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- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (06 Jan 2023), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (China), Innovative Licensing and Access Pathway (United Kingdom), Priority Review (Japan), Priority Review (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 |
Not Applicable | - | - | kctahqvkde(waxgwqqkgp) = xdjjguwkou ioeyrdvgrx (hvgtdipigr, 91.1) | - | 07 Apr 2025 | ||
Phase 3 | 1,795 | hdoqqmdkmo(ebbrrtlaaz) = rttmwcrvrg ahnljoxjwz (kxzjhecgxa ) View more | Positive | 30 Jul 2024 | |||
Placebo | hdoqqmdkmo(ebbrrtlaaz) = ntyrikkcss ahnljoxjwz (kxzjhecgxa ) | ||||||
Phase 3 | Alzheimer Disease ApoE e4 carriers | ApoE ε4 homozygous participants | 3,407 | Lecanemab 10 mg/kg biweekly | smphocpkgd(svluzufbzg) = sgqtdyprzs aplxobjmmp (wzbxviafbp ) View more | Positive | 10 May 2024 | |
placebo (Core Study) | tpckwfiyin(fwmaoufihv) = kxzldcrgmo zcgajizbza (coiumeqtlw ) | ||||||
Phase 3 | Alzheimer Disease amyloid PET centiloid levels | - | Lecanemab 10 mg/kg biweekly | yjnjygajfb(gycdirfqcz) = ptklwskahj bilnducjsq (odlhhycjgg ) | Positive | 09 Apr 2024 | |
Placebo | yjnjygajfb(gycdirfqcz) = jaspyukqks bilnducjsq (odlhhycjgg ) | ||||||
Phase 3 | 898 | (SC) | bjiwxpgigm(tdkpmrusum) = oqlzrntjrb pninlmevax (dezuwexsyc, 2.27) View more | Positive | 25 Oct 2023 | ||
(IV) | bjiwxpgigm(tdkpmrusum) = xzuadqnpgk pninlmevax (dezuwexsyc, 1.14) View more | ||||||
NCT01767311 (FDA) Manual | Phase 2 | Alzheimer Disease ApoE ε4 | 315 | nlqbhxxaug(webvjrsoop) = yqxmelsyqt sompigdhuj (twddrqrbsg, -3.91 to -0.72) View more | Positive | 06 Jan 2023 | |
placebo | hchtuhuneh(uxxirtdilg) = vnzbogwbtq faeefhhblz (xxvolmsbhi ) View more | ||||||
Phase 3 | Alzheimer Disease ApoE ε4 | 1,464 | doeqycgtdj(svzsrynfdw) = ngimaaveml zzspxnmpff (tklxkylcss ) Met View more | Positive | 06 Jan 2023 | ||
Placebo | doeqycgtdj(svzsrynfdw) = ykxshmpxvc zzspxnmpff (tklxkylcss ) Met View more | ||||||
Phase 3 | 1,795 | gqwaftbsah(fisafzgfru) = myleeawdkt dlmuechbfu (napksrnpic ) View more | Positive | 05 Jan 2023 | |||
Placebo | gqwaftbsah(fisafzgfru) = xgudjpgrro dlmuechbfu (napksrnpic ) | ||||||
Phase 2 | - | ablqlskwpr(rqoyryuuuu) = yfofrsrdil sphfcfefwy (nrifzjcbkl ) | - | 20 Dec 2022 | |||
Phase 2 | - | qspnutnzwq(nwrsltfphe) = ysahyviprh uhwgyrbxtq (uzbbdquezs ) | - | 20 Dec 2022 |