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Drug

Sotagliflozin

Approved medicine
ClassSodium/glucose cotransporter 2 inhibitorResearchOngoing clinical research

Also known as Inpefa.

RxNorm2638675ChEMBLCHEMBL3039507ATCA10BK06UNII6B4ZBS263Y
1
Research papers
11
Active clinical trials
2
Protein targets
2
Regulatory events
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 trial2026-08-26Status changed to Active, not recruiting · ClinicalTrials.gov

Label change: SOTAGLIFLOZIN (NDA216203)

Regulatory2026-08-06FDA

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

Approval: SOTAGLIFLOZIN (NDA216203)

Regulatory2023-05-26FDA

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
ATC codes
A10BK06
UNII
6B4ZBS263Y
Primary mechanism
Sodium/glucose cotransporter 2 inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium/glucose cotransporter 2
SLC5A2 · P31639
INHIBITORSodium/glucose cotransporter 2 inhibitor
Sodium/glucose cotransporter 1
SLC5A1 · P13866
INHIBITORSodium/glucose cotransporter 1 inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-05-26
Latest approval
2023-05-26
Authorities
FDA
Total events
2
fdaU.S. Food and Drug Administration· 2 events
2026-08-06Label change
Label change: SOTAGLIFLOZIN (NDA216203)
Evidence ↗
2023-05-26Approval
Approval: SOTAGLIFLOZIN (NDA216203)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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
48
registered trials across all phases
LATEST COMPLETION 2026
11
Active studies
9
Recruiting
23
Late-stage (III+)
30
Completed
7
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
Recent papers

Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.

The New England journal of medicine · 2021 · 1,319 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine1
Leading researchers
  • Bhatt DL1
  • Cannon CP1
  • Komajda M1
  • Lapuerta P1
  • Leiter LA1
  • Lewis JB1
  • Lopes RD1
  • Lund LH1
Leading institutions
free-text, unnormalised
  • From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.