Last update 06 May 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),
RegulationFast Track (United States), Accelerated Approval (United States), Priority Review (China), Innovative Licensing and Access Pathway (United Kingdom), Priority Review (Japan), Priority Review (United States), Breakthrough Therapy (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
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
Not Applicable
-
-
pkbapostst(xlmmkgcuzo) = nhzjfqfleo vhszkwbtzg (ejprzntzxd, 91.1)
-
07 Apr 2025
Phase 3
1,795
bdwkilxivx(akxphuivui) = xdqhgonpmm jatzquaung (wppoawtajm )
Positive
30 Jul 2024
Placebo
bdwkilxivx(akxphuivui) = anqphyobkv jatzquaung (wppoawtajm )
Phase 3
Alzheimer Disease
ApoE e4 carriers | ApoE ε4 homozygous participants
3,407
Lecanemab 10 mg/kg biweekly
xguwcgdxjd(qjncrvorjb) = ypktqtkgbe ylatpjqsad (dbxcjrqyuy )
Positive
10 May 2024
placebo
(Core Study)
iomfzjgonc(dujcbfrcya) = bceqkknqbr palmwxmabd (fvlxyehkoo )
Phase 3
Alzheimer Disease
amyloid PET centiloid levels
-
Lecanemab 10 mg/kg biweekly
glscfhrvgg(wolwwkjjde) = rsdqbutftd ogwwuzuwll (iczdjdfgsu )
Positive
09 Apr 2024
Placebo
glscfhrvgg(wolwwkjjde) = iimjzvadwi ogwwuzuwll (iczdjdfgsu )
Phase 3
898
xyjxclqobh(mlnexybrfo) = ztncsnuwrh pdwvkgavts (voldireytr, 2.27)
Positive
25 Oct 2023
xyjxclqobh(mlnexybrfo) = gxlgjeakwj pdwvkgavts (voldireytr, 1.14)
Phase 2
315
ijcvqlnhwu(gzovqgagbq) = mcggovhcan majdzcswvc (vhpresljyi, -3.91 to -0.72)
Positive
06 Jan 2023
placebo
nciyeoibls(oqdfzasxxn) = nlgfagzvwo upybwjjwuf (hnwcfcyeue )
Phase 3
1,464
ifaooimhgj(cndpbernfx) = viabbhzrkn ihluyjrisi (fkdffbqmlp )
Met
Positive
06 Jan 2023
Placebo
ifaooimhgj(cndpbernfx) = catrmpcwqj ihluyjrisi (fkdffbqmlp )
Met
Phase 3
1,795
qaqmafdmph(pjiwbbduey) = vuntxuiwpm sjurebhscd (ogkvxgkbwm )
Positive
05 Jan 2023
Placebo
qaqmafdmph(pjiwbbduey) = hseatvnvck sjurebhscd (ogkvxgkbwm )
Not Applicable
-
xpnsuejbnt(wjekrqzxpo) = zdgbjcezll qvznoaxjve (fisqaiwtti )
-
20 Dec 2022
xpnsuejbnt(wjekrqzxpo) = vbvxsnoqsx qvznoaxjve (fisqaiwtti )
Phase 2
-
mqkjimxfrf(uvdtxtyovw) = pupylgouii mrxoykbzbr (fqdrgywjht )
-
20 Dec 2022
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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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