Numerous clinical trials spanning Phase 1 to Phase 4 evaluate sotagliflozin across metabolic, renal, and cardiovascular conditions, including type 1 and type 2 diabetes, diabetic nephropathy, albuminuria, chronic kidney disease, and heart failure. Driven by industry sponsors, academic institutions, and foundations—including Lexicon Pharmaceuticals, Sanofi, King's College London, and the Juvenile Diabetes Research Foundation—these studies range in recruitment status from active, recruiting, and completed to terminated or not yet recruiting. Together, these trials assess the therapeutic efficacy, safety, bioequivalence, and renal or cardiovascular outcomes of sotagliflozin therapy.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07211802 | NOT_YET_RECRUITING | Type 1 Diabetes (T1D) |
University of California, San Diego |
2026-07-01 | PHASE3 |
| NCT07421518 | NOT_YET_RECRUITING | Type 1 Diabetes; Type 2 Diabetes |
AdventHealth Translational Research Institute |
2026-06 | PHASE2 |
| NCT07594145 | NOT_YET_RECRUITING | Type 1 Diabetes; T1D Heart Failure; Cardio-renal Vascular Function and Failure; Diabetic Chronic Kidney Disease |
Oregon Health and Science University |
2026-11-01 | PHASE2 |
| NCT06082063 | RECRUITING | Cardiovascular Diseases; Heart Failure; Type 1 Diabetes; Kidney Failure |
Steno Diabetes Center Copenhagen |
2024-07-01 | PHASE3 |
| NCT07572175 | NOT_YET_RECRUITING | Anthracycline-induced Cardiotoxicity; Lymphoma; Chemotherapy; Cardiotoxicity |
Icahn School of Medicine at Mount Sinai |
2026-07 | PHASE2 |
| NCT07547878 | NOT_YET_RECRUITING | Chronic Kidney Disease; Type 2 Diabetes |
Baylor Research Institute |
2026-04-30 | PHASE4 |
| NCT07325201 | NOT_YET_RECRUITING | Type 1 Diabetes Mellitus; Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM); Chronic Kidney Disease; Diabetic Ketoacidosis; Ketones |
HealthPartners Institute |
2026-09 | PHASE2 |
| NCT06217302 | RECRUITING | Diabetic Nephropathies; Kidney Failure, Chronic; Diabetes Mellitus Type 1; Heart Failure |
Alessandro Doria |
2024-10-31 | PHASE3 |
| NCT05696366 | ACTIVE_NOT_RECRUITING | Type 1 Diabetes |
University of California, San Diego |
2024-09-09 | PHASE1; PHASE2 |
| NCT06435156 | RECRUITING | Type 1 Diabetes; Heart Failure |
University of Dundee |
2025-01-28 | PHASE2 |
| NCT06147232 | NOT_YET_RECRUITING | Nephropathy; Diabetic Nephropathies; Diabetes Mellitus, Type 1; Albuminuria; Diabetic Complications Renal; Diabetic Complications Cardiovascular; Hypoxia |
Steno Diabetes Center Copenhagen |
2025-02 | PHASE2 |
| NCT06433050 | RECRUITING | Hypertrophic Cardiomyopathy Without Obstruction |
University of Pennsylvania |
2024-12-17 | EARLY_PHASE1 |
| NCT06481891 | ACTIVE_NOT_RECRUITING | Obstructive Cardiomyopathy, Hypertrophic; Non-obstructive Hypertrophic Cardiomyopathy |
Lexicon Pharmaceuticals |
2024-09-24 | PHASE3 |
| NCT06933056 | RECRUITING | Platelet Function and Reactivity Tests |
University of Michigan |
2025-09-02 | EARLY_PHASE1 |
| NCT06618976 | COMPLETED | Thrombosis |
Icahn School of Medicine at Mount Sinai |
2025-02-25 | PHASE4 |
| NCT05562063 | COMPLETED | Heart Failure With Preserved Ejection Fraction |
Juan Badimon |
2022-10-26 | PHASE4 |
| NCT06147232 | Not yet recruiting | Nephropathy|Diabetic Nephropathies|Diabetes Mellitus Type 1|Albuminuria|Diabetic Complications Renal|Diabetic Complications Cardiovascular|Hypoxia |
Steno Diabetes Center Copenhagen|Juvenile Diabetes Research Foundation|King''s College London|Glostrup University Hospital Copenhagen |
2024-08 | Phase 4 |
| NCT05405556 | COMPLETED | Kidney Transplant |
Martina McGrath, MD |
2022-10-17 | PHASE2 |
| NCT03315143 | TERMINATED | Heart Failure; Type 2 Diabetes Mellitus; Chronic Kidney Diseases |
Lexicon Pharmaceuticals |
2017-12-19 | PHASE3 |
| NCT03521934 | TERMINATED | Heart Failure; Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2018-06-15 | PHASE3 |
| NCT03761134 | TERMINATED | Type 2 Diabetes Mellitus |
Sanofi |
2018-11-30 | PHASE3 |
| NCT03760965 | TERMINATED | Type 2 Diabetes Mellitus |
