The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

开始日期2025-01-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

NCT06435156 / Not yet recruiting临床2期IIT

A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals with Heart Failure and Type 1 Diabetes.

People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.

开始日期2025-01-01

申办/合作机构

University Of Dundee

[+2]

NCT06510894 / RecruitingN/AIIT

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET

This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.
Participants will be asked to:
* undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
* take the provided sotagliflozin as instructed for 7 days leading up to the scan
* follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
* undergo an FDG PET/CT scan, which includes vitals and blood draws

开始日期2024-11-20

申办/合作机构

University of Pennsylvania

[+1]

100 项与索格列净相关的临床结果

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100 项与索格列净相关的转化医学

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100 项与索格列净相关的专利（医药）

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194

项与索格列净相关的文献（医药）

2025-01-01·DIABETOLOGIA

Molecular mechanisms underlying glucose-dependent insulinotropic polypeptide secretion in human duodenal organoids

Article

作者: Smith, Christopher A ; Santos-Hernández, Marta ; Guccio, Nunzio ; Davison, Adam ; Bany Bakar, Rula ; Kay, Richard G ; Miedzybrodzka, Emily L ; Alcaino, Constanza ; Gribble, Fiona M ; Reimann, Frank

Abstract:

Aims/hypothesis:

Glucose-dependent insulinotropic polypeptide (GIP) is an incretin hormone secreted by enteroendocrine K cells in the proximal small intestine. This study aimed to explore the function of human K cells at the molecular and cellular levels.

Methods:

CRISPR-Cas9 homology-directed repair was used to insert transgenes encoding a yellow fluorescent protein (Venus) or an Epac-based cAMP sensor (Epac-S-H187) in the GIP locus in human duodenal-derived organoids. Fluorescently labelled K cells were purified by FACS for RNA-seq and peptidomic analysis. GIP reporter organoids were employed for GIP secretion assays, live-cell imaging of Ca2+ using Fura-2 and cAMP using Epac-S-H187, and basic electrophysiological characterisation. The G protein-coupled receptor genes GPR142 and CASR were knocked out to evaluate roles in amino acid sensing.

Results:

RNA-seq of human duodenal K cells revealed enrichment of several G protein-coupled receptors involved in nutrient sensing, including FFAR1, GPBAR1, GPR119, CASR and GPR142. Glucose induced action potential firing and cytosolic Ca2+ elevation and caused a 1.8-fold increase in GIP secretion, which was inhibited by the sodium glucose co-transporter 1/2 (SGLT1/2) blocker sotagliflozin. Activation of the long-chain fatty acid receptor free fatty acid receptor 1 (FFAR1) induced a 2.7-fold increase in GIP secretion, while tryptophan and phenylalanine stimulated secretion by 2.8- and 2.1-fold, respectively. While CASR knockout blunted intracellular Ca2+ responses, a CASR/GPR142 double knockout was needed to reduce GIP secretory responses to aromatic amino acids.

Conclusions/interpretation:

The newly generated human organoid K cell model enables transcriptomic and functional characterisation of nutrient-sensing pathways involved in human GIP secretion. Both calcium-sensing receptor (CASR) and G protein-coupled receptor 142 (GPR142) contribute to protein-stimulated GIP secretion. This model will be further used to identify potential targets for modulation of native GIP secretion in diabetes and obesity.

Graphical Abstract:

2024-09-01·NEUROBIOLOGY OF DISEASE

Sotagliflozin attenuates cardiac dysfunction and depression-like behaviors in mice with myocardial infarction through the gut-heart-brain axis

Article

作者: Dai, Guangming ; Liao, Lei ; Feng, Ling ; Chang, Lijia ; Zhang, Lu ; Yang, Chengying ; Peng, Chendong ; Wei, Yan ; Wang, Tong ; Long, Yang ; Fan, Xinrong

Myocardial infarction (MI) and depression are leading causes of mortality and morbidity globally, and these conditions are increasing recognized as being fundamentally interconnected. The recently recognized gut-heart-brain axis offers insights into depression following MI, but effective treatments for this comorbidity remain lacking. To address this medical need, we employed an animal model of MI to investigate the potential repurposing of sotagliflozin (SOTA), an approved sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor for diabetes, for managing depression following MI and identifying potential SOTA-associated microbial mechanisms. SOTA treatment improved cardiac dysfunction and alleviated depression-like behaviors induced by MI, accompanied by alterations in gut microbiota composition, such as changes in the Prevotellaceae NK3B31 group, Alloprevotella, and Prevotellaceae UCG-001. Moreover, fecal microbiota transplantation (FMT) using fecal samples from SOTA-treated MI mice demonstrated that gut microbiota contributed to the beneficial effects of SOTA on cardiac dysfunction and depression-like behaviors in MI mice. Intriguingly, FMT-based intervention and concordance analysis of gut microbiota before and after FMT suggested that Prevotellaceae NK3B31 group, Alloprevotella, and Prevotellaceae UCG-001 were associated with the beneficial effects of SOTA. Furthermore, functional prediction of gut microbiota and correlation analysis support the significance of these dynamic microbial communities. In conclusion, these findings suggest that SOTA could serve as a potential drug to ameliorate cardiac dysfunction and depressive symptoms in MI patients via through the gut-heart-brain axis.

2024-09-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure

Article

作者: Bhatt, Ankeet S. ; Riddle, Matthew C ; Szarek, Michael ; Davies, Michael ; Steg, Ph Gabriel ; Wilcox, Christopher S ; Cannon, Christopher P. ; Testani, Jeffrey M. ; Kosiborod, Mikhail N ; Pitt, Bertram ; McGuire, Darren K ; Wilcox, Christopher S. ; Testani, Jeffrey M ; Leiter, Lawrence A. ; Bhatt, Deepak L ; Bhatt, Ankeet S ; Cannon, Christopher P ; Leiter, Lawrence A ; Voors, Adriaan A. ; Lund, Lars H ; Voors, Adriaan A ; Lund, Lars H. ; Bhatt, Deepak L. ; Lewis, Julia B. ; McGuire, Darren K. ; Kosiborod, Mikhail N. ; Lewis, Julia B ; Metra, Marco ; Riddle, Matthew C.

BACKGROUND:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown.

OBJECTIVES:

These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status.

METHODS:

SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4.

RESULTS:

Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. 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. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (P_trend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017).

CONCLUSIONS:

Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; NCT03521934).

171

项与索格列净相关的新闻（医药）

2024-12-20

·GlobeNewswire-Health Care

Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)

Confirms Previously Disclosed and Anticipated FDA DecisionTHE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This expected communication from the FDA aligns with the company’s previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline. "We are sincerely grateful to the patients and physicians who participated in our Zynquista™ clinical trials, and the broader diabetes community who strongly advocated for Zynquista’s approval," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline, including our near-term focus on LX9211 for diabetic neuropathic pain (DPNP) with top line data from our PROGRESS Phase 2b study anticipated in Q1 2025, and pursuing innovations that we believe can profoundly benefit patients." 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, growth and future operating results, discovery and development 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, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211, LX9851 and 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 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, 2023 and other subsequent disclosure documents 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. Investor ContactLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com Media ContactSheryl SeapyReal Chemistrycorpcomm@lexpharma.com

