Leqembi

(Lecanemab)

ApprovedMonoclonal antibody

Leqembi is a monoclonal antibody that works as Amyloid Beta Inhibitor.[2] It is being used across 6 indications, with its most advanced program in Approved.[1]

Leqembi is one of 178 monoclonal antibody programs targeting Cognitive impairment. It is currently in Approved.

Indications

Total Trials

Active Trials

177

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cognitive ImpairmentActive, not recruiting

Alzheimer DiseaseRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Alzheimer's DiseaseActive, not recruiting

Parkinson's DiseaseRecruiting

DementiaActive, not recruiting

Cognitive ImpairmentPhase 1

Active, not recruiting

Alzheimer DiseaseApproved

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Alzheimer's DiseasePhase 3

Active, not recruiting

Parkinson's DiseasePhase 2

Recruiting

DementiaPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Leqembi

Eisai

Approved

1 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

PORTRAZZA

Eli Lilly

Preclinical

8 4

Lenvima

Eisai

Preclinical

6 5

Imjudo

AstraZeneca

Preclinical

5 6

Vizimpro

Pfizer

Preclinical

4 7

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 8

Remeron

OOrganon and Co

Preclinical

1 9

Tyrosine Kinase Inhibitor

Pfizer

Preclinical

2 10

PD-1 Inhibitor

Johnson & Johnson

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Alzheimer's Disease

NCT06530732

Q4 2026

Recruiting

Early Alzheimer's Disease

NCT06871839

Q2 2027

Recruiting

Early Alzheimer's Disease

NCT06741553

Q3 2027

Phase 3Recruiting

Non-Small Cell Lung Cancer

NCT04468659

Phase 2Active, not recruiting

Early Alzheimer's Disease

NCT06602258

Clinical

Trials by Indication[1]

Alzheimer's Disease5 trials

Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

Recruiting·ZZhejiang Provincial People's Hospital·Phase 3·NCT06530732·60 enrolled

The Purpose of This Study is to Evaluate the Safety and Tolerability of X/T+X-EC in Participants With Alzheimer's Disease Who Are Currently Treated With Lecanemab.

Not yet recruiting·NNeurology Office of South Florida·Phase 2·NCT07212062·60 enrolled

Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT07152418·120 enrolled

Show 2 more trials

DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease

Active, not recruiting·WWashington University School of Medicine·Phase 3·NCT06384573·40 enrolled

CLARITY-AD Extension: Lecanemab in Early Alzheimer's

Recruiting· Biogen logo

Biogen·Phase 3·NCT03887455·1,500 enrolled

Early Alzheimer's Disease4 trials

The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease

Recruiting·CCuibai Wei，Clinical Professor··NCT06871839·120 enrolled

A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease

Completed· Eisai logo

Eisai·Phase 2·NCT01767311·856 enrolled

Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06741553·120 enrolled

Show 1 more trial

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease

Active, not recruiting· Eisai logo

Eisai·Phase 2·NCT06602258·105 enrolled

Dementia2 trials

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

Active, not recruiting·WWashington University School of Medicine·Phase 2/3·NCT01760005·490 enrolled

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·WWashington University School of Medicine·Phase 2/3·NCT05269394·197 enrolled

ALS1 trial

A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants

Completed· Eisai logo

Eisai·Phase 1·NCT05533801·160 enrolled

Outcome1 trial

Feasibility of Lecanemab Registry and Clinical Outcome Measures

Enrolling by invitation·HHealthPartners Institute··NCT06285448·20 enrolled

5 more indications

Cognitive impairment1 trial

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·AAli Rezai·Phase 1·NCT05469009·15 enrolled

ART1 trial

A Study of Subcutaneous Lecanemab in Healthy Participants

Completed· Eisai logo

Eisai·Phase 1·NCT05045716·60 enrolled

GIST1 trial

Cognitive Neurology Unit Clinical Registry

Recruiting·—··NCT05925621·500 enrolled

Alzheimer disease1 trial

Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers

Recruiting·TThe Fourth Affiliated Hospital of Zhejiang University School of Medicine·Approved·NCT07688460·100 enrolled

Non-Small Cell Lung Cancer1 trial

BRUIN MCL-321: Pirtobrutinib in Mantle Cell Lymphoma

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04468659·500 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 6, 2023

LEQEMBI

BLA BLA761269

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Lecanemab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lecanemab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lecanemab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761269). U.S. Food & Drug Administration.
[5]
PubMed — 2 publications indexed for Lecanemab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Amyloid Beta Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Eisai

Key Publications[5]

Amyloid-Related Imaging Abnormalities With Lecanemab: Safety Analysis

JAMA NeurolMay 15, 2023DOI: 10.1001/jamaneurol.2023.1356

Lecanemab in Early Alzheimer's Disease: CLARITY AD Phase 3 Results

N Engl J MedNov 29, 2022DOI: 10.1056/NEJMoa2212948

Leqembi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Alzheimer's Disease5 trials

Early Alzheimer's Disease4 trials

Dementia2 trials

ALS1 trial

Outcome1 trial

Cognitive impairment1 trial

ART1 trial

GIST1 trial

Alzheimer disease1 trial

Non-Small Cell Lung Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

Related News