INPEFA (sotagliflozin)
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults. It is used for patients with heart failure (regardless of ejection fraction) or for adults with type 2 diabetes mellitus who also have chronic kidney disease and other cardiovascular risk factors.
How INPEFA Works
Sotagliflozin is an inhibitor of both SGLT2 and SGLT1. By inhibiting SGLT2 in the kidneys, it reduces the reabsorption of glucose and sodium; this may influence physiological functions such as lowering cardiac preload and afterload and downregulating sympathetic activity. Inhibition of SGLT1 reduces the intestinal absorption of glucose and sodium, which likely contributes to gastrointestinal side effects like diarrhea. Although these pathways are identified, the precise mechanism by which sotagliflozin exerts its cardiovascular benefits has not been established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-05-26
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
INPEFA Approval History
What INPEFA Treats
3 indicationsINPEFA is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heart Failure
- Type 2 Diabetes
- Chronic Kidney Disease
INPEFA Target & Pathway
ProTarget
A transporter in the kidney that reabsorbs glucose back into the bloodstream. Blocking SGLT2 causes excess glucose to be excreted in urine, lowering blood sugar. These drugs also provide cardiovascular and kidney protection beyond glucose control.
INPEFA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INPEFA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INPEFA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to INPEFA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT07572175 SPARTACUS | GCO 25-0408 | Ph 2 | not yet recruiting | Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity |
| NCT06618976 SOTATHROMBUS | STUDY-24-00304 | Ph 4 | completed | Antithrombotic Activities of Sotagliflozin vs. Empagliflozin |
| NCT06435156 SOPHIST | 01-50-23 3-SRA-2023-1376-M-B, 1007807 | Ph 2 | recruiting | Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes |
| NCT06217302 SUGARNSALT | STUDY00000249 | Ph 3 | recruiting | Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease |
| NCT06481891 SONATA-HCM | LX4211.1-314-HCM | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy |
| NCT05562063 | GCO-22-0574 | Ph 4 | completed | Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients |
| NCT06147232 PLUTO | EUCT 2023-509450-55-00 | Ph 2 | not yet recruiting | Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia |
| NCT06082063 Steno1 | NNF 22OC0077730 | Ph 3 | recruiting | Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes |
| NCT05696366 SOTA | 806355 | Ph 1, Ph 2 | recruiting | Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes |
| NCT03521934 results posted | EFC15156 2017-003510-16, U1111-1190-7891 | Ph 3 | terminated | Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) |
| NCT03315143 SCORED results posted | EFC14875 2017-002644-32, U1111-1187-8703 | Ph 3 | terminated | Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk |
| NCT03242018 SOTA-CKD4 results posted | EFC15166 2016-004906-32, U1111-1190-7589 | Ph 3 | completed | 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 |
| NCT03386344 SOTA-BONE results posted | EFC15294 2017-002041-30, U1111-1195-6371 | Ph 3 | terminated | Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
| NCT03242252 SOTA-CKD3 results posted | EFC14837 2016-004889-26, U1111-1187-8662 | Ph 3 | completed | 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 |
| NCT03351478 SOTA-EMPA results posted | EFC14867 2016-001803-22, U1111-1190-7607 | Ph 3 | completed | 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 |
| NCT03292653 results posted | PDY15079 2017-002774-39, U1111-1190-7962 | Ph 2 | terminated | Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure |
| NCT03285594 SOTA-INS results posted | EFC14868 2016-001804-43, U1111-1190-7567 | Ph 3 | completed | 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 |
| NCT02384941 inTandem1 results posted | LX4211.1-309-T1DM | Ph 3 | completed | 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 |
| NCT01742208 results posted | LX4211.1-203-T1DM LX4211.203 | Ph 2 | completed | Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus |
| NCT02383940 results posted | LX4211.1-204-T1DM LX4211.204 | Ph 2 | completed | Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C |
| NCT02531035 inTandem3 results posted | LX4211.1-312-T1DM LX4211.312 | Ph 3 | completed | 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 |
| NCT02421510 inTandem2 results posted | LX4211.1-310-T1DM LX4211.310, 2014-005153-39 | Ph 3 | completed | 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 |
| NCT02459899 inTandem4 results posted | LX4211.1-206-T1DM LX4211.206 | Ph 2 | completed | Dose-ranging Study in Patients With Type 1 Diabetes Mellitus |
| NCT02647918 | LX4211.1-121-REN LX4211.121 | Ph 1 | completed | Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function |
| NCT02471274 | LX4211.1-116-HEP LX4211.116 | Ph 1 | completed | PK Study of Sotagliflozin in Subjects With Hepatic Impairment |
| NCT07594145 | 30027 | Ph 2 | not yet recruiting | Precision T1D Platform - New Therapies for Cardio-Renal Complications |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INPEFA FDA Label Details
Indications & Usage
FDA Label (PDF)INPEFA is indicated for the treatment of Heart Failure; Type 2 Diabetes; Chronic Kidney Disease.
INPEFA Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for INPEFA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 12 active patents
Trial Analysis
- • 28 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment