metformin

Trade name: glucophage

Small moleculeapproved

Approved

Mar 3, 1995

Metformin is the most widely used drug to treat type 2 diabetes, and is one of only two oral antidiabetic drugs on the World Health Organization (WHO) list of essential medicines. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. However, we still do not completely understand its mechanisms of action. The main effect of this drug from the biguanide family is to acutely decrease hepatic glucose production, mostly through a mild and transient inhibition of the mitochondrial respiratory chain complex I. In addition, the resulting decrease in hepatic energy status activates AMPK (AMP-activated protein kinase), a cellular metabolic sensor, providing a generally accepted mechanism for the action of metformin on hepatic gluconeogenesis. The use of metformin, the most commonly prescribed drug for type 2 diabetes, was repeatedly associated with the decreased risk of the occurrence of various types of cancers, especially of pancreas and colon and hepatocellular carcinoma. — NCATS

Clinical trial activity

821 trials · 610 clinical orgs · 72 marketing orgs

Phase 1
234
Phase 2
304
Phase 3
166
Phase 4
154

Earliest trial started Jul 31, 1996 (NCT00004992)

Timeline

1990s

  1. Mar 3, 1995

    Bristol-Myers Squibb — Earliest FDA Approval

  2. Mar 3, 1995

    Bristol-Myers Squibb — NDA Secondary Org

  3. Mar 3, 1995

    Merck Serono — NDA Secondary Org

  4. Mar 3, 1995

    Lipha — NDA Secondary Org

  5. Mar 3, 1995

    Bristol-Myers Squibb — NDA Organization

  6. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 24, 2002

    Atlas Chemical Industries — Marketing Organization

  3. Jan 24, 2002

    Chartwell Pharmaceuticals — Marketing Organization

  4. Jan 24, 2002

    Teva — Marketing Organization

  5. Jan 24, 2002

    Mylan — Marketing Organization

  6. Jan 24, 2002

    Watson Pharmaceuticals — Marketing Organization

  7. Jan 24, 2002

    Imperial Chemical Industries — Marketing Organization

  8. Jan 25, 2002

    Heritage Pharma — Marketing Organization

  9. Jan 25, 2002

    Barr Laboratories — Marketing Organization

  10. Jan 25, 2002

    Sandoz — Marketing Organization

  11. Jan 25, 2002

    Novartis — Marketing Organization

  12. Apr 23, 2002

    Apotex — Marketing Organization

  13. Oct 10, 2002

    SmithKline Beecham — Marketing Organization

  14. Oct 10, 2002

    GlaxoSmithKline — NDA Secondary Org

  15. Sep 11, 2003

    Sun Pharmaceuticals — NDA Secondary Org

  16. Sep 11, 2003

    Ranbaxy — NDA Secondary Org

  17. Oct 31, 2003

    Ranbaxy — Marketing Organization

  18. Jan 1, 2004

    Teva — Earliest Phase 1 Sponsor(trial)

