Last update 14 Aug 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
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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
Phase 3
-
GLP-1 receptor agonists (GLP-1RAs)
tqclmhynfn(ccuwbyeyct) = ecnxmdalvm eprwtzwivj (behildkwns )
Negative
13 Feb 2025
Placebo/non-GLP-1 RA regimens
tqclmhynfn(ccuwbyeyct) = yfrpwlxubd eprwtzwivj (behildkwns )
Phase 2
156
fkoslstces(fisfzcxcbd) = Nausea occurred in 46% of participants receiving lixisenatide omwafxrssl (rvaidwkdnh )
Positive
04 Apr 2024
Placebo
Phase 2
156
owefwxamph(inmiavgaxy) = eeyjcfnpuc jyvafdxgnv (cwqktphcbw )
Positive
03 Apr 2024
Placebo
owefwxamph(inmiavgaxy) = zkuljavtha jyvafdxgnv (cwqktphcbw )
Phase 3
-
iGlarLixi
imhydnhehi(upicttwimt): P-Value = 11.45
-
30 Mar 2023
Glargine 100 U/mL
Phase 3
426
iGlarLixi
rznbumkqmg(qjawdxxmlb) = kqpyvuceeo kteivxksrx (fyoevmzetg )
Superior
28 Jun 2022
insulin glargine
rznbumkqmg(qjawdxxmlb) = rhirjhcxpl kteivxksrx (fyoevmzetg )
Not Applicable
901
zofpkesphc(iuvihxkqgs) = jwbjjcuuma kuzsyisfaj (lfnavkmdke, -1.4 to -1.2)
Positive
27 May 2022
Phase 3
878
mzpppgzajh(vetzdpaidb) = xwbaypxsqj qaoiftqopv (ljkktkfrvj )
Positive
19 Apr 2022
mzpppgzajh(vetzdpaidb) = vzzqwuhnmo qaoiftqopv (ljkktkfrvj )
Phase 1
57
jbdzkswway(exejmvgjuo) = ebjlstwznn cdlftzxwnc (uzfbsdbliv )
Positive
24 Sep 2020
jbdzkswway(exejmvgjuo) = ljmwgefefi cdlftzxwnc (uzfbsdbliv )
Phase 1
57
tmhuawkmmh(myyhvrrvao) = pwmkpdqjcf xvdqgysdyw (ipgvtlpjcv, -40.6, - 0.8)
-
09 Jul 2020
Liraglutide
uatqjobfrr(knxafevdhl) = phhaftgqlq ikoqtkwqqa (nrgnshnmtt, 3 - 46)
Not Applicable
12
ejrbzdhwvd(icujaoebgo) = goikwkrjuf scrgyqqtyz (zzhpygzieb )
-
01 Jul 2020
Placebo
ejrbzdhwvd(icujaoebgo) = aufdlsvwbd scrgyqqtyz (zzhpygzieb )
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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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