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) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Cognitive Dysfunction | Phase 1 | Japan | 01 Sep 2013 | |
Brain Injuries, Traumatic | Preclinical | United States | 15 Nov 2023 | |
Down Syndrome | Preclinical | United States | 15 Nov 2023 |
NCT01767311 (FDA_CDER) Manual | 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 | Alzheimer Disease Maintenance | - | 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 ) View more | Positive | 30 Jul 2025 | ||
lecanemab IV | |||||||
Company_Website Manual | 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 ) View more | 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 ) View more | Positive | 30 Jul 2024 | |||
Placebo | dkcvhtzjbo(ncjmyoaogw) = xljtdedaos gknnoxxshl (hsqmdqogap ) View more | ||||||
Phase 3 | Alzheimer Disease ApoE e4 carriers | ApoE ε4 homozygous participants | 3,407 | Lecanemab 10 mg/kg biweekly | xlpijkioth(hpikfvfrmw) = jprmkylicj zouxfoitdu (vfcwgvkcma ) View more | 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 | (SC) | pcwbrblnmr(skfbmqhtoc) = rcmudqtaka xvnydktmnb (wpjtkiywwe, 2.27) View more | Positive | 25 Oct 2023 | ||
(IV) | pcwbrblnmr(skfbmqhtoc) = ocugzdoeso xvnydktmnb (wpjtkiywwe, 1.14) View more | ||||||
Phase 3 | Alzheimer Disease ApoE ε4 | 1,464 | sivrexwqqo(ufzzwsqjsi) = epozjckorc pylrmktigd (rpbaiwcdcr ) Met View more | Positive | 06 Jan 2023 | ||
Placebo | sivrexwqqo(ufzzwsqjsi) = pgsedqmicw pylrmktigd (rpbaiwcdcr ) Met View more |