Lecanemab History and Updates

69 events · 2012 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Lecanemab since 2012, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2026

Results postedLecanemab Trial Shows Lower ADCOMS Scores in Early Alzheimer's Disease· Mar 4, 2026

2025

FDA approvalLecanemab Autoinjector Gains FDA Approval on August 29, 2025· Aug 29, 2025

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Primary completion: NCT06741553

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

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06530732

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

Primary completionDec 3, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06602258

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

Primary completionDec 31, 2026· ClinicalTrials.gov

Primary completion: NCT06871839

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

Primary completionApr 30, 2027· ClinicalTrials.gov

Primary completion: NCT07505095

Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

Primary completionSep 1, 2027· ClinicalTrials.gov

Primary completion: NCT07152418

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

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07604896

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Primary completionDec 31, 2027· ClinicalTrials.gov

Primary completion: NCT06285448

Feasibility of Lecanemab Registry and Clinical Outcome Measures

Primary completionApr 1, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07212062

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

Primary completionApr 30, 2028· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT01760005

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Indiv

Primary completionApr 30, 2028· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT05269394

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Indiv

Primary completionJun 30, 2028· ClinicalTrials.gov

Primary completion: NCT05925621

Cognitive Neurology Unit Clinical Registry

Primary completionDec 21, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT04468659

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease a

Primary completionJun 30, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT03887455

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Primary completionJul 31, 2029· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT05469009

Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Stand

Primary completionJun 30, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT06384573

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

Primary completionJun 30, 2030· ClinicalTrials.gov

NA primary completion: NCT07544953

Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Past events

2026

Trial startedMay 31, 2026· ClinicalTrials.gov

NA trial started: NCT07544953

Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Trial registeredMay 22, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07604896

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Trial startedApr 30, 2026· ClinicalTrials.gov

Trial started: NCT07505095

Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

Trial registeredApr 22, 2026· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT07544953

Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Trial registeredApr 1, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07505095

Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

Results postedMar 4, 2026· ClinicalTrials.gov

Trial results posted: NCT01767311

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

FDA approval (supplemental)Jan 16, 2026· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Labeling (BLA 761269 S-11)

Sponsor: EISAI INC. Class: Labeling.

2025

FDA approval (supplemental)Dec 15, 2025· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Labeling (BLA 761269 S-12)

Sponsor: EISAI INC. Class: Labeling.

FDA approval (supplemental)Dec 15, 2025· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Labeling (BLA 761269 S-15)

Sponsor: EISAI INC. Class: Labeling.

Trial startedDec 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07212062

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

Trial registeredOct 8, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07212062

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

Trial registeredSep 3, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07152418

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

Trial startedSep 1, 2025· ClinicalTrials.gov

Trial started: NCT07152418

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

FDA approvalAug 29, 2025· FDA

FDA approved Lecanemab Autoinjector (lecanemab-irmb) (BLA 761375)

Sponsor: EISAI INC.

FDA approval (supplemental)Aug 21, 2025· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Labeling (BLA 761269 S-13)

Sponsor: EISAI INC. Class: Labeling.

Trial registeredMar 12, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06871839

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

Trial startedMar 10, 2025· ClinicalTrials.gov

Trial started: NCT06871839

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

FDA approval (supplemental)Jan 24, 2025· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Efficacy (BLA 761269 S-5)

Sponsor: EISAI INC. Class: Efficacy.

2024

Trial registeredDec 19, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06741553

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

Primary completionDec 10, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT01767311

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

FDA approval (supplemental)Nov 14, 2024· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Labeling (BLA 761269 S-8)

Sponsor: EISAI INC. Class: Labeling.

Trial startedSep 30, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06602258

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

Trial registeredSep 19, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06602258

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

Trial registeredJul 31, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06530732

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

Trial startedJul 1, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06530732

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

Trial startedJun 28, 2024· ClinicalTrials.gov

Trial started: NCT06741553

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

Trial startedJun 10, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06384573

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

Trial registeredApr 25, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06384573

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

Trial registeredFeb 29, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06285448

Feasibility of Lecanemab Registry and Clinical Outcome Measures

Trial startedJan 2, 2024· ClinicalTrials.gov

Trial started: NCT06285448

Feasibility of Lecanemab Registry and Clinical Outcome Measures

2023

Trial startedJul 16, 2023· ClinicalTrials.gov

Trial started: NCT05925621

Cognitive Neurology Unit Clinical Registry

FDA approval (supplemental)Jul 6, 2023· FDA

FDA approved supplemental application for Leqembi (lecanemab) — Efficacy (BLA 761269 S-1)

Sponsor: EISAI INC. Class: Efficacy.

Trial registeredJun 29, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05925621

Cognitive Neurology Unit Clinical Registry

FDA approvalJan 6, 2023· FDA

FDA approved Leqembi (lecanemab) (BLA 761269)

Sponsor: EISAI INC. Class: Type 1 - New Molecular Entity.

Primary completionJan 6, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05533801

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

2022

Trial registeredSep 9, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05533801

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

Trial startedSep 6, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05533801

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

Trial registeredJul 21, 2022· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT05469009

Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Stand

Trial startedJul 14, 2022· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT05469009

Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Stand

Trial registeredMar 8, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT05269394

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Indiv

2021

Trial startedDec 22, 2021· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT05269394

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Indiv

Primary completionDec 7, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT05045716

A Study of Subcutaneous Lecanemab in Healthy Participants

Trial registeredSep 16, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05045716

A Study of Subcutaneous Lecanemab in Healthy Participants

Trial startedSep 7, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT05045716

A Study of Subcutaneous Lecanemab in Healthy Participants

2020

Trial startedJul 14, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04468659

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease a

Trial registeredJul 13, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04468659

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease a

2019

Trial startedMar 27, 2019· ClinicalTrials.gov

Phase 3 trial started: NCT03887455

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Trial registeredMar 25, 2019· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03887455

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

2013

Trial registeredJan 14, 2013· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01767311

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

Trial registeredJan 3, 2013· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT01760005

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Indiv

2012

Trial startedDec 31, 2012· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT01760005

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Indiv

Trial startedDec 20, 2012· ClinicalTrials.gov

Phase 2 trial started: NCT01767311

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

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.