Drugs / Sotagliflozin
Sotagliflozin
also known as
SAR439954 · LX4211 · SOTA · Inpefa · LP-802034 · Sotagliflozina · Sotagliflozine · Zynquista
Small molecule targets SLC5A1, SLC5A2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | INPEFA | — | 2023-05-26 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Zynquista | — | 2022-03-22 | europa.eu ↗ |
| Approved | EU (EMA) | Zynquista | — | 2019-04-26 | europa.eu ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06933056 | Sep 2025 → Sep 2026 overdue | — | University of Michigan | Recruiting | No outcome recorded |
| Phase 123 trials · 1 met primary | ||||||
| Phase 1 | NCT03909451 | Apr → Aug 2019 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03802487 | Jan → Mar 2019 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03414723 | Jan → Mar 2018 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03387657 | Jan → Mar 2018 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03310944 | Oct → Dec 2017 | type 1 diabetes mellitus, type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03174548 | Jun → Sep 2017 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03070678 | Mar → Apr 2017 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03063580 | Feb → May 2017 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02940379 | Oct → Dec 2016 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02647918 | Dec 2015 → Sep 2017 | impaired renal function disease | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02494609 | Jul → Nov 2015 | — | Lexicon Pharmaceuticals | Unknown | No outcome recorded |
| Phase 1 | NCT02471274 | Jun → Dec 2015 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02300363 | Oct → Nov 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02300350 | Oct → Dec 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01916863 | Aug → Oct 2013 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01916850 | Aug → Oct 2013 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01913002 | Jul → Oct 2013 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01818232 | Mar → May 2013 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01555008 | Mar 2012 → Aug 2013 | impaired renal function disease, type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 1 | NCT01441232 | Oct → Nov 2011 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01334242 | Mar → Apr 2011 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01292993 | Feb → Mar 2011 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01188863 | Sep → Oct 2010 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 211 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT07594145 | Sep 2026 → Dec 2029 expected | cardio-renal syndrome, diabetic kidney disease, symptomatic heart failure, type 1 diabetes mellitus | Oregon Health and Science University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07325201 | Jun 2026 → May 2028 expected | diabetic kidney disease, type 1 diabetes mellitus | HealthPartners Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06147232 | Feb 2025 → May 2027 expected | diabetic kidney disease, proteinuria, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06435156 | Jan 2025 → Oct 2027 expected | heart failure, type 1 diabetes mellitus | University of Dundee | Recruiting | No outcome recorded |
| Phase 2 | NCT03462069 | Mar 2018 → Apr 2019 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT03292653 | Dec 2017 → Aug 2019 | heart failure | Lexicon Pharmaceuticals | Terminated | Missed primary |
| Phase 2 | NCT02459899 | Jul 2015 → Aug 2016 | type 1 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT02383940 | Apr 2015 → Sep 2016 | type 1 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01742208 | Feb 2013 → Jan 2014 | type 1 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01376557 | Jun 2011 → May 2012 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00962065 | Aug → Dec 2009 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 318 trials · 11 met primary · 2 missed | ||||||
| Phase 3 | NCT07211802 | Jul 2026 → Jul 2030 expected | type 1 diabetes mellitus | University of California, San Diego | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06481891 | Sep 2024 → Jul 2026 overdue | hypertrophic cardiomyopathy | Lexicon Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT03761134 | Nov 2018 → Apr 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT03760965 | Nov 2018 → Apr 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT03521934 | Jun 2018 → Jun 2020 | heart failure, type 2 diabetes mellitus | Lexicon Pharmaceuticals | Terminated | Met primary Stop: Business |
| Phase 3 | NCT03386344 | Feb 2018 → May 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Terminated | Met primary Stop: Business |
| Phase 3 | NCT03315143 | Dec 2017 → Jul 2020 | chronic kidney disease, heart failure, type 2 diabetes mellitus | Lexicon Pharmaceuticals | Terminated | Met primary Stop: Business |
| Phase 3 | NCT03332771 | Dec 2017 → Aug 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT03351478 | Nov 2017 → May 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03285594 | Sep 2017 → Sep 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03242252 | Aug 2017 → Mar 2019 | chronic kidney disease, type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Mixed |
