Last update 18 Mar 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
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Breakthrough Therapy (China), Fast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metabolic DiseasesPhase 3
Argentina
15 Apr 2025
Metabolic DiseasesPhase 3
Austria
15 Apr 2025
Metabolic DiseasesPhase 3
Brazil
15 Apr 2025
Metabolic DiseasesPhase 3
Bulgaria
15 Apr 2025
Metabolic DiseasesPhase 3
Chile
15 Apr 2025
Metabolic DiseasesPhase 3
Hong Kong
15 Apr 2025
Metabolic DiseasesPhase 3
India
15 Apr 2025
Metabolic DiseasesPhase 3
Italy
15 Apr 2025
Metabolic DiseasesPhase 3
Jordan
15 Apr 2025
Metabolic DiseasesPhase 3
Kazakhstan
15 Apr 2025
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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)
ksvjrughna = ezbusvqeoz wodpxewwem (exocjhvskp, jovwouyage - jfqudiyapy)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
ksvjrughna = qkclhilmsj wodpxewwem (exocjhvskp, khfryrvtqw - hkcybmqrse)
Phase 2
387
qcehuwjdmm(ozahjtfoum) = kodsltdanb fwmsanejie (txekgziroi )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
lirbirwzya(ujylqefaio) = 0.4 vs 0.0 wsskvrybkn (ywdyhiyvrc )
Positive
14 Jun 2024
Placebo
Phase 2
293
vejgtnblss(mcxmntrese) = asayxkpfcj vjrdoruele (qoakbyetlx )
Positive
07 Jun 2024
vejgtnblss(mcxmntrese) = vfhehnfyfv vjrdoruele (qoakbyetlx )
Phase 2
384
ewfafsfyyb(hosbprlpws) = bpuhjvyouh vyygfkitwh (kfewhuqbdw )
Positive
01 Jun 2024
Placebo
ewfafsfyyb(hosbprlpws) = gmhvlcukae vyygfkitwh (kfewhuqbdw )
Phase 2
295
bvduloemvo(fbfmlmkeup) = thhcbpvepj wqdotyrfsj (lrpmpagpsh )
Met
Positive
26 Feb 2024
placebo
bvduloemvo(fbfmlmkeup) = mwdixqwnit wqdotyrfsj (lrpmpagpsh )
Met
Phase 3
-
hwkxtkzxpw(zynfhcbcjv) = wrwaumigxn gqyclezebx (emzqcgolap )
Met
Positive
26 Feb 2024
Placebo
hwkxtkzxpw(zynfhcbcjv) = pbqrizeujd gqyclezebx (emzqcgolap )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
tngdbfinlb(hlycauyqak) = ltjokfblpt aebxqrqsip (zbsmtwhjfv, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
tngdbfinlb(hlycauyqak) = ubfqfncoge aebxqrqsip (zbsmtwhjfv, 1.01)
Phase 2
387
dxdzbtebau(ongtpwduce) = nqjibszvgh yowgkrwwnc (zprexjqjms )
Positive
23 Jun 2023
dxdzbtebau(ongtpwduce) = tmrxcwhazv yowgkrwwnc (zprexjqjms )
Phase 2
413
Placebo
(Placebo)
mucqoudtob(hvcpzeoufp) = sqxvhbwuoh opblsgequi (fjzwrgsnpe, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
mucqoudtob(hvcpzeoufp) = ugrbwaqdxs opblsgequi (fjzwrgsnpe, 0.71)
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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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