STEGLATRO
Steglatro (ertugliflozin) is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated for use in adults with type 2 diabetes mellitus. It is used as an adjunct to diet and exercise to improve glycemic control. The medication is not recommended for improving glycemic control in patients with type 1 diabetes mellitus.
How STEGLATRO Works
Ertugliflozin functions by inhibiting the sodium glucose co-transporter 2 (SGLT2), which is the primary transporter responsible for reabsorbing glucose from the kidneys back into the bloodstream. By blocking this transporter, the drug reduces the renal reabsorption of filtered glucose. This process lowers the renal threshold for glucose and increases the amount of glucose excreted through the urine.
Details
- Status
- Prescription
- First Approved
- 2017-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET
STEGLATRO Approval History
What STEGLATRO Treats
1 indicationsSTEGLATRO is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
STEGLATRO Target & Pathway
ProTarget
A transporter in the kidney that reabsorbs glucose back into the bloodstream. Blocking SGLT2 causes excess glucose to be excreted in urine, lowering blood sugar. These drugs also provide cardiovascular and kidney protection beyond glucose control.
STEGLATRO Competitors
Pro10 other drugs also target SGLT2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (SGLT2). 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.
STEGLATRO FDA Label Details
ProIndications & Usage
FDA Label (PDF)STEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. STEGLATRO is a sodium glucose co-transporter 2 (SGLT2) 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 for use to improve glycemic control in patients with type 1 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ] .
STEGLATRO Patents & Exclusivity
Patents (4 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.