TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

STEGLATRO

ERTUGLIFLOZIN
Metabolic Approved 2017-12-19

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.

Source: FDA Label • Merck

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.

Source: FDA Label
2
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-12-19
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: ERTUGLIFLOZIN

STEGLATRO Approval History

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What STEGLATRO Treats

1 indications

STEGLATRO 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
Source: FDA Label

STEGLATRO Target & Pathway

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Target

SGLT2 (Sodium-Glucose Co-Transporter 2) Transporter

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

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10 other drugs also target SGLT2. Compare mechanisms, indications, and trial activity.

View all 10 SGLT2 drugs →
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (SGLT2). Earlier expiry dates signal biosimilar/generic opportunities.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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Indications & 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

Latest Patent: Jul 2030

Patents (4 active)

US8080580 Expires Jul 13, 2030
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.