Last reviewed · How we verify
Actos (pioglitazone)
At a glance
| Generic name | pioglitazone |
|---|---|
| Sponsor | Takeda |
| Target | CDGSH iron-sulfur domain-containing protein 2, Bile salt export pump, CDGSH iron-sulfur domain-containing protein 1 |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Diabetes mellitus type 2
Boxed warnings
- 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)
Common side effects
- Upper respiratory tract infection
- Headache
- Sinusitis
- Myalgia
- Pharyngitis
Serious adverse events
- Congestive heart failure
Key clinical trials
- Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT (Phase 4)
- A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in Patients With Castration-resis (Phase 1)
- The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients (Phase 4)
- A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR3003" and Co-administration of "BR3003B" and "BR3003C" (Phase 1)
- Effects of Thiazolidinediones on Human Bone Marrow Stromal Cell Differentiation Capacity:In Vitro and In Vivo- A Pilot Study (NA)
- Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss (Phase 4)
- A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCl (ACTOS™) in Combination With TAK-536 in Subjects With Typ (Phase 2)
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Finding Study of Once-Daily Dosing of Sitaglipin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycem (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Actos CI brief — competitive landscape report
- Actos updates RSS · CI watch RSS
- Takeda portfolio CI