临床2期申请上市

2024-12-12

·生物制药小编

12月值得期待的新药上市决议

年末将至，拜登政府执掌的FDA也濒临尾声，领导人离职基本上是铁板钉钉的，但在这一年关到来之前，仍然有许多款新药将要在今年年内冲刺上市。外媒Biospace列举了这几款新药，本文将对这几款新药做简单解析。 Ionis的新收入olezarsen 今年以来Ionis的收入不佳，主要问题来自于SMA药物SPINRAZA承受着来自Zolgensma等药物的巨大竞争压力，而APOC ASO药物olezarsen就能成为该公司创收新来源。该药物主要针对一种叫做家族性乳糜微粒血症综合征（FCS）的罕见病，FCS患者脂蛋白脂肪酶功能异常，无法分解脂蛋白APOC-III，而APOC-III过多就会影响甘油三酯水平，患者从而面临急性胰腺炎发病风险增高，甚至于脑卒中等问题。olezarsen通过减少参与甘油三酯代谢的apoC-III蛋白的产生，解决了FCS的核心病因。目前来看，该药物获批的概率较高，此前III期临床达到主要终点，降甘油三酯达53%，PDUFA日定在了12月19日。有可能再次失败的Sotagliflozin Sotagliflozin（索格列净）是一种钠-葡萄糖协同转运蛋白SGLT1和SGLT2的双效口服抑制剂，由Lexicon开发。早先该药物在美国已有心衰适应症上市，而在欧盟也曾作为I型糖尿病的胰岛素辅助疗法上市，而此次定在20日的PDUFA是用来裁决欧盟的同款适应症能否在美国获批。尽管该适应症曾在欧洲上市的事实让该适应症在美国上市看起来很有希望，但实际情况往往出人意料。2019年时，该公司收到了FDA的CRL，原因在于FDA担心同时使用胰岛素和索格列净的患者发生糖尿病酮症酸中毒风险。在这一顾虑下，授权合作伙伴Guidehouse Germany GmbH出于商业原因，选择了“退货”，并在欧洲撤市。实际上，这一担忧有一定道理。索格列净作为一种钠-葡萄糖协同转运蛋白抑制剂，机制上是通过抑制肾脏对葡萄糖的重吸收来增加尿糖排泄，从而降低血糖水平。然而，这种机制可能导致体内胰岛素需求减少，因为部分葡萄糖被直接从尿中排出，而不是被身体吸收和利用。当胰岛素供应不足或身体对胰岛素的反应减弱时，就可能发生酮症酸中毒。具体从临床数据来看，FDA就会着力关注患者的肾脏功能数据，毕竟这会反映丙酮酸中毒的严重程度，早先FDA找来的外部专家也认为此适应症中的风险-效益特征存在不确定性，他希望看到该药物的更多数据，尤其是在轻度或早期肾脏损伤患者中的数据。第一个长效GLP-2？去年时，Zealand Pharma提交了长效GLP-2激动剂glepaglutide的上市申请，如今在22日，glepaglutide将迎来审判，这或许会标志着首款长效GLP-2激动剂的上市。 GLP-2是人体肠道L型细胞分泌的一种肠道激素，在体内具有促进肠上皮细胞增殖和小肠绒毛增生的作用。因此，临床上相关治疗药物主要被用于短肠综合症和过敏性肠炎。目前唯一一款上市的GLP-2类似物是武田的Teduglutide（替度鲁肽）。而替度鲁肽则是一款短效GLP-2激动剂，glepaglutide稳定状态下的有效半衰期约为88小时，而替度鲁肽半衰期约为1.3~3小时，显著短于glepaglutide，需要频繁治疗维持效果，因此glepaglutide的上市可能会改变GLP-2的市场格局。罕见病新药Imcivree试图拓宽使用人群 Rhythm Pharmaceuticals正提议将其注射药物Imcivree（setmelanotide）的标签扩展至患有特定遗传型肥胖的2岁及以上儿童。FDA预计将于12月26日公布其裁决。 