This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes.

Start Date01 Jul 2026

Sponsor / Collaborator

University of California San Diego

[+4]

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 with mild to moderate chronic kidney disease and those with normal renal function in three time periods.
2. Identify potentially modifiable ketosis risk factors.
3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors.
4. Gather information on how participants and clinicians like and use the CGM/CKM 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 the usefulness of CGM/CKM reports

Start Date01 Jun 2026

Sponsor / Collaborator

Health Partners Institute For Education & Research

[+1]

CTIS2023-509118-12-00

/ RecruitingPhase 2

Sotagliflozin for the treatment of post-bariatric hypoglycaemia: The ONSIDE study

Start Date03 Nov 2025

Sponsor / Collaborator

Steno Diabetes Center Copenhagen

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

265

Literatures (Medical) associated with Sotagliflozin

07 Feb 2026·SPECTROSCOPY LETTERS

Development and validation of stability indicating UPLC method for the estimation of Sotagliflozin and characterization of its degradation products by UPLC-MS/MS

Author: Satyanarayana, Neeli ; Sivakumar, P. ; Ranjitha, K.V.B. ; Loke, Shiva Krishna ; UggU, Saikrishna ; Vavilapalli, S. Narayana ; Jagan Mohan Reddy, B.

A simple, specific, validated reverse phase UPLC method has been developed for the estimation of Sotagliflozin and its degradation products, identified by UPLC-MS.As per our knowledge, no chromatog. method has been reported in the literature so far for the estimation of Sotagliflozin and its degradants.This method employs a chromatog. separation using a Ph Column (100 x 1.0 mm, 1.7 μm).The phase of mobility comprised of 0.1% FA: ACN in 50:50 volume/volume ratio with a flow rate of 0.2 mL/min at room temperatureThe UV measurement was taken at 242 nm using a PDA detector and Empower-2.0 software.The retention time of Sotagliflozin was found to be 0.761 min.It was determined that the results, consistency and measurement limitations had been acceptable and in the admissible range.The established method was validated statistically in terms of specificity, linearity, LOD, LOQ, precision, accuracy and robustness according to ICH guidelines, found to be within the specified limits.The narrated method showed excellent linearity within the concentration range of 4-60 μg/mL (R² = 0.9998) with regression equation y = 64712.07x + 46933.12.The LOD and LOQ values of Sotagliflozin were found to be 0.12 μg/mL (s/n = 3) and 0.4 μg/mL (s/n = 10) resp.The mean percentage recoveries were ranging from 100.3-100.6% for Sotagliflozin.The RSD values of all the anal. method validation parameters were found to be less than 2%.The forced degradation studies were conducted as per ICHQ2(R) guidelines and UPLC-MS had been utilized for the confirmation of structures of Sotagliflozin breakdown substances.The peaks of the degradants were well resolved from those of pure drug with significant differences in their retention times with acceptable tailing and resolutionThe proposed method can be applicable for the estimation of Sotagliflozin in the presence of its degradation products.In order to avoid potential instability, these experiments furnish the information about the conditions under which Sotagliflozin was unstable and appropriate precautions were made during the process of formulation.This method plays a significant role in various pharmaceutical applications, including quality control, stability testing, shelf-life determination and packaging integrity-optimization.

01 Feb 2026·ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY

Sotagliflozin Enhances Left Ventricular Function and Myocardial Perfusion in Chronic Myocardial Ischemia Through Metabolic and Redox Remodeling

Article

Author: Hamze, Jad ; Abid, M. Ruhul ; Reddy, Riya ; Muir, Kelsey C. ; Harris, Dwight D. ; Sellke, Frank W. ; Kanuparthy, Meghamsh ; Stone, Christopher

BACKGROUND::

Ischemic heart disease is the leading cause of mortality and human suffering globally. It often leaves patients with residual symptomatic burden despite current optimized procedural and medical options. Sotagliflozin, a dual SGLT1/2 (sodium-glucose cotransporter 1 and 2) inhibitor, has emerged for its clinically evident ischemic cardiovascular benefits. We hypothesize that sotagliflozin treatment exerts direct myocardial benefits in ischemic heart disease, independent of comorbid conditions.