  19. Apr 27, 2004

    Andrx — NDA Secondary Org

  20. Jul 30, 2004

    Impax Laboratories — Marketing Organization

  21. Oct 1, 2004

    Actavis — Marketing Organization

  22. Jan 14, 2005

    Aurobindo Pharma — Marketing Organization

  23. Apr 20, 2005

    Cadila Healthcare — Marketing Organization

  24. Jun 3, 2005

    Santarus — NDA Secondary Org

  25. Aug 29, 2005

    Takeda — Marketing Organization

  26. Aug 29, 2005

    Takeda — NDA Secondary Org

  27. Oct 27, 2005

    Epic Pharma Llc — Marketing Organization

  28. Jul 28, 2006

    Provident Pharm — Marketing Organization

  29. Aug 23, 2006

    Dr. Reddy's Laboratories — Marketing Organization

  30. Mar 30, 2007

    Merck — Marketing Organization

  31. Mar 30, 2007

    Merck — NDA Secondary Org

  32. Apr 12, 2007

    Dash Pharms — Marketing Organization

  33. Aug 6, 2007

    IPCA Laboratories Ltd. — Marketing Organization

  34. Apr 17, 2008

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  35. May 23, 2008

    Glenmark Pharmaceuticals — Marketing Organization

  36. Jun 23, 2008

    Novo Nordisk — Marketing Organization

  37. Jun 23, 2008

    Novo Nordisk — NDA Secondary Org

  38. Nov 25, 2008

    Indicus Pharma — Marketing Organization

  39. Dec 30, 2009

    Torrent Pharmaceuticals Limited — Marketing Organization

2010s

  1. Apr 22, 2010

    Granules India — Marketing Organization

  2. Nov 1, 2010

    Alkem Labs Ltd — Marketing Organization

  3. Nov 5, 2010

    AstraZeneca — Marketing Organization

  4. Nov 5, 2010

    AstraZeneca — NDA Secondary Org

  5. Jun 29, 2011

    Lupin — Marketing Organization

  6. Jan 18, 2012

    Inventia Hlthcare — Marketing Organization

  7. Jan 30, 2012

    Boehringer Ingelheim — Marketing Organization

  8. Jan 30, 2012

    Boehringer Ingelheim — NDA Secondary Org

  9. Mar 12, 2012

    Marksans Pharma — Marketing Organization

  10. Sep 11, 2013

    Sciegen Pharmaceticals — Marketing Organization

  11. Aug 8, 2014

    Johnson and Johnson — Marketing Organization

  12. Aug 8, 2014

    Johnson and Johnson — NDA Secondary Org

  13. Aug 28, 2014

    Zydus Discovery DMCC — Marketing Organization

  14. Apr 21, 2015

    Anchen Pharmaceuticals, Inc — Marketing Organization

  15. Apr 21, 2015

    Par Pharmaceuticals — Marketing Organization

  16. Oct 30, 2015

    Allergan PLC (2015) — Marketing Organization

  17. Nov 5, 2015

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  18. Nov 5, 2015

    Neogen — Marketing Organization

  19. Jan 21, 2016

    Amneal Pharmaceuticals — Marketing Organization

  20. Aug 1, 2016

    Sun Pharmaceuticals — Marketing Organization

  21. Dec 13, 2016

    Beximco — Marketing Organization

  22. Feb 23, 2017

    Intellipharmaceutics — Marketing Organization

  23. Dec 26, 2017

    Nostrum Laboratories — Marketing Organization

  24. Mar 19, 2018

    Sinotherapeutics — Marketing Organization

  25. Aug 27, 2018

    Laurus Labs Ltd — Marketing Organization

  26. Sep 10, 2018

    Prinston Inc — Marketing Organization

  27. Sep 24, 2018

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  28. Oct 12, 2018

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  29. Nov 2, 2018

    Novast Labs — Marketing Organization

  30. Dec 27, 2018

    Baheal Pharmaceutical — Marketing Organization

2020s

  1. Mar 3, 2020

    Saptalis Pharmaceuticals — Marketing Organization

  2. Apr 9, 2020

    Ajanta Pharma Ltd — Marketing Organization

  3. May 1, 2020

    MSN Laboratories — Marketing Organization

  4. Aug 3, 2021

    Amta — Marketing Organization

  5. Aug 11, 2021

    Unichem — Marketing Organization

  6. Sep 29, 2021

    TWi Biotechnology, Inc. — Marketing Organization

  7. Dec 3, 2021

    Harman Finochem — Marketing Organization

  8. Aug 19, 2022

    VistaPharm, Inc. — Marketing Organization

  9. Jan 10, 2023

    Micro Labs Ltd India — Marketing Organization

  10. Jun 20, 2023

    Apicore — Marketing Organization

  11. Nov 3, 2023

    Zydus Discovery DMCC — NDA Secondary Org

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewMar 3, 1995

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)C(=N)NC(=N)N
