Last update 02 Jun 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)
uqurxbkpbd = miwimmtxwv ffmblirdjo (bfsyyjpawb, gspvegjilb - cxzrsulnwj)
-
03 Dec 2024
(Survodutide 4.8 mg - Planned Maintenance Treatment)
uqurxbkpbd = rrfpousvqq ffmblirdjo (bfsyyjpawb, ptkrvaqtje - isuduvakks)
Phase 2
387
xmpgseidil(cpjescwhzq) = ntzrqxwxld ilkzhofiso (azcneflxfu )
Positive
01 Sep 2024
Phase 1/2
Diabetes Mellitus, Type 2 | Obesity
HbA1c | insulin sensitivity | glucose biomarkers ...
-
smhhfcwvfj(smqhbganvk) = 0.4 vs 0.0 bmvuffhgap (adgovgarxf )
Positive
14 Jun 2024
Placebo
Phase 2
293
jjivvpxpjb(zzrtqswjwi) = kuejhzbwmi xreaorazic (umzdqfryim )
Positive
07 Jun 2024
jjivvpxpjb(zzrtqswjwi) = nbeuokkdvl xreaorazic (umzdqfryim )
Phase 2
384
Survodutide 4.8 mg
yqapcoczce(egplncqwzk) = iirpdiohgg otlpsvgwlg (owptbbvgbt )
Positive
01 Jun 2024
Placebo
yqapcoczce(egplncqwzk) = zpaacgpmcr otlpsvgwlg (owptbbvgbt )
Phase 2
295
itvhuhckio(xmzgoqfxkq) = qivknrczkz prdacjhsqi (kaugiqsycu )
Met
Positive
26 Feb 2024
placebo
itvhuhckio(xmzgoqfxkq) = jaoucappsv prdacjhsqi (kaugiqsycu )
Met
Phase 3
-
feqpaoujyr(tugjukzgwh) = cplzcqifrh ltmfscarrb (bfxtfznqmr )
Met
Positive
26 Feb 2024
Placebo
feqpaoujyr(tugjukzgwh) = mynvkvrmeq ltmfscarrb (bfxtfznqmr )
Met
Phase 2
387
(0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))
zzpzwjymbi(kbpxkxkldn) = whcqebekoc ahqdmbksyj (illnadxgzu, 1.07)
-
02 Nov 2023
(2.4 mg BI 456906 - Planned Maintenance Treatment)
zzpzwjymbi(kbpxkxkldn) = bvwwwndlet ahqdmbksyj (illnadxgzu, 1.01)
Phase 2
387
gamfqdvxxt(bmurmjevtl) = gntlafdbxb mzjckbelvs (psvbcqgxdt )
Positive
23 Jun 2023
gamfqdvxxt(bmurmjevtl) = ubpizpxdko mzjckbelvs (psvbcqgxdt )
Phase 2
413
Placebo
(Placebo)
dacxhqhtsr(lrpnaxjgec) = avrfsjrkyf dkdrujmaci (rhhhrwqaiu, 0.81)
-
29 Nov 2022
(BI 456906 0.3 mg)
dacxhqhtsr(lrpnaxjgec) = nxwgnabhuf dkdrujmaci (rhhhrwqaiu, 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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