METHODS::

Yorkshire swine (n=22) underwent placement of an ameroid constrictor around the left circumflex coronary artery. Following a 2-week period in which the ameroid gradually closes, swine (n=18) were randomized to receive either 400 mg daily sotagliflozin (n=8) or no drug (n=10) for 5 weeks. Afterwards, swine underwent terminal harvest to acquire cardiac functional data with pressure-volume loops, myocardial perfusion by microsphere injection, and ventricular sectioning. To investigate the cellular and tissue-level impact of therapy, histology, immunoblotting, and high-throughput techniques were performed.

RESULTS::

Sotagliflozin swine had improved ejection fraction, cardiac output, and stroke work compared with no drug ( P <0.05) and a reduction in tau ( P =0.04). Absolute blood flow to the ischemic myocardium was increased in the sotagliflozin group ( P =0.03). Sotagliflozin swine had a reduction in 3-nitrotyrosine and trichrome staining, representing decreased reactive nitrogen species and myocardial fibrosis ( P =0.03 for both). Molecularly, sotagliflozin swine demonstrated increased expression of endothelial nitric oxide synthase and superoxide dismutase 3 ( P =0.02, P =0.04; respectively), with upregulated arginine metabolism, protein kinase A/cyclic adenosine monophosphate signaling, as well as glycolysis, fatty acid oxidation, and citric acid cycle.

CONCLUSIONS::

Sotagliflozin treatment improved left ventricular function, myocardial perfusion, and diastolic relaxation, likely through reduced nitrosative stress and myocardial fibrosis, improved nitric oxide coupling, enhanced insulin signaling, and favorable metabolic shifts. This study suggests a potential role for sotagliflozin as a cardioprotective therapy in patients with ischemic heart disease beyond current treatment strategies.

01 Feb 2026·CLINICAL NEPHROLOGY

Impact of diabetes on the effects of SGLT2 inhibitors on kidney outcomes: An updated drug/dose-dependent meta-analysis

Review

Author: Xu, Yanqiu ; Qian, Jingfeng

BACKGROUND:

Sodium-glucose co-transporter-2 (SGLT2) inhibitors provide renal and cardiovascular benefits in diabetes, but their effects in non-diabetic populations remain unclear. This meta-analysis evaluates the renal outcomes of SGLT2 inhibitors vs. placebo, focusing on diabetes status, subgroup variations, and drug-specific effects.

MATERIALS AND METHODS:

A systematic review of 31 randomized controlled trials (RCTs) (98,516 patients) was conducted. Studies including diabetic and non-diabetic patients were analyzed, with subgroup assessments based on diabetes status, drug type, dose, baseline estimated glomerular filtration rate (eGFR), chronic kidney disease (CKD) stage, and follow-up duration. Primary outcomes included kidney disease progression, while secondary outcomes encompassed renal adverse events, composite renal outcomes, acute kidney injury (AKI), diabetic ketoacidosis (DKA), and renal failure.

RESULTS:

SGLT2 inhibitors reduced progressive kidney disease risk in diabetic (OR = 0.64, 95% CI: 0.58 - 0.71) and non-diabetic patients (OR = 0.69, 95% CI: 0.57 - 0.83), with no effect modification by diabetes status (p = 0.49). Among diabetics, risk reductions were notable for canagliflozin 100 mg, dapagliflozin 10 mg, and empagliflozin 10-mg, particularly in patients with CKD stage 2 - 3 and baseline eGFR of 30 - 90 mL/min/1.73m². Among non-diabetics, dapagliflozin and empagliflozin showed consistent benefit. No differences in renal adverse events were observed in either group. DKA risk was elevated in diabetics receiving SGLT2 inhibitors (OR = 2.18, 95% CI: 1.61 - 2.97), particularly with ertugliflozin, sotagliflozin, and dapagliflozin.

CONCLUSION:

SGLT2 inhibitors confer renal protection in both diabetic and non-diabetic populations, supporting their use in CKD management across a broad spectrum of patients. However, careful drug selection is warranted in diabetic patients at risk for DKA.

