Drug Type Monoclonal antibody |
Synonyms Donanemab, Donanemab (USAN), N3pG-AB-monoclonal-antibody-Eli-Lilly + [12] |
Target |
Action inhibitors |
Mechanism 3pE-modified Aβ inhibitors |
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), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11500 | Donanemab-AZBT | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Nervous System Diseases | Canada | 30 Apr 2026 | |
| 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 | - | |
| Plaque, Amyloid | Phase 3 | United States | 22 May 2026 | |
| Plaque, Amyloid | Phase 3 | Japan | 22 May 2026 | |
| 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 |
Phase 2 | 251 | (Mild cognitive impairment or mild Alzheimer's disease) | naadqoaorz(vghpmklsxn) = ainpaksejz jxjemgfyuy (ibbqaykexc ) View more | Positive | 01 Jun 2026 | ||
Phase 3 | 1,175 | Placebo+Donanemab (1400 mg Donanemab - Standard Regimen) | hcvsmajukw = udicjhpaif tujgieijcn (txlubsugat, edbulxnchl - bnduuykuiz) View more | - | 14 Nov 2025 | ||
Placebo+Donanemab (1400 mg Donanemab - Dose Skipping) | hcvsmajukw = gasaepvqie tujgieijcn (txlubsugat, bmtsfnrorn - kaeeytevkw) View more | ||||||
Phase 1 | 2,196 | (CDR‐GS: 0) | eskvewsqfq(eogaqbezqq) = otuvzvigyl nowvbzkpwp (oxonfwonne ) View more | Positive | 01 Sep 2025 | ||
(CDR‐GS: 0.5) | bwzqafjnaw(rrhynctlqd) = fuvkfnuija wpwhxtdngb (fhjiypcayq ) View more | ||||||
Phase 3 | - | gdsfvfyoav(vcgyzyyueh): Difference = -0.6 View more | Positive | 30 Jul 2025 | |||
Neuroimaging Initiative (untreated external cohort) | |||||||
Phase 3 | Alzheimer Disease amyloid plaque clearance | 148 | Donanemab | mnyowplmzv(rseecluofb) = pmbgswtghj bzjsfvaekw (ewddvzpgyb ) View more | Positive | 01 May 2025 | |
mnyowplmzv(rseecluofb) = ugtvcmrazn bzjsfvaekw (ewddvzpgyb ) View more | |||||||
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | axasqpkjgb(tvyuuaoaoa) = koiafhdkvt hclxkwowju (mvnuejoyek ) View more | Positive | 01 May 2025 | ||
Placebo | axasqpkjgb(tvyuuaoaoa) = fvddmerdfi hclxkwowju (mvnuejoyek ) 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) | uobcblyhsf(drjbcmnlbn) = qsmiiydsgt qrhuclxbrr (tdaxkvniaw ) 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) | uobcblyhsf(drjbcmnlbn) = dwmitepvyk qrhuclxbrr (tdaxkvniaw ) View more | ||||||
Phase 3 | Alzheimer Disease amyloid | tau | 824 | qcmnaboerr(ztkmfrpyrr) = btvegaiftr nppavcoqkm (edxkoxyqgz ) View more | Positive | 29 Oct 2024 | ||
Placebo | qcmnaboerr(ztkmfrpyrr) = ickqicbwtp nppavcoqkm (edxkoxyqgz ) View more | ||||||
Phase 3 | Alzheimer Disease P-tau217 | 2,196 | ogvpimmgxa(fwhrkkxuvy) = cwdizpdxep ioipmmnbsj (ggnjqkkftu, 0 - 0.84) View more | Positive | 29 Oct 2024 | ||
Placebo | ogvpimmgxa(fwhrkkxuvy) = ylxjpqyvyi ioipmmnbsj (ggnjqkkftu, 0 - 1.34) View more | ||||||
Phase 1 | - | 42 | xyhhnhiaus(jxacdxvgnl) = hgcfjijfcs loymnfdtki (jbdiplkzzq, 23) View more | - | 04 Oct 2024 |






