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Label indication Monotherapy and Combination Therapy ACTOS is indicated as an adjunct 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 ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. FDA label
Pioglitazone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Pioglitazone HCl Tablets 45 mg |
| 2 | ACTIVE_COMPARATOR | Actos® Tablets 45 mg |
| Name | Type | Description |
|---|---|---|
| Pioglitazone HCl Tablets 45 mg | DRUG | 45mg, single dose fed |
| Actos® Tablets 45 mg | DRUG | 45mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...
Pioglitazone is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development, and the specific indication has not been disclosed. It is also known as Pioglitazone HCl Tablets 45 mg. The program includes two completed Phase 1 trials conducted in the United States.
Pioglitazone targets PPARG, the peroxisome proliferator-activated receptor gamma. It acts as an agonist at this receptor, meaning it activates PPARG signaling. PPARG is a nuclear receptor involved in regulating gene expression. This mechanism is the basis for the drug's activity as a small molecule therapeutic candidate.
Pioglitazone is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the clinical development program for this asset. The drug is formulated as Pioglitazone HCl Tablets 45 mg.
Pioglitazone is in Phase 1 clinical development. It is an investigational drug and is not approved. The program lists two completed Phase 1 trials with no active trials currently ongoing. Both studies were randomized, active-controlled, and enrolled a total of 76 participants.
Pioglitazone has been studied in two completed Phase 1 trials. NCT00649558 was a fasting study comparing Pioglitazone HCl Tablets 45 mg with Actos Tablets 45 mg, enrolling 36 healthy volunteers. NCT00649012 was a food-effect study of the same comparison, enrolling 40 healthy volunteers. Both trials were conducted in the United States.