NDAORALTABLET
Approved
Aug 2005
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
30
Data completeness
5/8 — Partial
Drug data last refreshed 1h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTOPLUS MET is a fixed-dose oral combination of pioglitazone (a thiazolidinedione PPARγ agonist) and metformin (a biguanide), approved for type 2 diabetes mellitus. It combines insulin sensitization in peripheral tissues and liver with hepatic glucose suppression and improved peripheral glucose uptake. The dual mechanism targets insulin resistance through complementary pathways without inducing hypoglycemia.
$0.131MPart D
LOE ApproachingDeclining
<0.1% of type 2 diabetes combination oral market
2.6 years to LOEProduct is in endgame phase with minimal market presence; brand team downsizing is typical at this stage.
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)
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
Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
Started Jun 2011
1,168 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
Worked on ACTOPLUS MET at Takeda? Share your interview experience or compensation data (+7 days Pro)
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.