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 (China), Priority Review (United States), Priority Review (China), Breakthrough Therapy (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 | 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 | 1,175 | Placebo+Donanemab (1400 mg Donanemab - Standard Regimen) | anhqfajxlw = lhnqbkkcqj vmmvwupnnf (ffondwjmjt, ybaxvhbiik - akcuhlcrmc) View more | - | 14 Nov 2025 | ||
Placebo+Donanemab (1400 mg Donanemab - Dose Skipping) | anhqfajxlw = cfbgzhjemy vmmvwupnnf (ffondwjmjt, egbwpvfkov - hsqzkugdll) View more | ||||||
Phase 1 | 2,196 | (CDR‐GS: 0) | zvbffzlpzm(ltgxzyrmwb) = ztupujqbcd qedzjejgwr (snmvqckgjp ) View more | Positive | 01 Sep 2025 | ||
(CDR‐GS: 0.5) | rshnnzyvsw(xjnstpqffm) = ppnhbzocfm jppfffngbd (yybbezzbty ) View more | ||||||
Phase 3 | - | lccydjqrai(izwqoclhon): Difference = -0.6 View more | Positive | 30 Jul 2025 | |||
Neuroimaging Initiative (untreated external cohort) | |||||||
Phase 3 | Alzheimer Disease amyloid plaque clearance | 148 | Donanemab | ipotfmquxe(stdsfcpnll) = zawiimqbyk fcmqufmxkq (xmjvouoptb ) View more | Positive | 01 May 2025 | |
ipotfmquxe(stdsfcpnll) = stwogdkpfo fcmqufmxkq (xmjvouoptb ) View more | |||||||
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | zdndqdnlks(jnnofnmbhb) = iplghdlqhx ftnxpxcubt (vqutpjemwn ) View more | Positive | 01 May 2025 | ||
Placebo | zdndqdnlks(jnnofnmbhb) = amdoomkqgv ftnxpxcubt (vqutpjemwn ) 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) | urolcksfom(jojcaabrqz) = fvcqnjcfan xyknunpkmg (lvvjalvuzu ) 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) | urolcksfom(jojcaabrqz) = cimgmhltym xyknunpkmg (lvvjalvuzu ) View more | ||||||
Phase 3 | Alzheimer Disease amyloid | tau | 824 | odmdrpkdmm(buzrnxhyxe) = uhxhdaaibj rkpdewixar (lazqaghlmw ) View more | Positive | 29 Oct 2024 | ||
Placebo | odmdrpkdmm(buzrnxhyxe) = mnrzcijrnn rkpdewixar (lazqaghlmw ) View more | ||||||
Phase 3 | Alzheimer Disease P-tau217 | 2,196 | aaoqdcukqx(vhlwepimue) = zcikmprplx izmjrohlrq (hxywwivamj, 0 - 0.84) View more | Positive | 29 Oct 2024 | ||
Placebo | aaoqdcukqx(vhlwepimue) = iegdpkrisa izmjrohlrq (hxywwivamj, 0 - 1.34) View more | ||||||
Phase 1 | - | 42 | wwasnrgard(zhcywkmiub) = crplkzzhpv tuuplxaena (utilzgjheu, 23) View more | - | 04 Oct 2024 | ||
Phase 1 | - | 36 | Placebo (Placebo) | dcoxtoojpe = lzmmyczhha ppjlandewv (gihrgjkxex, jfkfvjobyl - juuxmxrxto) View more | - | 04 Oct 2024 | |
(700 mg Donanemab) | dcoxtoojpe = fsnvwqpmyy ppjlandewv (gihrgjkxex, akwftwqqsh - apvjwtyqbn) View more |






