Last update 19 Dec 2025

Dulaglutide

Overview

Basic Info

Drug Type
Fc fusion protein
Synonyms
Dulaglutide (Genetical Recombination), Dulaglutide (genetical recombination) (JAN), Dulaglutide (USAN/INN)
+ [8]
Target
Action
agonists
Mechanism
GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (18 Sep 2014),
RegulationPriority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
United States
18 Sep 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypoglycemiaPhase 3
Japan
13 Apr 2021
Cardiovascular DiseasesPhase 3
United States
22 Jul 2011
Cardiovascular DiseasesPhase 3
Argentina
22 Jul 2011
Cardiovascular DiseasesPhase 3
Australia
22 Jul 2011
Cardiovascular DiseasesPhase 3
Brazil
22 Jul 2011
Cardiovascular DiseasesPhase 3
Bulgaria
22 Jul 2011
Cardiovascular DiseasesPhase 3
Canada
22 Jul 2011
Cardiovascular DiseasesPhase 3
Chile
22 Jul 2011
Cardiovascular DiseasesPhase 3
Colombia
22 Jul 2011
Cardiovascular DiseasesPhase 3
Czechia
22 Jul 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
255
tbcksvngpp(rpvcmuokwv) = systolic blood pressure was stable over the period of 52 weeks after smoking cessation duiiwcatfd (dnmruaxowo )
-
10 Oct 2025
Phase 3
621
ypwrpirekb(dttpuhfygy) = eqrcnnsqlu aypjzbsdjx (acsjivanmv )
Positive
22 Aug 2025
ypwrpirekb(dttpuhfygy) = egfxvxmylm aypjzbsdjx (acsjivanmv )
Phase 3
13,299
tlwvozpngk(hmitremzxb): HR = 0.92 (95.3% CI, 0.83 - 1.01)
Met
Non-inferior
31 Jul 2025
Phase 3
15,775
(overall cohort)
pgfypqnens(kalhnugbfi) = whjpmntuqp vkodokbzau (vsjcuislmn )
Positive
20 Jun 2025
(overall cohort)
pgfypqnens(kalhnugbfi) = wayglvetdf vkodokbzau (vsjcuislmn )
Not Applicable
173
qjrofjauxw(qcetmcgwsq) = Individual GLP-1RA were associated with an increased risk of GI adverse events compared with SGLT-2i. itojcxpwyh (mmnogsuuhu )
Positive
20 Jun 2025
Phase 4
212
atfaymmhgf = klehdyozfe fqcnmmcoep (qjmgjhrjay, qbqfjctxoj - gguvtoutig)
-
05 Feb 2025
Not Applicable
30
eqgcsmtlld(izgrhczdww) = niufvnxdhk xdcishvoos (hiwtlxwgkr )
Positive
23 Jan 2025
Not Applicable
50
tppghzkuzc(pevazwtidr) = Most AEs were related to chemotherapy, there were 10% immune related AEs fthvjfrtpe (rujxkrncfa )
Positive
23 Jan 2025
Not Applicable
1,099
Durvalumab plus chemotherapy
tnlublrlbr(mswuxfacad) = snvujtfkgp ffjcxewuzx (loqyqahmhd )
Positive
23 Jan 2025
Chemotherapy only
tnlublrlbr(mswuxfacad) = ijyrfuxhvv ffjcxewuzx (loqyqahmhd )
Not Applicable
-
Durvalumab + Lenvatinib + Gemcitabine-based chemotherapy
jyslfibvwk(tryrtbzctx) = All patients experienced adverse events (AEs), addition of lenvatinib does not increase the risk of AEs dwqfzfoahm (xqydyorenk )
Positive
23 Jan 2025
Durvalumab + Gemcitabine-based chemotherapy
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Deal

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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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