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Pioglitazone | CAS No: 111025-46-8 | GMP-certified suppliers
A medication that supports improved glycemic control in adults with type 2 diabetes mellitus when used alongside diet and exercise across major regulated markets.
Therapeutic categories
Primary indications
- Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- It is also available in combination with [metformin],[glimepiride],or [alogliptin]for the same indication
Product Snapshot
- Oral small‑molecule product supplied primarily as standard and extended‑release tablets
- Used to support glycemic control in adults with type 2 diabetes, including use in fixed‑dose combinations with other antihyperglycemics
- Approved in the US, EU, and Canada, with additional investigational listings in some markets
Clinical Overview
Pioglitazone enhances insulin responsiveness in adipose tissue, liver, and skeletal muscle. Its glucose-lowering activity reflects reduced hepatic gluconeogenesis, increased insulin-dependent glucose disposal, and downstream reductions in plasma glucose, insulin, and HbA1c. These effects occur without stimulating pancreatic beta cell insulin secretion.
The mechanism of action involves selective agonism of peroxisome proliferator-activated receptor-gamma. PPARγ activation modulates transcription of genes regulating lipid and glucose metabolism, including pathways involved in transport, utilization, and production. Through this genomic mechanism, the drug improves systemic insulin sensitivity and supports more physiologic glucose homeostasis.
Pioglitazone is administered orally and exhibits systemic bioactivity following absorption. It is a substrate of CYP2C8 and CYP3A pathways and may interact with inhibitors or inducers of these enzymes. It also demonstrates activity as a moderate CYP2C8 inhibitor and has documented interactions with OATP1B1 and OATP1B3 transport mechanisms. These characteristics may influence exposure when co-administered with other substrates of these systems.
Safety considerations are well established. Fluid retention is a class effect and may precipitate or worsen congestive heart failure; use should be avoided in patients with existing heart failure or those at elevated risk. An association with bladder cancer has been reported, and the drug should not be used in patients with active disease and should be used cautiously in those with a prior history.
Pioglitazone is available globally under several brand and combination products. For API procurement, sourcing should prioritize data-supported impurity profiles, regulatory documentation alignment, and reliable control of stereochemical integrity and residual solvent levels to ensure compliance with regional pharmaceutical quality standards.
Identification & chemistry
| Generic name | Pioglitazone |
|---|---|
| Molecule type | Small molecule |
| CAS | 111025-46-8 |
| UNII | X4OV71U42S |
| DrugBank ID | DB01132 |
Pharmacology
| Summary | Pioglitazone is a selective PPAR‑gamma agonist that modulates transcription of insulin‑responsive genes in adipose tissue, muscle, and liver. This activation enhances insulin sensitivity, promotes insulin‑dependent glucose utilization, and reduces hepatic glucose production. Its pharmacodynamic effect is improved glucose homeostasis in adults with type 2 diabetes. |
|---|---|
| Mechanism of action | Pioglitazone is a selective agonist at peroxisome proliferator-activated receptor-gamma (PPARγ) in target tissues for insulin action such as adipose tissue, skeletal muscle, and liver.Activation of PPARγ increases the transcription of insulin-responsive genes involved in the control of glucose and lipid production, transport, and utilization.Through this mechanism, pioglitazone both enhances tissue sensitivity to insulin and reduces the hepatic production of glucose (i.e. gluconeogenesis) - insulin resistance associated with type 2 diabetes mellitus is therefore improved without an increase in insulin secretion by pancreatic beta cells. |
| Pharmacodynamics | Pioglitazone enhances cellular responsiveness to insulin, increases insulin-dependent glucose disposal, and improves impaired glucose homeostasis.In patients with type 2 diabetes mellitus, these effects result in lower plasma glucose concentrations, lower plasma insulin concentrations, and lower HbA1c values. Significant fluid retention leading to the development/exacerbation of congestive heart failure has been reported with pioglitazone - avoid its use in patients in heart failure or at risk of developing heart failure.There is some evidence that pioglitazone may be associated with an increased risk of developing bladder cancer. Pioglitazone should not be used in patients with active bladder cancer and should be used with caution in patients with a history of bladder cancer. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Peroxisome proliferator-activated receptor gamma | Humans | agonist |
