Individual and Combined Endothelin Receptor and SGLT1/2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial

The aim of this study is to test the hypothesis that sotagliflozin (SGLT1/2 inhibitor) and ambrisentan (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.

Start Date01 Sep 2025

Sponsor / Collaborator

University Medical Center Groningen

[+2]

NCT06933056

/ Not yet recruitingEarly Phase 1IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Michigan

[+1]

NCT06618976

/ RecruitingPhase 4IIT

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

Start Date25 Feb 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

340

Literatures (Medical) associated with Sotagliflozin

01 Jul 2025·Journal of Managed Care & Specialty Pharmacy

Cost-effectiveness analysis model for sotagliflozin compared with insulin monotherapy for patients with type 1 diabetes and chronic kidney disease

Article

Author: Marin, Moises ; Kim, Jaehong ; Shafrin, Jason ; Anderson, Mariam ; Sikirica, Slaven ; Wang, Shanshan

BACKGROUND:

Patients with type 1 diabetes (T1D) have a greater than 50% lifetime risk of developing comorbid chronic kidney disease (CKD). Glycemic control can reduce diabetes-related complications and slow CKD progression. Adding sotagliflozin to insulin therapy reduced A1c by 0.46% compared with insulin monotherapy in patients with T1D. However, the long-term economic value for patients with both T1D and CKD remains unknown.

OBJECTIVE:

To evaluate the cost-effectiveness of sotagliflozin as an add-on to insulin in patients with T1D and CKD from a US payer perspective.

METHODS:

A Markov model was generated for individuals diagnosed with both T1D and comorbid CKD stage 3 from a US payer's perspective. Clinical and economic outcomes were assessed over 30 years and included number of patients prevented from dialysis and transplantation, life-years, quality-adjusted life-year (QALY) gains, incremental costs, incremental cost-effectiveness ratio (ICER), and net monetary benefit. Dynamic pricing, through genericization, was incorporated to account for the economic impacts of market entry by generics.

RESULTS:

Sotagliflozin add-on therapy improved survival, extending life expectancy by 1.27 years (13.08 with sotagliflozin vs 11.81 with insulin monotherapy). During the first 10 years after treatment initiation, dialysis and transplant utilization decreased by 3.06 (99.35 vs 102.41) and 1.73 (30.59 vs 32.32) per 1,000 patients, respectively. QALYs per patient increased by 0.63 (7.70 vs 7.07), largely driven by prolonged time in pre-end-stage renal disease health states (0.59; 6.75 vs 6.16). Total costs rose by $72,914 ($484,674 vs $411,760), primarily because of pharmacy costs increasing by $69,060 ($96,242 vs $27,364). The ICER was $115,677 per QALY and the model was most sensitive to pharmacy costs.

CONCLUSIONS:

Sotagliflozin is a cost-effective adjunct to insulin therapy for T1D and CKD patients, providing clinical benefits and falling below the $150,000/QALY willingness-to-pay threshold in 59% of probabilistic sensitivity analysis simulations.

01 Jun 2025·AMERICAN JOURNAL OF PHYSIOLOGY-ENDOCRINOLOGY AND METABOLISM

SGLT2 inhibitors use in kidney disease: what did we learn?

Review

Author: Khosla, Shikha G. ; Akunjee, Munaza M. ; Sen, Sabyasachi ; Nylen, Eric S.

