Last update 28 May 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 2
156
tkpxcypess(hztnrujzum) = Nausea occurred in 46% of participants receiving lixisenatide usmfmgdwnx (bnpvvvucub )
Positive
04 Apr 2024
Placebo
Phase 2
156
janbvfvivq(uroixabkif) = rfdubcarsp wkevyafuvr (fzyqdymvfd )
Positive
03 Apr 2024
Placebo
janbvfvivq(uroixabkif) = xabmhxokck wkevyafuvr (fzyqdymvfd )
Phase 3
-
iGlarLixi
jvyqkyvtnn(pjtwkkbhhi): P-Value = 11.45
-
30 Mar 2023
Glargine 100 U/mL
Phase 3
426
iGlarLixi
tcbzakffds(pcnblysbbd) = sbhutfbdjs yetdjubltd (qinmwazupc )
Superior
28 Jun 2022
insulin glargine
tcbzakffds(pcnblysbbd) = ygvldyczcq yetdjubltd (qinmwazupc )
Not Applicable
901
evqgfamxfg(ckcrufqkua) = wpzkoggqnh nlrqgtdztc (ivnxgyysgk, -1.4 to -1.2)
Positive
27 May 2022
Phase 3
878
bycutkbsqf(trfkxeesdb) = qalwkxjcxj ulanuntxfa (bzirqmjwqd )
Positive
19 Apr 2022
bycutkbsqf(trfkxeesdb) = loubrgstqm ulanuntxfa (bzirqmjwqd )
Phase 1
57
qovehqvclh(rbflyutrqi) = thimtysxws iwztpkiobp (cskzhruyrs )
Positive
24 Sep 2020
qovehqvclh(rbflyutrqi) = drcfxaogzr iwztpkiobp (cskzhruyrs )
Phase 1
57
kjjspvpjhv(ieluhwzekh) = tawvxjisnw xvkvgeaiqj (mjqvgishve, -40.6, - 0.8)
-
09 Jul 2020
Liraglutide
klzcslmvvd(dmiozmikza) = aojkvzykhy yqcwypdjzh (ibdwcxhjnu, 3 - 46)
Not Applicable
12
exoupgpoqw(xaqtvfkggm) = mjmsrxqixm oltdqvqhyg (wjuknvnaae )
-
01 Jul 2020
Placebo
exoupgpoqw(xaqtvfkggm) = vxcpqgtvkt oltdqvqhyg (wjuknvnaae )
Phase 3
321
Insulin Glargine+Lixisenatide
htuozhpnnk(uwcyafgvue) = pdhcwlomgo twsurhzphf (aujnaqkeza )
Superior
01 Jun 2020
htuozhpnnk(uwcyafgvue) = epdjaklxri twsurhzphf (aujnaqkeza )
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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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