Lexicon Pharmaceuticals Announces Publication of New Research Highlighting Sotagliflozin’s Biological Effects in Cardiovascular Disease

Lexicon-funded research reported effects on heart structure and clot formation in preclinical models, rather than patient trial results.

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) highlighted two preclinical studies examining sotagliflozin’s effects on heart muscle disease and blood clot formation.

In mice with hypertrophic cardiomyopathy (HCM), a disease involving thickened heart muscle, sotagliflozin improved cardiac structure and function, reduced fibrosis and oxidative stress, and increased activity in gene sets linked to cellular energy production. A second study found reduced platelet activation and clot formation in human blood tested outside the body and animal models, without adversely affecting normal blood clotting; empagliflozin did not show these effects. Both studies were investigator-initiated and funded by Lexicon. The company expects topline results from its ongoing Phase 3 SONATA-HCM trial in the first quarter of 2027.

5 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Phase 3 SONATA-HCM is ongoing; Lexicon expects topline results in the first quarter of 2027.
• Minor pointHCM mouse study normalized measures of diastolic function, reversed cardiac hypertrophy progression and reduced cardiac fibrosis.
• Minor pointHCM mouse study reduced oxidative stress and increased activity in mitochondrial gene sets associated with energy production.
• Minor pointPlatelet study reduced platelet activation and thrombus formation in ex vivo human blood and animal models, unlike empagliflozin.
• Minor pointNormal hemostasis, the process that stops bleeding, was not adversely affected in the platelet study.

Negative

• None.

Key Figures

Trial phase: Phase 3 Topline results timing: First quarter of 2027

Trial phase

Phase 3

Ongoing SONATA-HCM trial

Topline results timing

First quarter of 2027

SONATA-HCM trial

Key Terms

hypertrophic cardiomyopathy, sglt1, sglt2, ex vivo, +1 more

5 terms

hypertrophic cardiomyopathy medical

"in a mouse model of hypertrophic cardiomyopathy"

Hypertrophic cardiomyopathy is a genetic heart condition in which the heart muscle becomes abnormally thick, making it harder for the heart to pump and for electrical signals to travel normally; think of a pump whose walls have thickened so it moves less efficiently. Investors care because the condition drives demand for diagnostics, drugs and devices, affects workforce and insurance costs, and can influence clinical trial results, regulatory approvals and liability exposure in healthcare-related companies.

sglt1 medical

"dual SGLT1 and SGLT 2 inhibition"

SGLT1 is a protein in the body’s lining of the gut and some kidney cells that acts like a doorway, moving sugar from the digestive tract into cells. It matters to investors because drugs that block or modify this doorway can change how the body handles blood sugar, appetite and fluid balance, so successes or setbacks in SGLT1-targeted therapies can affect drug sales, trial outcomes, regulatory risk and long-term company value.

sglt2 medical

"dual SGLT1 and SGLT 2 inhibition"

SGLT2 is a protein in the kidneys that acts like a tiny reabsorption gate, returning glucose from urine back into the bloodstream; drugs called SGLT2 inhibitors block this gate to help lower blood sugar. Investors care because therapies aimed at SGLT2 have broad market potential beyond diabetes—often affecting heart and kidney outcomes—so clinical results, approvals, or safety signals can materially change a drug maker’s revenue and regulatory risk, similar to a new feature that expands or shrinks a product’s customer base.

ex vivo medical

"in ex vivo human blood and animal models"

Ex vivo describes tests or treatments performed on living cells, tissues, or organs that have been removed from the body and studied in an external environment. For investors, ex vivo work sits between basic lab dish tests and whole‑animal or human studies, offering a more realistic preview of how a therapy or diagnostic might behave in real tissue — like running an engine on a test stand before putting it back into a car — which can reduce scientific risk and inform development milestones.

hemostasis medical

"without adversely affecting normal hemostasis"

Hemostasis is the body’s process for stopping bleeding, using a coordinated set of responses that form clots and seal damaged vessels—think of it as the body's natural emergency patch and repair crew. It matters to investors because drugs, medical devices, and diagnostics that influence hemostasis can affect patient outcomes, regulatory approval paths, and market demand for treatments of bleeding disorders or clot-related conditions, so advances or safety issues can materially impact company value.

