ACTOS (pioglitazone hydrochloride)
ACTOS helps adults with type 2 diabetes manage their blood sugar levels when used alongside diet and exercise. It is used in various clinical settings, either as a standalone therapy or in combination with other medications. Because the drug relies on the body's own insulin to function, it is not used for patients with type 1 diabetes or diabetic ketoacidosis.
How ACTOS Works
This medication works by activating PPAR-gamma receptors in the liver, fat, and muscle tissue, which modulates the activity of genes involved in glucose and lipid metabolism. This process reduces insulin resistance, allowing the body to use its existing insulin more effectively to dispose of glucose. Consequently, the drug helps lower the amount of sugar produced by the liver and improves glucose uptake in peripheral tissues.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-07-15
- Routes
- ORAL
- Dosage Forms
- TABLET
ACTOS Approval History
What ACTOS Treats
1 indicationsACTOS is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
ACTOS Boxed Warning
CONGESTIVE HEART FAILURE • Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . • After initiation of ACTOS, 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 ACTOS must be consid...
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . • After initiation of ACTOS, 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 ACTOS must be considered. • ACTOS is not recommended in patients with symptomatic heart failure. • Initiation of ACTOS 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 ACTOS, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) • After initiation of ACTOS, 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 ACTOS must be considered. ( 5.1 ) • ACTOS is not recommended in patients with symptomatic heart failure. ( 5.1 ) • Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ( 4 , 5.1 )
ACTOS 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 ACTOS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ACTOS treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06446531 Pre-DM | STUDY00000485 Pre-DM | Ph 1 | recruiting | Prevention of Progression of Prediabetes, Obesity and CV Risk |
| NCT02278562 INSPIRED results posted | NEPH-011-11S | Ph 2 | completed | Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2 |
| 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 |
| NCT00814372 | M102-20814 | Ph 2 | terminated | Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin |
| 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.
ACTOS FDA Label Details
Indications & Usage
FDA Label (PDF)ACTOS is indicated for the treatment of Type 2 Diabetes.
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . • After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure ...
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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