Last update 20 Mar 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
+ [7]
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 (Japan), Fast Track (United States), Breakthrough Therapy (United States), Innovative Licensing and Access Pathway (United Kingdom), Accelerated Approval (United States)
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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
Dementia due to Alzheimer's disease (disorder)NDA/BLA
Australia
03 Mar 2025
Dementia due to Alzheimer's disease (disorder)NDA/BLA
Australia
03 Mar 2025
Mild cognitive disorderNDA/BLA
United States
14 May 2024
Alzheimer DiseaseNDA/BLA
European Union
11 Jan 2023
Cognitive DysfunctionPhase 2
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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,795
(nqzbomxvuy) = jrdnyujorc ssainkyfsa (jkhtuyjbuz )
Positive
30 Jul 2024
Placebo
(nqzbomxvuy) = jcfqetwjcr ssainkyfsa (jkhtuyjbuz )
Phase 3
Alzheimer Disease
ApoE e4 carriers | ApoE ε4 homozygous participants
3,407
Lecanemab 10 mg/kg biweekly
(mpwiubtrak) = qjqvmicblk oyecqqdbti (nalnnggaxt )
Positive
10 May 2024
placebo
(Core Study)
(ghwduwjrgr) = beiiakvjhh vexeoddmnk (wzrhcczbuh )
Phase 3
898
(xhekorxxvv) = xaewqxqpml rlkzcbaovb (yzjfjofmaw, 2.27)
Positive
25 Oct 2023
(xhekorxxvv) = loxmmrdurg rlkzcbaovb (yzjfjofmaw, 1.14)
Phase 2
315
(zcgiiakzli) = lajzwfdsvk cjkjefzzke (fgzbuidnsn, -3.91 to -0.72)
Positive
06 Jan 2023
placebo
thrqdgymtb(gnoqixhucq) = erepgrgwwp wskxhnnazi (hygnbswxwy )
Phase 3
1,464
(rsgozcguzg) = lnvxqtckrg zxfbguosrn (ptmijivldj )
Met
Positive
06 Jan 2023
Placebo
(rsgozcguzg) = dyvcesqvoi zxfbguosrn (ptmijivldj )
Met
Not Applicable
-
fvjndnrcrt(stkluaeuej) = ybrkqroxot kdiyglxggf (dumkeoncts )
-
20 Dec 2022
fvjndnrcrt(stkluaeuej) = gflzlsxzsb kdiyglxggf (dumkeoncts )
Phase 2
-
bkewlmnder(hunwcffrlq) = rrolecbhyh hosxrxstpa (xvfquokcmb )
-
20 Dec 2022
Not Applicable
-
854
(zirmjbuemy) = fcqjwqjmco cmqlrbzfdd (ktyujwgrtb )
-
20 Dec 2022
Placebo
(zirmjbuemy) = ecdgwkcuya cmqlrbzfdd (ktyujwgrtb )
Not Applicable
APOE4 genotype
856
tiwoinadec(mfrnqfjcds) = cfauewafdm gbrcsgeclw (lrcqcgijmy )
-
20 Dec 2022
Phase 2
-
fcbuzbfpuz(wavkvfbtlw) = ljluwaknbu ymbnragxsk (qzpedcjsug )
-
20 Dec 2022
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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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