Imcivree是一种黑皮素4受体激动剂，于2020年获得FDA批准，用于治疗6岁及以上因前阿黑皮素原（POMC）肽、前蛋白转化酶枯草溶菌素/kexin 1型（PCSK1）酶或瘦素受体（LEPR）缺陷导致的单基因或综合征型肥胖患者的慢性体重管理。2022年6月，Rhythm再次为Imcivree赢得FDA批准，此次是针对巴德-毕德尔综合征（BBS），这是一种同样以肥胖为特征的遗传性疾病。然而，目前Imcivree在美国仅适用于6岁及以上患者。Rhythm此次标签扩展的申请得到了一项多中心、开放标签的III期研究的支持，该研究涉及12名因双等位基因POMC/PCSK1或LEPR缺陷或临床诊断为BBS的肥胖儿童患者。数据显示，Imcivree使这些患者的体重指数平均降低了18.4%。之前因为制造问题收到了CRL，现在加入内卷 2023年12月时，Checkpoint Therapeutics的PD-L1抗体Cosibelimab因为第三方合同组织（CMO）的制造问题而被FDA发了CRL，不过CRL中并没有提及Cosibelimab有什么临床数据和安全性问题。因此，Cosibelimab这次成功上市的概率应该是很高的，对于Checkpoint Therapeutics来说，可能问题是如何应对之后需要面临的内卷市场。罕见病标准治疗的正名？ FDA将于12月28日之前公布其对Mirum Pharmaceuticals公司口服候选药物chenodiol（口服型鹅去氧胆酸）用于治疗罕见代谢病——脑腱黄瘤病（CTX）的决定。 CTX由CYP27A1基因突变引起，是一种渐进性且常被误诊的胆固醇代谢障碍疾病。由于CYP27A1编码编码固醇27-羟化酶基因，该基因突变会导致固醇27-羟化酶酶功能失调。而固醇27-羟化酶缺乏会导致胆固醇合成胆汁酸受阻，引起不同组织胆固醇代谢障碍。由于体内沉积的胆甾烷醇和胆固醇具有神经毒性作用，最终会对中枢-周围神经系统造成广泛损害。由于这种病经常容易被误诊，发病率也比较低，这就导致了一个奇怪的现象：尽管chenodiol被视为是这种疾病的标准治疗药物，但是一直以来chenodiol就因为缺乏临床试验数据在30多年来没有获得批准。现在新的监管申请得到了III期RESTORE试验数据（13名患者）的支持，该试验发现chenodiol可以显著降低患者体内胆汁醇水平，同时改善血清胆甾烷醇浓度。 O药皮下剂型扩展 BMS现在在力推O药的皮下注射剂型，FDA预计将于 12 月 29 日宣布其审批结果。如果获得批准，O药届时将成为第一款皮下注射的 PD-1 疗法，这会在PD-1市场内的激烈竞争中领先于对手K药。罕见病的新选择：crinecerfont 先天性肾上腺皮质增生症（CAH）是一组常染色体隐性遗传性疾病，主要由21-羟化酶等酶的缺乏引起，导致肾上腺无法正常合成皮质醇等生命所需的激素。这种酶的缺乏还导致促肾上腺皮质激素（ACTH）和肾上腺雄激素的过量产生，进而引发一系列临床症状，如电解质失衡、脱水、雄激素过量等。目前该疾病的标准治疗就是打糖皮质激素，然而激素打多了可能导致类固醇过量、骨质疏松和糖尿病等并发症。Neurocrine 公司开发的crinecerfont是一种 CRF1 拮抗剂。 CRF1是脑垂体中调节ACTH分泌的关键受体。通过拮抗CRF1受体，Crinecerfont能够降低ACTH的水平，进而减少肾上腺雄激素的产生。这种作用机制不依赖于糖皮质激素，因此为CAH患者提供了一种新的治疗途径。该药物在III期临床中显著降低了患者的雄烯二酮水平，患者可以在不损害雄烯二酮控制的情况下逐渐减少糖皮质激素的剂量。参考来源： https://www.biospace.com/fda/fda-action-alert-ionis-lexicon-astrazeneca-daiichi-sankyo-and-more

