Leqembi

(Lecanemab)

ApprovedMonoclonal antibody

Leqembi is a monoclonal antibody that works as Amyloid Beta Inhibitor.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Leqembi is one of 172 monoclonal antibody programs targeting Cognitive impairment. It is currently in Approved.

Indications

Total Trials

Active Trials

171

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 CancerRecruiting

Alzheimer's DiseaseRecruiting

Early Alzheimer's DiseaseCompleted

Cognitive ImpairmentPhase 1

Active, not recruiting

Alzheimer DiseaseApproved

Recruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

Alzheimer's DiseasePhase 3

Recruiting

Early Alzheimer's DiseasePhase 2

Completed

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Taxol

Taxotere

Leqembi

1 4

Remeron

OOrganon and Co

Preclinical

1 5

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—6

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—7

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 9

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

2 10

Pyrotinib Maleate

AstraZeneca

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Early Alzheimer's Disease

NCT06871839

Phase 3Active, not recruiting

Early Alzheimer's Disease

NCT03887455

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

Q2 2028

Recruiting

GIST

NCT05925621

Clinical

Trials by Indication[1]

Alzheimer's Disease6 trials

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

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

Show 3 more trials

The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Amyloid Removal Trial (ART): A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer's Disease

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

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Active, not recruiting·WWashington University School of Medicine·Preclinical·NCT05269394·197 enrolled

Active, not recruiting·WWashington University School of Medicine·Preclinical·NCT01760005·490 enrolled

Early Alzheimer's Disease5 trials

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

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

Show 2 more trials

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

A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Active, not recruiting· Biogen logo

Biogen·Phase 3·NCT03887455·1,906 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

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

Outcome1 trial

Feasibility of Lecanemab Registry and Clinical Outcome Measures

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

4 more indications

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 — 10 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]

Current role of boron neutron capture therapy in head and neck cancer: insights from 4 years of clinical experience.

Clin Transl Radiat OncolJan 1, 2027DOI: 10.1016/j.ctro.2026.101316

Orbital tumor in DICER1 syndrome (embryonal tumor with multilayered rosettes) successfully treated with intraarterial chemotherapy.

Am J Ophthalmol Case RepDec 1, 2026DOI: 10.1016/j.ajoc.2026.102655

Immunophenotypic insights into diabetes heterogeneity: The role of CD25-expressing T cells in Ghanaian type 1 diabetes cohorts.

J Transl AutoimmunDec 1, 2026DOI: 10.1016/j.jtauto.2026.100400

Upright positioning in pediatric radiotherapy: rationale, safety considerations and a research roadmap.

Tech Innov Patient Support Radiat OncolDec 1, 2026DOI: 10.1016/j.tipsro.2026.100432

Implementation of a nonprofit specialty clinic for vascular anomalies and birthmarks in Vietnam: A 12-year service evaluation.

JAAD IntDec 1, 2026DOI: 10.1016/j.jdin.2026.08.015

Deucravacitinib versus placebo in adults with moderate-to-severe hidradenitis suppurativa: A pilot study.

JAAD IntDec 1, 2026DOI: 10.1016/j.jdin.2026.08.009

Cinnamic acid and magnetized water: A novel nutritional strategy to enhance lamb productivity and meat quality.

Vet Anim SciDec 1, 2026DOI: 10.1016/j.vas.2026.100890

ZIF-8-gated cascade nanoreactor amplifies glucose-triggered CO release and ferroptosis for mild photothermal cancer therapy.

Mater Today BioDec 1, 2026DOI: 10.1016/j.mtbio.2026.103724

Protective effects of nano-zinc and nano-selenium compared with a toxin binder in broiler chickens fed aflatoxin B1-contaminated diets through antioxidant, immune, and skeletal responses.

Vet Anim SciDec 1, 2026DOI: 10.1016/j.vas.2026.100888

Dietary licorice improves carcass yield, hepatocellular protection, gut health, oxidative status, and cecal bacterial balance in broiler chickens.

Vet Anim SciDec 1, 2026DOI: 10.1016/j.vas.2026.100892

Leqembi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q2 2028

Trials by Indication[1]

Alzheimer's Disease6 trials

Early Alzheimer's Disease5 trials

ALS1 trial

Cognitive impairment1 trial

Outcome1 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]

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