183

News (Medical) associated with Sotagliflozin

20 Jan 2026

·www.prnewswire.com

Viatris Expands Innovative Portfolio in Cardiovascular Diseases with the Company's First Launch of Inpefa® (Sotagliflozin) for the Treatment of Heart Failure

Builds on Viatris' Scientific Leadership and Commercial Legacy in Cardiovascular Diseases PITTSBURGH, Jan. 20, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the launch of Inpefa® (sotagliflozin) in the United Arab Emirates (UAE), the first country within the Viatris territories to commercialize the treatment. Future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe. Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure. The treatment is approved in the U.S. and UAE to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. "The launch of Inpefa in the UAE marks another important step as we continue to deliver innovative medicines for patients around the world," said Corinne Le Goff, Viatris Chief Commercial Officer. "Heart failure is the world's leading cause of hospitalization, and as such there is an ongoing need for new treatments to help address this burden. This milestone also builds upon our robust legacy in cardiovascular diseases, reinforcing our commitment to expand the impact of Inpefa to help address the needs of patients around the world." "Our success in extending the global reach of Inpefa is evidence of our growing innovative pipeline, which includes several late-stage programs that are advancing at a very strong pace," said Philippe Martin, Viatris Chief R&D Officer. "With its dual SGLT inhibition, Inpefa provides cardiologists with a unique therapeutic option that provides early benefit in reducing heart failure-related outcomes, potentially offering a meaningful role in reducing healthcare burden. We have already submitted regulatory filings across several countries, including Canada, Australia and Mexico, and will continue to broaden our global submissions over the coming years." The approval of Inpefa is based on two pivotal Phase 3 trials—SOLOIST-WHF and SCORED—enrolling more than 11,800 patients globally and significantly reducing the risk of major cardiovascular events in high-risk populations. In SOLOIST-WHF, Inpefa reduced the composite risk of heart failure hospitalization, urgent visits, and cardiovascular death by 33% versus placebo in patients recently hospitalized for worsening heart failure, with benefits increasing up to 51% when initiated prior to discharge and evident within 30 days post-discharge. In SCORED, among patients with type 2 diabetes and chronic kidney disease with additional cardiovascular risk factors—both with and without heart failure—Inpefa achieved a 25% reduction in the same composite endpoint. Consistent with its dual SGLT1 and SGLT2 inhibition, MACE—defined as CV death, non-fatal MI, and non-fatal stroke—was reduced by 23%, with benefits observed as early as 94 days. It is the first SGLT inhibitor to show a significant reduction in both MI (32%) and stroke (34%). About Heart Failure Heart failure is the world's leading cause of hospitalization, affecting more than 64 million people worldwide. It is a serious condition that usually has no cure and occurs when the heart is not pumping as well as it should, hence compromising blood and oxygen supply to the tissues. It is estimated that one in every five people will develop heart failure during their lifetime. After hospital discharge, both mortality and readmission rates remain substantial worldwide. The 30-day post-discharge mortality is approximately 6.7%, and readmission rates average 13%, underscoring the ongoing risk during the vulnerable post-hospitalization period. At one year post-discharge mortality increases to an average 23%, and readmission rates increase to an average of 36%. About Inpefa (sotagliflozin) 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 primarily responsible for absorbing glucose and sodium in the small intestine, as well as for reabsorbing a small amount of glucose in the kidney's distal tubule. SGLT1 is also found in the heart and vascular endothelium, where it may influence cellular stress and inflammatory pathways—suggesting roles beyond glucose control. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. It was approved by the by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. Viatris and Lexicon Licensing Agreement In October 2024, Viatris announced it had entered into an exclusive licensing agreement with Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) for sotagliflozin in all markets outside of the U.S. and Europe. Inpefa is marketed by Lexicon Pharmaceuticals in the U.S. About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that Viatris expands innovative portfolio in cardiovascular diseases with the Company's first launch of Inpefa® (Sotagliflozin) for the treatment of heart failure; builds on Viatris' scientific leadership and commercial legacy in cardiovascular diseases; launch of Inpefa® (sotagliflozin) in the UAE, the first country within the Viatris territories to commercialize the treatment; future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe; Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure; the launch of Inpefa in the UAE marks another important step as we continue to deliver innovative medicines for patients around the world; this milestone also builds upon our robust legacy in cardiovascular diseases, reinforcing our commitment to expand the impact of Inpefa to help address the needs of patients around the world; our success in extending the global reach of Inpefa is evidence of our growing innovative pipeline, which includes several late-stage programs that are advancing at a very strong pace; with its dual SGLT inhibition, Inpefa provides cardiologists with a unique therapeutic option that provides early benefit in reducing heart failure-related outcomes, potentially offering a meaningful role in reducing healthcare burden; we have already submitted regulatory filings across several countries, including Canada, Australia and Mexico, and will continue to broaden our global submissions over the coming years; and the outcome of clinical trials. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. 21% more press release views with Request a Demo

