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glimepiride

Trade name: amaryl

Small moleculeapproved

Approved

Nov 30, 1995

Glimepiride, like glyburide and glipizide, is a "second-generation" sulfonylurea agents. Glimepiride is used with diet to lower blood glucose by increasing the secretion of insulin from pancreas and increasing the sensitivity of peripheral tissues to insulin. The mechanism of action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells, and increasing sensitivity of peripheral tissues to insulin. Glimepiride likely binds to ATP-sensitive potassium channel receptors on the pancreatic cell surface, reducing potassium conductance and causing depolarization of the membrane. Membrane depolarization stimulates calcium ion influx through voltage-sensitive calcium channels. This increase in intracellular calcium ion concentration induces the secretion of insulin. Glimepiride is used for concomitant use with insulin for the treatment of noninsulin-dependent (type 2) diabetes mellitus. Glimepiride`s original trade name is Amaryl. — NCATS

Clinical trial activity

248 trials · 155 clinical orgs · 23 marketing orgs

Phase 1
44
Phase 2
101
Phase 3
94
Phase 4
74

Earliest trial started Sep 1, 1999 (NCT00000620)

Timeline

1990s

  1. Nov 30, 1995

    Sanofi-Aventis — Earliest FDA Approval

  2. Nov 30, 1995

    Sanofi-Aventis — NDA Secondary Org

  3. Nov 30, 1995

    Sanofi-Aventis — NDA Organization

  4. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Teva — Earliest Phase 1 Sponsor(trial)

