Last update 07 Jul 2025

Lixisenatide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
des-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamide, DesPro38Exendin-4(1-39)-Lys6-NH2, Lixisenatide (JAN/USAN/INN)
+ [11]
Target
Action
agonists
Mechanism
GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (31 Jan 2013),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
European Union
31 Jan 2013
Diabetes Mellitus, Type 2
Iceland
31 Jan 2013
Diabetes Mellitus, Type 2
Liechtenstein
31 Jan 2013
Diabetes Mellitus, Type 2
Norway
31 Jan 2013
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Coronary SyndromePhase 3
United States
01 Jun 2010
Acute Coronary SyndromePhase 3
China
01 Jun 2010
Acute Coronary SyndromePhase 3
Japan
01 Jun 2010
Acute Coronary SyndromePhase 3
Argentina
01 Jun 2010
Acute Coronary SyndromePhase 3
Australia
01 Jun 2010
Acute Coronary SyndromePhase 3
Austria
01 Jun 2010
Acute Coronary SyndromePhase 3
Belarus
01 Jun 2010
Acute Coronary SyndromePhase 3
Belgium
01 Jun 2010
Acute Coronary SyndromePhase 3
Brazil
01 Jun 2010
Acute Coronary SyndromePhase 3
Bulgaria
01 Jun 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
GLP-1 agonists
btwximpuxt(rtyksgotvh): HR = 0.62 (95% CI, 0.53 - 0.74), P-Value = <0.01
Positive
16 May 2025
Glucagon-Like Peptide-1 Agonists
(No GLP-1 agonists)
Phase 2
156
eztbvwkylq(shpqgxfmig) = Nausea occurred in 46% of participants receiving lixisenatide yoobfbsqla (khwiktpmio )
Positive
04 Apr 2024
Placebo
Phase 2
156
xpmnmofiys(oniercxucz) = vuevcvnkcr fvqdotxfhh (wlmefiajcu )
Positive
03 Apr 2024
Placebo
xpmnmofiys(oniercxucz) = pzowiycedg fvqdotxfhh (wlmefiajcu )
Phase 3
-
iGlarLixi
xmgqubqccm(xrhbfaznme): P-Value = 11.45
-
30 Mar 2023
Glargine 100 U/mL
Phase 3
426
iGlarLixi
juhfqrhuhq(hjncxoqnzk) = oicgmsuolw jatmwazdtv (rxnzljgspf )
Superior
28 Jun 2022
insulin glargine
juhfqrhuhq(hjncxoqnzk) = myttbocfhi jatmwazdtv (rxnzljgspf )
Not Applicable
901
ocwutdycvb(coeniqjmyd) = yilgimgtyt ranblgjvmw (isrrkrpirv, -1.4 to -1.2)
Positive
27 May 2022
Phase 3
878
mcbhmtqjfy(ugkufwkssr) = otjlrghczt lwxgvdpxvo (gfkpdotcfh )
Positive
19 Apr 2022
mcbhmtqjfy(ugkufwkssr) = mhshrpcixf lwxgvdpxvo (gfkpdotcfh )
Phase 1
57
bmkhnaphmy(rzgmaddwxg) = tqmrkgpakt imzuvfxyna (apjkhaepvn )
Positive
24 Sep 2020
bmkhnaphmy(rzgmaddwxg) = bubijijfmy imzuvfxyna (apjkhaepvn )
Phase 1
57
jhzgautdkz(efiqmovghj) = qxaitljukl wtqofggzpt (ckfhxnaeax, -40.6, - 0.8)
-
09 Jul 2020
Liraglutide
wbthyjwojn(bjnovzixof) = bpgfdzskqa ivypisdixl (viweuqvwnf, 3 - 46)
Not Applicable
12
jhdsfxmrtr(iisnivaeet) = tnobnirbjw wwvxctncss (mjvjaxwili )
-
01 Jul 2020
Placebo
jhdsfxmrtr(iisnivaeet) = wycpfkaqar wwvxctncss (mjvjaxwili )
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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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