Drug ApprovalPhase 3Clinical ResultLicense out/inAHA

12 Jan 2026

·www.biospace.com

Lexicon Pharmaceuticals Provides a Business and Pipeline Update at the 44th Annual J.P. Morgan Healthcare Conference

SONATA-HCM on track for enrollment completion in 2026 and topline data in 2027 $10 million milestone payment triggered from licensing agreement with Novo Nordisk for LX9851 Zynquista on track for NDA resubmission and potential approval in 2026 Company presentation January 15 at 12:00 p.m. PT (3:00 p.m. ET) THE WOODLANDS, Texas, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a business and pipeline update at the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026 in San Francisco. “As we look ahead to 2026, Lexicon stands at the threshold of multiple potential catalysts demonstrating the strength of our pipeline and our cardiometabolic expertise. We have pioneered entirely new classes of investigative treatments for critical unmet medical needs, and advanced them into late-stage development,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “We're executing on multiple fronts to deliver breakthrough therapies for patients. We believe our strategic R&D investments will translate into tangible progress during 2026, driving value for both our shareholders and the patient communities we serve.” “As a result of our efforts in 2025 to reduce our operating expenses and become increasingly efficient in our operations, we ended the year with a strong cash balance sufficient to support the advancement of our programs and achieve key milestones into 2027,” said Scott Coiante, Lexicon’s senior vice president and chief financial officer. Business and Pipeline Highlights Sotagliflozin for Hypertrophic Cardiomyopathy (HCM) The SONATA-HCM pivotal Phase 3 study evaluating sotagliflozin in HCM remains on track The study is targeting enrollment of 500 patients with both obstructive and non-obstructive HCM, with anticipated enrollment completion in mid-2026. Topline results are anticipated in Q1 2027. ZYNQUISTA® (sotagliflozin) for Type 1 Diabetes (T1D) Lexicon remains on track for New Drug Application (NDA) resubmission in 2026 based on FDA feedback and additional clinical data from the STENO1 study Based on current STENO1 enrollment estimates, regulatory feedback from the U.S. Food and Drug Administration (FDA) supports a potential NDA resubmission and regulatory approval in 2026, if the patient exposure and safety data requirements identified by the FDA for STENO1 are achieved. STENO1 is a third-party funded, investigator-initiated study of sotagliflozin being conducted by the Steno Diabetes Center (Denmark). The FDA provided feedback that the STENO1 study appears to be of adequate design and employs sufficient data collection methods to provide viable evidence of the incidence of diabetic ketoacidosis (DKA) with adequate safety data, prior to its completion, to support review of a resubmission of the NDA for Zynquista as an adjunct to insulin for glycemic control in adults with T1D. Pilavapadin for Neuropathic Pain Lexicon and the FDA held a productive End-of-Phase 2 meeting in the fourth quarter of 2025 Lexicon continues to advance partnership discussions to maximize the global potential of this investigative therapy. Significant unmet need exists for new, non-opioid alternatives to pain therapy with various efforts underway to prioritize new methods of pain relief, including the potential introduction of supportive legislation. Global Commercial Progress and Strategic Partnerships International Expansion of sotagliflozin program by Viatris Regulatory approval received in the United Arab Emirates (UAE) with commercial supply provided by Lexicon and regulatory applications submitted in several other markets including Canada, Australia and New Zealand in 2025. Additional regulatory submissions and approvals are expected throughout 2026 in key international markets. Advancement of LX9851 (oral ACSL5 inhibitor) for Obesity by Novo Nordisk IND-enabling activities completed by Lexicon. $10 million milestone payment triggered in January, with potential for up to an additional $20 million in milestone payments in 2026. $45 million received from Novo Nordisk to date; up to $950 million in remaining potential milestones plus tiered royalties on net sales. 2025 Financial Update Lexicon ended 2025 with cash, investments and restricted cash of $125.2 million (unaudited), sufficient to support planned operations into 2027. Cash runway excludes the impact of milestone payments related to LX9851 and other non-dilutive capital opportunities related to pilavapadin. Presentation at the J.P. Morgan Healthcare Conference Mike Exton, Ph.D. Lexicon’s chief executive officer and director, will present a company update on January 15, 12:00 p.m. PT (3:00 p.m. ET). Scott Coiante, Lexicon’s chief financial officer, and Craig Granowitz, M.D., Ph.D., Lexicon’s chief medical officer, will participate in Q&A. The live event and replay of the presentations can be accessed via the Events page of the Company’s website at . 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 safely and effectively treat disease. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, obesity, cardiology, diabetes and other 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 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 3License out/inNDA

