Lowers the risk of cardiovascular death, hospitalization for heart failure, and urgent…. Sold as Inpefa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Sotagliflozin (sold as Inpefa), first approved May 26, 2023, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Inpefa | Part D | $6.7M | +14% | 1,541 |
| Precision T1D Platform - New Therapies for Cardio-Renal ComplicationsType 1 Diabetes, T1D Heart Failure · Oregon Health and Science University | Phase 2 | Not yet recruiting | May 18, 2026 |
| Sotagliflozin as Prevention of Anthracycline-Related CardiotoxicityAnthracycline-induced Cardiotoxicity, Lymphoma · Icahn School of Medicine at Mount Sinai | Phase 2 | Not yet recruiting | May 7, 2026 |
| Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)Chronic Kidney Disease, Type 2 Diabetes · Baylor Research Institute | Phase 4 | Enrolling by invitation | Apr 23, 2026 |
| Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 InhibitorsType 1 Diabetes, Type 2 Diabetes · AdventHealth Translational Research Institute | Phase 2 | Not yet recruiting | Feb 19, 2026 |
| Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM) · HealthPartners Institute | Phase 2 | Not yet recruiting | Jan 8, 2026 |
| The MICRON Study - A Steno 1 SubstudyType 1 Diabetes Mellitus · University of Aarhus | — | Recruiting | Dec 8, 2025 |
| CKM For Safe Use of SGLT2i in Type 1 DiabetesType 1 Diabetes (T1D) · University of California, San Diego | Phase 3 | Not yet recruiting | Oct 8, 2025 |
| 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)Cardiovascular Kidney Metabolic Syndrome · Ohio State University | — | Active, not recruiting | Sep 23, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| May 26, 2023 | InpefaNDA 216203 · New molecular entity | Lexicon Pharms Inc | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
