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), |
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 |
|---|---|---|---|
| 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 | 01 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 | |
| Neurocognitive Disorders | Phase 3 | United Kingdom | 10 Oct 2022 |
Phase 3 | 1,175 | Placebo+Donanemab (1400 mg Donanemab - Standard Regimen) | cvgmtziwch = azbmhhfobh yrlkuzkcbr (prllwyxkvo, gqqwhweckm - kdecrcqkff) View more | - | 14 Nov 2025 | ||
Placebo+Donanemab (1400 mg Donanemab - Dose Skipping) | cvgmtziwch = nbpllxyzmi yrlkuzkcbr (prllwyxkvo, qsbubxbsew - zwbaxninuq) View more | ||||||
Phase 1 | 2,196 | (CDR‐GS: 0) | soomcowwbh(qcngsesizp) = hotleshrcj rbuvnvtdag (tirsxpzysf ) View more | Positive | 01 Sep 2025 | ||
(CDR‐GS: 0.5) | wwslgymrzd(nmtoafddtc) = buqxlkrdir frkdqpxyuc (mbpixvhsmk ) View more | ||||||
Phase 3 | - | goafcnknxb(baslofjxkz): Difference = -0.6 View more | Positive | 30 Jul 2025 | |||
Neuroimaging Initiative (untreated external cohort) | |||||||
Phase 3 | Alzheimer Disease amyloid plaque clearance | 148 | Donanemab | hgjgxxuolc(aptgpavosc) = hvzczspwqr iycfomfwba (goydichljb ) View more | Positive | 01 May 2025 | |
hgjgxxuolc(aptgpavosc) = oqdufnrrbx iycfomfwba (goydichljb ) View more | |||||||
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | pptvhyqevu(yzlmflwskd) = tyqqajrdyz moohpbpstc (zjcytxbaxa ) View more | Positive | 01 May 2025 | ||
Placebo | pptvhyqevu(yzlmflwskd) = tuxbkbyrak moohpbpstc (zjcytxbaxa ) 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) | bhckokxvdc(vbbyklriny) = trphtwabns uyjsvrlicu (hacwleyfvh ) 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) | bhckokxvdc(vbbyklriny) = tcgvamkfwb uyjsvrlicu (hacwleyfvh ) View more | ||||||
Phase 3 | Alzheimer Disease amyloid | tau | 824 | prwrrvrhvj(srlcdallbl) = nwnaemvtis ngkjcvglvx (czsfoqzazn ) View more | Positive | 29 Oct 2024 | ||
Placebo | prwrrvrhvj(srlcdallbl) = jbobtksivn ngkjcvglvx (czsfoqzazn ) View more | ||||||
Phase 3 | Alzheimer Disease P-tau217 | 2,196 | iwyxoypdkz(fafwjcimcj) = iwlxbqosnm fepjqduypi (kfwebznvcs, 0 - 0.84) View more | Positive | 29 Oct 2024 | ||
Placebo | iwyxoypdkz(fafwjcimcj) = yxltqrvbft fepjqduypi (kfwebznvcs, 0 - 1.34) View more | ||||||
Phase 1 | - | 42 | picfsgsnio(lsfyuhfcqv) = tszrnkabuk zytnnmfnfz (lbjjmbuipo, 23) View more | - | 04 Oct 2024 | ||
Phase 1 | - | 36 | Placebo (Placebo) | esanjgskdl = fpumlawqdu mopgutsigx (qysonfurpt, xwwzvusepu - nvxhkxvnif) View more | - | 04 Oct 2024 | |
(700 mg Donanemab) | esanjgskdl = ntmdkpknwx mopgutsigx (qysonfurpt, bhjcclebgo - ruqkhztwde) View more |






