SEGLUROMET (ertugliflozin)
Segluromet is a combination medication used for adults with type 2 diabetes to help manage blood sugar levels alongside diet and exercise. It brings together two different types of medicine to provide a dual approach to glycemic control. This therapy is specifically for type 2 diabetes and is not recommended for patients with type 1 diabetes.
How SEGLUROMET Works
This drug works by using two distinct pathways to lower blood sugar. Ertugliflozin blocks the SGLT2 transporter in the kidneys, which prevents glucose from being reabsorbed into the blood and instead allows it to be removed through urine. Meanwhile, metformin reduces the amount of glucose the liver produces and the intestines absorb, while also helping the body's cells use insulin more effectively.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-12-19
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
SEGLUROMET Approval History
What SEGLUROMET Treats
1 indicationsSEGLUROMET 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
SEGLUROMET Boxed Warning
LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuri...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ] . Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7) , and Use in Specific Populations (8.6 , 8.7 )] . If metformin-associated lactic acidosis is suspected, immediately discontinue SEGLUROMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1) ] . WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning . Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/
SEGLUROMET 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.
SEGLUROMET 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 SEGLUROMET's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SEGLUROMET treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SEGLUROMET
3 of 20FDA-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.
SEGLUROMET FDA Label Details
Indications & Usage
FDA Label (PDF)SEGLUROMET is indicated for the treatment of Type 2 Diabetes.
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias...
Pro Intelligence Preview
Deep insights for SEGLUROMET
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 48 active patents
Trial Analysis
- • 14 total trials
- • Stage: Declining
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment