NDAORALTABLET
Approved
Jan 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
27
Data completeness
4/8 — Partial
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OSENI is a fixed-dose combination tablet containing alogliptin benzoate (a dipeptidyl peptidase-4 inhibitor) and pioglitazone hydrochloride (a thiazolidinedione), approved by the FDA in January 2013. It is indicated for type 2 diabetes mellitus in patients inadequately controlled on monotherapy or those already receiving both agents separately. The combination works by increasing insulin sensitivity and stimulating pancreatic beta cells to enhance glucose control.
$0.257MPart D
LOE ApproachingDeclining
2.6 years to LOEMinimal commercial activity with only $257K in Part D spending (339 claims in 2023) signals a mature, niche product with limited team expansion opportunities and likely efficiency-driven operations.
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 (27)
Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
Started Sep 2026
400 enrolled
Thoracolumbar Spinal Fusion
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
Started May 2018
72 enrolled
Healthy Volunteers
Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus
Started Jul 2017
0Diabetes Mellitus, Type 2
Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function
Started Jul 2017
96 enrolled
Diabetes
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
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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.