JANUVIA (sitagliptin phosphate)
Januvia (sitagliptin phosphate) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated to improve glycemic control in adults with type 2 diabetes mellitus. The medication is used as an adjunct to diet and exercise to manage blood glucose levels. It is not indicated for use in patients with type 1 diabetes or those with a history of pancreatitis.
How JANUVIA Works
Sitagliptin inhibits the enzyme DPP-4, which is responsible for the rapid inactivation of incretin hormones such as GLP-1 and GIP. By blocking this enzyme, the drug increases and prolongs the activity of these hormones, which are released by the intestine in response to food. These incretins stimulate insulin synthesis and release while lowering glucagon secretion, thereby reducing glucose production in the liver. This therapeutic effect occurs in a glucose-dependent manner, activating primarily when blood glucose concentrations are normal or elevated.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-10-16
- Patent Cliff
- 2023
- Revenue
- $350M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
JANUVIA Approval History
What JANUVIA Treats
1 indicationsJANUVIA is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
JANUVIA Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
JANUVIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JANUVIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JANUVIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to JANUVIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01131182 results posted | 0431-263 2010_538 | Ph 4 | completed | Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263) |
| NCT01177384 results posted | 0431-130 2010_543, CTRI/2011/10/002072 | Ph 3 | completed | Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130) |
| NCT00947011 results posted | NA_00018441 | Ph 2 | terminated | Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1) |
| NCT01076075 results posted | 0431-229 2010_513, MK-0431-229 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229) |
| NCT01189890 results posted | 0431-251 | Ph 3 | completed | Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251) |
| NCT01034111 results posted | 0431-178 2009_705 | Ph 3 | completed | A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178) |
| NCT00833027 results posted | 0431-103 MK0431-103, 2009_527 | Ph 4 | completed | ALPHA Sitagliptin Add on to Metformin (0431-103) |
| NCT00830076 results posted | 0431-110 2009_521 | Ph 1 | completed | A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110) |
| NCT00722371 results posted | 0431-102 2008_522 | Ph 3 | completed | MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2) |
| NCT00730275 results posted | 0431-081 2008_540 | Ph 1 | completed | A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081) |
| NCT00929201 results posted | 0431A-080 MK-0431A-080, 2009_607 | Ph 1 | completed | Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080) |
| NCT00642798 | 0431-108 2008_002 | Ph 1 | completed | An Open-Label, Single- & Multiple-Dose Study to Investigate the Pharmacokinetics of Sitagliptin 100 mg in Healthy Chinese Adult Subjects (0431-108)(COMPLETED) |
| NCT00847080 | MK-0431 | Ph 4 | completed | Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JANUVIA FDA Label Details
Indications & Usage
FDA Label (PDF)JANUVIA is indicated for the treatment of Type 2 Diabetes.
JANUVIA Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for JANUVIA
Revenue Insights
- • Q4-2025: $350M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2023
- • 18 active patents
Trial Analysis
- • 14 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment