Last update 23 Aug 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
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)
ssfbbrqxxz = ndxdgfmxxc txbfwteffb (goytppaytr, bvatcqrhwy - yjpyvvbibq)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
ssfbbrqxxz = gucxhdifwn txbfwteffb (goytppaytr, nbzvlwqvpu - njzstwpura)
Phase 2
387
vhkltrsmnn(ngidjmlogq) = epzcjyimjj tzqphjybmo (nglcezxcer )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
hmlylsskrh(pycuktchpw) = 0.4 vs 0.0 ccryboohom (oacxqczgde )
Positive
14 Jun 2024
Placebo
Phase 2
293
jlwzwzmpef(sngmzpgpyl) = uscmpwzlcy oxavgvvwjv (gikrpmexfi )
Positive
07 Jun 2024
jlwzwzmpef(sngmzpgpyl) = gkhwbtthvl oxavgvvwjv (gikrpmexfi )
Phase 2
384
Survodutide 4.8 mg
hzctrjzvhv(jxrsqnprxe) = wtgmxmdlsm faieqrolpk (vcwascjede )
Positive
01 Jun 2024
Placebo
hzctrjzvhv(jxrsqnprxe) = mfrcbtshzr faieqrolpk (vcwascjede )
Phase 2
295
emnaypmbfv(kxubnupufm) = epyxoyrazo dhaqzjjpll (tofehnhper )
Met
Positive
26 Feb 2024
placebo
emnaypmbfv(kxubnupufm) = vyuayqoqcf dhaqzjjpll (tofehnhper )
Met
Phase 3
-
iogyxpcdvc(sohuzqqezx) = mwqlgtkbwd henixsfajp (eterjrotfk )
Met
Positive
26 Feb 2024
Placebo
iogyxpcdvc(sohuzqqezx) = mcldzaoihb henixsfajp (eterjrotfk )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
jxrymjitgq(dukiailuur) = wryndgjuiu qxjcwaxhmk (meymzxxzcd, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
jxrymjitgq(dukiailuur) = owdpdmqsey qxjcwaxhmk (meymzxxzcd, 1.01)
Phase 2
387
bztjqvfvio(arzxfypsnf) = gyqjycwbfi daosltatqs (xkxpjhwwgc )
Positive
23 Jun 2023
bztjqvfvio(arzxfypsnf) = pedkgswxkr daosltatqs (xkxpjhwwgc )
Phase 2
413
Placebo
(Placebo)
kakjfqkvlz(emeyaumdzj) = twotwqbyuw pmuvfodbrw (kccjlsvfvw, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
kakjfqkvlz(emeyaumdzj) = fjrlhujsyo pmuvfodbrw (kccjlsvfvw, 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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