NDAORALTABLET
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
INPEFA (sotagliflozin) by Lexicon Pharmaceuticals is sodium-glucose transporter 2 inhibitors [moa]. First approved in 2023.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INPEFA (sotagliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor approved in May 2023. It is the first dual SGLT1/SGLT2 inhibitor indicated for heart failure, representing a novel mechanism within the SGLT2 class. The drug works by inhibiting renal glucose reabsorption and reducing cardiac workload through metabolic and hemodynamic effects.
$0.659MPart D
Peak4.3 years to LOEEarly-stage peak sales with minimal Part D penetration suggest the product is still ramping commercialization, requiring robust commercial team expansion across field and marketing functions.
Mechanism of Action
Sodium-Glucose Transporter 2 Inhibitors
Pharmacologic Class:
Sodium-Glucose Cotransporter 2 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
Started Sep 2025
20 enrolled
Platelet Function and Reactivity Tests
Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
Started Jan 2025
320 enrolled
Type 1 DiabetesHeart Failure
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
Started Oct 2024
150 enrolled
Diabetic NephropathiesKidney Failure, ChronicDiabetes Mellitus Type 1+1 more
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Started Sep 2024
500 enrolled
Obstructive Cardiomyopathy, HypertrophicNon-obstructive Hypertrophic Cardiomyopathy
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
Started Apr 2019
24 enrolled
Diabetes Mellitus
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.