trial2026-04-22Results expected Q2 2030 · ClinicalTrials.gov

Approval: Leqembi (EMA)

Regulatory2025-04-15EMA

Lecanemab: Appropriate Use Recommendations.

Research2023-01-01The journal of prevention of Alzheimer's disease

Lecanemab in Early Alzheimer's Disease.

Research2022-11-29The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lecanemab
Aliases & brands
Leqembi
RxNorm CUI
2626143
ChEMBL ID
CHEMBL3833321
ATC codes
N06DX04
UNII
12PYH0FTU9
Primary mechanism
Amyloid-beta A4 protein inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORAmyloid-beta A4 protein inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2025-04-152026-07-13)
Earliest approval
2025-04-15
Latest approval
2026-07-13
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-07-13Indication expansionMulti-authority
Indication expansion: LECANEMAB-IRMB (BLA761375)
Evidence ↗
2025-08-29ApprovalMulti-authority
Approval: LECANEMAB-IRMB (BLA761375)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2025-04-15ApprovalMulti-authority
Approval: Leqembi (EMA)
Indication: Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’sShow full indication

Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology (see section 4.4).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2023
10
Active studies
3
Recruiting
8
Late-stage (III+)
2
Completed
PHASE DISTRIBUTIONn = 12
Early Phase 11Phase 12Phase 21Phase 2 / 32Phase 34Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Lecanemab in Early Alzheimer's Disease.

The New England journal of medicine · 2023 · 3,691 cites

Lecanemab: Appropriate Use Recommendations.

The journal of prevention of Alzheimer's disease · 2023 · 626 cites
Recent papers

Lecanemab in Early Alzheimer's Disease.

The New England journal of medicine · 2023 · 3,691 cites

Lecanemab: Appropriate Use Recommendations.

The journal of prevention of Alzheimer's disease · 2023 · 626 cites
Major research themes4
Alzheimer Disease2Antibodies, Monoclonal, Humanized1Apolipoprotein E41Nootropic Agents1
Journals, researchers & institutions
Top journals
  • The journal of prevention of Alzheimer's disease1
  • The New England journal of medicine1
Leading researchers
  • Aisen P2
  • Apostolova L1
  • Atri A1
  • Bateman RJ1
  • Chen C1
  • Cohen S1
  • Cummings J1
  • Dhadda S1
Leading institutions
free-text, unnormalised
  • Yale School of Medicine1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.