Mol. weight
129.17 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • alogliptin benzoate / metformin hydrochloride
  • alogliptin / metformin
  • bolamyn sr
  • canagliflozin / metformin hydrochloride
  • cjc-1134
  • cjc-1134-pc
  • dapagliflozin propanediol monohydrate / metformin hydrochloride
  • diabex
  • diabex
  • diagemet xl
  • dmmet-01
  • dmmet-01
  • empagliflozin / metformin
  • ertugliflozin l-pyroglutamic acid/ metformin hydrochloride
  • fortamet
  • fortamet
  • glucamet 500
  • glucamet 850
  • glucient sr
  • glucophage
  • glucophage
  • glucophage
  • glucophage
  • glucophage
  • glucophage sr
  • glucophage xr
  • glucophage xr
  • glumetza
  • glumetza
  • glyformin
  • glyformin
  • hl-018
  • incb019602
  • la 6023
  • la-6023
  • la-6023
  • la-6023
  • ledermetin
  • linagliptin / metformin
  • merformin
  • metabet sr
  • metagliptin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformin
  • metformina
  • metformina
  • metformine
  • metformine
  • metformin glycinate
  • metformin glycinate
  • metformin hcl
  • metformin hcl
  • metformin hcl
  • metformin hydrochloride
  • metformin hydrochloride
  • metformin hydrochloride
  • metformin hydrochloride
  • metformin hydrochloride
  • metformin hydrochloride / dapagliflozin propanediol monohydrate
  • metformin hydrochloride / pioglitazone hydrochloride
  • metformin hydrochloride /saxagliptin hydrochloride
  • metforminum
  • metforminum
  • metformin xr
  • metsol
  • milform
  • orabet
  • orabet
  • pioglitazone / metformin hydrochloride
  • riomet
  • riomet
  • rosiglitazone / metformin hydrochloride,
  • sitagliptin / metformin hydrochloride
  • sukkarto sr
  • vildagliptin / metformin hydrochloride
  • yh1
  • yh1
  • yh14755

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06560333Phase 3Nov 30, 2026Eurofarma Laboratorios S.A.
NCT07057479Phase 3Sep 30, 2026Eurofarma Laboratorios S.A.
NCT07300059Phase 1Jul 15, 2026Aspargo Labs, Inc
NCT07300046Phase 1Jun 15, 2026Aspargo Labs, Inc
NCT07300033Phase 1May 15, 2026Aspargo Labs, Inc
NCT07300020Phase 1Apr 15, 2026Aspargo Labs, Inc
NCT07300007Phase 1Mar 15, 2026Aspargo Labs, Inc
NCT07275359Phase 1Mar 1, 2026Duke University, National Institute on Aging (NIA)
NCT07139405Phase 2Feb 28, 2026Myopharm Limited
NCT07291297Phase 2Feb 28, 2026University of North Carolina at Chapel Hill, Wake Forest University
NCT07226453Phase 2Feb 28, 2026The Pacific Pediatric Neuro-Oncology Consortium, University of California, San Francisco
NCT07136987Phase 3Jan 31, 2026National Institute for Research in Tuberculosis, Chennai, India, Open Source Pharma Foundation
NCT07007221Phase 2Jan 1, 2026University of Minnesota
NCT07272967Phase 4Jan 1, 2026Badr University
NCT06948825Phase 2Nov 30, 2025American Diabetes Association, George Washington University, University of North Carolina at Chapel Hill
NCT07158411Phase 1Nov 20, 2025Deciphera Pharmaceuticals LLC
NCT07222098Phase 1Nov 18, 2025Merck
NCT07223671Phase 1Nov 12, 2025Bristol-Myers Squibb
NCT07216131Phase 1Nov 10, 2025AstraZeneca, Parexel
NCT07229651Phase 2/Phase 3 (Phase 3)Nov 10, 2025Tanta University
Showing 20 of 821 trials
Page 1 / 42

Organizations

Research & Development (610)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ain Shams UniversityAcademic/Hospital171752017
Cairo UniversityAcademic/Hospital171352017
Tanta UniversityAcademic/Hospital161532014
Jiao Tong UniversityAcademic/Hospital151242017
Peking UniversityAcademic/Hospital15852015
Assiut UniversityAcademic/Hospital111152017
SanofiFor profit111122017
AstraZenecaFor profit10832011
Fudan UniversityAcademic/Hospital10652020
Merck KGaAFor profit10832018
National Cancer Institute (NCI)Government10332019
University of PittsburghAcademic/Hospital10942017
Beni Suef UniversityAcademic/Hospital9852019
Boehringer IngelheimFor profit9822015
Central South UniversityAcademic/Hospital9942017
University of GuadalajaraAcademic/Hospital9632008
Chinese Academy of Medical SciencesAcademic/Hospital8432017
Chong Kun Dang PharmaceuticalFor profit8812015
Huazhong University of Science and TechnologyAcademic/Hospital8722011
Hengrui Therapeutics, Inc.For profit7632017
610 organizations
Page 1 / 31

