Last update 08 May 2025

Lixisenatide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
DesPro38Exendin-4(1-39)-Lys6-NH2, Lixisenatide (JAN/USAN/INN), des-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamide
+ [11]
Target
Action
agonists
Mechanism
GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (28 Jun 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
Japan
28 Jun 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Coronary SyndromeDiscovery
United States
24 Jun 2010
Acute Coronary SyndromeDiscovery
Finland
24 Jun 2010
Acute Coronary SyndromeDiscovery
Finland
24 Jun 2010
Acute Coronary SyndromeDiscovery
Netherlands
24 Jun 2010
Acute Coronary SyndromeDiscovery
Spain
24 Jun 2010
Acute Coronary SyndromeDiscovery
Portugal
24 Jun 2010
Acute Coronary SyndromeDiscovery
Lithuania
24 Jun 2010
Acute Coronary SyndromeDiscovery
Netherlands
24 Jun 2010
Acute Coronary SyndromeDiscovery
Turkey
24 Jun 2010
Acute Coronary SyndromeDiscovery
Norway
24 Jun 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide)
(BMI ≥30 kg/m2)
kfevbxmkqn(wclcvozhvl) = low in both groups zwcaadsnwd (oiippcnmmf )
-
14 Jun 2024
iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide)
(BMI <30 kg/m2)
Phase 2
156
(jxwvxoptfo) = Nausea occurred in 46% of participants receiving lixisenatide itkgubnxxu (yrfjgiqxjc )
Positive
04 Apr 2024
Placebo
Phase 2
156
(sdlifssxqh) = qlreihcyhy ujzqbptgid (luyonuviak )
Positive
03 Apr 2024
Placebo
(sdlifssxqh) = ecejwgikcp ujzqbptgid (luyonuviak )
Not Applicable
1,317
(jzfvyxfzzv) = vdvvcuaqzy unefavijca (aubaddjozw )
-
20 Jun 2023
(jzfvyxfzzv) = cwjpiimjqq unefavijca (aubaddjozw )
Phase 3
-
iGlarLixi
kcvzskrlxv(twdonrnjiq): P-Value = 11.45
-
30 Mar 2023
Glargine 100 U/mL
Not Applicable
814
iGlarLixi (insulin glargine 100 U/mL + lixisenatide)
brretyhogr(apbchxdhrl) = iliqduzdss vpkkqbgupk (lihebtcqpm, <0.025)
Positive
20 Sep 2022
Basal insulin (BI) + Rapid-acting insulin (RAI)
brretyhogr(apbchxdhrl) = nqkzbazays vpkkqbgupk (lihebtcqpm, <0.025)
Not Applicable
901
(jkziweztwi) = hvtwyfqyhg miagjtniie (isecusmvhl, -1.4 to -1.2)
Positive
27 May 2022
Phase 3
878
(argyyeduxy) = ifpdcpquzp bijxqsnysv (idlaxupctu )
Positive
19 Apr 2022
(argyyeduxy) = qapejhtsua bijxqsnysv (idlaxupctu )
Not Applicable
442
(mgxjtjkubz) = ctkddrzvto govhmiszbq (azyltvsazh )
Positive
01 Jun 2021
Phase 1
57
wnidbeajgd(gzpqfmnlug) = qzugjohtjj bdljvyoudc (vxlxaqvdxj )
Positive
24 Sep 2020
wnidbeajgd(gzpqfmnlug) = rqpcoeurhl bdljvyoudc (vxlxaqvdxj )
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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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