INPEFA

GrowthSM

sotagliflozin

NDAORALTABLET
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
20

Mechanism of Action

Sodium-Glucose Transporter 2 Inhibitors

Pharmacologic Class:

Sodium-Glucose Cotransporter 2 Inhibitor

Clinical Trials (5)

NCT06217302Phase 3Recruiting

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

Started Oct 2024
NCT03909451Phase 1Completed

Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Started Apr 2019
24 enrolled
Diabetes Mellitus
NCT03776227Phase 1Completed

A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

Started Jan 2019
66 enrolled
Type 2 Diabetes MellitusHealthy Subjects
NCT03802487Phase 1Completed

Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects

Started Jan 2019
6 enrolled
Type 2 Diabetes MellitusHealthy Subjects
NCT03761134Phase 3Terminated

Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea

Started Nov 2018
377 enrolled
Type 2 Diabetes Mellitus

Loss of Exclusivity

LOE Date
Oct 7, 2030
55 months away
Patent Expiry
Oct 7, 2030
Exclusivity Expiry
May 26, 2028

Patent Records (3)

Patent #ExpiryTypeUse Code
7781577
May 4, 2028
SubstanceProduct
U-3628
8476413
May 29, 2028
SubstanceProduct
U-3628
8217156
Oct 7, 2030
SubstanceProduct