Ertugliflozin

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2.

• 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.ICD-10: E11.9

• STEGLATRO is contraindicated in patients with hypersensitivity to ertugliflozin or any excipient in STEGLATRO. Reactions such as angioedema have occurred [see Adverse Reactions (6.2) ].contraindicated

Assess renal function before initiating and as clinically indicated. ( 2.1 ) Correct volume depletion before initiating STEGLATRO. ( 2.1 ) Recommended starting dosage is 5 mg orally once daily, taken in the morning, with or without food. ( 2.2 ) Increase dosage to 15 mg orally once daily in those tolerating STEGLATRO and needing additional glycemic control. ( 2.2 ) Use is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2 . ( 2.2 ) Withhold STEGLATRO for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.3 ) 2.1 Prior to Initiation of STEGLATRO Assess renal function before initiating STEGLATRO and as clinically indicated [see Warnings and Precautions (5.3) ] . Assess volume status. In patients with volume depletion, correct this condition before initiating STEGLATRO [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5 , 8.6) ]. 2.2 Recommended Dosage The recommended starting dosage of STEGLATRO is 5 mg orally once daily, taken in the morning, with or without food. For additional glycemic control, the dosage may be increased to 15 mg orally once daily in patients tolerating STEGLATRO. Use of STEGLATRO is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2 . 2.3 Temporary Interruption for Surgery Withhold STEGLATRO for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting.

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue STEGLATRO if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. ( 5.1 ) Lower Limb Amputation: Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur. ( 5.2 ) Volume Depletion: May result in acute kidney injury. Before initiating, assess and correct volume status in patients with renal impairment or low systolic blood pressure, elderly patients, or patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.3 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. ( 5.4 ) Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. ( 5.5 ) Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment. ( 5.6 ) Genital Mycotic Infections: Monitor and treat if indicated.

The following important adverse reactions are described elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Lower Limb Amputation [see Warnings and Precautions (5.2) ] Volume Depletion [see Warnings and Precautions (5.3) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.6) ] Genital Mycotic Infections [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥ 5%) were female genital mycotic infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pool of Placebo-Controlled Trials Evaluating STEGLATRO 5 and 15 mg The data in Table 1 are derived from a pool of three 26-week, placebo-controlled trials. STEGLATRO was used as monotherapy in one trial and as add-on therapy in two trials [see Clinical Studies (14) ] . These data reflect exposure of 1,029 patients to STEGLATRO with a mean exposure duration of approximately 25 weeks.

Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. ( 8.1 ) Lactation: Breastfeeding not recommended. ( 8.2 ) Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume. ( 8.5 ) Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function. ( 8.6 ) 8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, STEGLATRO is not recommended during the second and third trimesters of pregnancy. The limited available data with STEGLATRO in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13 times the maximum clinical dose caused renal pelvic and tubule dilatations and renal mineralization that were not fully reversible.

Metabolism

The pharmacokinetics of ertugliflozin are similar in healthy subjects and patients with type 2 diabetes mellitus. The steady state mean plasma AUC and C max were 398 ng∙hr/mL and 81.3 ng/mL, respectively, with 5 mg ertugliflozin once-daily treatment, and 1,193 ng∙hr/mL and 268 ng/mL, respectively, with 15 mg ertugliflozin once-daily treatment.

In the event of an overdose with STEGLATRO, contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ the usual supportive measures as dictated by the patient's clinical status. Removal of ertugliflozin by hemodialysis has not been studied.

• Dec 19, 2017NDANDA209803Msd Sub Merck
• Dec 19, 2017NDANDA209805Msd Sub Merck
• Dec 19, 2017NDANDA209806Msd Sub Merck

1. 1Nausea957.6%
2. 2Product Dose Omission Issue897.1%
3. 3Vomiting816.5%
4. 4Urinary Tract Infection705.6%
5. 5No Adverse Event695.5%
6. 6Fungal Infection635.0%
7. 7Blood Glucose Increased604.8%
8. 8Diabetic Ketoacidosis594.7%
9. 9Diarrhoea514.1%
10. 10Dizziness493.9%
11. 11Drug Ineffective483.8%
12. 12Product Dose Omission342.7%
13. 13Rash322.6%
14. 14Decreased Appetite302.4%
15. 15Product Use Issue302.4%

The 10 most recently updated of 49 ClinicalTrials.gov registrations naming Ertugliflozin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Ertugliflozin: Cardioprotective Effects on Epicardial Fat
  Completed · Early phase 1 · Interventional · 61 enrolled · Stanford University
  NCT04167761updated 2026-06-04
• Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
  Not yet recruiting · Phase 4 · Interventional · 476 enrolled · Shanghai Zhongshan Hospital
  NCT07621380updated 2026-06-02
• Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
  Active not recruiting · Observational · 781,430 enrolled · Brigham and Women's Hospital
  NCT05220917updated 2026-05-15
• ERTU-SODIUM: Study on the Effects of Ertugliflozin on Sodium Storage, Interstitial Volume, and Plasma Volume in HFrEF
  Completed · Phase 4 · Interventional · 28 enrolled · Icahn School of Medicine at Mount Sinai
  NCT05152940updated 2026-05-11
• Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research Institute
  NCT07547878updated 2026-05-08
• DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study
  Completed · Phase 4 · Interventional · 41 enrolled · Amsterdam UMC, location VUmc
  NCT05727579updated 2026-04-15
• Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers
  Active not recruiting · Phase 1 · Interventional · 9 enrolled · AdventHealth Translational Research Institute
  NCT05662865updated 2026-03-30
• Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets in Healthy, Adult, Human Subjects Under Fed Condition.
  Completed · Phase 1 · Interventional · 36 enrolled · Humanis Saglık Anonim Sirketi
  NCT07266779updated 2025-12-05
• Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
  Completed · Phase 3 · Interventional · 166 enrolled · Merck Sharp & Dohme LLC
  NCT04029480updated 2025-10-31
• Ertugliflozin in Chronic Heart Failure
  Recruiting · Phase 2 · Interventional · 60 enrolled · Yale University
  NCT04438213updated 2025-10-08

Frequently asked questions

How does Ertugliflozin work?

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2.

What is Ertugliflozin used for?

According to FDA labeling, Ertugliflozin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ertugliflozin?

Ertugliflozin is classified as Sodium-glucose co-transporter 2 (SGLT2) inhibitors, Sodium-Glucose Transporter 2 Inhibitors.

What are the brand names for Ertugliflozin?

Ertugliflozin is marketed under brand names including Segluromet, Steglatro, Steglujan.

What are the contraindications for Ertugliflozin?

Ertugliflozin labeling lists contraindications including: STEGLATRO is contraindicated in patients with hypersensitivity to ertugliflozin or any excipient in STEGLATRO. Reactions such as angioedema have occurred [see Adverse Reactions (6.2) ].. Always consult the full prescribing information and a clinician.