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-- Preclinical study demonstrates positive effects of sotagliflozin on cardiac function and structure in hypertrophic cardiomyopathy --

-- Second preclinical study shows inhibitory effects of sotagliflozin on platelet activity and thrombus formation --

-- Findings underscore differentiated biology associated with dual SGLT1 and SGLT 2 inhibition --

THE WOODLANDS, Texas, Oct. 21, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a leading cardiometabolic biopharmaceutical company, today highlighted findings from two newly reported preclinical studies that provide additional insight into the biological effects of sotagliflozin, Lexicon's first-in-class dual SGLT1 and SGLT2 inhibitor. The investigator-initiated studies, funded by Lexicon and conducted by independent academic investigators, demonstrated favorable effects of sotagliflozin on key pathways involved in hypertrophic cardiomyopathy (HCM) and thrombotic cardiovascular events.

The first study, published in the Journal of Molecular and Cellular Cardiology Plus¹, found that sotagliflozin improved cardiac structure and function in a mouse model of hypertrophic cardiomyopathy, while reducing oxidative stress and upregulating mitochondrial gene sets associated with energy production in myocardial tissues. Investigators reported that sotagliflozin normalized measures of diastolic function, reversed progression of cardiac hypertrophy and reduced cardiac fibrosis, findings that support further evaluation of its potential in HCM.

The second study, published in the Journal of Clinical Investigation², demonstrated that sotagliflozin, but not the selective SGLT2 inhibitor empagliflozin, reduced platelet activation and thrombus formation in ex vivo human blood and animal models, including an SGLT1 gene murine knockout model, without adversely affecting normal hemostasis. These findings provide additional insight into the differentiated biology of dual SGLT1 and SGLT2 inhibition and may provide support for previously observed reductions in myocardial infarction and stroke risk associated with sotagliflozin in heart failure and Type 2 diabetes clinical studies

“These studies add to a growing body of evidence demonstrating the broad biological effects of sotagliflozin across multiple pathways relevant to cardiovascular disease,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon. “From cardiac remodeling and mitochondrial function to platelet activation and thrombosis, the findings continue to expand our understanding of the differentiated biology associated with dual SGLT1 and SGLT2 inhibition and further support the scientific rationale for evaluating sotagliflozin in areas of significant unmet need, including hypertrophic cardiomyopathy.”

Lexicon is currently evaluating sotagliflozin in the ongoing Phase 3 SONATA-HCM trial in patients with symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy. Topline results are expected in the first quarter of 2027.

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 Pharmaceuticals is a biopharmaceutical company pursuing novel medicines for patients with serious cardiometabolic diseases. Building on a proven legacy in genetic target discovery, Lexicon is advancing a clinical pipeline in areas of significant and often underserved need, with programs in hypertrophic cardiomyopathy (HCM), type 1 diabetes (T1D), obesity and other related metabolic conditions. Lexicon is committed to developing differentiated therapies that can be integrated broadly into clinical practice, with the goal of expanding treatment options for patients. Its capabilities extend from early-stage target discovery through clinical development and commercialization, strategically paired with high-impact collaborations to maximize the global reach of its medicines.

For additional information, please visit www.lexpharma.com.

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

¹ Qin F, et al. Sotagliflozin corrects myocardial phenotype, mitochondrial gene expression and oxidative stress in mice with hypertrophic cardiomyopathy. Journal of Molecular and Cellular Cardiology Plus. 2026;100873. doi:10.1016/j.jmccpl.2026.100873.

² Stanger L, et al. SGLT1/2 inhibitor sotagliflozin, but not SGLT2-selective inhibitor empagliflozin, attenuates platelet activation and thrombosis. Journal of Clinical Investigation. 2026. In-Press Preview. doi:10.1172/JCI201899.

FAQ

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What did Lexicon’s new sotagliflozin preclinical studies find?

Sotagliflozin improved heart structure and function in an HCM mouse model and reduced platelet activation and clot formation in human blood tested outside the body and animal models. The platelet study found no adverse effect on normal blood clotting. These were preclinical findings, not results from the ongoing patient trial.

When does Lexicon expect SONATA-HCM trial results?

Lexicon expects topline results from the ongoing Phase 3 SONATA-HCM trial in the first quarter of 2027. The trial evaluates sotagliflozin in patients with symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy.