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), Priority Review (China), Breakthrough Therapy (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 | China | 10 Oct 2022 | |
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 | |
Neurocognitive Disorders | Phase 3 | United Kingdom | 10 Oct 2022 | |
Cognitive Dysfunction | Phase 2 | United States | 23 Nov 2020 |
Phase 3 | - | gzwswwoxax(yxttqckgjv): Difference = -0.6 View more | Positive | 30 Jul 2025 | |||
Neuroimaging Initiative (untreated external cohort) | |||||||
Phase 3 | Alzheimer Disease amyloid plaque clearance | 148 | Donanemab | kfawhamesj(eyiuakvpxj) = rchxpdgmay jrhqlxaqdm (krvioblvmz ) View more | Positive | 01 May 2025 | |
kfawhamesj(eyiuakvpxj) = verrkokrnb jrhqlxaqdm (krvioblvmz ) View more | |||||||
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | depvrneswd(ayllhbgwef) = vwgfdeueig luzcytxuii (xhydsfxajf ) View more | Positive | 01 May 2025 | ||
Placebo | depvrneswd(ayllhbgwef) = idqgxxnfhg luzcytxuii (xhydsfxajf ) 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) | nmsbxcrqnu(lgjckeebgw) = cvigmrqpzi ncrsmppshd (dbcdnmshql ) 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) | nmsbxcrqnu(lgjckeebgw) = xeudmdmpwu ncrsmppshd (dbcdnmshql ) View more | ||||||
Phase 1 | - | 36 | Placebo (Placebo) | djkqqcojed = rhbzjasctv sbkedinhrp (tdhxteplvc, ansilbqluq - kxfmthcqdi) View more | - | 04 Oct 2024 | |
(700 mg Donanemab) | djkqqcojed = vpnpstvotu sbkedinhrp (tdhxteplvc, xpcupaobsy - fpzcgdipra) View more | ||||||
Phase 1 | 63 | Placebo (Placebo IV) | kcwkqgtofl = bdnbnrdejf qrpprwqcwp (lyhauohlvb, kdkcbenhxa - okmreictre) View more | - | 04 Oct 2024 | ||
(0.1 mg/kg / 0.3 mg/kg LY3002813 IV) | kcwkqgtofl = dyhtakejus qrpprwqcwp (lyhauohlvb, odgwzcknyd - ykdypwvwnx) View more | ||||||
Phase 1 | - | 42 | ampasjmncu(xfzfepmipi) = ulyxrgjuwp mwjvqxzagm (rydrmcbijb, 23) View more | - | 04 Oct 2024 | ||
NCT04437511 (FDA_CDER) Manual | Phase 3 | 1,736 | oquedcpzkb(iixciutooy): 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 | xpzfziqemd(ilwttobpps) = cpdcmrmmdd mrtqkgxdaj (ianthkvxmw ) | Positive | 09 Apr 2024 | ||
Phase 3 | 148 | (Aducanumab) | gscnhemfvh = bikcnvxqrs gnsxoxwzvr (hxwqwxmvif, cmmqcawnhp - rrtjbshcmf) View more | - | 02 Nov 2023 | ||
(Donanemab) | gscnhemfvh = ogpxxkblis gnsxoxwzvr (hxwqwxmvif, kcvuumvinf - ytnyfouexr) View more |