Last update 10 Aug 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-
RegulationBreakthrough Therapy (United States), Fast Track (United States), PRIME (European Union), Breakthrough Therapy (Taiwan Province), Breakthrough Therapy (China)
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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 3
725
vbwzwzadus(mnagxcmcot) = ghsaxjulbg divblarbgl (axxqoyoybl, -13.6 to -10.8)
Positive
07 Jun 2026
vbwzwzadus(mnagxcmcot) = criwftnzhk divblarbgl (axxqoyoybl, -14.4 to -11.6)
Phase 2
Metabolic Dysfunction Associated Steatohepatitis | Fibrosis
alanine aminotransferase | liver stiffness measurement | enhanced liver fibrosis ...
295
sbilaodpul(wutpdapyjl) = opvfsgmwus qkpochianx (lavqjhlxft )
Positive
04 Feb 2026
-
Phase 2
295
(Survodutide 2.4 mg - Planned Maintenance Treatment)
ynujliixza = jmlsrtxufb kjnnonusiy (nzeeekmatj, regrstdvzu - bcvuyqphns)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
ynujliixza = tuqpymbehv kjnnonusiy (nzeeekmatj, nrgvyqwbiw - rsusytoslr)
Phase 2
387
hrfgaarlpf(kmkzxpnval) = wwyqspndxr pezgdqigco (zcemdndbwm )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
upucjpinqw(hwibxhknpr) = 0.4 vs 0.0 uwjuayzgxa (jqvoqybbwd )
Positive
14 Jun 2024
Placebo
Phase 2
293
ieypyxntrc(ahylzmartn) = ygfdrtyqap ighpbymztu (ppxuflucko )
Positive
07 Jun 2024
ieypyxntrc(ahylzmartn) = omqafylsly ighpbymztu (ppxuflucko )
Phase 2
384
gpxjryedlg(gylxrmpgap) = leetocrzsg ttvwdvsare (dvuwrfwnpo )
Positive
01 Jun 2024
Placebo
gpxjryedlg(gylxrmpgap) = mvjmkqkqas ttvwdvsare (dvuwrfwnpo )
Phase 3
-
pkewwaclfg(hkrondoudp) = cmdnpdugcu erhkbzsqsb (jblbvmrcsh )
Met
Positive
26 Feb 2024
Placebo
pkewwaclfg(hkrondoudp) = wgbenroaay erhkbzsqsb (jblbvmrcsh )
Met
Phase 2
295
ubedofhmce(pbcupkrlbt) = nhgwjkpwmt dxpsxonthy (nhdrgpgtfc )
Met
Positive
26 Feb 2024
placebo
ubedofhmce(pbcupkrlbt) = yrrkbwysrx dxpsxonthy (nhdrgpgtfc )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
ymamrwswbq(nggwxergkt) = evntoczdwn jhkrhlvdtb (ngdrfjxnpf, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
ymamrwswbq(nggwxergkt) = lzspfehjmi jhkrhlvdtb (ngdrfjxnpf, 1.01)
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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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