pioglitazone
Trade name: actos
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
Earliest trial started Sep 1, 1999 (NCT00000620)
Timeline
1990s
2000s
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
- Mar 15, 2005
Alphapharm — Marketing Organization
2010s
- Feb 25, 2011
Mylan — Marketing Organization
- Feb 25, 2011
PHARMOBEDIENT — Marketing Organization
- Oct 26, 2012
Celltrion — Marketing Organization
- Oct 26, 2012
Chartwell Pharmaceuticals — Marketing Organization
- Jan 4, 2013
Sandoz — Marketing Organization
- Jan 4, 2013
Novartis — Marketing Organization
- Feb 6, 2013
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Feb 6, 2013
Neogen — Marketing Organization
- Feb 13, 2013
Accord Research — Marketing Organization
- Feb 13, 2013
Torrent Pharmaceuticals Limited — Marketing Organization
- Feb 13, 2013
Zydus Discovery DMCC — Marketing Organization
- Feb 13, 2013
Esteve Labs — Marketing Organization
- Feb 13, 2013
Nostrum Laboratories — Marketing Organization
- Feb 13, 2013
Aurobindo Pharma — Marketing Organization
- Feb 13, 2013
AiPing Pharm Inc — Marketing Organization
- Mar 12, 2013
US Antibiotics — Marketing Organization
- Mar 12, 2013
Neopharma — Marketing Organization
- Mar 12, 2013
Picket Pharms — Marketing Organization
- Jan 10, 2014
Teva — Marketing Organization
- Apr 7, 2014
Annora Pharma — Marketing Organization
- Apr 7, 2014
Lupin — Marketing Organization
- Oct 6, 2017
Puracap Pharmaceutical — Marketing Organization
- Apr 17, 2018
Prinston Inc — Marketing Organization
2020s
- Jan 22, 2021
Shuangcheng — Marketing Organization
- Jan 22, 2021
Corepharma — Marketing Organization
Indications
Studied for
- Adrenoleukodystrophy · Phase 2
- Airway Management · Phase 2
- Alcohol Drinking · Phase 2
- Alcoholism · Phase 2
- Alcohol-Related Disorders · Phase 2
- Altitude Sickness · Phase 4
- Alzheimer Disease · Phase 3
- Amyotrophic Lateral Sclerosis · Phase 2
- Androgens · Phase 3
- Anemia · Phase 1
- Angina Pectoris · Phase 4
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 3
- Aorta · Phase 2
- Aortic Valve Stenosis · Phase 2
- Arterial Occlusive Diseases · Phase 2/Phase 3
- Arthritis, Rheumatoid · Phase 3
- Ascites · Phase 4
- Asthma · Phase 4
- Astrocytoma · Phase 1
- Ataxia Telangiectasia · Phase 4
- Atherosclerosis · Phase 4
- Autism Spectrum Disorder · Phase 2
- Autoimmune Diseases · Phase 1
- Bipolar Disorder · Phase 4
- Blood Platelets · Phase 2
- Body Weight · Phase 4
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 2
- Bronchopulmonary Dysplasia · Phase 2
- Burns · Phase 2/Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Squamous Cell · Phase 2
- Cardiovascular Diseases · Phase 4
- Cerebral Hemorrhage · Phase 2
- Cocaine-Related Disorders · Phase 2
- Cognitive Dysfunction · Phase 2
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Coronary Restenosis · Phase 3
- Coronary Stenosis · Phase 4
- Coronavirus Infections · Phase 4
- COVID-19 · Phase 4
- Cystic Fibrosis · Phase 1
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Digestive System Diseases · Phase 4
- Drug Evaluation · Phase 4
- Drug Interactions · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Dyslipidemias · Phase 3
- Endocrine System Diseases · Phase 3
- Endometriosis · Phase 2/Phase 3
- Endothelium · Phase 4
- Fat Body · Phase 2
- Fatty Liver · Phase 4
- Fibrosis · Phase 4
- Friedreich Ataxia · Phase 3
- Gastroparesis · Early Phase 1
- Glioblastoma · Phase 1
- Glomerulonephritis · Phase 3
- Glucose Intolerance · Phase 4
- Glucose Metabolism Disorders · Phase 4
- Glycemic Control · Phase 3
- Gout · Phase 4
- Granulomatous Disease, Chronic · Phase 1/Phase 2
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 4
- Hearing Loss · Phase 3
- Heart Diseases · Phase 3
- Heart Failure, Diastolic · Phase 4
- Heart Ventricles · Phase 4
- Hepatitis · Phase 2
- Hepatitis B, Chronic · Phase 4
- Hepatitis C · Phase 4
- Hepatitis C, Chronic · Phase 4
