pioglitazone

Trade name: actos

Small moleculeapproved

Approved

Jul 15, 1999

Pioglitazone (brand name Actos) is a prescription drug of the thiazolidinedione class with hypoglycemic action used in the treatment of type 2 diabetes. Pioglitazone selectively stimulates the nuclear receptor peroxisome proliferator-activated receptor gamma (PPAR-γ) and to a lesser extent PPAR-α. It modulates the transcription of the genes involved in the control of glucose and lipid metabolism in the muscle, adipose tissue, and the liver. As a result, pioglitazone reduces insulin resistance in the liver and peripheral tissues, decreases gluconeogenesis in the liver, and reduces the quantity of glucose and glycated hemoglobin in the bloodstream. Pioglitazone is used to lower blood glucose levels in the treatment of diabetes mellitus type 2 (T2DM) either alone or in combination with a sulfonylurea, metformin, or insulin. Pioglitazone cannot be used in patients with a known hypersensitivity to pioglitazone, other thiazolidinediones or any of components of its pharmaceutical forms. It is ineffective and possibly harmful to diabetes mellitus type 1 and diabetic ketoacidosis. Pioglitazone can cause fluid retention and peripheral edema. As a result, it may precipitate congestive heart failure (which worsens with fluid overload in those at risk). It may cause anemia. Mild weight gain is common due to increase in subcutaneous adipose tissue. In studies, patients on pioglitazone had an increased proportion of upper respiratory tract infection, sinusitis, headache, myalgia and tooth problems. — NCATS

Clinical trial activity

490 trials · 346 clinical orgs · 27 marketing orgs

Phase 1
83
Phase 2
221
Phase 3
112
Phase 4
135

Earliest trial started Sep 1, 1999 (NCT00000620)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

  2. Jul 15, 1999

    Takeda — Earliest FDA Approval

  3. Jul 15, 1999

    Takeda — NDA Secondary Org

  4. Jul 15, 1999

    Takeda — NDA Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  3. Mar 15, 2005

    Alphapharm — Marketing Organization

2010s

  1. Feb 25, 2011

    Mylan — Marketing Organization

  2. Feb 25, 2011

    PHARMOBEDIENT — Marketing Organization

  3. Oct 26, 2012

    Celltrion — Marketing Organization

  4. Oct 26, 2012

    Chartwell Pharmaceuticals — Marketing Organization

  5. Jan 4, 2013

    Sandoz — Marketing Organization

  6. Jan 4, 2013

    Novartis — Marketing Organization

  7. Feb 6, 2013

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  8. Feb 6, 2013

    Neogen — Marketing Organization

  9. Feb 13, 2013

    Accord Research — Marketing Organization

  10. Feb 13, 2013

    Torrent Pharmaceuticals Limited — Marketing Organization

  11. Feb 13, 2013

    Zydus Discovery DMCC — Marketing Organization

  12. Feb 13, 2013

    Esteve Labs — Marketing Organization

  13. Feb 13, 2013

    Nostrum Laboratories — Marketing Organization

  14. Feb 13, 2013

    Aurobindo Pharma — Marketing Organization

  15. Feb 13, 2013

    AiPing Pharm Inc — Marketing Organization

  16. Mar 12, 2013

    US Antibiotics — Marketing Organization

  17. Mar 12, 2013

    Neopharma — Marketing Organization

  18. Mar 12, 2013

    Picket Pharms — Marketing Organization

  19. Jan 10, 2014

    Teva — Marketing Organization

  20. Apr 7, 2014

    Annora Pharma — Marketing Organization

  21. Apr 7, 2014

    Lupin — Marketing Organization

  22. Oct 6, 2017

    Puracap Pharmaceutical — Marketing Organization

  23. Apr 17, 2018

    Prinston Inc — Marketing Organization

2020s

  1. Jan 22, 2021

    Shuangcheng — Marketing Organization

  2. Jan 22, 2021

    Corepharma — Marketing Organization

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewJul 15, 1999

Chemistry & pharmacology

Loading structure…

SMILES

CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Mol. weight
356.45 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 2,4-thiazolidinedione
  • 2,4-thiazolidinedione
  • 2,4-thiazolidinedione
  • 2,4-thiazolidinedione potassium
  • (+-)-5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-2,4-thiazolidinedione
  • (+-)-5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-2,4-thiazolidinedione
  • 5-(4-(2-(5-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione
  • 5-{4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione
  • 5-{4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione
  • actos
  • actos
  • actos
  • actos
  • ad 4833
  • ad-4833
  • alogliptin / pioglitazone
  • diabiom
  • duetact
  • duetact
  • glidipion
  • glizofar
  • glustin
  • metformin hydrochloride / pioglitazone hydrochloride
  • pioglatazone
  • pioglitazona
  • pioglitazona
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone
  • pioglitazone / glimepiride
  • pioglitazone hcl
  • pioglitazone hcl
  • pioglitazone hcl
  • pioglitazone hydrochloride
  • pioglitazone hydrochloride
  • pioglitazone hydrochloride
  • pioglitazone hydrochloride
  • pioglitazone hydrochloride
  • pioglitazone hydrochloride
  • pioglitazone hydrochloride
  • pioglitazone / metformin hydrochloride
  • pioglitazonum
  • pioglitazonum
  • pioglitozone
  • pionorm
  • pionorm
  • sepioglin
  • t-174
  • thiazolidinedione
  • thiazolidinedione
  • thiazolidinedione
  • thiazolidinedione
  • thiazolidionedione
  • u 72107a
  • u-72107a
  • u-72107a
  • u-72107a
  • u72,107a