临床3期高管变更

2024-11-22

·GlobeNewswire-Health Care

Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity Efforts Expected to Reduce 2025 Operating Costs by $100 Million Conference Call and Webcast at 9:00 am ET THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact. This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. "While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities." Details of the Strategic Restructuring Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA® and all planned commercial activities for ZYNQUISTA.A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st.INPEFA to continue to be manufactured and made available to patients and existing prescribers.An expected reduction of 2025 full year operating costs by $100 million. This amount is in addition to the $40 million in expected 2025 cost savings announced in August as part of a realignment of resources. Reemerging as a Clinical Development-Focused Company Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including: The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data anticipated in Q1 2025.The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), with enrollment underway.IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders.Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications.Exploring strategic partnerships to advance and accelerate the value of our pipeline. Conference Call and Webcast InformationLexicon management will hold a live conference call and webcast today at 9:00 am ET / 8:00 am CT to review the details of this announcement. Participants can access the conference call live via webcast on the Events page of the Company’s website at https://www.lexpharma.com/media-center/events. 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 14 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 treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, metabolism and other therapeutic areas. 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, growth and future operating results, discovery and development 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, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211, LX9851 and 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 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, 2023 and other subsequent disclosure documents 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. Investor ContactLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com Media ContactMolly DevlinReal Chemistrycorpcomm@lexpharma.com

申请上市临床2期临床3期

100 项与索格列净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10669	索格列净	A10BK06	DB12713

