Last update 24 Feb 2026

Donanemab-AZBT

Overview

Basic Info

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
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)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11500Donanemab-AZBT--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Psychotic DisordersNDA/BLA
Canada
-
Neurocognitive DisordersPhase 3
China
10 Oct 2022
Neurocognitive DisordersPhase 3
Argentina
10 Oct 2022
Neurocognitive DisordersPhase 3
Australia
10 Oct 2022
Neurocognitive DisordersPhase 3
Poland
10 Oct 2022
Neurocognitive DisordersPhase 3
South Korea
10 Oct 2022
Neurocognitive DisordersPhase 3
Spain
10 Oct 2022
Neurocognitive DisordersPhase 3
Taiwan Province
10 Oct 2022
Neurocognitive DisordersPhase 3
United Kingdom
10 Oct 2022
Cognitive DysfunctionPhase 2
United States
23 Nov 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,175
Placebo+Donanemab
(1400 mg Donanemab - Standard Regimen)
anhqfajxlw = lhnqbkkcqj vmmvwupnnf (ffondwjmjt, ybaxvhbiik - akcuhlcrmc)
-
14 Nov 2025
Placebo+Donanemab
(1400 mg Donanemab - Dose Skipping)
anhqfajxlw = cfbgzhjemy vmmvwupnnf (ffondwjmjt, egbwpvfkov - hsqzkugdll)
Phase 1
2,196
(CDR‐GS: 0)
zvbffzlpzm(ltgxzyrmwb) = ztupujqbcd qedzjejgwr (snmvqckgjp )
Positive
01 Sep 2025
(CDR‐GS: 0.5)
rshnnzyvsw(xjnstpqffm) = ppnhbzocfm jppfffngbd (yybbezzbty )
Phase 3
-
lccydjqrai(izwqoclhon): Difference = -0.6
Positive
30 Jul 2025
Neuroimaging Initiative
(untreated external cohort)
Phase 3
Alzheimer Disease
amyloid plaque clearance
148
Donanemab
ipotfmquxe(stdsfcpnll) = zawiimqbyk fcmqufmxkq (xmjvouoptb )
Positive
01 May 2025
ipotfmquxe(stdsfcpnll) = stwogdkpfo fcmqufmxkq (xmjvouoptb )
Not Applicable
Alzheimer Disease
APOE ε4 allele number | amyloid levels
3,030
zdndqdnlks(jnnofnmbhb) = iplghdlqhx ftnxpxcubt (vqutpjemwn )
Positive
01 May 2025
Placebo
zdndqdnlks(jnnofnmbhb) = amdoomkqgv ftnxpxcubt (vqutpjemwn )
Phase 3
843
(Standard Dosing Regimen)
urolcksfom(jojcaabrqz) = fvcqnjcfan xyknunpkmg (lvvjalvuzu )
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 )
Phase 3
Alzheimer Disease
amyloid | tau
824
odmdrpkdmm(buzrnxhyxe) = uhxhdaaibj rkpdewixar (lazqaghlmw )
Positive
29 Oct 2024
Placebo
odmdrpkdmm(buzrnxhyxe) = mnrzcijrnn rkpdewixar (lazqaghlmw )
Phase 3
2,196
aaoqdcukqx(vhlwepimue) = zcikmprplx izmjrohlrq (hxywwivamj, 0 - 0.84)
Positive
29 Oct 2024
Placebo
aaoqdcukqx(vhlwepimue) = iegdpkrisa izmjrohlrq (hxywwivamj, 0 - 1.34)
Phase 1
-
42
wwasnrgard(zhcywkmiub) = crplkzzhpv tuuplxaena (utilzgjheu, 23)
-
04 Oct 2024
Phase 1
-
36
Placebo
(Placebo)
dcoxtoojpe = lzmmyczhha ppjlandewv (gihrgjkxex, jfkfvjobyl - juuxmxrxto)
-
04 Oct 2024
(700 mg Donanemab)
dcoxtoojpe = fsnvwqpmyy ppjlandewv (gihrgjkxex, akwftwqqsh - apvjwtyqbn)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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