Drug

Sotagliflozin

In clinical development

Emerging researchLate-stage development

Also known as Inpefa.

RxNorm2638675 ChEMBLCHEMBL3039507UNII6B4ZBS263Y

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic Obstructive And Non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

Clinical trial2026-06-15Results expected Q1 2028 · ClinicalTrials.gov

Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)

Clinical trial2026-05-20Results expected Q4 2029 · ClinicalTrials.gov

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Clinical trial2026-05-08Results expected Q1 2029 · ClinicalTrials.gov

SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)

Clinical trial2026-05-07Results expected Q2 2029 · ClinicalTrials.gov

A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals With Heart Failure and Type 1 Diabetes.

Clinical trial2026-04-06Results expected Q4 2027 · ClinicalTrials.gov

Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease

Clinical trial2026-03-24Results expected Q4 2028 · ClinicalTrials.gov

Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy

Clinical trial2026-02-11Results expected Q2 2027 · ClinicalTrials.gov

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

Clinical trial2026-02-10Completed · ClinicalTrials.gov

Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes

Clinical trial2025-10-08Results expected Q3 2030 · ClinicalTrials.gov

Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.

Research2020-11-16The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sotagliflozin

Aliases & brands

Inpefa

RxNorm CUI

2638675

ChEMBL ID

CHEMBL3039507

UNII

6B4ZBS263Y

Clinical trials

48 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 48

Early Phase 11Phase 114Phase 1 / 21Phase 29Phase 320Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Not yet recruitingPH IVBaylor Research Instituten=642029

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

CompletedPH IVIcahn School of Medicine at Mount Sinain=172026

SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes

CompletedPH IVJuan Badimonn=882025

Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes

Not yet recruitingPH IIIUniversity of California, San Diegon=522030

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

RecruitingPH IIIKey trialSteno Diabetes Center Copenhagenn=2,0002029

Recent completions

Trials that read out recently, adding to the completed evidence base.

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

CompletedPH IVIcahn School of Medicine at Mount Sinain=172026

SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes

CompletedPH IVJuan Badimonn=882025

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control

CompletedPH IIILexicon Pharmaceuticalsn=2772019

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

CompletedPH IIILexicon Pharmaceuticalsn=7872019

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)

CompletedPH IIILexicon Pharmaceuticalsn=5712019

A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy

CompletedPH IIILexicon Pharmaceuticalsn=9542019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.

The New England journal of medicine · 2021 · 1,319 cites