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Inpefa FDA Approval History

Last updated by Judith Stewart, BPharm on May 29, 2023.

FDA Approved: Yes (First approved May 26, 2023)
Brand name: Inpefa
Generic name: sotagliflozin
Dosage form: Tablets
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Heart Failure

Inpefa (sotagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of heart failure.

  • Inpefa is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure; or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
  • Inpefa is an oral inhibitor of sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1), two proteins responsible for glucose regulation. SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract.
  • SGLT2 inhibitors were initially developed to treat hyperglycemia in patients with diabetes mellitus, but have since been shown to lower the risk of hospitalization for heart failure among patients with type 2 diabetes (who are at substantial risk for this complication), and to reduce the risk of death from cardiovascular causes or hospitalization for heart failure in patients with heart failure (with or without diabetes). The SGLT inhibitor class was recommended as first-line treatment for heart failure by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in their joint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.
  • Inpefa tablets are taken orally, once daily.
  • Warnings and precautions associated with Inpefa include diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis; volume depletion; urosepsis and pyelonephritis; hypoglycemia with concomitant use with insulin and insulin secretagogues; necrotizing fasciitis of the perineum (Fournier’s Gangrene); and genital mycotic infections.
  • Common adverse reactions include urinary tract infection, volume depletion, diarrhea, and hypoglycemia.



Development timeline for Inpefa

May 27, 2023Approval FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure
Jul 27, 2022Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
May 31, 2022Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure
Feb 28, 2022Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022
Dec 30, 2021Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults with Type 2 Diabetes
Jan 14, 2021Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure
Mar 25, 2019FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
Jan 17, 2019FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
May 22, 2018FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes
Mar 26, 2018Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.