| Amine oxidase [flavin-containing] B | Humans | inhibitor |
ADME / PK
| Absorption | Following oral administration of pioglitazone, peak serum concentrations are observed within 2 hours (T<sub>max</sub>) - food slightly delays the time to peak serum concentration, increasing T<sub>max</sub> to approximately 3-4 hours, but does not alter the extent of absorption.Steady-state concentrations of both parent drug and its primary active metabolites are achieved after 7 days of once-daily administration of pioglitazone.C<sub>max</sub> and AUC increase proportionately to administered doses. |
|---|---|
| Half-life | The mean serum half-life of pioglitazone and its metabolites (M-III and M-IV) range from 3-7 hours and 16-24 hours, respectively. |
| Protein binding | Pioglitazone is >99% protein-bound in human plasma - binding is primarily to albumin, although pioglitazone has been shown to bind other serum proteins with a lower affinity.The M-III and M-IV metabolites of pioglitazone are >98% protein-bound (also primarily to albumin). |
| Metabolism | Pioglitazone is extensively metabolized by both hydroxylation and oxidation - the resulting metabolites are also partly converted to glucuronide or sulfate conjugates.The pharmacologically active M-IV and M-III metabolites are the main metabolites found in human serum and their circulating concentrations are equal to, or greater than, those of the parent drug.The specific CYP isoenzymes involved in the metabolism of pioglitazone are CYP2C8 and, to a lesser degree, CYP3A4. There is also some evidence to suggest a contribution by extrahepatic CYP1A1. |
| Route of elimination | Approximately 15-30% of orally administered pioglitazone is recovered in the urine. The bulk of its elimination, then, is presumed to be through the excretion of unchanged drug in the bile or as metabolites in the feces. |
| Volume of distribution | The average apparent volume of distribution of pioglitazone is 0.63 ± 0.41 L/kg. |
| Clearance | The apparent clearance of orally administered pioglitazone is 5-7 L/h. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support conventional oral solid dosage forms, with possible need for solubility‑enhancing excipients.
- Suitable for immediate‑ and extended‑release tablet technologies due to small‑molecule stability and solid‑state robustness.
- Food can delay absorption modestly, but no major formulation constraints arise from food effects.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patent protections for the API expired between 2011 and 2016, indicating that the product is now in a mature post‑exclusivity phase. With availability across Canada, the US, and the EU, the market is characterized by established competition and stable generic entry. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Pioglitazone was originally developed by an originator company with global commercialization, but the listed patents expired between 2011 and 2016, indicating that generic manufacturing is well established. Branded and generic products are present across the US, EU, and Canada, supported by a wide network of packagers and distributors. The mature patent landscape and broad market coverage reflect an environment with sustained generic competition. |
|---|
Safety
| Toxicity | The oral TDLo observed in mice is 24 mg/kg for 4 days and for rats is 3 mg/kg for 6 days. One instance of overdose was reported during clinical trials with pioglitazone in which a patient took an oral dose of 120mg daily for four days, followed by 180mg daily for seven days- this patient did not report any adverse clinical symptoms during this time. In the event of overdosage, employ symptomatic and supportive measures according to the patient's clinical status. |
|---|
- Low‑range oral TDLo values reported in rodents (mice: 24 mg/kg over 4 days
- Rats: 3 mg/kg over 6 days) indicate measurable toxicity margins relevant for hazard assessment during API handling
- Clinical trial exposure up to 180 mg/day for short duration produced no observed acute adverse effects, suggesting low acute human toxicity but not excluding risk under concentrated manufacturing conditions
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Pioglitazone is a type of Glitazones
Glitazones, also known as thiazolidinediones (TZDs), are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of type 2 diabetes mellitus. These compounds act as insulin sensitizers, enhancing the body's response to insulin, thereby promoting glucose utilization and regulating blood sugar levels.
Glitazones exert their therapeutic effects by activating the peroxisome proliferator-activated receptor gamma (PPAR-γ), a nuclear receptor found predominantly in adipose tissue. PPAR-γ activation leads to improved insulin sensitivity in adipocytes, skeletal muscle cells, and hepatocytes, resulting in decreased hepatic glucose production and increased glucose uptake in peripheral tissues.
