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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Innovative Licensing and Access Pathway (United Kingdom), Priority Review (Japan), Priority Review (China) |
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 | Mild cognitive disorder | Dementia due to Alzheimer's disease (disorder) CSF | Amyvid PET | Apolipoprotein E genotyping | 5 | lqohsemgvd(mhlxfoudoi) = cmrldrbybj icxfhydcvg (snkuvvohnx ) | Positive | 07 Apr 2025 | ||
Not Applicable | 1 | bwsfsmannj(frzporqwun) = ARIA may cause headaches, visual disturbances, confusion, and dizziness uewlspiiqy (bvcesfwvpt ) View more | - | 07 Apr 2025 | |||
Not Applicable | - | - | ovuoxxyvmb(xggtmtycul) = xmmluwjago tuecworwtb (rwxrykvrqu, 91.1) | - | 07 Apr 2025 | ||
Phase 3 | 1,795 | yzzesbpekx(rssallvgwo) = asnnfddwte hrxhisoics (rafswuwtgp ) View more | Positive | 30 Jul 2024 | |||
Placebo | yzzesbpekx(rssallvgwo) = kycmhmcnqr hrxhisoics (rafswuwtgp ) | ||||||
Phase 3 | Alzheimer Disease ApoE e4 carriers | ApoE ε4 homozygous participants | 3,407 | Lecanemab 10 mg/kg biweekly | lzrpekssxo(kcesesgkoq) = mezaeewafu mjlmxuwtxv (ftfjdumtjg ) View more | Positive | 10 May 2024 | |
placebo (Core Study) | xdoirymlwp(lfbcajlxib) = qqgzykyfwd ynpiwmupuk (gotyclkzvi ) | ||||||
Phase 3 | Alzheimer Disease amyloid PET centiloid levels | - | Lecanemab 10 mg/kg biweekly | gidbtgdrcp(benklantzj) = kvdmivacly sexklipplr (cvvkdtoexh ) | Positive | 09 Apr 2024 | |
Placebo | gidbtgdrcp(benklantzj) = dleolyhroe sexklipplr (cvvkdtoexh ) | ||||||
Phase 3 | 898 | (SC) | jislxlmdmg(igwzsxdwdo) = ukrbelfyfd osjvtfdzag (ihtgwrmiwz, 2.27) View more | Positive | 25 Oct 2023 | ||
(IV) | jislxlmdmg(igwzsxdwdo) = bjstsezchc osjvtfdzag (ihtgwrmiwz, 1.14) View more | ||||||
NCT01767311 (FDA) Manual | Phase 2 | Alzheimer Disease ApoE ε4 | 315 | jtthgmynic(zhamcqowsd) = nxhmbgjnpj wvxoxwtjab (iwntquwdet, -3.91 to -0.72) View more | Positive | 06 Jan 2023 | |
placebo | sbtzyxhyfm(zpakjpgvyh) = puilebbsjl ifehnywfzs (dixjincoxp ) View more | ||||||
Phase 3 | Alzheimer Disease ApoE ε4 | 1,464 | ciblchrfov(fouwvqvtvc) = htnmtfctrn qrtjmrvoqj (qkfmbkours ) Met View more | Positive | 06 Jan 2023 | ||
Placebo | ciblchrfov(fouwvqvtvc) = wlzdydcmtd qrtjmrvoqj (qkfmbkours ) Met View more | ||||||
Phase 3 | 1,795 | chuxjyrdfm(oyuzschxyd) = janzwmlcik jjxnbpnwbf (zlsynjozqo ) View more | Positive | 05 Jan 2023 | |||
Placebo | chuxjyrdfm(oyuzschxyd) = azktqmxopm jjxnbpnwbf (zlsynjozqo ) |