NDAORALTABLET
Approved
Jul 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
5/8 — Partial
DUETACT (pioglitazone and glimepiride) by Takeda. Approved for sulfonylurea [epc]. First approved in 2006.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DUETACT is an oral combination tablet containing pioglitazone (thiazolidinedione) and glimepiride (sulfonylurea) approved in 2006 for type 2 diabetes management. It combines insulin sensitization with insulin secretion stimulation to improve glycemic control. The fixed-dose combination targets patients requiring dual-agent therapy who have inadequate control on monotherapy.
LOE Approaching1.7 years to LOE
Product is in final years before loss of exclusivity with limited commercial growth opportunity; smaller brand teams likely focusing on transition planning and generic erosion mitigation.
Mechanism of Action
Pharmacologic Class:
Sulfonylurea
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.
Started Dec 2006
91 enrolled
Diabetes Mellitus
Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.
Started Aug 2006
63 enrolled
Oxidative StressCoronary Artery DiseaseType 2 Diabetes
Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease.
Started Oct 2003
458 enrolled
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.