- Heroin Dependence · Phase 1/Phase 2
- HIV · Phase 4
- HIV-Associated Lipodystrophy Syndrome · Phase 3
- HIV Infections · Phase 4
- Hyperandrogenism · Phase 1/Phase 2
- Hypercholesterolemia · Phase 3
- Hyperglycemia · Phase 1/Phase 2
- Hyperinsulinism · Early Phase 1
- Hypertension · Phase 4
- Hypertension, Portal · Phase 4
- Hypertension, Pulmonary · Phase 2
- Hypoglycemic Agents · Phase 4
- Infertility · Early Phase 1
- Infertility, Female · Early Phase 1
- Inflammation · Phase 4
- Insulin Resistance · Phase 4
- Intermittent Claudication · Phase 2/Phase 3
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukoplakia, Oral · Phase 2
- Lipodystrophy · Phase 4
- Liposarcoma · Phase 2
- Liposarcoma, Myxoid · Phase 2
- Livedoid Vasculopathy · Phase 2
- Liver · Phase 4
- Liver Cirrhosis · Phase 4
- Liver Diseases · Phase 4
- Lung Diseases · Phase 2
- Lung Neoplasms · Phase 2
- Lupus Erythematosus, Systemic · Phase 4
- Major Depressive Disorder · Phase 4
- Meningioma · Phase 1
- Menstruation Disturbances · Phase 1/Phase 2
- Metabolic Diseases · Phase 3
- Metabolic Syndrome · Phase 4
- Metabolism · Phase 4
- Molecular Mechanisms of Pharmacological Action · Phase 4
- Multiple Myeloma · Phase 1/Phase 2
- Multiple Sclerosis · Phase 1/Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 1
- Muscle Fatigue · Phase 2
- Muscular Diseases · Phase 1
- Musculoskeletal Diseases · Phase 1
- Myocardial Infarction · Phase 4
- Myocardial Reperfusion Injury · Phase 4
- Myositis · Phase 1
- Myositis, Inclusion Body · Phase 1
- Neoplasms · Phase 2
- Nervous System Diseases · Phase 1
- Neuromuscular Diseases · Phase 1
- Non-alcoholic Fatty Liver Disease · Phase 4
- Obesity · Phase 4
- Opioid-Related Disorders · Phase 2
- Oropharyngeal Neoplasms · Phase 2
- Osteoporosis · Phase 4
- Overweight · Phase 1
- Oxidative Stress · Phase 4
- Pancreatic Neoplasms · Phase 2
- Pancreatitis · Phase 2
- Pancreatitis, Chronic · Phase 2
- Parkinson Disease · Phase 2
- Percutaneous Coronary Intervention · Phase 4
- Peripheral Arterial Disease · Early Phase 1
- Pharmacokinetics · Phase 2
- Pharmacology · Phase 4
- Physiological Effects of Drugs · Phase 4
- Pioglitazone · Phase 4
- Pneumonia · Early Phase 1
- Polycystic Kidney Diseases · Phase 2
- Polycystic Ovary Syndrome · Phase 4
- Prediabetic State · Phase 4
- Pressure Ulcer · Phase 2
- Prostatic Neoplasms · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Proteinuria · Phase 3
- Psoriasis · Phase 2
- Psychological Distress · Phase 2
- Radiation · Phase 2
- Renal Insufficiency, Chronic · Phase 4
- Risk Reduction Behavior · Phase 3
- Sepsis · Phase 1/Phase 2
- Shock, Septic · Phase 1/Phase 2
- Sleep Apnea, Obstructive · Phase 4
- Sodium-Glucose Transporter 2 Inhibitors · Phase 4
- Spinal Cord Injuries · Phase 2
- Steatitis · Phase 4
- Stroke · Phase 3
- Thiazolidinediones · Phase 4
- Thyroid Neoplasms · Phase 2
- Tobacco Use Disorder · Phase 1/Phase 2
- Vascular Diseases · Phase 4
Mechanism of action
Combination products
actoplus met
with metformin
Also known as actoplus, actoplus met xr
duetact
with glimepiride
oseni
with alogliptin
Approval history
- approvedPriority reviewJul 15, 1999
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL595 ↗
- WikipediaThiazolidinedione ↗
- NCATSJQT35NPK6C ↗
- ChEMBLCHEMBL85398 ↗
- ChEMBLCHEMBL1715 ↗
- WikipediaPioglitazone ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07057479 | Phase 3 | Sep 30, 2026 | Eurofarma Laboratorios S.A. |
| NCT07053319 | Phase 1 | Feb 1, 2026 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio |
| NCT07056699 | Phase 3 | Jan 30, 2026 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio |
| NCT07180745 | Phase 4 | Nov 1, 2025 | Badr University |
| NCT06922656 | Phase 4 | Sep 15, 2025 | Dasman Diabetes Institute |
| NCT07158346 | Phase 1 | Aug 18, 2025 | Celltrion |
| NCT07083401 | Phase 1 | Jul 5, 2025 | Boryung Pharmaceutical Company |
