Full Press Release Details
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 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 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.