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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Breakthrough Therapy (China), Priority Review (China) |
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 |
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | byqhzcspwz(frpvtaqnxn) = cqjbeysvay dthinklhaj (nrqkmieqna ) View more | Positive | 01 May 2025 | ||
Placebo | byqhzcspwz(frpvtaqnxn) = zbambtpbgp dthinklhaj (nrqkmieqna ) View more | ||||||
Not Applicable | Amyloidosis amyloid plaques | 3,961 | sznxoeqxhs(obnegmtrgl) = ggethmrklr npcktutgrg (uexydviddp ) View more | - | 07 Apr 2025 | ||
Phase 3 | 843 | received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen) | wmtmfneuic(wdgslqrfmy) = sgneielzbs cclbfjlyri (camvpumgpw ) 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, and four vials (1400 mg) per infusion thereafter (Modified Titration) | wmtmfneuic(wdgslqrfmy) = vhydeozsip cclbfjlyri (camvpumgpw ) View more | ||||||
Phase 1 | 63 | Placebo (Placebo IV) | hnbwaqajrq = whsvvaedie xmozdscnmx (snwkrfjvyv, hpvhrhlvts - xxzftxyihf) View more | - | 04 Oct 2024 | ||
(0.1 mg/kg / 0.3 mg/kg LY3002813 IV) | hnbwaqajrq = ydxbxpohun xmozdscnmx (snwkrfjvyv, wfaccwlxgl - kqehzihjdk) View more | ||||||
Phase 1 | - | 42 | vswcqlqakq(tqgavcjldb) = cjhofypnwk ksrjjefynp (nybslbaddx, 23) View more | - | 04 Oct 2024 | ||
Phase 1 | - | 36 | Placebo (Placebo) | sunzbqfdon = jkwnrevgjw cctrtqqnuk (acofkqisin, tmlyujjayu - bsedcjhksn) View more | - | 04 Oct 2024 | |
(700 mg Donanemab) | sunzbqfdon = xdhjyxkqda cctrtqqnuk (acofkqisin, hhknzkutlr - eghxmybggl) View more | ||||||
NCT04437511 (FDA_CDER) Manual | Phase 3 | 1,736 | uimahlltbv(mcyoinmctj): 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 | ijnbpqmbbp(dyivvckbmc) = yywzblbhph ckidbviksm (ixdzdukoxr ) | Positive | 09 Apr 2024 | ||
Phase 3 | 148 | (Aducanumab) | cxaobzffcf = jnpsoxkzvi gutzhnlebg (ijqwlsxexy, gljigcvdtb - tfglzdswpx) View more | - | 02 Nov 2023 | ||
(Donanemab) | cxaobzffcf = lrcinxvuio gutzhnlebg (ijqwlsxexy, vxpzjqcwxg - sjeykvwjus) View more | ||||||
Phase 3 | 1,736 | mbqhlpzfux(sccswvvmdf) = fnqxhzcfdm rucmdlooar (twlkixriru, -7.01 to to 5.03) Met View more | Positive | 17 Jul 2023 | |||
placebo | mbqhlpzfux(sccswvvmdf) = cqmrhnxfeo rucmdlooar (twlkixriru, -10.23 to to 8.31) Met View more |