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Inpefa (SOTAGLIFLOZIN)
Inpefa works by blocking the sodium/glucose cotransporter 2 in the kidneys, reducing glucose reabsorption and lowering blood sugar levels.
Inpefa (SOTAGLIFLOZIN) is a small molecule Sodium-Glucose Cotransporter 2 Inhibitor developed by Lexicon Pharms Inc. It targets the sodium/glucose cotransporter 2 to treat chronic kidney disease at increased risk of cardiovascular disease, diabetes mellitus type 1, diabetes mellitus type 2 at increased risk of cardiovascular disease, and heart failure. Inpefa was FDA approved in 2023 and is currently patented. Key safety considerations include its mechanism of action, which may affect blood sugar and electrolyte levels. As a relatively new medication, its long-term effects and potential interactions are still being studied.
At a glance
| Generic name | SOTAGLIFLOZIN |
|---|---|
| Sponsor | Lexicon Pharms Inc |
| Drug class | Sodium-Glucose Cotransporter 2 Inhibitor [EPC] |
| Target | Sodium/glucose cotransporter 2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea. The mechanism for sotagliflozins cardiovascular benefits has not been established.
Approved indications
- Chronic kidney disease at increased risk of cardiovascular disease
- Diabetes mellitus type 1
- Diabetes mellitus type 2 at increased risk of cardiovascular disease
- Heart failure
Common side effects
- Urinary tract infection
- Volume depletion
- Diarrhea
- Hypoglycemia
- Dizziness
- Genital mycotic infection
Key clinical trials
- Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease (PHASE3)
- Antithrombotic Activities of Sotagliflozin vs. Empagliflozin (PHASE4)
- A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy (PHASE3)
- Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors (PHASE2)
- Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy (EARLY_PHASE1)
- Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring (PHASE2)
- The MICRON Study - A Steno 1 Substudy
- Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Inpefa CI brief — competitive landscape report
- Inpefa updates RSS · CI watch RSS
- Lexicon Pharms Inc portfolio CI