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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. There was no evidence of fetal harm in increases   ...    corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations).","Geriatric use":"No dosage adjustment of STEGLATRO is recommended based on age. In STEGLATRO clinical   ...    patients treated with STEGLATRO were 75 years and older. Patients 65 years and older had a higher  No dosage adjustment of STEGLATRO is necessary in patients with mild or moderate hepatic impairment. Ertugliflozin has not been studied in patients with severe hepatic impairment and is not   ...    Moderate hepatic impairment (based on the Child-Pugh classification) did not result in an increase in  exposure of   ...    exposure is not considered clinically meaningful. There is no","Paediatric use":"Safety and effectiveness of STEGLATRO in pediatric patients under 18 years of age have not been established.","Renal impairment":"Higher incidence of adverse reactions related to reduced intravascular volume and renal function.","Hepatic impairment":"No dosage adjustment of STEGLATRO is necessary in patients with mild or moderate hepatic impairment. Ertugliflozin has not been studied in patients with severe hepatic impairment and is not   ...    Moderate hepatic impairment (based on the Child-Pugh classification) did not result in an increase in  exposure of   ...    exposure is not considered clinically meaningful. 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Trends","source":"www.datainsightsmarket.com"},{"url":"https://www.strategicmarketresearch.com/market-report/sglt2-inhibitors-market","date":"2026-04-07","type":"news","title":"SGLT2 Inhibitors Market Size ($25.8 Billion) 2030","source":"www.strategicmarketresearch.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_sglt2_inhibitor_steglatro_ertugliflozin_and_fixed_dose_combination_steglujan_ertugliflozin_and_sitagliptin_for_adults_with_type_2_diabetes","date":"2026-04-07","type":"news","title":"FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and ...","source":"www.pfizer.com"},{"url":"https://www.healio.com/news/endocrinology/20171221/fda-approves-ertugliflozin-for-type-2-diabetes","date":"2026-04-07","type":"news","title":"FDA approves ertugliflozin for type 2 diabetes - Healio","source":"www.healio.com"}],"manufacturing":[],"molecularData":{"oral":true,"chemblId":"CHEMBL1770248","moleculeType":"Small molecule","molecularWeight":"436.89"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL1770248"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":39,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"commercialAnalysis":{"text":"Ertugliflozin 5 mg, developed by Pfizer, is a Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor used to treat type 2 diabetes mellitus as an adjunct to diet and exercise. The global SGLT2 inhibitors market, in which Ertugliflozin 5 mg operates, was valued at USD 19.2 billion in 2024 and is expected to grow at a CAGR of 7.4% from 2025 to 2034, reaching USD 38.6 billion by 2034 [1]. This growth is driven by the increasing prevalence of type 2 diabetes, expanding therapeutic indications, and patient preference for oral therapies.\n\nThe competitive landscape of the SGLT2 inhibitors market is dominated by established players such as Empagliflozin and Dapagliflozin, which have gained popularity due to their dual advantages of achieving glycemic control and reducing cardiovascular risks [2]. However, Ertugliflozin 5 mg has carved out a niche for itself in the market, with a revenue trajectory that is expected to contribute to the overall growth of the SGLT2 inhibitors market. According to a report by Strategic Market Research, the SGLT2 inhibitors market size is expected to reach USD 25.8 billion by 2030 [3].\n\nKey upcoming catalysts for the SGLT2 inhibitors market include patent cliffs, label expansions, and pipeline competitors. The International Diabetes Federation estimates that by 2045, one in eight adults, nearly 783 million people globally, will be living with diabetes, with more than 90% of these patients estimated to have type 2 diabetes [1]. This rising disease burden is expected to drive demand for novel SGLT2 inhibitors, thereby contributing to market growth.\n\nIn conclusion, Ertugliflozin 5 mg is well-positioned in the SGLT2 inhibitors market, with a revenue trajectory that is expected to contribute to the overall growth of the market. However, the competitive landscape is dominated by established players, and the market is expected to face challenges from patent cliffs, label expansions, and pipeline competitors.\n\nReferences:\n[1] Global market insights, SGLT2 Inhibitors Market Size & Share Report, 2025 – 2034\n[2] Data insights market, SGLT2 Inhibitors Market 2026-2034 Trends\n[3] Strategic Market Research, SGLT2 Inhibitors Market Size ($25.8 Billion) 2030","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.gminsights.com/industry-analysis/sglt2-inhibitors-market","date":"","title":"SGLT2 Inhibitors Market Size & Share Report, 2025 – 2034","source":"www.gminsights.com"},{"url":"https://www.datainsightsmarket.com/reports/sglt2-inhibitors-market-9651","date":"","title":"SGLT2 Inhibitors Market 2026-2034 Trends","source":"www.datainsightsmarket.com"},{"url":"https://www.strategicmarketresearch.com/market-report/sglt2-inhibitors-market","date":"","title":"SGLT2 Inhibitors Market Size ($25.8 Billion) 2030","source":"www.strategicmarketresearch.com"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[{"date":"2025 Jan-Dec","pmid":"40028005","title":"Cardiovascular and Renal Outcomes with Ertugliflozin by Baseline Use of Renin-Angiotensin-Aldosterone System Inhibitors or Diuretics, Including Mineralocorticoid Receptor Antagonist: Analyses from the VERTIS CV Trial.","journal":"Kidney diseases (Basel, Switzerland)"},{"date":"2024 Oct 22","pmid":"39438942","title":"Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial.","journal":"Cardiovascular diabetology"},{"date":"2024 Nov","pmid":"39219437","title":"Effects of ertugliflozin on uric acid and gout-related outcomes in persons with type 2 diabetes and cardiovascular disease: Post hoc analyses from VERTIS CV.","journal":"Diabetes, obesity & metabolism"},{"date":"2024 Oct","pmid":"39217453","title":"Ertugliflozin to Reduce Arrhythmic Burden in Patients with ICDs/CRT-Ds.","journal":"NEJM evidence"},{"date":"2023 Apr","pmid":"37069970","title":"Effects of Ertugliflozin on Kidney Outcomes in Patients With Heart Failure at Baseline in the Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes (VERTIS CV) Trial.","journal":"Kidney international reports"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[{"hr":"-0.67","nctId":"NCT04029480","phase":"PHASE3","pValue":"","ciLower":"-1.06","ciUpper":"-0.29","endpoint":"Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)","enrollment":166}],"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":12,"withResults":12},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T08:28:21.969367+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}