06 Nov 2025

·www.globenewswire.com

Lexicon Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides R&D Updates

FDA End-of-Phase 2 meeting for pilavapadin in DPNP to be held by year-end All IND-enabling studies of LX9851 for obesity completed and submitted to licensee Novo Nordisk Site initiation for SONATA-HCM Phase 3 study of sotagliflozin in both obstructive and non-obstructive HCM completed; enrollment completion on target for 2026 Additional data in support of potential resubmission of Zynquista for type 1 diabetes submitted to FDA Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended September 30, 2025, and provided an update on key corporate milestones and accomplishments. “Lexicon ushered in 2025 with an ambitious slate of objectives embracing and driving our renewed R&D focus,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “As we approach year-end, I’m pleased and proud of our significant R&D, operational and partnering accomplishments so far this year. We expect 2026 to be a pivotal year as these strategic initiatives progress with the potential to create lasting value for our stakeholders.” “We continue to practice diligent resource allocation and prioritize our strong R&D pipeline with a focus on programs that have the greatest potential for patient impact and value creation,” said Scott Coiante, Lexicon’s senior vice president and chief financial officer. “Our optimized operational spend and focus on strategic collaborations have enabled us to end the third quarter on strong financial footing.” Third Quarter 2025 Business and Pipeline Highlights Pilavapadin (LX9211) for Diabetic Peripheral Neuropathic Pain (DPNP)Pilavapadin is an orally delivered, small molecule drug candidate for the treatment of DPNP, among other potential indications. Pilavapadin has the potential to be the first oral, non-opioid drug therapy approved in neuropathic pain in more than 20 years. Key recent data presentation highlights include: Oral presentations at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings in September 2025, demonstrating that pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 12 and was generally well tolerated in the PROGRESS Phase 2b study in DPNP.Oral presentation at the Arrowhead 19th Annual Pain Therapeutics Summit in October 2025, with results from a post-hoc pooled analysis of the Phase 2 RELIEF-DPN-1 and Phase 2b PROGRESS studies supporting advancement of the 10 mg dose into Phase 3 development for DPNP. End-of-Phase 2 meeting scheduled with FDA during the fourth quarter of 2025 and partnership discussions are ongoing. LX9851 for Obesity and Associated Cardiometabolic Disorders LX9851 is a first-in-class, non-incretin, oral, small molecule inhibitor of acyl-CoA synthetase 5 (ACSL5) in IND-enabling studies for obesity and weight management. In March 2025, Lexicon announced an exclusive licensing agreement for LX9851 with Novo Nordisk. Under the terms of the agreement, Lexicon received an upfront payment of $45 million in April and is eligible to receive up to $1 billion in upfront and potential development, regulatory and sales milestone payments. Lexicon is also eligible for tiered royalties on net sales of LX9851.Lexicon has completed all IND-enabling studies of LX9851. Our licensee Novo Nordisk is now preparing for IND submission and initiation of clinical development, which would potentially trigger up to an additional $30 million in near-term milestone payments to Lexicon. Sotagliflozin Sotagliflozin is an oral inhibitor of sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1) and has been studied in approximately 20,000 patients across multiple cardiometabolic indications. Heart Failure (INPEFA®) Sotagliflozin is commercially available in the U.S. for heart failure as INPEFA®.Lexicon presented a post-hoc analysis of the SCORED and SOLOIST-WHF studies of sotagliflozin at the European Society of Cardiology (ESC) 2025 Congress, demonstrating that sotagliflozin provides consistent relative risk reduction in heart failure and major cardiovascular events across all age ranges, including in adults older than 75. Hypertrophic Cardiomyopathy (HCM) Enrollment continues to accelerate in SONATA-HCM, a pivotal Phase 3 placebo-controlled study with a targeted enrollment of 500 patients with obstructive or nonobstructive HCM. Lexicon has completed the initiation of 130 sites in 20 countries across the United States, Europe and Latin America. Viatris License for All Indications Ex-U.S. and Ex-Europe Lexicon has supported