NDAORALTABLET
Approved
Aug 2005
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
30
Data completeness
5/8 — Partial
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTOPLUS MET is a fixed-dose combination of pioglitazone (a thiazolidinedione insulin sensitizer) and metformin (a biguanide), approved in 2005 for oral treatment of type 2 diabetes. It combines two complementary mechanisms to improve glycemic control by enhancing insulin sensitivity and reducing hepatic glucose production. This adjunct therapy is used in patients inadequately controlled on either agent alone.
$0.131MPart D
LOE ApproachingDeclining
2.5 years to LOEMinimal current commercial activity signals a mature, low-revenue product with contracted team resources and limited growth opportunity.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (30)
Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
Started Jun 2011
1,168 enrolled
Type 2 Diabetes
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
Started Jun 2011
294 enrolled
Type 2 Diabetes
Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus
Started Jul 2010
1,103 enrolled
Type 2 Diabetes Mellitus
HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
Started Oct 2009
4 enrolled
HIV Infections
Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Started Jul 2009
1,067 enrolled
Type 2 Diabetes Mellitus
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.