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07057479Phase 3Sep 30, 2026Eurofarma Laboratorios S.A.
NCT07053319Phase 1Feb 1, 2026National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio
NCT07056699Phase 3Jan 30, 2026National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio
NCT07180745Phase 4Nov 1, 2025Badr University
NCT06922656Phase 4Sep 15, 2025Dasman Diabetes Institute
NCT07158346Phase 1Aug 18, 2025Celltrion
NCT07083401Phase 1Jul 5, 2025Boryung Pharmaceutical Company
NCT07083388Phase 1Jul 3, 2025Boryung Pharmaceutical Company
NCT06972732Phase 4Jun 11, 2025Boryung Pharmaceutical Company
NCT06851962Phase 4Apr 30, 2025University of Valencia
NCT06989723Phase 4Jan 1, 2025Celltrion, Seoul National University
NCT06729996Phase 2Dec 16, 2024Mayo Clinic, University of Pittsburgh
NCT06657209Phase 4Dec 15, 2024Stanford University
NCT06246799Phase 3Nov 30, 2024National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio
NCT07083232Phase 4Oct 30, 2024Al Azhar University
NCT06594172Phase 2Sep 10, 2024Fujian Medical University, Guangzhou Medical University, Shantou University, Southern Medical University
NCT06336798Phase 2Aug 31, 2024Emory University, National Heart, Lung, and Blood Institute (NHLBI)
NCT06571591Phase 3Aug 27, 2024Celltrion
NCT06399835Phase 4Feb 1, 2024Daewoong Pharmaceutical Co. LTD., Seoul National University
NCT06135584N/ANov 18, 2023Hangzhou Normal University
Showing 20 of 490 trials
Page 1 / 25

Organizations

Research & Development (346)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TakedaFor profit664052000
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government24651999
MerckFor profit221852003
AstraZenecaFor profit151442002
University of Texas, San AntonioAcademic/Hospital151442002
The University of Texas, DallasAcademic/Hospital12752002
Eli LillyFor profit10432000
Boehringer IngelheimFor profit8822007
National Heart, Lung, and Blood Institute (NHLBI)Government8331999
Stanford UniversityAcademic/Hospital8752000
Yonsei UniversityAcademic/Hospital8722004
Daiichi SankyoFor profit7732004
Department of Veteran AffairsGovernment7732004
GlaxoSmithKlineFor profit7742005
Mayo ClinicAcademic/Hospital7542000
National Institutes of Health (NIH)Government7042002
RocheFor profit7732006
SanofiFor profit7722001
University of VermontAcademic/Hospital7542000
Bristol-Myers SquibbFor profit6112005
346 organizations
Page 1 / 18

Marketing (30)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGFeb 13, 2013
AiPing Pharm IncFor profitMKTGFeb 13, 2013
AlphapharmFor profitMKTGMar 15, 2005
Annora PharmaFor profitMKTGApr 7, 2014
Aurobindo PharmaFor profitMKTGFeb 13, 2013
CelltrionFor profitMKTGOct 26, 2012
Chartwell PharmaceuticalsFor profitMKTGOct 26, 2012
CorepharmaFor profitMKTGJan 22, 2021
Esteve LabsFor profitSYNFeb 13, 2013
Esteve LabsFor profitMKTGFeb 13, 2013
LupinFor profitMKTGApr 7, 2014
Macleods Pharmaceuticals, LtdFor profitMKTGFeb 6, 2013
MylanFor profitMKTGFeb 25, 2011
MylanFor profitSYNAug 17, 2012
NeogenFor profitMKTGFeb 6, 2013
NeopharmaFor profitMKTGMar 12, 2013
Nostrum LaboratoriesFor profitMKTGFeb 13, 2013
NovartisFor profitMKTGJan 4, 2013
PHARMOBEDIENTFor profitMKTGFeb 25, 2011
Picket PharmsFor profitMKTGMar 12, 2013
Prinston IncFor profitMKTGApr 17, 2018
Puracap PharmaceuticalFor profitMKTGOct 6, 2017
SandozFor profitMKTGJan 4, 2013
ShuangchengFor profitMKTGJan 22, 2021
TakedaFor profitNDA2Jul 15, 1999
TakedaFor profitNDAJul 15, 1999
TevaFor profitMKTGJan 10, 2014
Torrent Pharmaceuticals LimitedFor profitMKTGFeb 13, 2013
US AntibioticsFor profitMKTGMar 12, 2013
Zydus Discovery DMCCFor profitMKTGFeb 13, 2013