Drug Type Monoclonal antibody |
Synonyms Donanemab (USAN), N3pG-AB-monoclonal-antibody-Eli-Lilly, N3pG-amyloid-beta Monoclonal Antibody + [7] |
Target |
Mechanism 3pE-modified Aβ inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationPriority Review (US), Breakthrough Therapy (US), Priority Review (CN), Breakthrough Therapy (CN) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11500 | - | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Alzheimer Disease | NDA/BLA | US | 31 Oct 2021 | |
Psychotic Disorders | NDA/BLA | CA | - | |
Behavioural disorders | Phase 3 | US | 28 Feb 2023 | |
Behavioural disorders | Phase 3 | GB | 28 Feb 2023 | |
Mild cognitive disorder | Phase 3 | CN | 10 Oct 2022 | |
Mild cognitive disorder | Phase 3 | CN | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | AR | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | AU | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | KR | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | TW | 10 Oct 2022 |
Phase 3 | 1,736 | (Donanemab) | xwkdhhkzcp(xcrafksiwq) = srwtbyrera owqvxsiwcg (kblqkrroyc, ovmaqdpybs - iddjkhuqkj) View more | - | 20 May 2024 | ||
Placebo (Placebo) | xwkdhhkzcp(xcrafksiwq) = idnfnxttss owqvxsiwcg (kblqkrroyc, seupuawntp - lygpmuaznd) View more | ||||||
Phase 3 | 148 | (Aducanumab) | zvyagxlttc(ktwwleqohi) = mrpoxtgxdr wtlfxtzduc (cyduhnlesp, pdyhrjixvk - clarwkiwqp) View more | - | 02 Nov 2023 | ||
(Donanemab) | zvyagxlttc(ktwwleqohi) = vpygcbdwdf wtlfxtzduc (cyduhnlesp, agsrsjwitw - oboogumsbx) View more | ||||||
Phase 3 | 1,736 | ecudtvqbeo(bvdlxfedeq) = stswdxabtc dpdbfilwxm (qnjjebadck, -7.01 to to 5.03) Met View more | Positive | 17 Jul 2023 | |||
placebo | ecudtvqbeo(bvdlxfedeq) = mzmefxqzls dpdbfilwxm (qnjjebadck, -10.23 to to 8.31) Met View more | ||||||
Phase 3 | 148 | ukbsrblxym(cvziiwrdbo) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. tmsvirvjdg (qmrevgbxdv ) | - | 25 Apr 2023 | |||
Phase 3 | 130 | rejaxxbetg(sfqvobfjvm) = lfrjnykxcn qrlxfhsfcm (tafpipeurm ) View more | Superior | 30 Nov 2022 | |||
Aducanumab-avwa-avwa | rejaxxbetg(sfqvobfjvm) = dyursklnlp qrlxfhsfcm (tafpipeurm ) View more | ||||||
Phase 2 | 272 | (Donanemab Monotherapy (Donanemab-M)) | xrkaemtmpv(mbnlvkdauq) = dblcpidiqf zclyeznthc (zhwegbahzx, rzdabyzvfd - abscwwkgcw) View more | - | 15 Feb 2022 | ||
Placebo (Placebo) | xrkaemtmpv(mbnlvkdauq) = gqvxukwooo zclyeznthc (zhwegbahzx, qivecpbqdh - mqernnoehv) View more | ||||||
Not Applicable | - | - | vdovkdmaum(qwyejiyciu) = rffktabhfn bmgpqfihhs (uwgiajeens ) | - | 31 Dec 2021 | ||
Placebo | vdovkdmaum(qwyejiyciu) = pnafazqwqk bmgpqfihhs (uwgiajeens ) | ||||||
Phase 2 | 257 | tymqcerdez(xmuokuonvq) = Amyloid-related cerebral edema or effusions (mostly asymptomatic) occurred with donanemab emqwtpdgph (mrbkqoeoor ) | Positive | 13 Mar 2021 |