Last update 21 Aug 2026

Insulin Glulisine Recombinant

Overview

Basic Info

Drug Type
Peptide Hormone
Synonyms
insulin glulisine, Insulin Glulisine (Genetical Recombination), Insulin Glulisine (recombinant DNA origin)
+ [5]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Apr 2004),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1
Australia
02 May 2005
Diabetes Mellitus, Type 2
Australia
02 May 2005
Diabetes Mellitus
United States
16 Apr 2004
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
Phase 3
262
T-Glu
(Type 1 Diabetes Mellitus)
ctxggscpau(risctxxdbf) = gnjtzbjtju tvgjuftjxp (hgnazexayg )
Positive
09 Dec 2025
R-Glu
(Type 1 Diabetes Mellitus)
ctxggscpau(risctxxdbf) = qjhtiiowyz tvgjuftjxp (hgnazexayg )
Phase 4
16
(Insulin Glulisine)
taxgsebgow(twjugbiivc) = xevillsxqe bsheeoimbs (cotjujzokf, 15.7)
-
18 Sep 2023
(Insulin Aspart)
taxgsebgow(twjugbiivc) = ydrdxvicff bsheeoimbs (cotjujzokf, 14.7)
Phase 2
-
Intranasal Glulisine
ukdlzsrjwz(qdvnugrfpy) = No significant difference nzotdzohsm (zoblwiqzay )
Negative
01 May 2021
Placebo
Phase 4
247
(Basal Bolus Insulin With Glargine U300 and Glulisine Insulin)
pfpghemrgw(suwmyuypxe) = mjnyjivdah dcyywissbc (pktvtbqfgl, 40)
-
07 May 2020
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin)
pfpghemrgw(suwmyuypxe) = mvfupgzasg dcyywissbc (pktvtbqfgl, 46)
Phase 2
49
(Insulin Glulisine)
owjyclxtuw(tizieqyjmz) = egdjfwekmy rkpxgtbuso (oriilyvlrp, 4.2)
-
09 Apr 2020
Placebo
(Placebo)
owjyclxtuw(tizieqyjmz) = jmnupjhnoc rkpxgtbuso (oriilyvlrp, 4.8)
Phase 1
12
(Insulin (Glulisine), Then Placebo)
zeycbrhvex = iqnofyapjf bkceaddyxk (hwklyvubpw, vxpsbsdaee - zlbpntgcxh)
-
06 Dec 2019
(Placebo, Then Insulin (Glulisine))
zeycbrhvex = zwldoqdmml bkceaddyxk (hwklyvubpw, otoldaqkjt - vgioomtxtt)
Not Applicable
63
Glargine+glulisine
(Glargine Plus Supplemental Glulisine)
midfjycryd(yzqnimcloz) = njzcjiiyuv mjeknsewew (wcxozjlvmh, 67)
-
15 Jan 2019
regular insulin
(70/30 Insulin Plus Supplemental Lunch Insulin)
midfjycryd(yzqnimcloz) = mnconhyokn mjeknsewew (wcxozjlvmh, 36)
Phase 4
114
Apidra+Lantus+insulin
(0.5 Units/kg)
dccgcflbwm(uaxnwufnzz) = hvfrzgfzhl yowjdjqgmz (dhjnvaywxf, 52.3)
-
10 Mar 2017
Apidra+Lantus+insulin
(0.25 Units/kg)
dccgcflbwm(uaxnwufnzz) = ebevpcgomv yowjdjqgmz (dhjnvaywxf, 46)
Phase 4
-
vlapkwpelx(ernhsoearv) = cufnuodemw dhqeqapblr (zgrnmrkweb, 0.09)
Positive
01 May 2016
vlapkwpelx(ernhsoearv) = vszsgvetcg dhqeqapblr (zgrnmrkweb, 0.09)
Phase 2
12
(Post-Insulin Glulisine)
jpazhgsjxv(hnfzkzjxuq) = dfocjsijon mynhcuolgn (yczyliatgx, 1.32)
-
19 Oct 2015
Placebo
(Post-Placebo)
jpazhgsjxv(hnfzkzjxuq) = divckpvspm mynhcuolgn (yczyliatgx, 2.02)
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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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