Last reviewed 2026-04-20 · How we verify

Steglatro (ERTUGLIFLOZIN)

Steglatro works by blocking the kidneys' ability to reabsorb glucose, allowing excess glucose to be excreted in the urine.

Steglatro (ertugliflozin) is a small molecule medication originally developed by Merck Sharp Dohme and currently owned by MSD Sub Merck. It targets the low-affinity sodium-glucose cotransporter, a protein responsible for glucose reabsorption in the kidneys. Steglatro is FDA-approved for the treatment of type 2 diabetes mellitus and is available in both patented and generic forms. As a sodium-glucose cotransporter 2 (SGLT2) inhibitor, Steglatro works by reducing glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine. It is considered a valuable treatment option for patients with type 2 diabetes, particularly those with established cardiovascular disease.

At a glance

Mechanism of action

Think of your kidneys like a filter that helps remove waste and excess fluids from your blood. In people with type 2 diabetes, the kidneys have trouble filtering out glucose, which can build up in the blood and cause problems. Steglatro helps the kidneys do their job by blocking the reabsorption of glucose, allowing it to be excreted in the urine and reducing blood sugar levels.

Approved indications

• Glycemic control in type 2 diabetes

Boxed warnings

• 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/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL. ( 5.1 ) Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, 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. ( 5.1 ) If lactic acidosis is suspected, discontinue SEGLUROMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. ( 5.1 )

Common side effects

• Diabetic ketoacidosis
• Product dose omission issue
• No adverse event

Drug interactions

• Topiramate, zonisamide, acetazolamide, dichlorphenamide (carbonic anhydrase inhibitors)
• Ranolazine, vandetanib, dolutegravir, cimetidine (OCT2/MATE inhibitors)
• Alcohol
• Insulin or insulin secretagogues
• Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid
• Lithium
• SGLT2 inhibitors (self-reference for context)
• SGLT2 inhibitors (self-reference for context)

Key clinical trials

• Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
• 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. (PHASE1)
• Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059) (PHASE3)
• Ertugliflozin in Chronic Heart Failure (PHASE2)
• Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
• Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study (PHASE3)
• DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes (PHASE4)
• ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure (PHASE2)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Steglatro CI brief — competitive landscape report
• Steglatro updates RSS · CI watch RSS
• Merck & Co. portfolio CI