Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health & Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.

Start Date01 Nov 2026

Sponsor / Collaborator

Oregon Health & Science University

[+2]

NCT07325201

/ Not yet recruitingPhase 2IIT

Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:
1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods.
2. Identify potentially modifiable ketosis risk factors.
3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable.
4. Gather information on how participants and clinicians like and use the DGK reports.
Participants will be asked to:
* Meet with study investigators to determine if they are eligible
* Sign written informed consent
* Take a pregnancy test, if applicable
* Have blood taken to assess kidney function and hemoglobin A1c
* Take the study medication, following the study team instructions
* Wear the study provided sensor throughout participation.
* Complete 5 in person visits, and 11 phone check ins over a nine-month period
* Provide feedback on their experience, usefulness of CGM/CKM reports, and the most valuable factors of the Ketone Action Plan (KAP).

Start Date01 Sep 2026

Sponsor / Collaborator

Health Partners Institute For Education & Research

[+1]

NCT07572175

/ Not yet recruitingPhase 2IIT

SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)

This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.

Start Date01 Jul 2026

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

312

Literatures (Medical) associated with Sotagliflozin

01 Aug 2026·DIABETES OBESITY & METABOLISM

Cardiorenal Safety and Efficacy of Sotagliflozin: A Stratified Meta‐Analysis by Diabetes Type and Dosage

Review

Author: Yue, Rongchuan ; Liao, Junlei ; Huang, Yijuan

ABSTRACT:

Aims:

Sotagliflozin is a novel dual sodium‐glucose cotransporter inhibitor (SGLTi). At present, the comprehensive assessment of its influence on cardiorenal outcomes in diabetic patients remains inadequate.

Materials and Methods:

We retrieved and screened RCTs of sotagliflozin for diabetes from online databases. Primary endpoint was the expanded major adverse cardiovascular and heart failure composite endpoint, comprising cardiovascular death, heart failure hospitalisation, non‐fatal myocardial infarction, and non‐fatal stroke; secondary endpoint was substantial renal function decline. Pooled effect sizes were calculated as relative risk (RR) and 95% confidence interval (CI). Cochrane RoB 2.0 assessed bias risk. Subgroup, sensitivity, cumulative analyses, and publication bias tests verified result robustness.

Results:

After strict screening, 11 high‐quality RCT datasets (including 7 peer‐reviewed full publications and 4 ClinicalTrials.gov registry records) were ultimately included. Meta‐synthesis results demonstrated that sotagliflozin was associated with a reduced risk of the expanded cardiovascular composite endpoint (RR = 0.80, 95% CI [0.75, 0.88], p < 0.01). Regarding the incidence of a substantial decline in renal function, the sotagliflozin group showed a potential protective tendency, but it was not statistically significant (RR = 0.77, 95% CI [0.46, 1.27], p = 0.53). Subgroup analyses revealed that sotagliflozin maintained a highly consistent cardiovascular benefit in patients with type 2 diabetes mellitus, in studies adopting flexible dose titration (200 → 400 mg), and across different follow‐up periods. Sensitivity and cumulative analyses confirmed the high robustness of the core findings.

Conclusions:

Sotagliflozin provides significant and consistent cardiovascular benefit in patients with diabetes, particularly type 2 diabetes, with good safety. A potential renal protective trend exists. It is an effective treatment for diabetic patients at high cardiovascular risk.

