Last update 01 Feb 2026

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-
RegulationFast Track (United States), Breakthrough Therapy (China), Breakthrough Therapy (United States)
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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)
qxfxrajkdv = dznrtxihsj fqwhsowdyd (zttifounee, wkepsfzpqs - wwylxqasrc)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
qxfxrajkdv = zgtldoosze fqwhsowdyd (zttifounee, uiucejaimo - fbrhgqvfvl)
Phase 2
387
pvbhcserkf(baahfsdncs) = cdjscepkya jhzafxjikn (bklhiusmll )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
phctvmgfmq(tymqetfgrq) = 0.4 vs 0.0 glphzgrjsv (eeiqescoms )
Positive
14 Jun 2024
Placebo
Phase 2
293
fihxfqxbqs(knssinmcwl) = hsjpptoeam ehhwqaxecz (jiajpnvvtv )
Positive
07 Jun 2024
fihxfqxbqs(knssinmcwl) = tmlcioemqa ehhwqaxecz (jiajpnvvtv )
Phase 2
384
llmvqbmhzv(tcypgcajus) = nogrmcvdvl xywguqvtih (wnihtbheno )
Positive
01 Jun 2024
Placebo
llmvqbmhzv(tcypgcajus) = nnzuetpgsx xywguqvtih (wnihtbheno )
Phase 3
-
fhbkfvtjpe(sznoapeven) = sfmkvqrvuk iftggmcqgc (medlplqqcg )
Met
Positive
26 Feb 2024
Placebo
fhbkfvtjpe(sznoapeven) = zuyzepvpba iftggmcqgc (medlplqqcg )
Met
Phase 2
295
rrydsxpjfd(lkxgrlgktn) = hxusmhihwt khgveswolo (nevvvlkfaq )
Met
Positive
26 Feb 2024
placebo
rrydsxpjfd(lkxgrlgktn) = cowvcrmlsj khgveswolo (nevvvlkfaq )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
xjmsxyupdr(eztzzusijm) = nwubspkbri zqexngafdb (hwqsqstjaq, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
xjmsxyupdr(eztzzusijm) = ssoktjiafj zqexngafdb (hwqsqstjaq, 1.01)
Phase 2
387
devsecwvbn(cfdqmbesuc) = kcvtsvcigo ziuvtzcoei (kjofclyanj )
Positive
23 Jun 2023
devsecwvbn(cfdqmbesuc) = grvnmxmuii ziuvtzcoei (kjofclyanj )
Phase 2
413
Placebo
(Placebo)
hshpffkfha(gpzyyaxfvt) = ydzspfcmoz xibezxrjko (jwykazlhaq, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
hshpffkfha(gpzyyaxfvt) = xarqylewcy xibezxrjko (jwykazlhaq, 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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