Inpefa

(Sotagliflozin)

ApprovedSmall molecule

Inpefa is a small molecule that works as a Sodium/glucose Cotransporter 1 Inhibitor; Sodium/glucose Cotransporter 2 Inhibitor.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Inpefa is one of 293 small molecule programs targeting Cardiac Sarcoidosis. It is currently in Approved.

Indications

Total Trials

Active Trials

292

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cardiac SarcoidosisActive, not recruiting

Diabetes MellitusCompleted

Nasopharyngeal NeoplasmActive, not recruiting

CardiomyopathyApproved

Liver DiseaseApproved

Kidney DiseaseApproved

Heart Failure With Preserved Ejection FractionCompleted

Cardiomyopathy, HypertrophicActive, not recruiting

Heart FailureTerminated

Chronic Kidney DiseaseNot yet recruiting

Cardiac SarcoidosisPreclinical

Active, not recruiting

Diabetes MellitusApproved

Completed

Nasopharyngeal NeoplasmApproved

Active, not recruiting

CardiomyopathyApproved

Approved

Liver DiseaseApproved

Approved

Kidney DiseaseApproved

Approved

Heart Failure With Preserved Ejection FractionApproved

Completed

Cardiomyopathy, HypertrophicPhase 3

Active, not recruiting

Heart FailureApproved

Terminated

Chronic Kidney DiseasePhase 2

Not yet recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

Inpefa

LLexicon Pharmaceuticals

Approved

1 2

Brethine

Sanofi

Preclinical

1 3

Medrol

Pfizer

Preclinical

1 4

Amidate

Pfizer

Preclinical

1 5

Activase

Zemplar

Adriamycin

Savaysa

Xifaxan

2 10

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Cardiomyopathy, Hypertrophic

NCT06481891

Q2 2027

Phase 2Not yet recruiting

Chronic Kidney Disease

NCT06147232

Phase 1Recruiting

Hypertrophic Cardiomyopathy

NCT06433050

Q4 2027

Phase 2Recruiting

Type 1 Diabetes

NCT06435156

Recruiting

CAR

NCT06510894

Q1 2028

Phase 1/2Recruiting

Type 1 Diabetes

NCT05696366

Clinical

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Terminated·LLexicon Pharmaceuticals·Phase 3·NCT03386344·376 enrolled

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02926950·518 enrolled

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03332771·954 enrolled

Show 6 more trials

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03066830·507 enrolled

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

Terminated· Sanofi logo

Sanofi·Phase 3·NCT03761134·377 enrolled

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02926937·399 enrolled

Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise

Terminated· Sanofi logo

Sanofi·Phase 3·NCT03760965·276 enrolled

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03285594·571 enrolled

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03351478·770 enrolled

Type 1 Diabetes5 trials

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02531035·1,405 enrolled

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes

Recruiting·UUniversity of Dundee·Phase 2·NCT06435156·320 enrolled

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

Recruiting·UUniversity of California, San Diego·Phase 1/2·NCT05696366·24 enrolled

Show 2 more trials

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

Recruiting·AAlessandro Doria·Phase 3·NCT06217302·150 enrolled

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

Not yet recruiting·OOregon Health and Science University·Phase 2·NCT07594145·57 enrolled

Type 1 Diabetes Mellitus5 trials

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Completed·LLexicon Pharmaceuticals·Phase 2·NCT02459899·141 enrolled

Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Completed·LLexicon Pharmaceuticals·Phase 2·NCT01742208·36 enrolled

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02421510·782 enrolled

Show 2 more trials

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

Completed·LLexicon Pharmaceuticals·Phase 2·NCT02383940·87 enrolled

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02384941·793 enrolled

Type 2 Diabetes4 trials

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03242018·277 enrolled

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03242252·787 enrolled

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Terminated·LLexicon Pharmaceuticals·Phase 3·NCT03521934·1,222 enrolled

Show 1 more trial

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

Terminated·LLexicon Pharmaceuticals·Phase 3·NCT03315143·10,584 enrolled

Interaction4 trials

Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03070678·16 enrolled

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

Completed· Sanofi logo

Sanofi·Phase 1·NCT03387657·16 enrolled

A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

Completed· Sanofi logo

Sanofi·Phase 1·NCT03414723·16 enrolled

Show 1 more trial

A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

Completed· Sanofi logo

Sanofi·Phase 1·NCT02940379·24 enrolled

16 more indications

Female2 trials

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

Completed· Sanofi logo

Sanofi·Phase 1·NCT03802487·6 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 1·NCT03776227·66 enrolled

Tics2 trials

A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03174548·14 enrolled

Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin

Completed· Sanofi logo

Sanofi·Phase 1·NCT03063580·16 enrolled

CAR1 trial

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression

Recruiting·UUniversity of Pennsylvania··NCT06510894·40 enrolled

Oral1 trial

Oral Contraceptive DDI Study

Unknown status·LLexicon Pharmaceuticals·Phase 1·NCT02494609·30 enrolled

Hypertension1 trial

Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension

Completed· Sanofi logo

Sanofi·Phase 2·NCT03462069·41 enrolled

MPA1 trial

Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03310944·12 enrolled

Heart Failure1 trial

Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure

Terminated·LLexicon Pharmaceuticals·Phase 2·NCT03292653·32 enrolled

Hypertrophic Cardiomyopathy1 trial

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

Recruiting·UUniversity of Pennsylvania·Phase 1·NCT06433050·26 enrolled

Chronic Kidney Disease1 trial

Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia

Not yet recruiting·SSteno Diabetes Center Copenhagen·Phase 2·NCT06147232·69 enrolled

Antithrombotic1 trial

Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

Active, not recruiting·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT06618976·17 enrolled

Function1 trial

Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02647918·50 enrolled

Cardiovascular Disease1 trial

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Recruiting·SSteno Diabetes Center Copenhagen·Phase 3·NCT06082063·2,000 enrolled

Hepatic Impairment1 trial

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02471274·32 enrolled

Cardiomyopathy, Hypertrophic1 trial

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)

Active, not recruiting·LLexicon Pharmaceuticals·Phase 3·NCT06481891·500 enrolled

Heart Failure With Preserved Ejection Fraction1 trial

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

Completed·JJuan Badimon·Approved·NCT05562063·88 enrolled

Unspecified2 trials

Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03909451·24 enrolled

Sotagliflozin Bioequivalence Study

Completed· Sanofi logo

Sanofi·Phase 1·NCT03211195·76 enrolled

Regulatory

FDA Approval Timeline[4]

May 26, 2023

INPEFA

NDA NDA216203

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Sotagliflozin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sotagliflozin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sotagliflozin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216203). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Inpefa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Lexicon Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium/glucose Cotransporter 1 Inhibitor; Sodium/glucose Cotransporter 2 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LLexicon Pharmaceuticals

Patent Landscape[5]

Patent Cliff

May 4, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7781577May 4, 2028

8476413May 29, 2028

8217156Oct 7, 2030

Inpefa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Type 1 Diabetes5 trials

Type 1 Diabetes Mellitus5 trials

Type 2 Diabetes4 trials

Interaction4 trials

Female2 trials

Tics2 trials

CAR1 trial

Oral1 trial

Hypertension1 trial

MPA1 trial

Heart Failure1 trial

Hypertrophic Cardiomyopathy1 trial

Chronic Kidney Disease1 trial

Antithrombotic1 trial

Function1 trial

Cardiovascular Disease1 trial

Hepatic Impairment1 trial

Cardiomyopathy, Hypertrophic1 trial

Heart Failure With Preserved Ejection Fraction1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News