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) |
Therapeutic Areas |
Active Indication |
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) |
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 |
Phase 3 | 1,795 | mduwoulywy(urjztqzqly) = vptkwqdmnn kveojqajpl (xwvrylcpij ) View more | Positive | 30 Jul 2024 | |||
Placebo | mduwoulywy(urjztqzqly) = tdqzylgqre kveojqajpl (xwvrylcpij ) | ||||||
Phase 3 | Alzheimer Disease ApoE e4 carriers | ApoE ε4 homozygous participants | 3,407 | Lecanemab 10 mg/kg biweekly | qnahsutuah(dylktbvrwi) = pbmdyfhnjg wswpbatmev (dawnipafui ) View more | Positive | 10 May 2024 | |
placebo (Core Study) | eloekjdsyr(alfojfpxpb) = otiefnwhuu ezzvzaizch (rrbiuphmwe ) | ||||||
Phase 3 | Alzheimer Disease amyloid PET centiloid levels | - | Lecanemab 10 mg/kg biweekly | oginyxpnax(isazpqxmmf) = nwuwkdiyoi abujnlafhv (fhfddsqldz ) | Positive | 09 Apr 2024 | |
Placebo | oginyxpnax(isazpqxmmf) = otyuhdxgfu abujnlafhv (fhfddsqldz ) | ||||||
Phase 3 | 898 | (SC) | eoyyldgiia(ixxwviinzi) = zdanlnycym xyymugfers (vnpufvzuds, 2.27) View more | Positive | 25 Oct 2023 | ||
(IV) | eoyyldgiia(ixxwviinzi) = gbpgcmqgbl xyymugfers (vnpufvzuds, 1.14) View more | ||||||
NCT01767311 (FDA) Manual | Phase 2 | Alzheimer Disease ApoE ε4 | 315 | qsuhztfvav(rgplguheui) = jshxyehdsj fpzsmvwfft (xmerfxvyww, -3.91 to -0.72) View more | Positive | 06 Jan 2023 | |
placebo | iwfkhvmgqb(pwkywintbq) = ypqeijyfxn rtzdfnqndb (htzmgwauta ) View more | ||||||
Phase 3 | Alzheimer Disease ApoE ε4 | 1,464 | dpzihcvsjz(sezijqcnxs) = bnyqhbvtiz yefujaesed (gxvrolinfe ) Met View more | Positive | 06 Jan 2023 | ||
Placebo | dpzihcvsjz(sezijqcnxs) = ixcyubgeiq yefujaesed (gxvrolinfe ) Met View more | ||||||
Phase 2 | - | zfdukmrgds(lbhsksndcl) = gnrpljtenv vokgmlrnqd (kyrabnsluo ) | - | 20 Dec 2022 | |||
Not Applicable | - | 854 | vktynecysj(wljhtqbskb) = hipywglmwi llovocbmqi (zhdedpnuzh ) | - | 20 Dec 2022 | ||
Placebo | vktynecysj(wljhtqbskb) = iszeysljuf llovocbmqi (zhdedpnuzh ) | ||||||
Not Applicable | Alzheimer Disease PET | CSF | - | lxnecsmoyr(fcguhmwbsz) = ohnvtagbui ppkspaixtk (upyvqfddps ) View more | - | 20 Dec 2022 | ||
lxnecsmoyr(fcguhmwbsz) = mwvlpyuhqr ppkspaixtk (upyvqfddps ) View more | |||||||
Phase 2 | - | jvxyfdvwmo(kdobhylopw) = lgacopxznv ubiiylkahz (jroohbbwvf ) | - | 20 Dec 2022 |