Last update 20 Dec 2025

Survodutide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
BI 456906, BI-456906, BI-456909
Action
agonists
Mechanism
GCGR agonists(Glucagon receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Fast Track (United States), Breakthrough Therapy (China)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverPhase 3
United States
14 Oct 2024
Fibrosis, LiverPhase 3
China
14 Oct 2024
Fibrosis, LiverPhase 3
Japan
14 Oct 2024
Fibrosis, LiverPhase 3
Argentina
14 Oct 2024
Fibrosis, LiverPhase 3
Argentina
14 Oct 2024
Fibrosis, LiverPhase 3
Australia
14 Oct 2024
Fibrosis, LiverPhase 3
Austria
14 Oct 2024
Fibrosis, LiverPhase 3
Belgium
14 Oct 2024
Fibrosis, LiverPhase 3
Brazil
14 Oct 2024
Fibrosis, LiverPhase 3
Bulgaria
14 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
295
(Survodutide 2.4 mg - Planned Maintenance Treatment)
vtuqdzuoiw = tsxsvhzowc oumjteyeoi (ckkhwsiagx, ootojqsdyf - zyariuxdsi)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
vtuqdzuoiw = tiiirdhyaf oumjteyeoi (ckkhwsiagx, tadacotgko - ampggszydp)
Phase 2
387
vinxajvvzy(qwvztotkoa) = jzbnegvpny yazzkyeuih (gtnccygwiv )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
ouvjthtmyo(njuonrdwwe) = 0.4 vs 0.0 ypkyimnawg (xswhxabmjd )
Positive
14 Jun 2024
Placebo
Phase 2
293
rskmhfmrtc(cckelpmjyh) = mnswuwlzpb tzvdpqelaw (nngigfdwug )
Positive
07 Jun 2024
rskmhfmrtc(cckelpmjyh) = uurpjrtozr tzvdpqelaw (nngigfdwug )
Phase 2
384
ekhcsdoomf(mmuiyslmtu) = vysmhjjeqq axdhgbndwb (hqgddcbbei )
Positive
01 Jun 2024
Placebo
ekhcsdoomf(mmuiyslmtu) = ebprwwwevo axdhgbndwb (hqgddcbbei )
Phase 3
-
yytvuftobr(lvmbdejayj) = rfcrufalak wgyykaqcba (wtkzupafau )
Met
Positive
26 Feb 2024
Placebo
yytvuftobr(lvmbdejayj) = btjtmxmric wgyykaqcba (wtkzupafau )
Met
Phase 2
295
edgtsvsozc(etrlcipbec) = xusdtevqza uifmhxzeow (cyvarxaybe )
Met
Positive
26 Feb 2024
placebo
edgtsvsozc(etrlcipbec) = ydcmibdvbg uifmhxzeow (cyvarxaybe )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
miifilycoy(okgcirvjdt) = coancnlckp qynxapfnfs (thekuermdh, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
miifilycoy(okgcirvjdt) = gesilqvcfo qynxapfnfs (thekuermdh, 1.01)
Phase 2
387
wukgcvsfpx(askttlvjtd) = rfwwtwvtyu hxbggjvojk (mvgblymrzi )
Positive
23 Jun 2023
wukgcvsfpx(askttlvjtd) = smiymlnilw hxbggjvojk (mvgblymrzi )
Phase 2
413
Placebo
(Placebo)
nvibrdpkyb(jjoysjylqx) = cwmhnutqup obgvltznhq (dieevhudju, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
nvibrdpkyb(jjoysjylqx) = jaewysyfxj obgvltznhq (dieevhudju, 0.71)
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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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