Chronic kidney disease (CKD) increases the risk for cardiovascular morbidity and mortality and it’s prevalence continues to rise throughout the world. Newer, more efficacious therapies, slow progression of CKD, decrease long-term sequela like end-stage kidney disease (ESKD) and cardiovascular events, improving survival. Postmarketing cardiovascular outcome trials (CVOT) have demonstrated improved cardiovascular outcomes with the use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) like canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin in patients with type 2 diabetes mellitus (T2DM), Similarly, secondary analysis of CVOT and renal outcome trials with the use of SGLT2i in patients without T2DM showed improved renal function and albuminuria. In these studies, nondiabetic CKD was defined as an estimated glomerular filtration rate (eGFR) of 20–75 mL/min/1.73 m2 with albuminuria ranging from 200 to 5,000 mg/g in the absence of diabetes. As a class effect, in addition to modulation of hemodynamic and metabolic activities, SGLT2i exert renal protection by suppressing inflammation and fibrosis. We conducted an extensive search in the PubMed database for original papers published from 2009 through 2024 using keywords such as nondiabetic kidney disease, diabetic kidney disease, SGLT2i, and kidney outcomes. Based on our research of published literature, we present a review and propose, consideration of SGLT2i in nondiabetic kidney disease for long-term cardiovascular and renal benefit (Dharia A, Khan A, Sridhar VS, Cherney DZI. Annu Rev Med 74: 369–384, 2023). We will highlight relevant translational studies to propose a possible cell-based mechanism for cardiovascular benefits noted secondary to use of SGLT2i.

01 Jun 2025·DIABETES RESEARCH AND CLINICAL PRACTICE

Comparative efficacy and safety of SGLT2 inhibitor class members in patients with heart failure and type 2 diabetes: A systematic review and network meta-analysis of randomized controlled trials

Review

Author: Su, Angela Y ; Valenzuela, German V ; Pasupuleti, Vinay ; Hernandez, Adrian V ; Csere, Molly M ; Shan, Ryan

We conducted a systematic review with pairwise (PMA) and network meta-analyses (NMA) to evaluate sodium-glucose transport protein 2 inhibitor (SGLT2i) effects in patients with both heart failure (HF) and type 2 diabetes mellitus (T2DM). Five databases were searched up to April 15, 2025. Primary outcomes were all-cause mortality (ACM), cardiovascular death (CVD), all-cause hospitalization (ACH), and hospitalization for heart failure (HHF). SGLT2i class effects versus control were assessed via PMA and individual SGLT2i comparative efficacy via NMA plus ranking using p-scores. Seventeen randomized controlled trials (n = 17,809) were included. Arms included canagliflozin (n = 2), dapagliflozin (n = 6), empagliflozin (n = 6), ertugliflozin (n = 1), ipragliflozin (n = 1), sotagliflozin (n = 1), placebo (n = 13), and standard of care (n = 4). Compared to control, SGLT2i significantly reduced ACM (HR 0.87, 95 %CI 0.78 to 0.98, low quality of evidence [QoE]), ACH (HR 0.74, 95 %CI 0.62 to 0.88, high QoE), and HHF (HR 0.70, 95 %CI 0.63 to 0.77, low QoE); but not CVD (HR 0.87, 95 %CI 0.76 to 1.00, very low QoE). Canagliflozin ranked highest in decreasing ACM (p-score = 0.86), CVD (p-score = 0.82), and HHF (p-score = 0.88). In patients with HF and T2DM, SGLT2i class effects include ACM, ACH, and HHF reduction. Among SGLT2i, canagliflozin showed greatest ACM, CVD, and HHF benefit.

175

News (Medical) associated with Sotagliflozin

23 Jun 2025

·www.globenewswire.com

Data Demonstrating Sotagliflozin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes When Added to Insulin Presented at the 85th Scientific Sessions of the American Diabetes Association (ADA)

