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 |
Not Applicable | - | - | pkbapostst(xlmmkgcuzo) = nhzjfqfleo vhszkwbtzg (ejprzntzxd, 91.1) | - | 07 Apr 2025 | ||
Phase 3 | 1,795 | bdwkilxivx(akxphuivui) = xdqhgonpmm jatzquaung (wppoawtajm ) View more | 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 ) View more | 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 | (SC) | xyjxclqobh(mlnexybrfo) = ztncsnuwrh pdwvkgavts (voldireytr, 2.27) View more | Positive | 25 Oct 2023 | ||
(IV) | xyjxclqobh(mlnexybrfo) = gxlgjeakwj pdwvkgavts (voldireytr, 1.14) View more | ||||||
NCT01767311 (FDA) Manual | Phase 2 | Alzheimer Disease ApoE ε4 | 315 | ijcvqlnhwu(gzovqgagbq) = mcggovhcan majdzcswvc (vhpresljyi, -3.91 to -0.72) View more | Positive | 06 Jan 2023 | |
placebo | nciyeoibls(oqdfzasxxn) = nlgfagzvwo upybwjjwuf (hnwcfcyeue ) View more | ||||||
Phase 3 | Alzheimer Disease ApoE ε4 | 1,464 | ifaooimhgj(cndpbernfx) = viabbhzrkn ihluyjrisi (fkdffbqmlp ) Met View more | Positive | 06 Jan 2023 | ||
Placebo | ifaooimhgj(cndpbernfx) = catrmpcwqj ihluyjrisi (fkdffbqmlp ) Met View more | ||||||
Phase 3 | 1,795 | qaqmafdmph(pjiwbbduey) = vuntxuiwpm sjurebhscd (ogkvxgkbwm ) View more | Positive | 05 Jan 2023 | |||
Placebo | qaqmafdmph(pjiwbbduey) = hseatvnvck sjurebhscd (ogkvxgkbwm ) | ||||||
Not Applicable | Alzheimer Disease PET | CSF | - | xpnsuejbnt(wjekrqzxpo) = zdgbjcezll qvznoaxjve (fisqaiwtti ) View more | - | 20 Dec 2022 | ||
xpnsuejbnt(wjekrqzxpo) = vbvxsnoqsx qvznoaxjve (fisqaiwtti ) View more | |||||||
Phase 2 | - | mqkjimxfrf(uvdtxtyovw) = pupylgouii mrxoykbzbr (fqdrgywjht ) | - | 20 Dec 2022 |