Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes
Lexicon Pharmaceuticals (NASDAQ:LXRX) has provided an update regarding its New Drug Application (NDA) for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor for type 1 diabetes treatment. The company has submitted additional clinical data to the FDA from three ongoing third-party funded studies conducted at Steno Diabetes Center, Joslin Diabetes Center, and University of Dundee to address concerns about diabetic ketoacidosis risk raised in a December 2024 complete response letter.
The FDA has indicated it needs more time to review the new data and will now provide feedback from the September Type D meeting in Q4 2025, later than the previously expected end-of-September timeline. The studies aim to support Zynquista's benefit-risk profile as an adjunct to insulin for glycemic control in adults with type 1 diabetes.
Lexicon Pharmaceuticals (NASDAQ:LXRX) ha fornito un aggiornamento riguardo la sua domanda di nuovo medicinale (NDA) per Zynquista® (sotagliflozin), inibitore orale SGLT1/SGLT2 destinato al trattamento del diabete di tipo 1. L'azienda ha presentato all'FDA ulteriori dati clinici provenienti da tre studi in corso finanziati da terze parti, condotti presso Steno Diabetes Center, Joslin Diabetes Center e University of Dundee, per affrontare le preoccupazioni relative al rischio di chetoacidosi diabetica espresse in una lettera di risposta completa di dicembre 2024.
L'FDA ha indicato che necessita di più tempo per rivedere i nuovi dati e fornirà ora feedback dall'incontro Type D di settembre nel Q4 2025, più tardi rispetto alla timeline precedente prevista per la fine di settembre. Gli studi mirano a supportare il profilo beneficio-rischio di Zynquista come complemento all'insulina per il controllo glicemico in adulti con diabete di tipo 1.
Lexicon Pharmaceuticals (NASDAQ:LXRX) ha proporcionado una actualización sobre su solicitud de nuevo fármaco (NDA) para Zynquista® (sotagliflozin), un inhibidor oral de SGLT1/SGLT2 para el tratamiento de la diabetes tipo 1. La empresa ha presentado a la FDA datos clínicos adicionales de tres estudios financiados por terceros en curso, realizados en Steno Diabetes Center, Joslin Diabetes Center y University of Dundee, para abordar preocupaciones sobre el riesgo de cetoacidosis diabética expresadas en una carta de respuesta completa de diciembre de 2024.
La FDA ha indicado que necesita más tiempo para revisar los nuevos datos y ahora proporcionará comentarios tras la reunión Type D de septiembre en Q4 2025, más tarde que el plazo inicialmente previsto para finales de septiembre. Los estudios buscan respaldar el perfil beneficio-riesgo de Zynquista como complemento a la insulinoterapia para el control glucémico en adultos con diabetes tipo 1.
Lexicon Pharmaceuticals (NASDAQ:LXRX)는 Zynquista® (sotagliflozin)에 대한 신약신청(NDA)에 관해 업데이트를 제공했습니다. 이는 제1형 당뇨 치료를 위한 경구용 SGLT1/SGLT2 억제제입니다. 회사는 2024년 12월의 완전한 응답 서한에서 제기된 제당병증 위험에 대한 우려를 해소하기 위해 독립 자금으로 진행 중인 세 가지 연구에서 추가 임상 데이터를 FDA에 제출했습니다. 연구는 Steno Diabetes Center, Joslin Diabetes Center, University of Dundee에서 수행되었습니다.
FDA는 새로운 데이터를 검토하는 데 더 많은 시간이 필요하다고 밝혔으며, 9월 Type D 회의의 피드백은 이제 2025년 4분기(Q4 2025)에 제공될 예정이며, 9월 말로 예정되었던 이전 일정보다 늦습니다. 이러한 연구들은 Zynquista의 이점-위험 프로파일을 성인 제1형 당뇨병의 인슐린 보조 치료로서의 혈당 조절을 지원하기 위한 것입니다.
Lexicon Pharmaceuticals (NASDAQ:LXRX) a fourni une mise à jour concernant sa demande de médicament nouveau (NDA) pour Zynquista® (sotagliflozin), un inhibiteur oral SGLT1/SGLT2 destiné au traitement du diabète de type 1. L'entreprise a soumis à la FDA des données cliniques additionnelles issues de trois études financées par des tiers en cours, menées au Steno Diabetes Center, au Joslin Diabetes Center et à l'University of Dundee, afin de répondre aux préoccupations concernant le risque d'acidose diabétique exprimées dans une lettre de réponse complète de décembre 2024.
