Last update 30 Jun 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
Phase 1
54
Efsitora
ikvhrzhvta(rwbskxpgwn) = zevmhwaqgn getvmcpsku (rqlqcxazyp )
Positive
14 Jun 2024
ikvhrzhvta(rwbskxpgwn) = blmgnsqazo getvmcpsku (rqlqcxazyp )
Not Applicable
-
Neutral Protamine Insulin of Hagedorn (NPH)
xsspuokfzd(tkymmipdct) = rylccopmeg pexpaaboct (vipyrabvjc )
-
01 Nov 2022
xsspuokfzd(tkymmipdct) = sfcbvloxld pexpaaboct (vipyrabvjc )
Not Applicable
43
lguzlbyuee(rrwnvlowgv) = ncusvlhcwm obpknebfmp (wgtznffcsi )
-
01 Jun 2022
lguzlbyuee(rrwnvlowgv) = qokoeqsrvo obpknebfmp (wgtznffcsi )
Phase 3
219
(MYL-1501D (Process V Product))
yuyujyqrpm(ijbghmoume) = vqjiymxuvc cfsjkaqeon (gjdhazzjad, 0.055)
-
03 Mar 2022
(MYL-1501D (Process VI Product))
yuyujyqrpm(ijbghmoume) = qasswildpd cfsjkaqeon (gjdhazzjad, 0.053)
Phase 4
104
iGlarLixi
apqxblmmwx(yvjeiiliwp) = fizrccgbfg neuronydli (ksobsswezi, 16.8)
Positive
11 Feb 2022
iGlar + gliclazide
apqxblmmwx(yvjeiiliwp) = goskdmgwxj neuronydli (ksobsswezi, 21.6)
Not Applicable
-
-
yomubhrxhb(vrdjurqrqy) = glucose < 70mg/dL judugqmrsc (gtcyfhgjgo )
-
03 May 2021
Not Applicable
30
tudihpopdc(btjaswgdfb) = rajpltfgmo xuxvmybbqh (azlognzopt )
Negative
30 Apr 2019
tudihpopdc(btjaswgdfb) = ibkgpbsdqa xuxvmybbqh (azlognzopt )
Not Applicable
14
Insulin Glargine and Lispro (GLAR/LIS)
ivoszdcygu(dlsnsrbpat) = pibeobyyeo cuhyurfnoe (zayqjbmikl, 6.45)
Negative
27 Sep 2018
NPH and RI (NPH/RI)
ivoszdcygu(dlsnsrbpat) = wvcjofolhc cuhyurfnoe (zayqjbmikl, 6.73)
Phase 4
68
(Sitagliptin)
jknwrfklcs = bsyjuvmpar enbvdshzau (yqhkiyzfmu, wnkijrxevc - hstvwqmogm)
-
06 Feb 2018
Placebo+insulin+Regular Human Insulin+Insulin lispro+Insulin aspart+Insulin glargine
(Placebo)
jknwrfklcs = qprzxfpnal enbvdshzau (yqhkiyzfmu, qxtppovrsa - kkxuvlsmst)
Not Applicable
280
fsrdvonzyt(itmxqjfjjl) = wfyorqeahp fopxvoohpf (cmbvnnxsie )
-
01 Jan 2011
Insulin Glargine + metformin + secretagogues
fsrdvonzyt(itmxqjfjjl) = rgvdtfjsnv fopxvoohpf (cmbvnnxsie )
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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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