licensee Viatris in its regulatory filing strategy for sotagliflozin outside of the U.S. and Europe, with preparations underway by Viatris for regulatory approval submissions in a number of ex-U.S. and ex-European markets.Lexicon has shipped the first commercial order of INPEFA to Viatris in the United Arab Emirates, the first country to obtain approval outside of the U.S. Type 1 Diabetes (T1D) (ZYNQUISTA®) The Company remains focused on bringing ZYNQUISTA to market for people with T1D who have not benefitted from a new treatment in over two decades.Lexicon has submitted new data to U.S. Food and Drug Administration (FDA) supporting the benefit risk profile of Zynquista in T1D. The Company is currently engaged with FDA and expects regulatory feedback in the fourth quarter of 2025 regarding a potential resubmission of its New Drug Application (NDA). Third Quarter 2025 Financial HighlightsRevenues: Total revenues for the third quarter of 2025 increased to $14.2 million from $1.8 million for the corresponding period in 2024. Total revenues for the third quarter of 2025 consist of $13.2 million of licensing revenue derived from the Company’s licensing agreement with Novo Nordisk and $1.0 million of revenues from US sales of INPEFA. Research and Development (R&D) Expenses: Research and development expenses for the third quarter of 2025 decreased to $18.8 million from $25.8 million for the corresponding period in 2024, primarily reflecting lower external research expense on the PROGRESS clinical trial partially offset by increased investment in the SONATA Phase 3 clinical trial. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the third quarter of 2025 decreased to $7.6 million from $39.6 million for the corresponding period in 2024. The decrease in 2025 reflects lower costs as a result of the Company’s strategic repositioning in late 2024 and the significantly reduced marketing efforts for INPEFA in 2025. Net Loss: Net loss for the third quarter of 2025 was $12.8 million, or $0.04 per share, as compared to a net loss of $64.8 million, or $0.18 per share, in the corresponding period in 2024. For the third quarters of 2025 and 2024, net losses included non-cash, stock-based compensation expense of $3.4 million, and $2.8 million, respectively. Cash, Investments, and Restricted Cash: As of September 30, 2025, Lexicon had $145.0 million in cash and investments including $29 million in restricted cash, as compared to $238.0 million in cash and investments as of December 31, 2024. 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 https://investors.lexpharma.com/. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. 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. 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 safely and effectively treat disease. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in heart failure, neuropathic pain, diabetes and 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 Lexicon Pharmaceuticals, Inc.Selected Financial Data Consolidated Statements of Operations Data Three Months Ended September 30, Nine Months Ended September 30,(In thousands, except per share data) 2025 2024 2025 2024 (Unaudited) (Unaudited)Revenues: Net product revenue $1,008 $1,741 $3,592 $4,451 Licensing revenue 13,154 — 40,698 — Royalties and other revenue 20 9 20 76 Total revenues 14,182 1,750 44,310 4,527 Operating expenses: Cost of sales 10 71 73 268 Research and development, including stock-based compensation of $1,832, $1,460, $5,026 and $4,733, respectively 18,757 25,780 49,806 57,795 Selling, general and administrative, including stock-based compensation of $1,612, $1,341, $4,656 and $7,229, respectively 7,602 39,592 28,562 110,844 Total operating expenses 26,369 65,443 78,441 168,907 Loss from operations (12,187) (63,693) (34,131) (164,380)Interest and other expense (2,155) (4,562) (6,308) (11,721)Interest income and other, net 1,573 3,444 5,628 9,464 Net loss $(12,769) $(64,811) $(34,811) $(166,637) Net loss per common share, basic and diluted $(0.04) $(0.18) $(0.10) $(0.54)Weighted average common shares outstanding, basic and diluted 363,399 361,492 362,927 306,109 As of As of Consolidated Balance Sheet Data September 30, 2025 December 31, 2024 (In thousands) Cash and investments $115,950 $237,957 Restricted cash 29,000 — Property and equipment, net 1,981 2,484 Goodwill 44,543 44,543 Total assets 205,927 298,420 Long-term debt, net 56,508 100,298 Accumulated deficit (2,002,053) (1,967,242) Total stockholders' equity 120,159 145,950