Oral presentation highlighted the post-hoc analysis during the “Interventions to Prevent Hypoglycemia: Bench to Bedside” session Treatment with sotagliflozin resulted in no increased risk and a reduction in hypoglycemia events, particularly in patients with blood glucose ≤55 mg/dL THE WOODLANDS, Texas, June 23, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that a post-hoc analysis of clinical study data showing a reduction in hypoglycemic events when sotagliflozin was added to optimized insulin therapy for people with type 1 diabetes (T1D) was presented yesterday during the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois. The ADA emphasizes that hypoglycemia remains an important patient management issue in T1D. Its Standards of Care in Diabetes -- 2025 clinical update states, "Health care professionals should be vigilant in preventing hypoglycemia." In addition, severe hypoglycemia accounts for 5% of T1D hospitalizations and up to 10% of T1D deaths. Chronic kidney disease (CKD) is an important, independent risk factor for hypoglycemia in people with T1D. Approximately 20% to 40% of people with T1D develop CKD. Treatment with sotagliflozin as an adjunct to insulin therapy has been shown to improve glycemic control while also reducing hypoglycemic events. The aim of this post-hoc analysis was to evaluate the effect of kidney function on hypoglycemia risk in patients with T1D who were being treated with sotagliflozin, a dual inhibitor of SGLT 1 and 2, as an adjunct to optimized insulin therapy. Researchers analyzed pooled data from inTandem 1 and inTandem 2, identically designed 52-week Phase 3 clinical trials in which once-daily 200 mg and 400 mg doses of sotagliflozin were compared to placebo when added to optimized insulin therapy. In these studies, documented hypoglycemia was defined as blood glucose of ≤ 70 mg/dL and ≤ 55 mg/dL, and severe hypoglycemia per the ADA Level 3 definition. Results were evaluated by subgroups defined by estimated glomerular filtration rate (eGFR) cut points: eGFR < 60 ml/min/1.73m2, eGFR ≥ 60 to < 90 ml/min/1.73m2, and eGFR ≥ 90 ml/min/1.73m2. The overall trend favored sotagliflozin, indicating no increased risk and a reduction in hypoglycemia events, particularly in patients with blood glucose ≤55 mg/dL. Notably, the effect appears consistent across eGFR subgroups, suggesting that sotagliflozin maintains this similar trend regardless of kidney function. Treatment with sotagliflozin generally resulted in severe hypoglycemia event rates lower than that of placebo. “This analysis is important because it demonstrated that adding sotagliflozin on top of optimized insulin therapy resulted in fewer people developing significant hypoglycemia,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “Practitioners recognize that hypoglycemia remains an obstacle to optimal care in people with diabetes.” About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. About Lexicon Pharmaceuticals  Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications.  For additional information, please visit www.lexpharma.com.   Safe Harbor Statement  This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:  Lisa DeFrancesco   Lexicon Pharmaceuticals, Inc.  lexinvest@lexpharma.com

Phase 3Clinical Result

18 Jun 2025

·www.einpresswire.com

Lexicon to Present Data at the 85th Scientific Sessions of the American Diabetes Association (ADA)

Oral presentation on study demonstrating the ability of sotagliflozin to reduce the risk of hypoglycemic events regardless of kidney function in people with type 1 diabetes THE WOODLANDS, Texas, June 18, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from a study evaluating the impact of sotagliflozin on hypoglycemia in people with type 1 diabetes will be delivered as an oral presentation on Sunday, June 22, during the 85th Scientific Sessions of the American Diabetes Association (ADA). At the meeting, the company will also present topline data from its PROGRESS Phase 2b study evaluating pilavapadin (LX9211) in adults with diabetic peripheral neuropathic pain. The congress is being held June 20–23, 2025 at the McCormick Place Convention Center in Chicago, Illinois. The ADA recently emphasized that hypoglycemia remains an important patient management issue in type 1 diabetes. Its Standards of Care in Diabetes -- 2025 clinical update states, “Health care professionals should be vigilant in preventing hypoglycemia.” In a session entitled “Interventions to Prevent Hypoglycemia: Bench to Bedside,” Lexicon US Medical Affairs team member M. Belinda Hardin, PharmD, BCPS, will present sotagliflozin clinical efficacy data segmented by three common kidney-function subgroups: Estimated Glomerular Filtration Rate (eGFR) of < 60 ml/min/1.73m 2 , ≥ 60 to < 90 ml/min/1.73m 2 , and ≥ 90 ml/min/1.73m 2 . “We appreciate the opportunity to share our study results in an oral presentation at this important gathering of the diabetes community,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We anticipate lively discussions following Dr. Hardin’s presentation and throughout the ‘Interventions to Prevent Hypoglycemia’ session.” Presentation details: “Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function” -- Sunday, June 22, 4:00-4:15 p.m. CT, Presentation 244-OR, W181 A-C, presented by M. Belinda Hardin, PharmD, BCPS, US Medical Affairs, Lexicon Pharmaceuticals, Inc. on behalf of the inTandem study investigators During the 85th Scientific Sessions, Lexicon also will present topline data from its PROGRESS Phase 2b study evaluating pilavapadin (LX9211) in adults with diabetic peripheral neuropathic pain. Presentation details: “Pilavapadin, an Oral, Non-opioid, AAK1 Inhibitor for Diabetic Peripheral Neuropathic Pain (DPNP)--Results from a Phase 2b, Dose-Ranging, Randomized, Multicenter Study” -- Sunday, June 22, 12:30-1:30 p.m. CT, Board No. 1876, Poster Hall F1 About Sotagliflozin Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. About the PROGRESS Study The PROGRESS study commenced in December 2023 and enrolled 496 adult patients with a diagnosis of diabetes (type 1 or type 2) and moderate to severe DPNP. The study was placebo-controlled with a primary endpoint of change from baseline to Week 8 in ADPS and evaluated three treatment groups receiving once daily pilavapadin doses of 10 mg, 20 mg or 20 mg for seven days followed by 10 mg thereafter. Secondary endpoints included change from baseline to Week 8 in burning pain and pain interference on sleep. Study design permitted patients to remain on one stable-dose DPNP therapy (e.g. gabapentin, pregabalin or duloxetine) without withdrawing from therapies that, although inadequate, may be providing some benefit — aligning with how new DPNP drugs are likely to be used in practice. About DPNP DPNP is a debilitating chronic complication of diabetes which can result in burning pain, numbness, and other symptoms in the hands, feet, legs and arms. There are approximately 9 million patients in the U.S. who are suffering with DPNP. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications.  For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries : Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2Clinical Result