  3. Oct 6, 2005

    Dr. Reddy's Laboratories — Marketing Organization

  4. Oct 6, 2005

    Epic Pharma Llc — Marketing Organization

  5. Oct 6, 2005

    Invagen Pharms — Marketing Organization

  6. Oct 6, 2005

    Ranbaxy — Marketing Organization

  7. Oct 6, 2005

    Teva — Marketing Organization

  8. Oct 6, 2005

    Chartwell Pharmaceuticals — Marketing Organization

  9. Nov 23, 2005

    SmithKline Beecham — Marketing Organization

  10. Nov 23, 2005

    GlaxoSmithKline — NDA Secondary Org

  11. Nov 28, 2005

    Mylan — Marketing Organization

  12. Dec 23, 2005

    Prinston Inc — Marketing Organization

  13. Feb 3, 2006

    Watson Pharmaceuticals — Marketing Organization

  14. Jul 28, 2006

    Takeda — Marketing Organization

  15. Jul 28, 2006

    Takeda — NDA Secondary Org

  16. Aug 23, 2007

    Accord Research — Marketing Organization

  17. Sep 22, 2009

    Ionis Pharmaceuticals, Inc. — Marketing Organization

2010s

  1. Apr 26, 2010

    Actavis — Marketing Organization

  2. Jun 29, 2012

    Aurobindo Pharma — Marketing Organization

  3. Jun 29, 2012

    Viva Healthcare — Marketing Organization

  4. Jun 29, 2012

    Micro Labs Ltd India — Marketing Organization

  5. Jan 4, 2013

    Sandoz — Marketing Organization

  6. Jan 4, 2013

    Novartis — Marketing Organization

  7. Apr 17, 2013

    Indoco Remedies — Marketing Organization

  8. Aug 1, 2013

    Hikma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedNov 30, 1995

Chemistry & pharmacology

Loading structure…

SMILES

CCC1=C(C)CN(C(=O)NCCC2=CC=C(C=C2)S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)C1=O
Mol. weight
490.616 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-(4-(2-(3-ethyl-4-methyl-2-oxo-3-pyrrolinecarboxamido)ethyl)phenylsulfonyl)-3-(4-methylcyclohexyl)urea
  • amarel
  • amaryl
  • amaryl
  • amaryl
  • amaryl
  • amaryl
  • aventis behring brand of glimepiride
  • aventis brand of glimepiride
  • aventis pharma brand of glimepiride
  • diameprid
  • gemigliptin
  • gemigliptin
  • gemigliptin
  • gemigliptin
  • gemigliptin
  • gemigliptin
  • gemigliptin
  • gemigliptin
  • glimax
  • glimepirida
  • glimepirida
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimepiride
  • glimépiride
  • glimépiride
  • glimepiridum
  • glimepiridum
  • glimperide
  • glirid
  • glymepiride
  • hoe 490
  • hoe-490
  • hoe-490
  • hoe-490
  • hoechst brand of glimepiride
  • lacer brand of glimepiride
  • lc15-0444
  • lc15-0444
  • lc15-0444
  • lc15-0444
  • ls15-0444
  • niddaryl
  • n,n-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide
  • pf-04937319
  • pf-04937319
  • pf-04937319
  • pioglitazone / glimepiride
  • roname
  • rosiglitazone / glimepiride
  • zemiglo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07288749Phase 3Jan 1, 2026Anhui Medical University, Capital Medical University, Central South University, China Medical University, Chinese Academy of Medical Sciences, Fudan University, Huazhong University of Science and Technology, Nanjing Medical University, People's Liberation Army of China, Sichuan Huaxi Hopsital, Southwest Medical University, Tianjin Medical University, Wuhan Central Hospital, Xiamen University, Xinjiang Medical University, Zhengzhou University
NCT06759922Phase 4Jan 1, 2025Bahria University
NCT05975528Phase 4Aug 31, 2023Yonsei University
NCT06068686N/AOct 1, 2022Damanhour University
NCT05386186Phase 4Jan 1, 2022Jiangsu University, Peking University
NCT04841096Phase 3Jun 30, 2021Centro de Investigación Médica Aguascalientes (Red OSMO), Laboratorios Silanes S.A. de C.V., Mérida Investigación Clínica, Oncológico Potosino (Red OSMO)
NCT04528212Phase 4Nov 1, 2020Damanhour University
NCT05468879N/ASep 21, 2020PT Harsen Laboratories, PT Pharma Metric Labs
NCT04287387Phase 4Mar 2, 2020Chinese Academy of Medical Sciences
NCT05663736Phase 4Jan 1, 2020Seoul National University
NCT03917940N/AJan 1, 2019Damanhour University
NCT03775902N/ADec 19, 2018University of Copenhagen
NCT03693560Phase 4Oct 8, 2018Damanhour University, Government of Egypt, Tanta University
NCT03332771Phase 3Dec 1, 2017Sanofi
NCT03804411Phase 4Aug 1, 2017Government of Russia
NCT03180281N/AJul 1, 2017Jiao Tong University
NCT03118713Phase 4Mar 23, 2017Astellas
NCT03081676N/AMar 8, 2017University of Copenhagen
NCT03060980Phase 3Mar 3, 2017Intarcia Therapeutics
NCT04237493Phase 4Feb 14, 2017University of Jordan
Showing 20 of 248 trials
Page 1 / 13

Organizations

Research & Development (155)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit312452008
LGFor profit242242009
SanofiFor profit232132001
Novo NordiskFor profit161542000
PfizerFor profit16942010
Seoul National UniversityAcademic/Hospital14842007
TakedaFor profit131152003
Eli LillyFor profit11552006
Boehringer IngelheimFor profit10842006
AstraZenecaFor profit9832006
GlaxoSmithKlineFor profit9832005
Handok Pharmaceuticals Co., Ltd.For profit7732006
NovartisFor profit7532004
Catalysis SLFor profit5522009
Korea UniversityAcademic/Hospital5022007
Laboratorios Silanes S.A. de C.V.For profit5532007
Bristol-Myers SquibbFor profit4032008
Damanhour UniversityAcademic/Hospital4422018
Catholic University of KoreaAcademic/Hospital3112007
Intarcia TherapeuticsFor profit3312013
155 organizations
Page 1 / 8

Marketing (27)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGAug 23, 2007
ActavisFor profitMKTGApr 26, 2010
Aurobindo PharmaFor profitMKTGJun 29, 2012
Chartwell PharmaceuticalsFor profitMKTGOct 6, 2005
Dr. Reddy's LaboratoriesFor profitMKTGOct 6, 2005
Epic Pharma LlcFor profitMKTGOct 6, 2005
GlaxoSmithKlineFor profitNDA2Nov 23, 2005
HikmaFor profitMKTGAug 1, 2013
Indoco RemediesFor profitMKTGApr 17, 2013
Invagen PharmsFor profitMKTGOct 6, 2005
Ionis Pharmaceuticals, Inc.For profitMKTGSep 22, 2009
Micro Labs Ltd IndiaFor profitMKTGJun 29, 2012
MylanFor profitMKTGNov 28, 2005
NovartisFor profitMKTGJan 4, 2013
Prinston IncFor profitMKTGDec 23, 2005
RanbaxyFor profitMKTGOct 6, 2005
RanbaxyFor profitSYNJul 20, 2005
SandozFor profitMKTGJan 4, 2013
Sanofi-AventisFor profitNDA2Nov 30, 1995
Sanofi-AventisFor profitNDANov 30, 1995
SmithKline BeechamFor profitMKTGNov 23, 2005
TakedaFor profitMKTGJul 28, 2006
TakedaFor profitNDA2Jul 28, 2006
TevaFor profitMKTGOct 6, 2005
TevaFor profitSYNApr 1, 2016
Viva HealthcareFor profitMKTGJun 29, 2012
Watson PharmaceuticalsFor profitMKTGFeb 3, 2006