Marketing (122)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGOct 1, 2004
ActavisFor profitSYNJun 16, 2004
Ajanta Pharma LtdFor profitMKTGApr 9, 2020
Alkem Labs LtdFor profitMKTGNov 1, 2010
Alkem Labs LtdFor profitSYNOct 22, 2018
Allergan PLC (2015)For profitMKTGOct 30, 2015
Amneal PharmaceuticalsFor profitMKTGJan 21, 2016
Amneal PharmaceuticalsFor profitSYNJun 5, 2006
AmtaFor profitMKTGAug 3, 2021
Anchen Pharmaceuticals, IncFor profitMKTGApr 21, 2015
AndrxFor profitNDA2Apr 27, 2004
ApicoreFor profitMKTGJun 20, 2023
ApotexFor profitMKTGApr 23, 2002
ApotexFor profitSYNMar 10, 2014
AstraZenecaFor profitMKTGNov 5, 2010
AstraZenecaFor profitNDA2Nov 5, 2010
Atlas Chemical IndustriesFor profitMKTGJan 24, 2002
Aurobindo PharmaFor profitMKTGJan 14, 2005
Aurobindo PharmaFor profitSYNNov 14, 2007
Aurobindo PharmaFor profitSYNJul 20, 2012
Baheal PharmaceuticalFor profitMKTGDec 27, 2018
Barr LaboratoriesFor profitMKTGJan 25, 2002
BeximcoFor profitMKTGDec 13, 2016
Boehringer IngelheimFor profitMKTGJan 30, 2012
Boehringer IngelheimFor profitNDA2Jan 30, 2012
Bristol-Myers SquibbFor profitNDA2Mar 3, 1995
Bristol-Myers SquibbFor profitNDAMar 3, 1995
Cadila HealthcareFor profitMKTGApr 20, 2005
Chartwell PharmaceuticalsFor profitSYNJan 24, 2002
Chartwell PharmaceuticalsFor profitMKTGJan 24, 2002
Dash PharmsFor profitMKTGApr 12, 2007
Dr. Reddy's LaboratoriesFor profitSYNFeb 1, 2021
Dr. Reddy's LaboratoriesFor profitMKTGAug 23, 2006
Dr. Reddy's LaboratoriesFor profitSYNAug 9, 2023
Epic Pharma LlcFor profitMKTGOct 27, 2005
GlaxoSmithKlineFor profitNDA2Oct 10, 2002
Glenmark PharmaceuticalsFor profitMKTGMay 23, 2008
Glenmark PharmaceuticalsFor profitSYNNov 25, 2019
Granules IndiaFor profitMKTGApr 22, 2010
Granules IndiaFor profitSYNMar 16, 2018
Granules IndiaFor profitSYNMar 16, 2018
Harman FinochemFor profitSYNDec 3, 2021
Harman FinochemFor profitMKTGDec 3, 2021
Heritage PharmaFor profitMKTGJan 25, 2002
Heritage PharmaFor profitSYNJun 3, 2009
Heritage PharmaFor profitSYNJun 3, 2009
IPCA Laboratories Ltd.For profitMKTGAug 6, 2007
Impax LaboratoriesFor profitMKTGJul 30, 2004
Impax LaboratoriesFor profitSYNFeb 18, 2004
Imperial Chemical IndustriesFor profitMKTGJan 24, 2002
Indicus PharmaFor profitMKTGNov 25, 2008
IntellipharmaceuticsFor profitMKTGFeb 23, 2017
Inventia HlthcareFor profitSYNJan 18, 2012
Inventia HlthcareFor profitMKTGJan 18, 2012
Johnson and JohnsonFor profitMKTGAug 8, 2014
Johnson and JohnsonFor profitNDA2Aug 8, 2014
Laurus Labs LtdFor profitMKTGAug 27, 2018
Laurus Labs LtdFor profitSYNAug 27, 2018
LiphaFor profitNDA2Mar 3, 1995
LupinFor profitMKTGJun 29, 2011
