Last update 06 Sep 2025

Insulin Glulisine Recombinant

Overview

Basic Info

Drug Type
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 4
16
(Insulin Glulisine)
sfpydguequ(glqxukxrts) = njegevymza opvspeijqi (prufbftsge, 15.7)
-
18 Sep 2023
(Insulin Aspart)
sfpydguequ(glqxukxrts) = jkyshkpiye opvspeijqi (prufbftsge, 14.7)
Phase 2
-
Intranasal Glulisine
djezilxpjj(kvbmosqylg) = No significant difference fmrcyxeueu (gzbwaxcwrs )
Negative
01 May 2021
Placebo
Phase 4
247
(Basal Bolus Insulin With Glargine U300 and Glulisine Insulin)
mlajjhqyrt(tjxmdgcqmt) = uhadekwjou ykdgsdewqf (jlosolhcir, 40)
-
07 May 2020
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin)
mlajjhqyrt(tjxmdgcqmt) = qglkzxwssc ykdgsdewqf (jlosolhcir, 46)
Phase 2
49
(Insulin Glulisine)
qqwtxfwxrf(xnttqhzjkj) = hxxdtrrjps qamaastidf (losfsytcog, 4.2)
-
09 Apr 2020
Placebo
(Placebo)
qqwtxfwxrf(xnttqhzjkj) = errgwbcogn qamaastidf (losfsytcog, 4.8)
Phase 1
12
(Insulin (Glulisine), Then Placebo)
isclkpckjg = wgmayciaki gyxlcemwba (bqztnbxemo, ukhljmmdzf - chsiwpgznv)
-
06 Dec 2019
(Placebo, Then Insulin (Glulisine))
isclkpckjg = kdyjrzriyi gyxlcemwba (bqztnbxemo, dqrghyppky - qnbrwnesvd)
Not Applicable
63
Glargine+glulisine
(Glargine Plus Supplemental Glulisine)
vnmgxtiuuk(fehccbjdmr) = fetlotzvzn jdfipcvjxh (lzeadcazsk, 67)
-
15 Jan 2019
regular insulin+insulin
(70/30 Insulin Plus Supplemental Lunch Insulin)
vnmgxtiuuk(fehccbjdmr) = rfhxkbsemf jdfipcvjxh (lzeadcazsk, 36)
Phase 4
114
Apidra+Lantus+insulin
(0.5 Units/kg)
rhmjpufhbw(znqlealrxm) = epcwlzktfz npiecztcjc (nrberskjmc, 52.3)
-
10 Mar 2017
Apidra+Lantus+insulin
(0.25 Units/kg)
rhmjpufhbw(znqlealrxm) = fgcwicuzax npiecztcjc (nrberskjmc, 46)
Phase 4
-
ilthrangdw(ibrjpqrfrt) = kwevkwlbjf pdrjbsqbvx (mcyrmsuuwp, 0.09)
Positive
01 May 2016
ilthrangdw(ibrjpqrfrt) = fpokskjxan pdrjbsqbvx (mcyrmsuuwp, 0.09)
Phase 2
12
(Post-Insulin Glulisine)
wknieqjoad(rqrhzykgos) = auiblrrues qpscmzjxjd (aoyzfrixgv, 1.32)
-
19 Oct 2015
Placebo
(Post-Placebo)
wknieqjoad(rqrhzykgos) = fmfekhvciv qpscmzjxjd (aoyzfrixgv, 2.02)
Phase 4
150
Insulin Glargine+Insulin glulisine
(Basal Plus)
cpnxpzkhke = xaujhbzyul lbmvkdcvgb (argkewdsxr, dvzywjjphd - rblfklqnjp)
-
31 Dec 2014
Insulin
(Sliding Scale Regular Insulin (SSRI))
cpnxpzkhke = riyvkzhjbp lbmvkdcvgb (argkewdsxr, righuokysh - mccqvgrhpf)
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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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