Pioglitazone: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Pioglitazone appears in the FDA drug-label database. Marketed as PIOGLITAZONE.
- Drug class
- Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; Thiazolidinedione (FDA established pharmacologic class)
- Mechanism of action
- Peroxisome Proliferator-activated Receptor alpha Agonists; Peroxisome Proliferator-activated Receptor gamma Agonists (as stated on the FDA label)
- Boxed warning
- The FDA label for Pioglitazone carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Monotherapy and Combination Therapy Pioglitazone tablets are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . Important Limitations of Use Pioglitazone tablets exert their antihyperglycemic effects only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3) ] . Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ( 1 , 14 ) Important Limitations of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Superpotent — Macleods Pharma Usa Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-09-23 |
| Superpotent and Failed Tablet/Capsule Specifications — Aurobindo Pharma USA Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-12-29 |
| Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. — Macleods Pharma Usa Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2020-01-24 |
Phase breakdown
Conditions being studied
Recruiting trials involving Pioglitazone
- A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
- Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
- Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
- Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
- Insulin Regulation of Lipolysis and Lipolysis Proteins
- Low-Dose Pioglitazone in Patients With NASH (AIM 2)
- Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide
- Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
- Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
- Quantifying Hepatic Mitochondrial Fluxes in Humans
- Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Common questions
Is Pioglitazone FDA-approved?
Yes, marketed as PIOGLITAZONE. Its FDA label carries a boxed warning.
How many recruiting trials involve Pioglitazone?
11 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.