MSN LaboratoriesFor profitMKTGMay 1, 2020
MSN LaboratoriesFor profitSYNNov 27, 2019
Macleods Pharmaceuticals, LtdFor profitMKTGNov 5, 2015
Marksans PharmaFor profitMKTGMar 12, 2012
MerckFor profitMKTGMar 30, 2007
MerckFor profitNDA2Mar 30, 2007
Merck SeronoFor profitNDA2Mar 3, 1995
Micro Labs Ltd IndiaFor profitMKTGJan 10, 2023
MylanFor profitMKTGJan 24, 2002
MylanFor profitSYNJan 29, 2002
NeogenFor profitMKTGNov 5, 2015
Nostrum LaboratoriesFor profitMKTGDec 26, 2017
Nostrum LaboratoriesFor profitSYNJul 26, 2006
NovartisFor profitMKTGJan 25, 2002
Novast LabsFor profitMKTGNov 2, 2018
Novo NordiskFor profitMKTGJun 23, 2008
Novo NordiskFor profitNDA2Jun 23, 2008
Par PharmaceuticalsFor profitMKTGApr 21, 2015
Prinston IncFor profitMKTGSep 10, 2018
Prinston IncFor profitSYNApr 5, 2022
Provident PharmFor profitMKTGJul 28, 2006
RanbaxyFor profitSYNSep 11, 2003
RanbaxyFor profitMKTGOct 31, 2003
RanbaxyFor profitNDA2Sep 11, 2003
SandozFor profitMKTGJan 25, 2002
SandozFor profitSYNJul 30, 2013
SantarusFor profitNDA2Jun 3, 2005
Saptalis PharmaceuticalsFor profitMKTGMar 3, 2020
Sciegen PharmaceticalsFor profitMKTGSep 11, 2013
Shijiazhuang Pharma Group (CSPC)For profitMKTGApr 17, 2008
SinotherapeuticsFor profitMKTGMar 19, 2018
SmithKline BeechamFor profitMKTGOct 10, 2002
Sun PharmaceuticalsFor profitNDA2Sep 11, 2003
Sun PharmaceuticalsFor profitMKTGAug 1, 2016
Sun PharmaceuticalsFor profitSYNFeb 9, 2006
Sun PharmaceuticalsFor profitSYNJan 29, 2002
Sun PharmaceuticalsFor profitSYNFeb 21, 2002
Sun PharmaceuticalsFor profitSYNAug 1, 2016
Sunshine Lake Pharma Co., Ltd.For profitMKTGOct 12, 2018
Sunshine Lake Pharma Co., Ltd.For profitSYNOct 12, 2018
TWi Biotechnology, Inc.For profitMKTGSep 29, 2021
TakedaFor profitMKTGAug 29, 2005
TakedaFor profitNDA2Aug 29, 2005
TevaFor profitMKTGJan 24, 2002
TevaFor profitSYNDec 16, 2002
TevaFor profitSYNOct 28, 2005
TevaFor profitSYNMar 10, 2014
TevaFor profitSYNSep 29, 2015
Torrent Pharmaceuticals LimitedFor profitMKTGDec 30, 2009
Torrent Pharmaceuticals LimitedFor profitSYNJan 24, 2007
Torrent Pharmaceuticals LimitedFor profitSYNFeb 18, 2010
UnichemFor profitMKTGAug 11, 2021
VistaPharm, Inc.For profitMKTGAug 19, 2022
Watson PharmaceuticalsFor profitMKTGJan 24, 2002
Watson PharmaceuticalsFor profitSYNJan 25, 2002
Watson PharmaceuticalsFor profitSYNDec 14, 2004
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGSep 24, 2018
Zydus Discovery DMCCFor profitMKTGAug 28, 2014
Zydus Discovery DMCCFor profitSYNFeb 29, 2016
Zydus Discovery DMCCFor profitSYNApr 18, 2005
Zydus Discovery DMCCFor profitSYNJan 31, 2011
Zydus Discovery DMCCFor profitNDA2Nov 3, 2023