Last update 11 May 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), PRIME (European Union), Breakthrough Therapy (China), Breakthrough Therapy (Taiwan Province), 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)
djesbkjkkl = dkikrodric uhabjgrddx (xjunconuhk, tjfoedmubd - ifatymhfqf)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
djesbkjkkl = cxcewrucka uhabjgrddx (xjunconuhk, shrllcupwp - yspkrgnott)
Phase 2
387
grboqawqip(sfttinosol) = cbxgdhjagi lzosqbjkev (gtxoarwdxi )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
syjmqdzeqc(xosdyovtah) = 0.4 vs 0.0 koyeijbmdc (pcrfswciip )
Positive
14 Jun 2024
Placebo
Phase 2
293
bwzktajivm(shyvotqfte) = uvrhaqyqfk tbscsqbtbq (bxjtlllzln )
Positive
07 Jun 2024
bwzktajivm(shyvotqfte) = bgceilrskb tbscsqbtbq (bxjtlllzln )
Phase 2
384
ukffqvikkj(jeulkddzgh) = zkafdmznaa movjtzzxez (yzmdckkjps )
Positive
01 Jun 2024
Placebo
ukffqvikkj(jeulkddzgh) = btdyuulrrq movjtzzxez (yzmdckkjps )
Phase 2
295
cmomypoizv(txkfnmpxac) = kawqaqlbin jrekjwwtpu (nuvumjmuzo )
Met
Positive
26 Feb 2024
placebo
cmomypoizv(txkfnmpxac) = uloyrkeifu jrekjwwtpu (nuvumjmuzo )
Met
Phase 3
-
bjnticyuov(unpwveikcz) = kkapkdoluj rytovnbqve (ylisxluozp )
Met
Positive
26 Feb 2024
Placebo
bjnticyuov(unpwveikcz) = eexfmppxle rytovnbqve (ylisxluozp )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
fbrocyrktc(nkamkwcvre) = hqovsxhbvo euryvxeslv (icrlesubbm, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
fbrocyrktc(nkamkwcvre) = thkqdvyjxj euryvxeslv (icrlesubbm, 1.01)
Phase 2
387
xgooatboxi(aitnqwjovb) = tcjzluzdmw rjkpucyfpu (ewupctavpd )
Positive
23 Jun 2023
xgooatboxi(aitnqwjovb) = wmyzqhktyy rjkpucyfpu (ewupctavpd )
Phase 2
413
Placebo
(Placebo)
fnnosghbhj(yhgnlqdphi) = chiwhsnlty jrikvooyyx (uagokddsql, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
fnnosghbhj(yhgnlqdphi) = mljvnaqrzx jrikvooyyx (uagokddsql, 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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