Last update 12 Sep 2025

Lecanemab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-amyloid beta protofibril antibody, Immunoglobulin G1, anti-(human beta-amyloid protofibril) (human-mus musculus monoclonal BAN2401 heavy chain), disulfide with human-mus musculus monoclonal BAN2401 light chain, dimer, lecanemab-irmb
+ [8]
Target
Action
inhibitors
Mechanism
APP inhibitors(Beta amyloid A4 protein inhibitors)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (06 Jan 2023),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (China), Innovative Licensing and Access Pathway (United Kingdom), Priority Review (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Lecanemab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Dementia due to Alzheimer's disease (disorder)
United Kingdom
22 Aug 2024
Mild cognitive disorder
United Kingdom
22 Aug 2024
Alzheimer Disease
United States
06 Jan 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cognitive DysfunctionPhase 1
Japan
01 Sep 2013
Brain Injuries, TraumaticPreclinical
United States
15 Nov 2023
Down SyndromePreclinical
United States
15 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
856
LEQEMBI 10 mg/kg Every Two Weeks
mmqlhtsaoj(dhkrljrgsd) = LEQEMBI had a 64% likelihood of 25% or greater slowing of progression on the primary endpoint relative to placebo at Week 53, which did not meet the prespecified success criterion of 80%. ijhdfxelna (qvolhalolh )
-
29 Aug 2025
Placebo
Phase 3
-
biiohdvtqc(tzftsitmvc) = ayeokddelr qipioisizy (ikdxybekah )
Positive
12 Aug 2025
placebo
biiohdvtqc(tzftsitmvc) = mcfumibbvv qipioisizy (ikdxybekah )
Not Applicable
-
tdotkfvsyv(scrracmrku) = Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing. Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months. Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10 mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E. zxgokhkpbd (ofcrvjwjqj )
Positive
30 Jul 2025
Not Applicable
178
fquiwiyoix(svjjbjgrud) = 83.6% of patients either remained at the same clinical stage or improved from mild dementia to MCI (stable: 76.9%, improvement: 6.7%) mvvxmlxdmy (dkuydvksgt )
Positive
30 Jul 2025
Not Applicable
-
-
xuodvlgotv(grkebionic) = jzydedtxfs ognkgzglrx (fsdqdfgere, 91.1)
-
07 Apr 2025
Phase 3
1,795
dkcvhtzjbo(ncjmyoaogw) = ectwqtsrjc gknnoxxshl (hsqmdqogap )
Positive
30 Jul 2024
Placebo
dkcvhtzjbo(ncjmyoaogw) = xljtdedaos gknnoxxshl (hsqmdqogap )
Phase 3
Alzheimer Disease
ApoE e4 carriers | ApoE ε4 homozygous participants
3,407
Lecanemab 10 mg/kg biweekly
xlpijkioth(hpikfvfrmw) = jprmkylicj zouxfoitdu (vfcwgvkcma )
Positive
10 May 2024
placebo
(Core Study)
qsivehlyct(vuhuokecpa) = muibeeooar jcwnivcrwv (wyybxybumq )
Phase 3
Alzheimer Disease
amyloid PET centiloid levels
-
Lecanemab 10 mg/kg biweekly
ptldhjcajm(zggvqpvexg) = cpdzwhzizp hinoerrklm (uwfusowzwj )
Positive
09 Apr 2024
Placebo
ptldhjcajm(zggvqpvexg) = xjmnkpieuw hinoerrklm (uwfusowzwj )
Phase 3
898
pcwbrblnmr(skfbmqhtoc) = rcmudqtaka xvnydktmnb (wpjtkiywwe, 2.27)
Positive
25 Oct 2023
pcwbrblnmr(skfbmqhtoc) = ocugzdoeso xvnydktmnb (wpjtkiywwe, 1.14)
Phase 3
1,464
sivrexwqqo(ufzzwsqjsi) = epozjckorc pylrmktigd (rpbaiwcdcr )
Met
Positive
06 Jan 2023
Placebo
sivrexwqqo(ufzzwsqjsi) = pgsedqmicw pylrmktigd (rpbaiwcdcr )
Met
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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