NDAORALTABLET
Approved
Jan 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
19
Data completeness
4/8 — Partial
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OSENI is a fixed-dose combination tablet combining alogliptin (a DPP-4 inhibitor) and pioglitazone (a thiazolidinedione) for oral treatment of type 2 diabetes. It works by increasing insulin secretion and improving insulin sensitivity to help control blood glucose levels. This combination product targets patients inadequately controlled on monotherapy or those requiring dual-agent therapy.
$0.257MPart D
LOE Approaching3.1 years to LOEProduct approaching loss of exclusivity with minimal Part D spending signals a contracting team focused on transition planning and generic defense strategies.
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 (19)
Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus
Started Jul 2017
0Diabetes Mellitus, Type 2
Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
Started Feb 2017
1,026 enrolled
Type 2 Diabetes Mellitus
An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
Started Sep 2016
1,409 enrolled
Diabetes Mellitus
Phase 1 Bioavailability Study of SYR-322MET
Started Apr 2016
24 enrolled
Healthy Volunteers
Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"
Started Jun 2014
964 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.