Phase 2Clinical ResultLicense out/inPhase 3Financial Statement

100 Deals associated with Sotagliflozin

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KEGG	Wiki	ATC	Drug Bank
D10669	Sotagliflozin	A10BK06	DB12713

R&D Status

Approved

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02531035 \| NCT02384941 \| NCT02421510 (inTandem3, ASN2025) Manual	Not Applicable	Diabetes Mellitus, Type 1	2,829	Sotagliflozin (pooled 200 and 400mg)	xkivedvvuh(luajgskhsi) = Sotagliflozin significantly reduced the estimated 10-year CVD risk following 24 weeks of treatment compared with placebo. tahvzgvobn (jecbedntya ) 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	pcfgsaqfcl(ikuevomory) = gtagxpefis xqwojvlshh (cvudhudhkn ) View more	Positive	30 Aug 2025
				placebo	pcfgsaqfcl(ikuevomory) = kqtpgfwxyw xqwojvlshh (cvudhudhkn ) View more
NCT03315143 (SCORED, Lancet) Manual	Phase 3	Ischemia	10,584	Sotagliflozin	fhiymzvkhu(cyzkutjlvg) = jbijjradvd ltmgfxnbbh (sngrexhmav ) View more	Positive	14 Feb 2025
				Placebo	fhiymzvkhu(cyzkutjlvg) = kckqixsrgq ltmgfxnbbh (sngrexhmav ) View more
NCT02531035 \| NCT02384941 \| NCT02421510 (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	-	Sotagliflozin 200mg (CKD)	ozbyauqwqx(unjoawdell) = jcoxikbcug eekjnbxlzo (hktndcield ) View more	Positive	01 Nov 2024
				Sotagliflozin 400mg (CKD)	ozbyauqwqx(unjoawdell) = gyqsejrkbt eekjnbxlzo (hktndcield ) View more
NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	iihcgajygf(ymoxytjfsv) = uxcrmnhvtm daicpxndit (lbeoqtdpeh )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	iihcgajygf(ymoxytjfsv) = vcyxoqucjh daicpxndit (lbeoqtdpeh )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	yrytodupjn(aoihmqetkn) = 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 yyfpqetdrb (hxjksmpsfo )	Positive	01 Sep 2024
				Placebo
ESC2024	Not Applicable	Diabetes Mellitus	-	Sotagliflozin	kjejmofifc(yptyocmeny) = tssnghmumc ibyjwaddwf (ayndatioki ) View more	-	30 Aug 2024
				Placebo	kjejmofifc(yptyocmeny) = hymlvgzeaz ibyjwaddwf (ayndatioki ) View more
924-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2 Add-on	570	Sotagliflozin 400 mg	aypulpdlqr(ubnqysjmxd) = lvvmbeutec feefvgtupm (paidkofkyw )	Positive	14 Jun 2024
				Sotagliflozin 200 mg	aypulpdlqr(ubnqysjmxd) = vyozaokdon feefvgtupm (paidkofkyw )
917-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2	770	Sotagliflozin 400 mg	mxyjugsyho(piehztexgz) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy pdgdlwetek (gcuxubkhnm ) View more	Positive	14 Jun 2024
				Empagliflozin 25 mg
NCT03315143 (SCORED, GlobeNewswire) Manual	Phase 3	Heart Failure	1,932	INPEFA® (sotagliflozin)	unumtqzmow(xoenyxjsel) = sajdmhckle jiwssnfiud (jomzxyxvcr )	Positive	14 May 2024

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