20 Jul 2026·Cureus Journal of Medical Science

Efficacy and Safety of SGLT2 Inhibitors and Sotagliflozin in Heart Failure: A Systematic Review and Meta-Analysis of 59 Randomized Controlled Trials

Review

Author: Ayres Muller, Victor ; Muller Ferreira, Vicky

Sodium-glucose cotransporter-2 (SGLT2) inhibitors have become a cornerstone of heart failure (HF) therapy, yet the totality of randomized evidence - including smaller trials beyond the landmark cardiovascular (CV) outcome studies - has not been comprehensively synthesized. We searched PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP) from inception to March 2026 for randomized controlled trials (RCTs) comparing any SGLT2 inhibitor or the dual sodium-glucose cotransporter-1/2 (SGLT1/SGLT2) inhibitor sotagliflozin with placebo or standard care in adults with HF. Random-effects Mantel-Haenszel risk ratios (RRs) with Hartung-Knapp-Sidik-Jonkman (HKSJ) confidence intervals (CIs) were used. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. The protocol was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO; CRD420251167908). Of 6,239 records identified, 114 studies met inclusion criteria and 59 RCTs (29,692 participants) were included in the quantitative synthesis. SGLT2 inhibitors reduced all-cause mortality (ACM; RR 0.90, 95% CI 0.83-0.98; p = 0.016; 26 trials; low certainty), although trim-and-fill adjustment for publication bias attenuated the finding (adjusted RR 0.92, 95% CI 0.84-1.00). HF hospitalization (HFH) was reduced (RR 0.74, 95% CI 0.69-0.79; 15 trials; moderate certainty), as were CV death (RR 0.86, 95% CI 0.76-0.98; seven trials; moderate certainty), the composite of CV death and HFH (RR 0.80, 95% CI 0.75-0.85; eight trials; high certainty), and serious adverse events (RR 0.94, 95% CI 0.90-0.99; 20 trials; high certainty). Genital infections were significantly increased (RR 3.75, 95% CI 1.72-8.19); no significant increases were observed for diabetic ketoacidosis (DKA), acute kidney injury (AKI), urinary tract infection (UTI), or hypotension. Subgroup analyses showed a greater ACM benefit in HF with reduced ejection fraction (HFrEF) than in HF with preserved ejection fraction (HFpEF) (interaction p = 0.039). Results were directionally consistent across 13 sensitivity scenarios and five alternative statistical models. SGLT2 inhibitors reduce HFH, CV death, the composite endpoint, and serious adverse events with moderate-to-high certainty; the all-cause mortality reduction is of low certainty and sensitive to publication bias.

01 Jul 2026·Neurotherapeutics

Sotagliflozin improves cognitive deficits and attenuates neuroinflammation of Alzheimer's disease

Article

Author: Yang, Hao ; Jia, Jianping ; Ning, Yuye ; Chen, Meilin

Effective treatments for Alzheimer's disease (AD) are limited. Due to shared pathological mechanisms between AD and diabetes, antidiabetic drugs like sodium-glucose cotransporter-2 inhibitors (SGLT2is) are potential therapeutic options. Although SGLT2is have shown cognitive benefits in diabetes models, their effects in AD models are not fully established. This study aimed to evaluate the therapeutic effects of sotagliflozin (Sota), an SGLT2i, in both in vivo and in vitro AD models. The network pharmacology analysis was used to predict the potential targets and pathways of Sota. And we selected 6-month-old APP/PS1 transgenic mice to investigate the effects of Sota. Cognitive function was assessed using the Morris water maze test. Immunohistochemistry and immunofluorescence were employed to quantify amyloid-beta (Aβ) plaque deposition in the hippocampal or cortex and analyze neuronal loss. Additionally, amyloid β oligomers induction and microglial cells were used to evaluate the effects of Sota on the release of pro-inflammatory mediators and to investigate the underlying mechanisms. In vivo, Sota treatment improved cognitive impairments, reduced pro-inflammatory cytokines, inhibited microglial activation, and promoted neuronal survival. In vitro, Sota mitigated Aß oligomer-induced toxicity in microglial cells by decreasing reactive oxygen species and pro-inflammatory cytokine release. Mechanistically, Sota treatment was associated with suppression of extracellular signal-regulated kinase (ERK) signaling. Our findings suggest that Sota improved cognitive impairment and attenuates neuroinflammation in AD. Sota may be a promising candidate for the treatment of AD.

191

News (Medical) associated with Sotagliflozin

31 Aug 2026

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Lexicon Announces New Post Hoc SOLOIST-WHF Analysis Demonstrating Consistent Sotagliflozin Results Across Baseline Blood Pressure Levels in Patients with Recent Worsening Heart Failure

Findings presented at ESC Congress 2026 and simultaneously published in JACC: Heart Failure THE WOODLANDS, Texas, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced results from a post hoc analysis of the Phase 3 SOLOIST-WHF trial evaluating the efficacy and safety of sotagliflozin across the spectrum of baseline systolic blood pressure in patients recently hospitalized for worsening heart failure. 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. Among patients with baseline systolic blood pressure as low as 100 mmHg, treatment with sotagliflozin was associated with a reduction in cardiovascular death and heart failure-related events, without an increase in hypotension or acute kidney injury (AKI). “Patients hospitalized for recent worsening heart failure and lower systolic blood pressure are often considered among the most clinically vulnerable,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We were encouraged to see that the results of sotagliflozin treatment remained consistent across the spectrum of baseline blood pressure in SOLOIST-WHF, providing additional insight into the potential utility of sotagliflozin in a particularly high-risk heart failure population.” The SOLOIST-WHF trial randomized 1,222 patients with type 2 diabetes admitted for worsening heart failure to treatment with the dual SGLT 1 and 2 inhibitor sotagliflozin or placebo. The analysis demonstrated that the effect of sotagliflozin was consistent across the spectrum of baseline systolic blood pressure (SBP), with no evidence that treatment effect varied by baseline blood pressure. Among patients with a baseline SBP <110 mmHg (n=201), those randomized to sotagliflozin experienced a reduction in total occurrences of cardiovascular deaths and HF-related events (HR 0.56 (95% CI 0.33-0.95), p=0.03). These data suggest efficacy of sotagliflozin in even the lowest SBP stratum. There was no difference in the incidence of adverse events of hypotension between treatment groups (p=0.34) or AKI (p=0.69). Additionally, patients with a baseline SBP ≥ 110 mmHg (n=1175) also experienced a reduction in total occurrences of cardiovascular deaths and HF-related events (HR 0.69 (95%CI 0.53-0.91), p=0.01). 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. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM). About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit . Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin. In addition, this press release may also contain forward-looking 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. 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, 2025, 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 Media Inquiries: Dave Belian Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com For Investor Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com 1 Zitelny E, et al. Benefit of Sotagliflozin Across the Full Range of Baseline Blood Pressure in the SOLOIST-WHF Trial. JACC: Heart Failure. Published online August 2026. DOI: 10.1016/j.jchf.2026.103368.

Clinical ResultPhase 3

06 Aug 2026

·www.biospace.com

Lexicon Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Clinical Updates

Enrollment complete in Phase 3 SONATA-HCM study; top-line data expected Q1 2027 NDA resubmission activities for ZYNQUISTA ® in type 1 diabetes nearing completion Phase 1 clinical development of LX9851 ongoing by Novo Nordisk Conference call and webcast at 8:30 am ET ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); THE WOODLANDS, Texas, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2026, and provided an update on key corporate milestones and accomplishments. “Lexicon continued to make strong progress during the second quarter, with the refinement of our strategy and sharpening of our focus beginning to bear fruit across our business,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “Among all the accomplishments, I’m particularly pleased that we have completed enrollment of our SONATA-HCM study on time, reflecting strong clinical interest for a novel class of medicine to treat HCM. Overall, I could not be more confident in how these opportunities are poised to shape the company over the coming months.” “We remain very focused on disciplined, targeted capital allocation as we continue to advance our clinical programs,” said Scott Coiante, Lexicon’s chief financial officer. “With early commercial planning now underway for our late-state pipeline, we are committed to maximizing the value of these opportunities to create long-term shareholder value.” Second Quarter 2026 Business and Pipeline Highlights Cardiometabolic Sotagliflozin Sotagliflozin is a unique oral inhibitor of sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2) and has been studied in approximately 20,000 patients across multiple cardiometabolic indications. Sotagliflozin is commercially available in the U.S. for heart failure as INPEFA ® . Hypertrophic Cardiomyopathy (HCM ) Enrollment has been completed in SONATA-HCM, a pivotal Phase 3 placebo-controlled study, substantially exceeding its enrollment target of 500 patients across both non-obstructive (nHCM) or obstructive HCM (oHCM). The primary efficacy endpoint will assess improvement in symptoms for the entire population (nHCM and oHCM). The final study population included a substantial majority of patients with nHCM, providing a robust opportunity to evaluate sotagliflozin in a patient group for whom effective treatment options remain limited, as well as a meaningful cohort of patients with oHCM. Lexicon continues to expect topline results in the first quarter of 2027. Type 1 Diabetes (T1D) (ZYNQUISTA ® ) Lexicon remains focused on bringing ZYNQUISTA to market for glycemic control in adults with T1D, a patient population for which there are no treatment options beyond insulin. STENO1, a third-party funded, investigator-initiated study of sotagliflozin being conducted by the STENO Diabetes Center (Denmark) is approaching the patient exposure and safety data requirements previously identified by the U.S. Food and Drug Administration (FDA) as being adequate to support a resubmission of the company's New Drug Application (NDA), which Lexicon anticipates will occur in the fourth quarter of 2026 based on current estimated timing of data collection. The safety data received to date from this open-label trial continue to support the resubmission. Viatris License for All Indications Ex-U.S. and Ex-Europe Lexicon continues to support licensee Viatris in its regulatory filing and commercial strategy for sotagliflozin outside of the U.S. and Europe. Viatris has obtained regulatory approval for heart failure in the United Arab Emirates and Bahrain and has submitted applications for regulatory approval for heart failure in several other markets, including Saudi Arabia, Canada, Australia, New Zealand, Mexico, Singapore, Oman, Thailand, Turkey, Malaysia, Philippines, and Kuwait. Viatris anticipates regulatory decisions in Australia and Canada and regulatory submissions in other markets in 2026. LX9851 LX9851 is a first-in-class, non-incretin, oral, small molecule inhibitor of acyl-CoA synthetase 5 (ACSL5) in development by licensee Novo Nordisk for obesity and associated metabolic disorders. Obesity and Associated Cardiometabolic Disorders In March 2026, Novo Nordisk initiated a Phase 1 study investigating single and multiple ascending doses of LX9851 compared to placebo in overweight or obese people. The Phase 1 program is expected to be completed in the first quarter of 2027. Under the terms of Lexicon’s exclusive license agreement with Novo Nordisk, Lexicon received an upfront payment of $45 million and two $10 million payments related to clinical development. Lexicon is eligible to receive a third $10 million milestone payment as early as later this year and up to an aggregate of $1 billion in upfront and development, regulatory and sales milestone payments. Lexicon is also eligible for tiered royalties on net sales of LX9851. Pilavapadin (LX9211) Discovered using Lexicon’s unique approach to gene science and target identification, pilavapadin is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain and is exploring its potential in other indications. Diabetic Peripheral Neuropathic Pain (DPNP ) Pilavapadin has the potential to be the first oral, non-opioid drug therapy approved in neuropathic pain in more than 20 years. Lexicon continues to explore strategic opportunities to maximize the global potential of this investigative therapy. Second Quarter 2026 Financial Highlights Revenues: Total revenues were $0.7 million for the second quarter of 2026, consisting of net sales of INPEFA. Total revenues for the second quarter of 2025 were $28.9 million, consisting of $27.6 million in licensing revenue recognized from the Novo Nordisk licensing agreement and $1.3 million from net sales of INPEFA. Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2026 increased to $17.4 million from $15.7 million for the corresponding period in 2025, reflecting higher external research expense in 2026 related to the Company’s ongoing SONATA-HCM Phase 3 clinical trial. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2026 increased to $9.8 million from $9.4 million for the corresponding period in 2025. The increase in 2026 reflects higher professional and consulting costs. Net Loss: Net loss for the second quarter of 2026 was $31.8 million, or $0.07 per share, as compared to net income of $3.3 million, or $0.01 per share, in the corresponding period in 2025. Net loss for the second quarter of 2026 and net income for the second quarter of 2025 included non-cash, stock-based compensation expense of $3.3 million and $3.2 million, respectively. Cash, Investments and Restricted Cash: As of June 30, 2026, Lexicon had $190.6 million in cash and investments, as compared to $125.2 million in cash, investments, and restricted cash as of December 31, 2025. The increase in cash and investments reflects net proceeds of $96.2 million from the sale of common and preferred stock in February 2026. Hercules Capital Loan Facility In May 2026, Lexicon entered into a $100 million loan facility with Hercules Capital. An initial $55 million tranche was funded at closing and used to repay Lexicon’s previous loan facility with Oxford Finance. The second $20 million tranche is available for draw at Lexicon’s option subject to the achievement of certain clinical, regulatory and financial milestones and specified timing requirements. The third $25 million tranche is available for draw at Lexicon’s option subject to Hercules’ consent and specified timing requirements. Conference Call and Webcast Information Lexicon management will hold a live conference call and webcast today at 8:30 am ET / 7:30 am CT to review its financial and operating results and to provide a general business update. A live audio webcast of the call can be accessed by visiting the Events page of the Company’s investor relations website at . Participants who wish to ask a question may join by phone at 800-715-9871 and use passcode 9826247. An archived version of the webcast will be available on the website for 30 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit . 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, 2025, 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 Media Inquiries: Dave Belian Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com For Investor Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com Lexicon Pharmaceuticals, Inc. Selected Financial Data Consolidated Statements of Operations Data Three Months Ended June 30, Six Months Ended June 30, (In thousands, except per share data) 2026 2025 2026 2025 (Unaudited) (Unaudited) Revenues: Net product revenue $ 680 $ 1,322 $ 1,770 $ 2,584 Licensing and milestone revenue — 27,544 20,000 27,544 Royalties and other revenue 12 — 24 — Total revenues 692 28,866 21,794 30,128 Operating expenses: Cost of sales 39 33 147 63 Research and development, including stock-based compensation of $1,384, $1,620, $2,753 and $3,194, respectively 17,443 15,747 30,199 31,050 Selling, general and administrative, including stock-based compensation of $1,952, $1,575, $3,661 and $3,044, respectively 9,750 9,350 18,984 20,958 Total operating expenses 27,232 25,130 49,330 52,071 Income (loss) from operations (26,540 ) 3,736 (27,536 ) (21,943 ) Interest and other expense (2,609 ) (2,318 ) (4,199 ) (4,153 ) Interest and other income 1,723 1,834 3,266 4,053 Loss on early extinguishment of debt $ (4,349 ) $ — $ (4,349 ) $ — Net income (loss) $ (31,775 ) $ 3,252 $ (32,818 ) $ (22,043 ) Net income (loss) per common share, basic $ (0.07 ) $ 0.01 $ (0.08 ) $ (0.06 ) Net income (loss) per common share, diluted $ (0.07 ) $ 0.01 $ (0.08 ) $ (0.06 ) Weighted average common shares outstanding, basic 437,653 363,294 419,050 362,687 Weighted average common shares outstanding, diluted 437,653 363,570 419,050 362,687 As of As of Consolidated Balance Sheet Data June 30, 2026 December 31, 2025 (In thousands) Cash and investments $ 190,610 $ 96,230 Restricted cash — 29,000 Property and equipment, net 1,651 1,863 Goodwill 44,543 44,543 Total assets 250,060 184,987 Current portion of long-term debt — 4,595 Long-term debt, net 51,437 49,408 Accumulated deficit (2,050,401 ) (2,017,583 ) Total stockholders' equity 174,525 107,538