La FDA a indiqué qu'elle avait besoin de plus de temps pour examiner les nouvelles données et fournira désormais des retours lors de la réunion Type D de septembre en Q4 2025, plus tard que le calendrier prévu initialement pour la fin septembre. Les études visent à étayer le profil bénéfice-risque de Zynquista en tant que complément à l'insuline pour le contrôle glycémique chez les adultes atteints de diabète de type 1.
Lexicon Pharmaceuticals (NASDAQ:LXRX) hat ein Update zu ihrem Antrag auf Zulassung eines neuen Medikaments (NDA) für Zynquista® (sotagliflozin), einen oralen SGLT1/SGLT2-Hemmer zur Behandlung des Typ-1-Diabetes, bereitgestellt. Das Unternehmen hat der FDA zusätzliche klinische Daten aus drei laufenden von Dritten finanzierten Studien vorgelegt, die am Steno Diabetes Center, Joslin Diabetes Center und der University of Dundee durchgeführt wurden, um Bedenken hinsichtlich des Risikos der diabetischen Ketoazidose aus dem Dezember 2024 vollständigen Antwortschreiben zu adressieren.
Die FDA hat mitgeteilt, dass sie mehr Zeit zur Überprüfung der neuen Daten benötigt, und wird nun Feedback aus dem Type D-Treffen im Q4 2025 liefern, später als der zuvor erwartete Endtermin Ende September. Die Studien sollen das Nutzen-Risiko-Profil von Zynquista als Ergänzung zu Insulin zur Blutzuckerkontrolle bei Erwachsenen mit Typ-1-Diabetes unterstützen.
Lexicon Pharmaceuticals (NASDAQ:LXRX) قدمت تحديثاً بخصوص طلب دواء جديد (NDA) لـ Zynquista® (sotagliflozin)، وهو مثبّط فموي لـ SGLT1/SGLT2 لعلاج مرض السكري من النوع 1. قدمت الشركة لل FDA بيانات سريرية إضافية من ثلاثة دراسات ممولة من طرف ثالث، ما زالت قيد التنفيذ، أجريت في Steno Diabetes Center، Joslin Diabetes Center، وUniversity of Dundee لمعالجة المخاوف المرتبطة بخطر الحماض الكيتوني السكري التي أثيرت في رسالة الرد الشاملة من ديسمبر 2024.
أفادت إدارة الغذاء والدواء بأنها بحاجة إلى مزيد من الوقت لمراجعة البيانات الجديدة وستقدم الآن التعليقات من اجتماع النوع D في Q4 2025، أخر من الجدول السابق المتوقع بنهاية سبتمبر. تهدف الدراسات إلى دعم ملف فائدة-مخاطر Zynquista كمكمل للإنسولين للتحكم في سكر الدم لدى البالغين المصابين بالسكري من النوع 1.
Lexicon Pharmaceuticals (NASDAQ:LXRX) 已就其新药申请（NDA）就Zynquista®（sotagliflozin）提供更新，该药为治疗1型糖尿病的口服SGLT1/SGLT2抑制剂。公司已向FDA提交来自三项正在进行的第三方资助研究的额外临床数据，这些研究在Steno Diabetes Center、Joslin Diabetes Center和University of Dundee进行，旨在解决2024年12月完整答复函中提出的糖尿病酮酸中毒风险的担忧。
FDA表示需要更多时间来审查新数据，现在将于2025年第四季度（Q4 2025）的9月Type D会议后提供反馈，晚于先前预期的9月末时间线。这些研究旨在支持Zynquista作为胰岛素辅助治疗以改善成人1型糖尿病血糖控制的获益-风险特征。
- None.
- FDA delayed feedback timeline to Q4 2025, extending beyond initial September expectation
- Previous complete response letter cited concerns about increased diabetic ketoacidosis risk
- Uncertainty remains about FDA approval pathway
Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter
Company seeks alignment on reasonable path forward for Zynquista NDA resubmission
FDA feedback from Type D meeting now expected during the fourth quarter
THE WOODLANDS, Texas, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced an update to the previous submission of additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D). The FDA has informed Lexicon that it requires additional time to review this data and now expects to provide feedback from the September Type D meeting in the fourth quarter, previously anticipated by end of September.
As previously disclosed, the submission of additional clinical data followed a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1)1, the Joslin Diabetes Center (SUGARNSALT)2 and the University of Dundee (SOPHIST)3 supporting the benefit-risk profile of Zynquista in T1D.
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.
References
1“Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes (Steno1).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06082063. Accessed 4 Sept. 2025.
2“Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease (SUGARNSALT).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06217302. Accessed 4 Sept 2025.
3“SOPHIST Clinical Trial.” University of Dundee, www.sites.dundee.ac.uk/sophist-trial/. Accessed 4 Sept. 2025.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates, including sotagliflozin. 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, regulatory interactions relating to its drug candidates, 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
FAQ
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