19 May 2025

·www.globenewswire.com

SONATA-HCM Study Design Presented at Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology

Lexicon is evaluating the safety and efficacy of sotagliflozin in patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) Pivotal Phase 3 clinical trial is actively enrolling patients in 20 countries, with all sites expected to be operational by Q3 2025 THE WOODLANDS, Texas, May 19, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced details of its “SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)” study were presented on Saturday, May 17. The study design was disclosed in Belgrade, Serbia at one of the premier international heart failure meetings: Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology. Enrollment is underway in SONATA-HCM, with all study sites in 20 countries expected to be operational by September 2025. Lexicon believes there is potential for the study results to support a supplemental new drug application (sNDA) for sotagliflozin for both obstructive and non-obstructive HCM. SONATA-HCM is the only ongoing Phase 3 study in both obstructive and non-obstructive HCM. It is a randomized, double-blind, placebo-controlled multicenter trial that will evaluate the efficacy of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, on symptoms, function, and other patient-reported outcomes, as well as safety in patients with symptomatic HCM. The study is designed to enroll 500 patients worldwide, 250 with obstructive HCM and 250 with non-obstructive HCM. The primary efficacy endpoint is improvement in symptoms, as measured by change from baseline to week 26, in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ) CSS survey. "There is a huge unmet need for people suffering from HCM, with no approved or effective therapies for non-obstructive HCM," said Sharlene M. Day, M.D., co-principal investigator for SONATA-HCM and Presidential Professor and Director of Translational Research in the Division of Cardiovascular Medicine and the Cardiovascular Institute at the University of Pennsylvania Perelman School of Medicine. "I'm very excited to be testing the potential for sotagliflozin to improve symptoms in a broad number of patients across the spectrum of HCM, as has previously been demonstrated in patients with heart failure with reduced and preserved ejection fraction. Sotagliflozin’s tolerability profile and immediate benefits observed in patients with heart failure could potentially make it a very appealing option for patients with HCM if the benefits do indeed extend to this population." As a chronic, progressive disease, HCM can worsen over time and lead to other complications, including heart failure and stroke. Sotagliflozin is a proven drug for the treatment of heart failure, with an established safety record and significant use in clinical practice. A growing body of evidence suggests that sotagliflozin’s dual inhibition of SGLT1 and SGLT2 reduces the risk of major adverse cardiovascular events (MACE), including heart attack and stroke, as most recently published in The Lancet in February 2025. “SONATA-HCM is an important study with the potential to support a broad label to enhance the care of patients with both obstructive and non-obstructive HCM,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. For more information on the study, visit the SONATA-HCM page on ClinicalTrials.gov. About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. Safe Harbor StatementThis press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:Lisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

