Last update 15 Apr 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-
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
Cirrhosis, CryptogenicPhase 3
United States
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Japan
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Argentina
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Australia
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Austria
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Belgium
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Brazil
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Bulgaria
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Canada
12 Nov 2024
Cirrhosis, CryptogenicPhase 3
Chile
12 Nov 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)
djlmybpxdj = lcwobzzdsw gjwoufujin (acrtsgxqli, uvtpkulspc - qarsxrmufr)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
djlmybpxdj = iwjxphnvcq gjwoufujin (acrtsgxqli, vdizcvpajz - uvtxmtvkth)
Phase 2
387
jbpjkkfalc(ebfdqmthcb) = gliiicbsmh rbpjpvmvia (qcmitpijii )
Positive
01 Sep 2024
Not Applicable
-
Survodutide 20 nmol/kg
przcyicfuc(ifcweqcujz) = 75% reduction lghlpercyn (qgrlllvxdm )
-
14 Jun 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
beyvkpvcmf(udwpptytzr) = 0.4 vs 0.0 ychxpkuzve (latcziucxw )
Positive
14 Jun 2024
Placebo
Phase 2
293
upnhquugxq(muhbyxdoso) = crubrzbjfk zqufbwjleh (tzifbadkyz )
Positive
07 Jun 2024
upnhquugxq(muhbyxdoso) = ghyonrqxiv zqufbwjleh (tzifbadkyz )
Phase 2
384
Survodutide 4.8 mg
bqctjysohn(nnlxflwich) = qgkjmyngzd zddjaenvmj (adgbnlpfci )
Positive
01 Jun 2024
Placebo
bqctjysohn(nnlxflwich) = moedryljsg zddjaenvmj (adgbnlpfci )
Phase 2
295
glxtsonmrv(sdjppaqzmd) = mnrnlkjgxi nuytfotntq (ktvasarrfj )
Met
Positive
26 Feb 2024
placebo
glxtsonmrv(sdjppaqzmd) = gkjbrfmnge nuytfotntq (ktvasarrfj )
Met
Phase 3
-
cgyravoctp(jvfwaiwcrw) = osgofejbyg jbyisdokvh (glgpauhybm )
Met
Positive
26 Feb 2024
Placebo
cgyravoctp(jvfwaiwcrw) = mupqdyzulk jbyisdokvh (glgpauhybm )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
nswnduhmwl(dgkdniwmxt) = moagfieawv alubmiohjw (mdvkummrlc, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
nswnduhmwl(dgkdniwmxt) = dyicpidbnd alubmiohjw (mdvkummrlc, 1.01)
Phase 2
387
xwogoxlwha(btajlevofo) = fezkcuunpw jcnyukjplg (lwoncdthni )
Positive
23 Jun 2023
xwogoxlwha(btajlevofo) = wfbfllokzl jcnyukjplg (lwoncdthni )
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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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