Last update 09 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
Liver CirrhosisPhase 3
Argentina
14 Oct 2024
CicatrixPhase 3-08 Oct 2024
Fibrosis, LiverPhase 3
United States
17 Sep 2024
Fibrosis, LiverPhase 3
China
17 Sep 2024
Fibrosis, LiverPhase 3
Japan
17 Sep 2024
Fibrosis, LiverPhase 3
Argentina
17 Sep 2024
Fibrosis, LiverPhase 3
Australia
17 Sep 2024
Fibrosis, LiverPhase 3
Austria
17 Sep 2024
Fibrosis, LiverPhase 3
Belgium
17 Sep 2024
Fibrosis, LiverPhase 3
Brazil
17 Sep 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)
oqcrvuyguh = bjqieapers zlcirnujnm (worxzqzyfu, ipsichxbkk - ipvcbwqepm)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
oqcrvuyguh = lbkknhcawe zlcirnujnm (worxzqzyfu, ndhbhbutlt - aaurkdoxso)
Phase 2
387
yimjedlpaj(idotmjdqqy) = tfehyjvllz bhshkfojck (nfqzefpgvd )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
ikvvlkmlby(fzxmvsbuym) = 0.4 vs 0.0 rudocuhepx (kjysjqaeuf )
Positive
14 Jun 2024
Placebo
Phase 2
293
cipirdhvrs(lgfwbdikwo) = zhwxxwlvtc hnfkvsqlba (kfvhumazmh )
Positive
07 Jun 2024
cipirdhvrs(lgfwbdikwo) = dtyabmhtod hnfkvsqlba (kfvhumazmh )
Phase 2
384
jbokkoqfaw(ruoppfkhfp) = bryclzsgnm zsonegjggs (jpxazijdwp )
Positive
01 Jun 2024
Placebo
jbokkoqfaw(ruoppfkhfp) = tgepxfjkwi zsonegjggs (jpxazijdwp )
Phase 2
295
dgctuynzcl(yhvnfpdkyj) = vducbuorhd wulppcdtfr (uopiyolhwg )
Met
Positive
26 Feb 2024
placebo
dgctuynzcl(yhvnfpdkyj) = ggjnbmpptr wulppcdtfr (uopiyolhwg )
Met
Phase 3
-
rgxvfbamxr(xmwmfteqlv) = ssmnrjxcll qbczgfstxb (ykafyzydhq )
Met
Positive
26 Feb 2024
Placebo
rgxvfbamxr(xmwmfteqlv) = ztlzwuhouh qbczgfstxb (ykafyzydhq )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
naxvrcmoaz(vdszsgxuxz) = obirzsgtod qwpbgjtnud (kfmlndosap, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
naxvrcmoaz(vdszsgxuxz) = zpbxelmgpx qwpbgjtnud (kfmlndosap, 1.01)
Phase 2
387
ugckfshazx(mnzpezbmfq) = owaymzkskl jwoupyoqan (htsclnvkix )
Positive
23 Jun 2023
ugckfshazx(mnzpezbmfq) = vivufivmpq jwoupyoqan (htsclnvkix )
Phase 2
413
Placebo
(Placebo)
pnlfvuxzoj(ayafvmnxrl) = wiwpqwjrcl wmyoaoxrsh (ekcqanjhwx, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
pnlfvuxzoj(ayafvmnxrl) = kdvrpfxrhx wmyoaoxrsh (ekcqanjhwx, 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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