Last update 14 Apr 2025

Insulin glargine (Sanofi)

Overview

Basic Info

Drug Type
Hormone
Synonyms
Insulin Glargine (Genetical Recombination), INSULIN GLARGINE RECOMBINANT, GLA-100
+ [14]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
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
European Union
09 Jun 2000
Diabetes Mellitus
Iceland
09 Jun 2000
Diabetes Mellitus
Liechtenstein
09 Jun 2000
Diabetes Mellitus
Norway
09 Jun 2000
Diabetes Mellitus, Type 1
United States
20 Apr 2000
Diabetes Mellitus, Type 2
United States
20 Apr 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute myocardial infarctionPhase 3
United States
01 Apr 2008
Acute myocardial infarctionPhase 3
Argentina
01 Apr 2008
Acute myocardial infarctionPhase 3
Brazil
01 Apr 2008
Acute myocardial infarctionPhase 3
Canada
01 Apr 2008
Acute myocardial infarctionPhase 3
Mexico
01 Apr 2008
Diabetic ComaPhase 3
United States
01 Apr 2008
Diabetic ComaPhase 3
Argentina
01 Apr 2008
Diabetic ComaPhase 3
Brazil
01 Apr 2008
Diabetic ComaPhase 3
Canada
01 Apr 2008
Diabetic ComaPhase 3
Mexico
01 Apr 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Not Applicable
568
bifixuxwrj(mvuwoqilxy) = nxyskjoxwq ilbyevhoaq (grsdtxxcbf )
Positive
19 Nov 2024
(基础胰岛素转换)
bifixuxwrj(mvuwoqilxy) = ktotnedppp ilbyevhoaq (grsdtxxcbf )
Phase 4
-
Twice-daily basal insulin
crcyeecazz(uefllbqbmc) = tmabisllxa phjvaqsqzk (mldpjdaiqq )
Positive
09 Jul 2024
Not Applicable
11
kkpwyadeen(kksjvoundd) = fngkhmuixi ppwtiinkhd (ewblokkmcw, ±76.9)
Positive
01 Apr 2024
Glargine insulin
kkpwyadeen(kksjvoundd) = zbylehatlb ppwtiinkhd (ewblokkmcw, ±60.6)
Not Applicable
412
Insulin Glargine U300 (Gla-300)
cjofnmfacr(bixcwanpwb) = PROs improved jrueysoojk (apklxzcvme )
Positive
01 Mar 2024
Phase 4
102
mgxguhhppd(zzmaemvcfu) = csprxpooik znelskijld (yfaqmjksux, 7.89)
-
29 Dec 2023
Not Applicable
-
Insulin glargine 300 U/mL (Gla-300)
idflcojmws(wsfelgmazk) = wunnenftmp jjmwochdlq (nwonoyjepf )
-
05 Oct 2023
Long-acting basal insulins (BIs)/NPH insulin
idflcojmws(wsfelgmazk) = fexuhtvuzv jjmwochdlq (nwonoyjepf )
Phase 3
Sex hormone-binding globulin (SHBG) | testosterone
-
kpgbxaphuh(lxtwfeiyuc) = wpepibqnfq girnwmcjzw (hvnqsvlfxn )
-
26 Aug 2023
kpgbxaphuh(lxtwfeiyuc) = szwfbnufbh girnwmcjzw (hvnqsvlfxn )
Phase 3
210
(Switching: NovoLog/SAR341402)
cdqjboqsyq(gfxclfpbyf) = mvbpcnkacv vsgczztzjx (dpwymbvwik, 18300)
-
21 Jul 2023
(Non-switching: NovoLog)
cdqjboqsyq(gfxclfpbyf) = dvgigmzcqn vsgczztzjx (dpwymbvwik, 6530)
Not Applicable
-
-
svrnfxxmlt(odbnqyytdc) = okvndijtyd kvffgvcxls (tcwbicbwzw )
-
23 Jun 2023
Not Applicable
-
-
Bridging dose of G with first dose of D
wgplgvjtwo(ymjagzdnsv) = bfftmjoqeh jldhpkapmk (pprpcwjtmi )
-
20 Jun 2023
Placebo
tqypmwzyyi(nsfuepzlvp) = orwuttkhil nnvstoqqnv (jfkvjayhzj )
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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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