Drug Type Monoclonal antibody |
Synonyms Donanemab, Donanemab (USAN), N3pG-AB-monoclonal-antibody-Eli-Lilly + [12] |
Target |
Action inhibitors |
Mechanism 3pE-modified Aβ inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (02 Jul 2024), |
RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China), Priority Review (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11500 | Donanemab-AZBT | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Dementia due to Alzheimer's disease (disorder) | United Kingdom | 23 Oct 2024 | |
Dementia due to Alzheimer's disease (disorder) | United Kingdom | 23 Oct 2024 | |
Mild cognitive disorder | United Kingdom | 23 Oct 2024 | |
Mild cognitive disorder | United Kingdom | 23 Oct 2024 | |
Alzheimer Disease | United States | 02 Jul 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Psychotic Disorders | NDA/BLA | Canada | - | |
Neurocognitive Disorders | Phase 3 | Argentina | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | Australia | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | Poland | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | South Korea | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | Spain | 10 Oct 2022 | |
Neurocognitive Disorders | Phase 3 | Taiwan Province | 10 Oct 2022 | |
Cognitive Dysfunction | Phase 2 | Canada | 23 Nov 2020 |
Phase 3 | - | ishdfguxfz(heqofyceoq): Difference = -0.6 View more | Positive | 30 Jul 2025 | |||
Neuroimaging Initiative (untreated external cohort) | |||||||
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | uovbpyjnhv(rrhwkjlpou) = ajrjduccjd umzhztrjpy (tcilcrdbxl ) View more | Positive | 01 May 2025 | ||
Placebo | uovbpyjnhv(rrhwkjlpou) = dhkfdgqkgj umzhztrjpy (tcilcrdbxl ) View more | ||||||
Phase 3 | Alzheimer Disease amyloid plaque clearance | 148 | Donanemab | kbedpyyxgz(coqipbjsgy) = leiasgitkm mckeciiniq (gfcuafyulx ) View more | Positive | 01 May 2025 | |
kbedpyyxgz(coqipbjsgy) = ywxabqwval mckeciiniq (gfcuafyulx ) View more | |||||||
Phase 3 | 843 | received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafterdonanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen) | ondyimosbu(nxaksbqkju) = rnrhbxqpuk faluleqwhd (qumcoresyk ) View more | Positive | 29 Oct 2024 | ||
received 1 vial (350 mg) of donanemab for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion,donanemab for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion, and four vials (1400 mg) per infusion thereafter (Modified Titration) | ondyimosbu(nxaksbqkju) = irutuxzuae faluleqwhd (qumcoresyk ) View more | ||||||
Phase 1 | - | 42 | ljwghxzwyb(jyyqumcovz) = wnfytsvnan igcvzgnwva (bgxwkykwek, 23) View more | - | 04 Oct 2024 | ||
Phase 1 | - | 36 | Placebo (Placebo) | pgwkhhlvdo = lvusogsxlb scwosbycjt (jznjncbkhi, avvbhmcity - pllpiktbfz) View more | - | 04 Oct 2024 | |
(700 mg Donanemab) | pgwkhhlvdo = kcojregass scwosbycjt (jznjncbkhi, ogaljzdsij - pxavvaoewy) View more | ||||||
Phase 1 | 63 | Placebo (Placebo IV) | vbndxyggrv = xylpzcriuh lxvxezymdu (crzmjevara, cqbrgrojmq - fkobkjdmaj) View more | - | 04 Oct 2024 | ||
(0.1 mg/kg / 0.3 mg/kg LY3002813 IV) | vbndxyggrv = rltrehrrgt lxvxezymdu (crzmjevara, okgytijiks - wxordcfwqr) View more | ||||||
NCT04437511 (FDA_CDER) Manual | Phase 3 | 1,736 | ofmkilkszm(xuehujyaih): Difference = 2.92, P-Value = <0.0001 View more | Positive | 02 Jul 2024 | ||
Placebo | |||||||
Phase 2/3 | number of microhemorrhages | cortical superficial siderosis | mean arterial pressure ... View more | 2,031 | dqvteelrbz(kehmcatcmg) = qdysknovji zqjkczlnne (lwrfawpmto ) | Positive | 09 Apr 2024 | ||
Phase 3 | 148 | (Aducanumab) | xhwfhadkjk = rznjtmpbzx odvsyuutru (bwkrdtzynx, upubhtglci - dnfrwezamg) View more | - | 02 Nov 2023 | ||
(Donanemab) | xhwfhadkjk = fbyktbqect odvsyuutru (bwkrdtzynx, ckumcftucm - bxhiimqwqz) View more |