STEGLUJAN (ertugliflozin) · Merck
Steglujan is a fixed-dose combination of ertugliflozin (an SGLT2 inhibitor) and sitagliptin (a DPP-4 inhibitor) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not recommended for use in patients with type 1 diabetes. Steglujan 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 pancreatitis while using this therapy.
How STEGLUJAN Works
Steglujan utilizes two complementary mechanisms to improve glycemic control. The **ertugliflozin** component inhibits the sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubules, which reduces the reabsorption of filtered glucose and lowers the renal threshold for glucose, resulting in increased urinary glucose excretion. The **sitagliptin** component is a DPP-4 inhibitor that slows the inactivation of incretin hormones, such as GLP-1 and GIP. By increasing and prolong
Details
- Status
- Prescription
- First Approved
- 2017-12-19
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
STEGLUJAN Approval History
What STEGLUJAN Treats
1 indicationsSTEGLUJAN is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
STEGLUJAN 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.
STEGLUJAN 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 STEGLUJAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications STEGLUJAN treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
STEGLUJAN FDA Label Details
Indications & Usage
FDA Label (PDF)STEGLUJAN ® is 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 [see Warnings and Precautions ]. Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions ] . STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT...
STEGLUJAN Patents & Exclusivity
Patents (5 active)
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Deep insights for STEGLUJAN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 20 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.