NDAORALTABLET
Approved
Oct 2006
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
5/8 — Partial
Drug data last refreshed 12h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JANUVIA (sitagliptin) is an oral small-molecule DPP-4 inhibitor approved in 2006 for type 2 diabetes management. It works by increasing incretin hormone levels to stimulate insulin secretion in response to glucose elevation. The drug is typically used as monotherapy or in combination with other antidiabetic agents.
$4.1BPart D
LOE ApproachingDeclining
8mo to LOEMature franchise nearing patent cliff (0.7 years to LOE); brand team focus shifting to lifecycle extension and managed decline strategy.
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 (20)
A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
Started Apr 2026
12 enrolled
Healthy Volunteers
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator
Started Jun 2024
34 enrolled
Healthy Subjects
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
Started Apr 2024
34 enrolled
Healthy Subjects
Bioequivalence Study of Sitagliptin/Metformin Extended-Release Tablets in Healthy Subjects
Started Feb 2023
76 enrolled
Healthy Volunteers
Semaglutide vs Sitagliptin
Started Oct 2022
58 enrolled
Liver Transplant; ComplicationsDiabetes MellitusNASH - Nonalcoholic Steatohepatitis+1 more
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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.