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 16 indications, with its most advanced program in Approved.[1]

Inpefa is one of 408 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

407

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

CardiomyopathyApproved

Nasopharyngeal NeoplasmActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Kidney DiseaseApproved

Cardiac SarcoidosisActive, not recruiting

Diabetes MellitusActive, not recruiting

HypertensionActive, not recruiting

Liver DiseaseApproved

Heart FailureActive, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

CardiomyopathyApproved

Approved

Nasopharyngeal NeoplasmApproved

Active, not recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Kidney DiseaseApproved

Approved

Cardiac SarcoidosisPreclinical

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

HypertensionPhase 2

Active, not recruiting

Liver DiseaseApproved

Approved

Heart FailureApproved

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Inpefa

LLexicon Pharmaceuticals

Approved

4 2

Byetta

AstraZeneca

Preclinical

55 3

Cysteine Hydrochloride

Novartis

Preclinical

1 4

Glargine

Eli Lilly

Preclinical

8 5

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 6

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 7

GLP-1

RRigshospitalet, Denmark

Preclinical

1 8

Henagliflozin

TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Preclinical

1 9

Antiplatelet Drug

FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Preclinical

1 10

Glucagon-Like Peptide-1 (GLP-1)

Novo Nordisk

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Hypertrophic Cardiomyopathy

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 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

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

Show 6 more trials

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 Patients With Type 2 Diabetes Mellitus on Background of Metformin

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02926950·518 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 Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Completed·LLexicon Pharmaceuticals·Phase 3·NCT03332771·954 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 on Background of Sulfonylurea Alone or With Metformin

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

Type 1 Diabetes Mellitus5 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·NCT02421510·782 enrolled

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

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

Show 2 more trials

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Completed·LLexicon Pharmaceuticals·Phase 2·NCT02459899·141 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

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

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

Show 1 more trial

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

Type 1 Diabetes4 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 to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

Recruiting·AAlessandro Doria·Phase 3·NCT06217302·150 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 1 more trial

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes

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

Interaction4 trials

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

Completed· Sanofi logo

Sanofi·Phase 1·NCT02940379·24 enrolled

A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

Completed· Sanofi logo

Sanofi·Phase 1·NCT03414723·16 enrolled

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

Show 1 more trial

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

Completed· Sanofi logo

Sanofi·Phase 1·NCT03387657·16 enrolled

15 more indications

Hypertrophic Cardiomyopathy2 trials

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

Recruiting·LLexicon Pharmaceuticals·Phase 3·NCT06481891·500 enrolled

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

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

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

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

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

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

Oral1 trial

Oral Contraceptive DDI Study

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

CAR1 trial

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

Recruiting·UUniversity of Pennsylvania··NCT06510894·40 enrolled

Hepatic Impairment1 trial

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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

Antithrombotic1 trial

Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

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

MPA1 trial

Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03310944·12 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

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 Bioequivalence Study

Completed· Sanofi logo

Sanofi·Phase 1·NCT03211195·76 enrolled

Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03909451·24 enrolled

Regulatory

FDA Approval Timeline[4]

May 26, 2023

INPEFA

NDA NDA216203

Sources

References

[1]
ClinicalTrials.gov — 45 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

Q3 2026

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Type 1 Diabetes Mellitus5 trials

Type 2 Diabetes4 trials

Type 1 Diabetes4 trials

Interaction4 trials

Hypertrophic Cardiomyopathy2 trials

Tics2 trials

Female2 trials

Chronic Kidney Disease1 trial

Heart Failure1 trial

Function1 trial

Cardiovascular Disease1 trial

Oral1 trial

CAR1 trial

Hepatic Impairment1 trial

Antithrombotic1 trial

MPA1 trial

Hypertension1 trial

Heart Failure With Preserved Ejection Fraction1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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