Phase 3

100 Deals associated with Sotagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10669	Sotagliflozin	A10BK06	DB12713

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Heart Failure	United States	Lexicon Pharmaceuticals, Inc.	26 May 2023
Diabetes Mellitus, Type 1	European Union	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Iceland	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Liechtenstein	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Norway	NCI Healthcare LLC	26 Apr 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	United States	Lexicon Pharmaceuticals, Inc.	21 Jun 2024
Diabetic Nephropathies	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Diabetic Nephropathies	Phase 3	Canada	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Kidney Failure, Chronic	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Kidney Failure, Chronic	Phase 3	Canada	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Argentina	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Belgium	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Brazil	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Georgia	Lexicon Pharmaceuticals, Inc.	24 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03315143 (SCORED, Lancet) Manual	Phase 3	Ischemia	10,584	Sotagliflozin	lrmnzlihnb(cclwvegvns) = vjadcxyhhk nzkzahnkqz (edosprcehe ) View more	Positive	14 Feb 2025
				Placebo	lrmnzlihnb(cclwvegvns) = uewjhjwpnw nzkzahnkqz (edosprcehe ) View more
NCT02531035 \| NCT02384941 \| NCT02421510 (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	-	Sotagliflozin 200mg (CKD)	zrfidimlco(qrpccdqkha) = ggfkhkiico dvlwcdlill (abfrypazql ) View more	Positive	01 Nov 2024
				Sotagliflozin 400mg (CKD)	zrfidimlco(qrpccdqkha) = iobwdfwxis dvlwcdlill (abfrypazql ) View more
NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	vhtuhwmpps(lnkgnrxqgj) = vdkrcibngr tyagrwxjbm (dfnvdkqnbw )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	vhtuhwmpps(lnkgnrxqgj) = izbmnqfptb tyagrwxjbm (dfnvdkqnbw )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	pcuprxwstt(exkcvttegt) = The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups njwglvcvwy (rjvicpvkeh )	Positive	01 Sep 2024
				Placebo
ESC2024	Not Applicable	Diabetes Mellitus	-	Sotagliflozin	otorekzjkz(aumjdpokup) = afibsbumqj gdhndzrqxo (nxgeruqtuh ) View more	-	30 Aug 2024
				Placebo	otorekzjkz(aumjdpokup) = didhdlvmff gdhndzrqxo (nxgeruqtuh ) View more
924-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2 Add-on	570	Sotagliflozin 400 mg	gjgqzapvay(nzdisickyt) = qjarkwmjxh vwucotrrxw (xufioevgdp )	Positive	14 Jun 2024
				Sotagliflozin 200 mg	gjgqzapvay(nzdisickyt) = bsrufyjoza vwucotrrxw (xufioevgdp )
917-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2	770	Sotagliflozin 400 mg	xfsmkqajqd(dondoeijjl) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy ezbffmtngg (viulacffiv ) View more	Positive	14 Jun 2024
				Empagliflozin 25 mg
NCT03315143 (SCORED, GlobeNewswire) Manual	Phase 3	Heart Failure	1,932	INPEFA® (sotagliflozin)	wautpckenb(ixscxlytsi) = zhgwgdmbgs sxhqnaqyus (rnuswjehxp )	Positive	14 May 2024
SOLOIST-WHF and SCORED (ESC2024)	Not Applicable	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	ufrbrrahmw(bzexyzdsuk) = peswxlwdzo ctixtivzey (jwuhclsyug )	Positive	14 May 2024
NCT03315143 (SCORED, ACC2024) Manual	Phase 3	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	10,584	Sotagliflozin	ugztkqruri(smglpphmjq) = didwelynxy jnufajyrvn (czsnatpwaz ) View more	Positive	25 Mar 2024
				Placebo	ugztkqruri(smglpphmjq) = kjvdobqgio jnufajyrvn (czsnatpwaz ) View more

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