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心脏衰竭	美国	Lexicon Pharmaceuticals, Inc.	2023-05-26
1型糖尿病	欧盟	NCI Healthcare LLC	2019-04-26
1型糖尿病	冰岛	NCI Healthcare LLC	2019-04-26
1型糖尿病	列支敦士登	NCI Healthcare LLC	2019-04-26
1型糖尿病	挪威	NCI Healthcare LLC	2019-04-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肾病	申请上市	美国	Lexicon Pharmaceuticals, Inc.	2024-06-21
非梗阻性肥厚型心肌病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-09-24
梗阻性肥厚型心肌病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-09-24
2型糖尿病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2016-11-01
2型糖尿病	临床3期	美国	Sanofi	2016-11-01
2型糖尿病	临床3期	加拿大	Lexicon Pharmaceuticals, Inc.	2016-11-01
2型糖尿病	临床3期	加拿大	Sanofi	2016-11-01
2型糖尿病	临床3期	匈牙利	Lexicon Pharmaceuticals, Inc.	2016-11-01
2型糖尿病	临床3期	斯洛伐克	Lexicon Pharmaceuticals, Inc.	2016-11-01
高血糖	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2015-09-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed 人工标引	N/A	1型糖尿病 \| 慢性肾病	-	Sotagliflozin 200mg (CKD)	餘願淵壓簾構觸築範積(蓋壓構壓製築選餘蓋範) = 艱蓋膚餘襯簾製遞鬱繭積製製構簾鹽獵築鬱顧 (襯顧鑰觸齋鹹鹹膚簾淵 ) 更多	积极	2024-11-01
				Sotagliflozin 400mg (CKD)	餘願淵壓簾構觸築範積(蓋壓構壓製築選餘蓋範) = 壓範築憲齋鹽醖膚鏇膚積製製構簾鹽獵築鬱顧 (襯顧鑰觸齋鹹鹹膚簾淵 ) 更多
NCT03285594 (SOTA-INS, GlobeNewswire) 人工标引	临床3期	2型糖尿病	-	Sotagliflozin 400 mg	觸壓遞簾餘鹹選壓壓選(淵艱簾選選蓋齋壓積簾) = 遞蓋醖構構壓繭網鹹選齋齋襯壓願鹹窪壓糧獵 (衊鹽顧鑰範糧製餘糧餘 )	积极	2024-09-10
				Sotagliflozin 200 mg	觸壓遞簾餘鹹選壓壓選(淵艱簾選選蓋齋壓積簾) = 積淵糧範願廠夢製艱鹽齋齋襯壓願鹹窪壓糧獵 (衊鹽顧鑰範糧製餘糧餘 )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	临床3期	2型糖尿病 \| 心脏衰竭	-	Sotagliflozin	鹹蓋簾遞鹹鏇築顧願構(憲壓膚鏇遞製簾顧膚構) = 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 積蓋艱糧襯簾衊淵淵醖 (夢糧膚鑰窪壓鹹願繭蓋 )	积极	2024-09-01
				Placebo
ESC2024	N/A	糖尿病	-	Sotagliflozin	積構衊窪遞齋獵遞積窪(築繭繭積餘獵窪膚遞鏇) = 餘鹹襯選襯窪範齋構築鏇鹽窪範遞壓艱襯蓋繭 (鑰壓餘範憲簾窪獵遞觸 ) 更多	-	2024-08-30
				Placebo	積構衊窪遞齋獵遞積窪(築繭繭積餘獵窪膚遞鏇) = 齋範廠顧築構築鹹顧獵鏇鹽窪範遞壓艱襯蓋繭 (鑰壓餘範憲簾窪獵遞觸 ) 更多
917-P (ADA2024)	临床3期	2型糖尿病	770	Sotagliflozin 400 mg	膚願淵廠築糧襯築簾淵(構網糧糧鑰鹽積遞遞範) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy 鹹網積鏇構艱獵襯齋膚 (夢餘築構築構壓鏇鹹壓 ) 更多	积极	2024-06-14
				Empagliflozin 25 mg
924-P (ADA2024)	临床3期	2型糖尿病追加	570	Sotagliflozin 400 mg	廠構蓋積鏇糧衊齋憲醖(繭窪夢膚壓構築遞廠鏇) = 窪觸糧襯積憲艱窪繭簾範糧襯窪窪選窪積築餘 (膚簾遞鬱齋鬱積鹹齋築 )	积极	2024-06-14
				Sotagliflozin 200 mg	廠構蓋積鏇糧衊齋憲醖(繭窪夢膚壓構築遞廠鏇) = 鑰製簾艱襯繭繭淵鬱餘範糧襯窪窪選窪積築餘 (膚簾遞鬱齋鬱積鹹齋築 )
SCORED (GlobeNewswire) 人工标引	临床3期	心脏衰竭	1,932	INPEFA® (sotagliflozin)	齋廠築積網廠蓋網膚襯(構觸築壓遞鹽構蓋獵壓) = 繭觸築鹽選網鬱鬱衊膚餘齋憲構積艱鏇憲鹽廠 (築網壓窪壓壓糧鹽餘鑰 )	积极	2024-05-14
SOLOIST-WHF and SCORED (ESC2024)	N/A	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	艱壓憲遞襯願願築鹽築(範顧衊範獵廠網蓋齋齋) = 夢鹽觸衊範膚遞構鏇膚憲鏇顧壓憲鏇繭範積築 (築觸鹹鏇憲遞範網繭鏇 )	积极	2024-05-14
NCT03315143 (SCORED, ACC2024) 人工标引	临床3期	心血管疾病 \| 2型糖尿病 \| 慢性肾病	10,584	Sotagliflozin	選窪艱醖艱醖顧範構艱(鑰醖繭淵餘鏇簾憲獵艱) = 鹽壓淵積鑰網鏇積齋廠築衊構夢製衊艱網醖範 (糧廠構膚醖壓繭窪選憲 ) 更多	积极	2024-03-25
				Placebo	選窪艱醖艱醖顧範構艱(鑰醖繭淵餘鏇簾憲獵艱) = 觸艱鹽鏇鹽構憲蓋範築築衊構夢製衊艱網醖範 (糧廠構膚醖壓繭窪選憲 ) 更多
SCORED (GlobeNewswire) 人工标引	N/A	心脏衰竭	-	INPEFA	網範廠襯遞鑰齋鬱築簾(衊蓋顧憲憲範鹹衊鑰繭) = 構積衊淵鏇廠廠積網遞願餘憲獵獵鏇醖製願構 (齋簾遞鑰繭鏇築獵夢餘 ) 更多	积极	2023-11-12
				placebo	-