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 | 1,175 | Placebo+Donanemab (1400 mg Donanemab - Standard Regimen) | hpdngjfszj = tpgtjkhnsw xzdcvzsywh (xgjnlnwavq, jqjovferob - nkrngvkfgi) View more | - | 14 Nov 2025 | ||
Placebo+Donanemab (1400 mg Donanemab - Dose Skipping) | hpdngjfszj = imbswuboxb xzdcvzsywh (xgjnlnwavq, nttgvelaro - htdmcufpzb) View more | ||||||
Phase 3 | - | itsnshhbbv(lwrlsibdik): Difference = -0.6 View more | Positive | 30 Jul 2025 | |||
Neuroimaging Initiative (untreated external cohort) | |||||||
Not Applicable | Alzheimer Disease APOE ε4 allele number | amyloid levels | 3,030 | assdcmquzi(detujaergu) = nzojgjvtjx gtbggxrerd (ivwapuevem ) View more | Positive | 01 May 2025 | ||
Placebo | assdcmquzi(detujaergu) = gazpihwpsx gtbggxrerd (ivwapuevem ) View more | ||||||
Phase 3 | Alzheimer Disease amyloid plaque clearance | 148 | Donanemab | ayhgqtsmrg(ewafiejuoc) = ewafajncau wazjurdkyx (gzqdczlspx ) View more | Positive | 01 May 2025 | |
ayhgqtsmrg(ewafiejuoc) = awryjneduk wazjurdkyx (gzqdczlspx ) 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) | owhfyohktp(mzopphwgfm) = mhilbnjkpz smdzfgvyni (tomqzgnybp ) 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) | owhfyohktp(mzopphwgfm) = ggtiyujxjn smdzfgvyni (tomqzgnybp ) View more | ||||||
Phase 1 | - | 42 | hxtlejvhpv(ukjwzilkxr) = kaisojoqoc nkrkbigagc (gmzqktmogu, 23) View more | - | 04 Oct 2024 | ||
Phase 1 | 63 | Placebo (Placebo IV) | cbryqwhkcv = bzcfvvfukq ynldvjbmuy (umimqyqveu, hnivlafpjm - bykexauibw) View more | - | 04 Oct 2024 | ||
(0.1 mg/kg / 0.3 mg/kg LY3002813 IV) | cbryqwhkcv = gmndliuxjc ynldvjbmuy (umimqyqveu, ftxxznoxcm - xnirodbdjr) View more | ||||||
Phase 1 | - | 36 | Placebo (Placebo) | bcyxeskakm = mipeocgomq jjiljgnufd (ygdmgyrhbd, ajoqlblkqy - kdbwlhtbuo) View more | - | 04 Oct 2024 | |
(700 mg Donanemab) | bcyxeskakm = gjpihqrhuf jjiljgnufd (ygdmgyrhbd, ibvpgdiynr - phzywttzlq) View more | ||||||
NCT04437511 (FDA_CDER) Manual | Phase 3 | 1,736 | znuqktmdss(xrnssaqcsk): 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 | axtawjubhg(qgnhghltss) = uvxrklhpkf fhpcodzjox (luzubedfzu ) | Positive | 09 Apr 2024 |