The primary glitazone medications available in the market include rosiglitazone and pioglitazone. These drugs are administered orally and are typically prescribed in conjunction with other antidiabetic medications, such as metformin or sulfonylureas, to achieve optimal glycemic control.
Glitazones are characterized by their high specificity for PPAR-γ receptors, which distinguishes them from other antidiabetic drug classes. However, their use may be associated with certain adverse effects, such as weight gain, fluid retention, and an increased risk of heart failure. Therefore, close monitoring and individual patient assessment are essential when prescribing glitazones.
In conclusion, glitazones are a valuable class of pharmaceutical APIs utilized in the management of type 2 diabetes. Their ability to enhance insulin sensitivity through PPAR-γ activation makes them an effective therapeutic option, albeit with potential side effects that require careful consideration in clinical practice.
Pioglitazone (Glitazones), classified under Anti-diabetics
Anti-diabetics, belonging to the pharmaceutical API (Active Pharmaceutical Ingredient) category, are a group of compounds designed to manage and treat diabetes mellitus, a chronic metabolic disorder characterized by high blood sugar levels. These medications play a vital role in controlling diabetes and preventing complications associated with the disease.
Anti-diabetics encompass a wide range of drug classes, including biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists. Each class works through different mechanisms to regulate blood sugar levels and improve insulin sensitivity.
Biguanides, such as metformin, reduce glucose production by the liver and enhance insulin sensitivity in peripheral tissues. Sulfonylureas, like glipizide, stimulate insulin secretion from pancreatic beta cells. Thiazolidinediones, including pioglitazone, improve insulin sensitivity in muscle and adipose tissues. DPP-4 inhibitors, such as sitagliptin, increase insulin release and inhibit glucagon secretion. SGLT2 inhibitors, like dapagliflozin, decrease renal glucose reabsorption, leading to increased urinary glucose excretion. GLP-1 receptor agonists, such as exenatide, enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety.
These anti-diabetic APIs serve as the foundational ingredients for the formulation of various oral tablets, capsules, and injectable medications used in the treatment of diabetes. By targeting different aspects of glucose regulation, they help patients achieve and maintain optimal blood sugar levels, thus reducing the risk of diabetic complications, such as cardiovascular disease, neuropathy, and nephropathy.
It is crucial for healthcare professionals to prescribe and administer these anti-diabetic medications appropriately, considering factors like the patient's medical history, co-existing conditions, and potential drug interactions. Regular monitoring of blood glucose levels and close medical supervision are necessary to ensure effective diabetes management.
In conclusion, anti-diabetics form a critical category of pharmaceutical APIs used for the treatment of diabetes. These compounds, encompassing various drug classes, work through distinct mechanisms to regulate blood sugar levels and improve insulin sensitivity. By facilitating glucose control, anti-diabetic APIs help mitigate the risk of complications associated with diabetes mellitus, ultimately promoting better health outcomes for patients.
Pioglitazone API manufacturers & distributors
Compare qualified Pioglitazone API suppliers worldwide. We currently have 20 companies offering Pioglitazone API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aarambh Life Science | Producer | India | India | CoA, GMP | 19 products |
| Biocon | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 36 products |
| Cipla | Producer | India | India | CoA, USDMF | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, MSDS, USDMF, WC | 170 products |
| Erregierre | Producer | Italy | Italy | CoA, USDMF | 44 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CoA, JDMF | 18 products |
| Hetero Drugs | Producer | India | India | CEP, CoA, GMP, JDMF | 98 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 90 products |
| Ind-Swift Labs. | Producer | India | India | CoA, FDA, GMP, KDMF, USDMF, WC | 27 products |
| Inist St Co. | Producer | South Korea | South Korea | CoA, JDMF | 8 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| MSN Organics | Producer | India | India | CEP, CoA, FDA, KDMF, USDMF, WC | 21 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sumitomo Chemical | Producer | Japan | Japan | CoA, JDMF | 28 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| USV | Producer | India | India | CoA, FDA, GMP, KDMF, USDMF, WC | 35 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
| Zhejiang Huayi | Producer | China | China | CEP, CoA, FDA, WC | 9 products |
When sending a request, specify which Pioglitazone API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Pioglitazone API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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