TRADJENTA
Tradjenta (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The medication is not recommended for use in patients with type 1 diabetes, as it would not be effective in that population. Additionally, the drug has not been studied in patients with a history of pancreatitis, and it is unknown if these patients are at an increased risk for developing the condition while using this treatment.
How TRADJENTA Works
Linagliptin functions by inhibiting DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By blocking this enzyme, the drug increases the concentrations of active incretin hormones, which stimulate the release of insulin from pancreatic beta cells in a glucose-dependent manner. Furthermore, these hormones reduce glucagon secretion from pancreatic alpha-cells, resulting in a reduction of hepatic glucose output.
Details
- Status
- Prescription
- First Approved
- 2011-05-02
- Routes
- ORAL
- Dosage Forms
- TABLET
TRADJENTA Approval History
What TRADJENTA Treats
1 indicationsTRADJENTA is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
TRADJENTA 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.
TRADJENTA Competitors
Pro6 other drugs also target GLP-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (GLP-1). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
TRADJENTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use Not recommended in patients with type 1 diabetes mellitus as it would not be effective Has not been studied in patients with a history of pancreatitis Limitations of Use TRADJENTA is not recommended in patients with type 1 diabetes mellitus as it would not be effective. TRADJENTA has...
TRADJENTA Patents & Exclusivity
Patents (16 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.