Phase 1Phase 3License out/inFinancial StatementDrug Approval

27 Jul 2026

·www.biospace.com

Lexicon Pharmaceuticals Completes Enrollment of Pivotal Phase 3 SONATA-HCM Study of Sotagliflozin in Symptomatic Non-Obstructive and Obstructive Hypertrophic Cardiomyopathy (HCM)

Study substantially exceeded enrollment target of 500 patients Topline results anticipated in Q1 2027 THE WOODLANDS, Texas, July 27, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that randomization of patients has been completed in the pivotal Phase 3 “ SO tagliflozi N in Patients with Symptom AT ic obstructive A nd non-obstructive H ypertrophic C ardio M yopathy (SONATA-HCM)” clinical trial evaluating sotagliflozin in patients with non-obstructive (nHCM) and obstructive (oHCM) hypertrophic cardiomyopathy. The study substantially exceeded its enrollment target of 500 patients across more than 130 sites in 20 countries. The primary efficacy endpoint will assess improvement in symptoms for the entire population (nHCM and oHCM). The final study population included a substantial majority of patients with non-obstructive HCM, providing a robust opportunity to evaluate sotagliflozin in a patient group for whom effective treatment options remain limited, as well as a meaningful cohort of patients with obstructive HCM. Lexicon believes the final study population will enable a thorough assessment of sotagliflozin's potential across the spectrum of symptomatic HCM. Topline results are anticipated in the first quarter of 2027. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Completion of patient enrollment in SONATA-HCM marks an important milestone for patients living with the symptoms of HCM, a chronic, progressive disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We believe that sotagliflozin, a dual SGLT1 and SGLT2 inhibitor with a unique mechanism of action as compared to currently available treatments, has the potential to be a differentiated option for symptomatic HCM patients. We look forward to sharing topline results in the first quarter of 2027.” SONATA-HCM is the only ongoing Phase 3 study in both non-obstructive and obstructive HCM and is the largest Phase 3 study including both nHCM and oHCM to date. SONATA-HCM is a randomized, double-blind, placebo-controlled, multinational trial that is evaluating the efficacy of sotagliflozin on symptoms, function, and other patient-reported outcomes, as well as safety, in patients with symptomatic 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). Patients with symptomatic HCM on a stable dose of guideline-directed therapy for HCM, including cardiac myosin inhibitors, were permitted to enroll in the study depending on certain criteria. “For patients living with hypertrophic cardiomyopathy, there remains a significant need for additional treatment options that can help address persistent symptoms and improve daily function,” said Sharlene M. Day, M.D., co-principal investigator for SONATA-HCM, Presidential Professor, Director of Translational Research of the Penn Cardiovascular Institute, University of Pennsylvania. “Having a well-tolerated medication with a distinct mechanism of action that can complement other therapies would be an important advance for physicians and patients.” “Completing enrollment in SONATA-HCM is a major achievement for the HCM community and reflects the commitment of investigators, study teams and participants,” said Carolyn Y. Ho, M.D., co-principal investigator for SONATA-HCM, Professor of Medicine at Harvard Medical School and Medical Director of the Cardiovascular Genetics Center at Brigham and Women’s Hospital. “We are grateful to the patients involved in this trial, whose partnership is essential to advancing research and hopefully bringing a novel treatment option to people living with HCM.” 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. Sotagliflozin is also currently under investigation for hypertrophic cardiomyopathy (HCM). About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit . Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin in hypertrophic cardiomyopathy. In addition, this press release may also contain forward-looking 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, 2025, 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 Media Inquiries: Dave Belian Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com For Investor Inquiries: Lisa DeFrancesco Lexicon 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.

