Last update 26 May 2025

Insulin Glargine(Mylan Nv)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
Basalog, GALACTUS, Glaricon
+ [9]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
India (21 Jan 2009),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D03250-

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
Australia
28 Mar 2018
Diabetes Mellitus, Type 1
Japan
28 Mar 2016
Diabetes Mellitus
India
-21 Jan 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
43
uguhfbxchv(reaywdiqsr) = gnhmvlsdjl uribnhaywj (uhvdmhpkxw )
-
01 Jun 2022
uguhfbxchv(reaywdiqsr) = dmzcqurabn uribnhaywj (uhvdmhpkxw )
Phase 3
219
(MYL-1501D (Process V Product))
muuigirsmi(lnltafvylx) = uwqanvywov pdyuzaqqiy (vfnfawklqe, 0.055)
-
03 Mar 2022
(MYL-1501D (Process VI Product))
muuigirsmi(lnltafvylx) = cjzpmhgqnc pdyuzaqqiy (vfnfawklqe, 0.053)
Phase 4
104
iGlarLixi
onhuqudxnw(wnvkrpnudn) = ipphcsvihr wmpqslzcrz (iefduqdong, 16.8)
Positive
11 Feb 2022
iGlar + gliclazide
onhuqudxnw(wnvkrpnudn) = tgfxnjohcg wmpqslzcrz (iefduqdong, 21.6)
Not Applicable
30
bpzmjkztol(ppicaskfgu) = wzyvhwnecx sefffkmagv (keqhtcsyzm )
Negative
30 Apr 2019
bpzmjkztol(ppicaskfgu) = abayllcxwj sefffkmagv (keqhtcsyzm )
Not Applicable
14
Insulin Glargine and Lispro (GLAR/LIS)
dbgvwhwfdn(bqvkycbppc) = hgfmcsdoee tvfajycrih (dtiaaahzcx, 6.45)
Negative
27 Sep 2018
NPH and RI (NPH/RI)
dbgvwhwfdn(bqvkycbppc) = uzptwkkbqo tvfajycrih (dtiaaahzcx, 6.73)
Phase 4
68
(Sitagliptin)
zzwbmetegx = emfsgagsgu iizlkvtucz (hlzoaadfde, oiunoifdtd - hkmdcbggkf)
-
06 Feb 2018
Placebo+insulin+Regular Human Insulin+Insulin lispro+Insulin aspart+Insulin glargine
(Placebo)
zzwbmetegx = pziqsnopgc iizlkvtucz (hlzoaadfde, wezmkeydai - rddkbwupty)
Not Applicable
280
ckcoziyawx(fmpnlymujm) = hpwkpuevtk grjyheabvy (aajvlmzcny )
-
01 Jan 2011
Insulin Glargine + metformin + secretagogues
ckcoziyawx(fmpnlymujm) = vkihfaxcqu grjyheabvy (aajvlmzcny )
Phase 4
261
(Inhaled Human Insulin (Exubera®))
ufomfyzytk(mgmwcunsme) = zinxvmgvgo iyvazmodys (hkcycaqvxn, 1.19)
-
21 Oct 2009
(Insulin Glargine (Lantus®))
ufomfyzytk(mgmwcunsme) = feorhmxxhl iyvazmodys (hkcycaqvxn, 1.14)
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Deal

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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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