| Phase 3 | NCT03242018 | Aug 2017 → May 2019 | chronic kidney disease, type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT03066830 | Feb 2017 → Apr 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02926937 | Nov 2016 → Apr 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02926950 | Nov 2016 → Feb 2019 | type 2 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02531035 | Sep 2015 → Apr 2017 | hyperglycemia, type 1 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02421510 | May 2015 → Nov 2016 | type 1 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02384941 | Mar 2015 → Sep 2016 | type 1 diabetes mellitus | Lexicon Pharmaceuticals | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06618976 | Feb 2025 → Feb 2026 | thrombotic disease | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT05562063 | Oct 2022 → Jun 2025 | diastolic heart failure | Juan Badimon | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 0 | NCT06433050 Comparator | Dec 2024 → Apr 2027 expected | hypertrophic cardiomyopathy | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05696366 Comparator | Sep 2024 → Jan 2028 expected | type 1 diabetes mellitus | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07572175 Comparator | Jul 2026 → Jun 2029 expected | cardiomyopathy due to anthracyclines, lymphoma, poisoning | Icahn School of Medicine at Mount Sinai | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07421518 Background | Jun 2026 → Apr 2030 expected | type 1 diabetes mellitus, type 2 diabetes mellitus | AdventHealth Translational Research Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06217302 Comparator | Oct 2024 → Dec 2028 expected | chronic renal failure syndrome, diabetic kidney disease, heart failure, type 1 diabetes mellitus | Alessandro Doria | Recruiting | No outcome recorded |
| Phase 3 | NCT06082063 Comparator | Jul 2024 → Jul 2029 expected | heart failure, kidney failure, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Recruiting | No outcome recorded |
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Lexicon Pharmaceuticals | Results Lexicon Announces New Post Hoc SOLOIST-WHF Analysis Demonstrating Consistent Sotagliflozin Results Across Baseline Blood Pressure Levels in Patients with Recent Worsening Heart Failure lexpharma.com ↗
The data, which were presented yesterday at ESC Congress 2026 in Munich, Germany and simultaneously published in JACC: Heart Failure 1 , demonstrated that the results of sotagliflozin treatment were maintained regardless of baseline systolic blood pressure. |
| 2026-06-03 | Lexicon Pharmaceuticals | Results Lexicon to Present Data at the American Diabetes Association (ADA) 2026 Scientific Sessions lexpharma.com ↗
Presentations highlight consistent A1c reductions with sotagliflozin in type 1 diabetes and pharmacokinetics of pilavapadin across renal function groups |
All press releases naming this drug 5 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sotagliflozin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07211802 ↗ |
| Known as | Inpefa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039507 ↗ |
| Known as | LP-802034 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039507 ↗ |
| Known as | LX4211 | “A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and Ortho-Cyclen®, an Oral Contraceptive Containing Norgestimate and...” NCT02494609 ↗13“Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in...” PMID 23911260 ↗ Jul 2013 |
| Known as | SAR439954 | “Drug: sotagliflozin (SAR439954)” NCT02940379 ↗15“Drug: sotagliflozin (SAR439954)” NCT03310944 ↗ “Drug: Sotagliflozin (SAR439954)” NCT02926937 ↗ “Drug: sotagliflozin (SAR439954)” NCT03760965 ↗ “Drug: Sotagliflozin (SAR439954)” NCT03332771 ↗ “Sotagliflozin (SAR439954)” NCT03174548 ↗ “Sotagliflozin (SAR439954)” NCT03909451 ↗ “Sotagliflozin (SAR439954)” NCT03414723 ↗ “Sotagliflozin (SAR439954)” NCT03070678 ↗ “Sotagliflozin (SAR439954)” NCT02926950 ↗ “Sotagliflozin (SAR439954)” NCT03462069 ↗ |
| Known as | SOTA | “One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA)...” NCT06217302 ↗1“Sotagliflozin (SOTA) followed by 3 drugs in a random order” NCT06933056 ↗ |
| Known as | Sotagliflozina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039507 ↗ |
| Known as | Sotagliflozine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039507 ↗ |
| Known as | Zynquista | “The drug is sold in the United States as Zynquista and is currently available for prescription use through regular pharmacy channels.” NCT07325201 ↗ |
| Action | Inhibit | “LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial.” PMID 22739142 ↗ Jul 20122“Sodium/glucose cotransporter 1 inhibitor” CHEMBL3039507 ↗ “Sodium/glucose cotransporter 2 inhibitor” CHEMBL3039507 ↗ |
| Modality | Small molecule | — CHEMBL3039507 ↗ |
| Route | Oral | “to receive a once-daily oral dose of placebo or 150 or 300 mg of the dual SGLT1/SGLT2 inhibitor LX4211 for 28 days.” PMID 22739142 ↗ Jul 2012 |
| Target | SLC5A1 | “Sodium/glucose cotransporter 1 inhibitor” CHEMBL3039507 ↗ |
| Target | SLC5A2 | “Sodium/glucose cotransporter 2 inhibitor” CHEMBL3039507 ↗ |