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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.

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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	Bulgaria	Lexicon Pharmaceuticals, Inc.	24 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05562063 (SOTA-P-CARDIA, CTgov)	Phase 4	Heart failure with normal ejection fraction	88	Sotagliflozin (Sotagliflozin)	zzcgxkkofr(njtgoavapy) = mxkobxdwep wcmpgyuueh (arrlioajfe, yzsdrrlmab - gbzaiofths) View more	-	24 Jun 2026
				Placebo (Placebo)	zzcgxkkofr(njtgoavapy) = hcspimkmhb wcmpgyuueh (arrlioajfe, buinusxyqz - nissulefat) View more
NCT02531035 \| NCT02384941 \| NCT02421510 (inTandem3, ASN2025) Manual	Not Applicable	Diabetes Mellitus, Type 1	2,829	Sotagliflozin (pooled 200 and 400mg)	bmucqikiqn(gymqibssqq) = Sotagliflozin significantly reduced the estimated 10-year CVD risk following 24 weeks of treatment compared with placebo. hqqcxisffm (mqvtxclzxf ) View more	Positive	06 Nov 2025
				Placebo
NCT03521934 \| NCT03315143 (SCORED, Company_Website \| ESC2025) Manual	Phase 3	Heart Failure \| Kidney Failure, Chronic \| Chronic Kidney Diseases	11,806	Sotagliflozin	qsptkemwlx(kksmpuxqyh) = gikdzycwcz jsaakdtjpv (rckfnmhcdj ) View more	Positive	30 Aug 2025
				placebo	qsptkemwlx(kksmpuxqyh) = ceyeecpoic jsaakdtjpv (rckfnmhcdj ) View more
NCT03315143 (SCORED, Lancet) Manual	Phase 3	Ischemia	10,584	Sotagliflozin	wbuebcrboy(ylzacbvnra) = rqxwymwjkz vlmhshyluc (jdaboxdvzu ) View more	Positive	14 Feb 2025
				Placebo	wbuebcrboy(ylzacbvnra) = hbbjesxogz vlmhshyluc (jdaboxdvzu ) View more
NCT05562063 (SOTA-P-CARDIA, Pubmed \| Cardiovasc Drugs Ther)	Phase 3	Heart failure with normal ejection fraction	400	Sotagliflozin	vrkfticxhf(gwqvihgdic) = gfvmdzdplk qryoibztnv (jycoouvanf )	Positive	01 Feb 2025
NCT02531035 \| NCT02384941 \| NCT02421510 (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	-	Sotagliflozin 200mg (CKD)	igaptuxzgc(uijulidssu) = umxdqsxtqa ediieymovw (jywinruxxu ) View more	Positive	01 Nov 2024
				Sotagliflozin 400mg (CKD)	igaptuxzgc(uijulidssu) = mrpcjwonfs ediieymovw (jywinruxxu ) View more
NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	vdbcufuiwo(gejxhajstk) = qcwwbjtzfe rutsfoqnis (jfewowoslm )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	vdbcufuiwo(gejxhajstk) = xzkbceckqh rutsfoqnis (jfewowoslm )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	uoddvxwjfv(nsuoxjnegi) = 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 zmizdyfuvf (imwatytuvz )	Positive	01 Sep 2024
				Placebo
ESC2024	Not Applicable	Diabetes Mellitus	-	Sotagliflozin	htmfzdbmev(ziyythtmln) = edpvmhtswz gdpcniruhf (xiegvvyrhl ) View more	-	30 Aug 2024
				Placebo	htmfzdbmev(ziyythtmln) = qtgnqamgon gdpcniruhf (xiegvvyrhl ) View more
917-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2	770	Sotagliflozin 400 mg	eimdpssmso(ndajpfkusb) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy rrsoaezvcv (ldydpjkhom ) View more	Positive	14 Jun 2024
				Empagliflozin 25 mg

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