PIOGLITAZONE HYDROCHLORIDE
Pioglitazone hydrochloride helps adults with type 2 diabetes improve their blood sugar control when used alongside diet and exercise. It can be used as a standalone therapy or in combination with other medications to manage the condition. Because the drug requires the presence of the body's own insulin to function, it is not used for patients with type 1 diabetes or diabetic ketoacidosis.
How PIOGLITAZONE HYDROCHLORIDE Works
This medication works by activating PPAR-gamma receptors in the liver, muscles, and fat tissue to improve how the body responds to insulin. This process reduces insulin resistance, which allows for better glucose disposal and decreases the amount of sugar the liver produces.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-08-17
- Routes
- ORAL
- Dosage Forms
- TABLET
PIOGLITAZONE HYDROCHLORIDE Approval History
What PIOGLITAZONE HYDROCHLORIDE Treats
1 indicationsPIOGLITAZONE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
PIOGLITAZONE HYDROCHLORIDE Boxed Warning
CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone , and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazon...
WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone , and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. Pioglitazone is not recommended in patients with symptomatic heart failure. Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning. Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. (5.1) After initiation of pioglitazone, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. (5.1) Pioglitazone is not recommended in patients with symptomatic heart failure. (5.1) Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. (4 , 5.1)
PIOGLITAZONE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PIOGLITAZONE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PIOGLITAZONE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PIOGLITAZONE HYDROCHLORIDE
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01352182 results posted | PIOSEPSIS1217 | Ph 1, Ph 2 | completed | Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock |
| NCT03457597 | CORT125134-126 | Ph 1 | completed | Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s |
| NCT01342770 results posted | NCI-2011-03826 NCI-2011-03826, MAYO-MAY10-15-02 | Ph 2 | terminated | Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer |
| NCT00604578 | 080047 08-H-0047 | Ph 2 | withdrawn | Pioglitazone Hydrochloride (Actos(Registered Trademark)) to Treat Asthma |
| NCT00722371 results posted | 0431-102 2008_522 | Ph 3 | completed | MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2) |
| NCT00951379 results posted | NCI-2012-03152 NCI-2012-03152, UWI H-2009-0106 | Ph 2 | terminated | Pioglitazone for Oral Premalignant Lesions |
| NCT02473627 | DS1971-A-E105 | Ph 1 | completed | A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS |
| NCT01589445 T2DMCT results posted | BS-67/2008-09 BMRC/ERC/2007-2010/2024 | Ph 4 | completed | Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects |
| NCT00680745 results posted | D1690C00005 | Ph 3 | completed | Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients |
| NCT01088919 | 1941-CL-0060 | Ph 1 | completed | A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PIOGLITAZONE HYDROCHLORIDE FDA Label Details
Indications & Usage
PIOGLITAZONE HYDROCHLORIDE is indicated for the treatment of Type 2 diabetes mellitus.
WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone , and after dose increases, monitor patients carefully for signs and symptoms of heart...
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ACTOS
Full clinical data, patents, trials, and competitive landscape for pioglitazone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment