STEGLATRO (ertugliflozin)
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
- Patent Cliff
- 2031
- 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 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 STEGLATRO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications STEGLATRO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to STEGLATRO
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05152940 ERTU-SODIUM | PD21-12423 | Ph 4 | completed | ERTU-SODIUM: Study on the Effects of Ertugliflozin on Sodium Storage, Interstitial Volume, and Plasma Volume in HFrEF |
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT04438213 | 2000027951 MISP59625 | Ph 2 | recruiting | Ertugliflozin in Chronic Heart Failure |
| NCT03416270 ERADICATE-HF results posted | 17-5627 | Ph 2 | completed | ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure |
| NCT04231331 EFFORT results posted | 2019-1690 | Ph 3 | completed | Ertugliflozin for Functional Mitral Regurgitation |
| NCT03717194 ERTU-GLS results posted | B-2018-498-002 | Ph 3 | completed | Effect of Ertugliflozin on Cardiac Function in Diabetes |
| NCT01986881 results posted | 8835-004 2013-002518-11, B1521021 | Ph 3 | completed | Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004) |
| NCT01018823 | 8835-037 | Ph 1 | completed | A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037) |
| NCT00989079 | 8835-036 | Ph 1 | completed | A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036) |
| NCT03640221 Ertugliflozin | 51991 | Ph 4 | withdrawn | Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes. |
| NCT01948986 results posted | 8835-009 B1521023, MK-8835-009 | Ph 1 | completed | Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009) |
| NCT02226003 results posted | 8835-017 2014-001049-25, B1521047 | Ph 3 | completed | Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017) |
| NCT01223339 | 8835-041 | Ph 1 | completed | Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041) |
| NCT01127308 | 8835-038 | Ph 1 | completed | A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038) |
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
Indications & Usage
FDA Label (PDF)STEGLATRO is indicated for the treatment of Type 2 diabetes mellitus.
STEGLATRO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for STEGLATRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 6 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.