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insulin glargine

Trade name: toujeo

Recombinant proteinapproved

Approved

Apr 20, 2000

Insulin glargine, a long-acting form of insulin, was marketed under the brand name LANTUS. Lantus is indicated for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. The primary activity of insulin glargine is regulation of glucose metabolism. It lowers blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. The off-label use of insulin glargine is the treatment type 2 diabetes in children and the treatment of gestational diabetes. — NCATS

Clinical trial activity

576 trials · 211 clinical orgs · 5 marketing orgs

Phase 1
83
Phase 2
232
Phase 3
208
Phase 4
222

Earliest trial started Sep 1, 1999 (NCT00000620)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Apr 20, 2000

    Aventis — Earliest FDA Approval

  2. Apr 20, 2000

    Aventis — NDA Organization

  3. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Feb 25, 2015

    Sanofi-Aventis — NDA Secondary Org

  2. Dec 16, 2015

    Eli Lilly — NDA Secondary Org

  3. Jul 19, 2017

    Merck — NDA Secondary Org

2020s

  1. Jun 11, 2020

    Mylan — Marketing Organization

  2. Jun 11, 2020

    Mylan — NDA Secondary Org

  3. Dec 17, 2021

    Eli Lilly — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • soliqua

    with lixisenatide

    Also known as insulin glargine and lixisenatide

Approval history

  • approvedApr 20, 2000

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • abasaglar
  • abasaglar kwikpen
  • glargine insulin
  • hoe-71gt
  • hoe-71gt
  • hoe-901
  • hoe-901
  • iglarlixi
  • ins lantus
  • ins lantus opticlik
  • ins lantus optiset
  • ins lantus solostar
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine
  • insulin glargine (genetical recombination)
  • insulin glargine / lixisenatide
  • insulin glargine (rdna origin)
  • insulin glargine (rdna origin)
  • insulin glargine recombinant
  • insulin glargine recombinant
  • insulin glargine recombinant
  • insulin glargine recombinant
  • lantus
  • lantus
  • lantus
  • lantus
  • lantus
  • lantus solostar
  • ly2963016
  • mk-1293
  • mk-1293
  • sar161271
  • toujeo
  • toujeo
  • toujeo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07224893Phase 4Dec 1, 2025Eastern Virginia Medical School
NCT07165652Phase 1Oct 13, 2025Xentria, Inc.
NCT07171684N/AOct 1, 2025Rutgers University
NCT07076199Phase 3Aug 11, 2025Novo Nordisk
NCT07274644Phase 4Mar 29, 2025Nanjing University
NCT06767761Phase 3Feb 18, 2025Gan and Lee Pharmaceuticals, USA
NCT06767735Phase 3Feb 14, 2025Gan and Lee Pharmaceuticals, USA
NCT06688123Phase 2Nov 30, 2024Hengrui Therapeutics, Inc.
NCT06627478Phase 1Oct 29, 2024Xentria, Inc.
NCT06492226Phase 1Jul 30, 2024Xentria, Inc.
NCT06871761Phase 3May 8, 2024Hengrui Therapeutics, Inc.
NCT06881264Phase 3Apr 30, 2024Hengrui Therapeutics, Inc.
NCT06340854Phase 3Apr 19, 2024Novo Nordisk
NCT06370715Phase 4Apr 18, 2024Cipla, Eli Lilly
NCT06619301Phase 3Apr 1, 2024Loyola University
NCT06269107Phase 3Feb 15, 2024Novo Nordisk
NCT06178874N/ADec 31, 2023Ain Shams University
NCT06107153N/ANov 1, 2023University of Basrah
NCT05780151Phase 4Jun 30, 2023European Commission, Sanofi, Utrecht University
NCT07070752Phase 3Apr 14, 2023Geropharm
Showing 20 of 576 trials
Page 1 / 29

Organizations

Research & Development (211)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit17614852000
Novo NordiskFor profit988652002
Eli LillyFor profit907852002
Emory UniversityAcademic/Hospital202022005
MerckFor profit191542007
Profil GmbHFor profit12222006
AstraZenecaFor profit9822003
Boehringer IngelheimFor profit9022011
AdociaFor profit8812013
BiodelFor profit7722006
McMaster UniversityAcademic/Hospital7522003
Gan and Lee Pharmaceuticals, USAFor profit6622015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government6031999
AlkermesFor profit5012005
Hengrui Therapeutics, Inc.For profit5522023
Ain Shams UniversityAcademic/Hospital4432019
AmylinFor profit4032004
MylanFor profit4412014
PfizerFor profit4322006
Rush UniversityAcademic/Hospital4312004
211 organizations
Page 1 / 11

Marketing (9)

OrganizationOrg typeRelationshipDate
AventisFor profitNDAApr 20, 2000
Eli LillyFor profitNDA2Dec 16, 2015
Eli LillyFor profitMKTGDec 17, 2021
MerckFor profitNDA2Jul 19, 2017
MylanFor profitMKTGJun 11, 2020
MylanFor profitNDA2Jun 11, 2020
Sanofi-AventisFor profitSYNApr 20, 2000
Sanofi-AventisFor profitNDA2Feb 25, 2015
Sanofi-AventisFor profitSYNNov 21, 2016