| NCT07083388 | Phase 1 | Jul 3, 2025 | Boryung Pharmaceutical Company |
| NCT06972732 | Phase 4 | Jun 11, 2025 | Boryung Pharmaceutical Company |
| NCT06851962 | Phase 4 | Apr 30, 2025 | University of Valencia |
| NCT06989723 | Phase 4 | Jan 1, 2025 | Celltrion, Seoul National University |
| NCT06729996 | Phase 2 | Dec 16, 2024 | Mayo Clinic, University of Pittsburgh |
| NCT06657209 | Phase 4 | Dec 15, 2024 | Stanford University |
| NCT06246799 | Phase 3 | Nov 30, 2024 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, San Antonio |
| NCT07083232 | Phase 4 | Oct 30, 2024 | Al Azhar University |
| NCT06594172 | Phase 2 | Sep 10, 2024 | Fujian Medical University, Guangzhou Medical University, Shantou University, Southern Medical University |
| NCT06336798 | Phase 2 | Aug 31, 2024 | Emory University, National Heart, Lung, and Blood Institute (NHLBI) |
| NCT06571591 | Phase 3 | Aug 27, 2024 | Celltrion |
| NCT06399835 | Phase 4 | Feb 1, 2024 | Daewoong Pharmaceutical Co. LTD., Seoul National University |
| NCT06135584 | N/A | Nov 18, 2023 | Hangzhou Normal University |
Organizations
Research & Development (346)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Takeda | For profit | 66 | 40 | 5 | 2000 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 24 | 6 | 5 | 1999 |
| Merck | For profit | 22 | 18 | 5 | 2003 |
| AstraZeneca | For profit | 15 | 14 | 4 | 2002 |
| University of Texas, San Antonio | Academic/Hospital | 15 | 14 | 4 | 2002 |
| The University of Texas, Dallas | Academic/Hospital | 12 | 7 | 5 | 2002 |
| Eli Lilly | For profit | 10 | 4 | 3 | 2000 |
| Boehringer Ingelheim | For profit | 8 | 8 | 2 | 2007 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 8 | 3 | 3 | 1999 |
| Stanford University | Academic/Hospital | 8 | 7 | 5 | 2000 |
| Yonsei University | Academic/Hospital | 8 | 7 | 2 | 2004 |
| Daiichi Sankyo | For profit | 7 | 7 | 3 | 2004 |
| Department of Veteran Affairs | Government | 7 | 7 | 3 | 2004 |
| GlaxoSmithKline | For profit | 7 | 7 | 4 | 2005 |
| Mayo Clinic | Academic/Hospital | 7 | 5 | 4 | 2000 |
| National Institutes of Health (NIH) | Government | 7 | 0 | 4 | 2002 |
| Roche | For profit | 7 | 7 | 3 | 2006 |
| Sanofi | For profit | 7 | 7 | 2 | 2001 |
| University of Vermont | Academic/Hospital | 7 | 5 | 4 | 2000 |
| Bristol-Myers Squibb | For profit | 6 | 1 | 1 | 2005 |
Marketing (30)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Feb 13, 2013 |
| AiPing Pharm Inc | For profit | MKTG | Feb 13, 2013 |
| Alphapharm | For profit | MKTG | Mar 15, 2005 |
| Annora Pharma | For profit | MKTG | Apr 7, 2014 |
| Aurobindo Pharma | For profit | MKTG | Feb 13, 2013 |
| Celltrion | For profit | MKTG | Oct 26, 2012 |
| Chartwell Pharmaceuticals | For profit | MKTG | Oct 26, 2012 |
| Corepharma | For profit | MKTG | Jan 22, 2021 |
| Esteve Labs | For profit | SYN | Feb 13, 2013 |
| Esteve Labs | For profit | MKTG | Feb 13, 2013 |
| Lupin | For profit | MKTG | Apr 7, 2014 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Feb 6, 2013 |
| Mylan | For profit | MKTG | Feb 25, 2011 |
| Mylan | For profit | SYN | Aug 17, 2012 |
| Neogen | For profit | MKTG | Feb 6, 2013 |
| Neopharma | For profit | MKTG | Mar 12, 2013 |
| Nostrum Laboratories | For profit | MKTG | Feb 13, 2013 |
| Novartis | For profit | MKTG | Jan 4, 2013 |
| PHARMOBEDIENT | For profit | MKTG | Feb 25, 2011 |
| Picket Pharms | For profit | MKTG | Mar 12, 2013 |
| Prinston Inc | For profit | MKTG | Apr 17, 2018 |
| Puracap Pharmaceutical | For profit | MKTG | Oct 6, 2017 |
| Sandoz | For profit | MKTG | Jan 4, 2013 |
| Shuangcheng | For profit | MKTG | Jan 22, 2021 |
| Takeda | For profit | NDA2 | Jul 15, 1999 |
| Takeda | For profit | NDA | Jul 15, 1999 |
| Teva | For profit | MKTG | Jan 10, 2014 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Feb 13, 2013 |
| US Antibiotics | For profit | MKTG | Mar 12, 2013 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 13, 2013 |