Sanofi |
2018-11-27 | PHASE3 |
| NCT03285594 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2017-09-15 | PHASE3 |
| NCT03909451 | COMPLETED | Diabetes Mellitus |
Sanofi |
2019-04-28 | PHASE1 |
| NCT03292653 | TERMINATED | Cardiac Failure Aggravated |
Lexicon Pharmaceuticals |
2017-12-04 | PHASE2 |
| NCT03332771 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2017-12-01 | PHASE3 |
| NCT03386344 | TERMINATED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2018-02-19 | PHASE3 |
| NCT03242018 | COMPLETED | Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 4 |
Lexicon Pharmaceuticals |
2017-08-16 | PHASE3 |
| NCT03351478 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2017-11-27 | PHASE3 |
| NCT03776227 | COMPLETED | Type 2 Diabetes Mellitus; Healthy Subjects |
Sanofi |
2019-01-25 | PHASE1 |
| NCT02926937 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2016-11-11 | PHASE3 |
| NCT03462069 | COMPLETED | Diabetes Mellitus |
Sanofi |
2018-03-12 | PHASE2 |
| NCT03066830 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2017-02-24 | PHASE3 |
| NCT03802487 | COMPLETED | Type 2 Diabetes Mellitus; Healthy Subjects |
Sanofi |
2019-01-14 | PHASE1 |
| NCT03242252 | COMPLETED | Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 3 |
Lexicon Pharmaceuticals |
2017-08-16 | PHASE3 |
| NCT02926950 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2016-11 | PHASE3 |
| NCT03414723 | COMPLETED | Diabetes Mellitus; Healthy Subjects |
Sanofi |
2018-01-15 | PHASE1 |
| NCT03387657 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2018-01-03 | PHASE1 |
| NCT03310944 | COMPLETED | Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus |
Sanofi |
2017-10-18 | PHASE1 |
| NCT03174548 | COMPLETED | Diabetes Mellitus |
Sanofi |
2017-06-12 | PHASE1 |
| NCT02647918 | COMPLETED | Renal Impairment; Healthy |
Lexicon Pharmaceuticals |
2015-12 | PHASE1 |
| NCT03211195 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2017-06-29 | PHASE1 |
| NCT03242018 | Completed | Type 2 Diabetes Mellitus|Chronic Kidney Disease Stage 4 |
Lexicon Pharmaceuticals|Sanofi |
2017-08-16 | Phase 3 |
| NCT03174548 | Completed | Diabetes Mellitus |
Sanofi |
2017-06-12 | Phase 1 |
| NCT03063580 | COMPLETED | Diabetes Mellitus |
Sanofi |
2017-02-27 | PHASE1 |
| NCT03070678 | COMPLETED | Diabetes Mellitus |
Sanofi |
2017-03-14 | PHASE1 |
| NCT02531035 | COMPLETED | Type 1 Diabetes Mellitus (T1DM); High Level of Sugar (Glucose) in the Blood |
Lexicon Pharmaceuticals |
2015-09 | PHASE3 |
| NCT03070678 | Completed | Diabetes Mellitus |
Sanofi |
2017-03-14 | Phase 1 |
| NCT02940379 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2016-10 | PHASE1 |
| NCT02421510 | COMPLETED | Type 1 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2015-05 | PHASE3 |
| NCT02926937 | Completed | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals|Sanofi |
2016-11-11 | Phase 3 |
| NCT02383940 | COMPLETED | Type 1 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2015-04 | PHASE2 |
| NCT02384941 | COMPLETED | Type 1 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2015-03 | PHASE3 |
| NCT02459899 | COMPLETED | Type 1 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2015-07 | PHASE2 |
| NCT02471274 | COMPLETED | Hepatic Impairment; Healthy |
Lexicon Pharmaceuticals |
2015-06 | PHASE1 |
| NCT02494609 | UNKNOWN | Healthy |
Lexicon Pharmaceuticals |
2015-07 | PHASE1 |
| NCT01742208 | COMPLETED | Type 1 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2013-02 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-10-08)
Check the
Sotagliflozin (LX4211)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Sotagliflozin (LX4211) Solubility in DMSO
- Sotagliflozin (LX4211) Stock Solution
- Sotagliflozin (LX4211) Storage
- Sotagliflozin (LX4211) Stability
- Sotagliflozin (LX4211) Molecular Weight
- Sotagliflozin (LX4211) SMILES
- Sotagliflozin (LX4211) CAS Number
- Sotagliflozin (LX4211) Chemical Structure (2D and 3D)
- Sotagliflozin (LX4211) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.