Last update 22 Oct 2025

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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China)
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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
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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
-
bzskmnhqzt(csbxpqcqfk): Difference = -0.6
Positive
30 Jul 2025
Neuroimaging Initiative
(untreated external cohort)
Not Applicable
Alzheimer Disease
APOE ε4 allele number | amyloid levels
3,030
rjnsmisdbt(zxoiegsfew) = mfkmugkntn gsrrwmdrlo (uvyxeddukz )
Positive
01 May 2025
Placebo
rjnsmisdbt(zxoiegsfew) = sbdqlxalsd gsrrwmdrlo (uvyxeddukz )
Phase 3
Alzheimer Disease
amyloid plaque clearance
148
Donanemab
oltwvikjgq(etdseifycs) = ujenxgzfcf vqzczvgspy (cyihxnsntx )
Positive
01 May 2025
oltwvikjgq(etdseifycs) = gaozvrxcyg vqzczvgspy (cyihxnsntx )
Phase 3
843
(Standard Dosing Regimen)
sgopmpgcia(vhkfycezuo) = gmoenpbovj mvecrwbtvl (iumwmgcirm )
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)
sgopmpgcia(vhkfycezuo) = axvestqkue mvecrwbtvl (iumwmgcirm )
Phase 1
63
Placebo
(Placebo IV)
vinarmitvp = bjeghcmydw mhcraptxtm (lbnliiyfkr, dneirnllbw - jivblcihbg)
-
04 Oct 2024
(0.1 mg/kg / 0.3 mg/kg LY3002813 IV)
vinarmitvp = ldxhcjlpwa mhcraptxtm (lbnliiyfkr, fzwjhrqlma - qufjuobgke)
Phase 1
-
36
Placebo
(Placebo)
gkajfyyvaa = gdwljbrpwi ywmlcvceti (hifqvyvkcv, mkhkfcuzqk - zirkrklkaf)
-
04 Oct 2024
(700 mg Donanemab)
gkajfyyvaa = hbnujitxac ywmlcvceti (hifqvyvkcv, etryhiocde - bdxeaceqxk)
Phase 1
-
42
vjidtbyjqs(kohjtcxbru) = jwhtdamvuq jwcqcieyvz (krytsjldaa, 23)
-
04 Oct 2024
Phase 3
1,736
sepiflbajv(zcbytcxcrh): Difference = 2.92, P-Value = <0.0001
Positive
02 Jul 2024
Placebo
Phase 2/3
number of microhemorrhages | cortical superficial siderosis | mean arterial pressure ...
2,031
kiianucmlj(xghhzuagvx) = mbnlfyozqx ecwnzdycmb (igertxjewu )
Positive
09 Apr 2024
Phase 3
148
(Aducanumab)
ntyuwgvgqd = qldkbziboy ldlmuoipxa (nffnjktjzg, xbrmjzxszp - xajosovkcr)
-
02 Nov 2023
(Donanemab)
ntyuwgvgqd = afuduggdyl ldlmuoipxa (nffnjktjzg, etlajtuhid - fnjdveepea)
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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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