Tenapanor Hydrochloride

Analysis of IBS in America 2024 Real-World Survey Demonstrates that severity of IBS-C correlates with financial hardship and distressWALTHAM, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the company presented data supporting the company’s first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the Digestive Disease Week Conference (DDW), now underway in San Diego. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. “Ardelyx is committed to continuing to grow our understanding both of the IBS patient experience and the possible impact that our first-in-class retainagogue, IBSRELA, can have on different patient populations,” said Laura Williams, Chief Patient Officer. “We are especially pleased to continue our partnership with the IBS in America Real-World Survey which helps unveil new insights into the lived experience of patients with IBS, especially as it relates to quality of life. We are also pleased to be able to share data we continue to collect on the safety and tolerability of IBSRELA in other important patient groups.” Poster # Mo1257, entitled “Patient-Reported IBS-C Symptom Severity Correlates Positively With Financial Burden: Results From the IBS in America 2024 Real-World Survey,” demonstrated that greater IBS-C symptom severity is associated with greater financial hardship and distress, or financial toxicity. Based on data from the IBS in America 2024 Real-World supplemental survey, the Functional Assessment of Chronic Illness Therapy Measure of Financial Toxicity (FACIT-COST®) and Patient-Reported Outcomes Measurement Information System® (PROMIS®) gastrointestinal (GI) symptom scales were used to assess financial toxicity and symptoms, respectively. Poster #Sa1643, entitled “Safety and Tolerability of Tenapanor in Pediatric Patients With Irritable Bowel Syndrome With Constipation: An Analysis of Blinded Safety Data from a Phase 3 Study and its Open-Label Extension,” reports interim, blinded safety results from the Phase 3 R-ALLY study of tenapanor in pediatric patients aged ≥12 to <18 years-old with IBS-C, and its open-label safety extension study. No serious adverse events or unexpected safety signals were reported as part of either study. Diarrhea was the only adverse event related to study drug, which is consistent with tenapanor’s mechanism of action. Poster #Sa1673, entitled “Neither Tenapanor nor its Major Metabolite Were Detected in the Breast Milk of Healthy Lactating Females After 4 Days of Dosing: A Phase 1, Open-Label, Pharmacokinetic Study,” presents data from a four-day study that was conducted to assess the pharmacokinetics of tenapanor and its primary metabolite, M1, in breast milk, as well as the safety and tolerability of tenapanor in healthy lactating females. The results of the study showed that tenapanor was not present at detectable levels in the breast milk of healthy lactating females after repeated oral administration. Tenapanor and M1 were below the limit of quantitation at all concentrations and all time points, and no unexpected treatment-emergent adverse events were reported. Poster presentations are now publicly available and can be accessed on demand here. About IBSRELA® (tenapanor)IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, thus retaining luminal water content, which accelerates intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In a rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability. About Irritable Bowel Syndrome with Constipation (IBS-C)Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the U.S. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTSIBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. CONTRAINDICATIONSIBSRELA is contraindicated in: patients less than 6 years of age due to the risk of serious dehydrationpatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSRisk of Serious Dehydration in Pediatric Patients IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%). INDICATION IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Please see full Prescribing Information, including Boxed Warning, for additional risk information. About ArdelyxArdelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook. Investor and Media Contacts: Lindsey Manuellmanuel@ardelyx.com

4月29日晚间，复星医药发布公告，宣布了一项重要的人事变动。公司董事会收到吴以芳、王可心的书面辞职函，由于工作安排的调整，吴以芳辞去公司董事长职务，王可心辞去联席董事长职务。经公司第九届董事会第七十八次会议审议批准，吴以芳由执行董事改任非执行董事；王可心继续担任执行董事。同时，陈玉卿由非执行董事改任执行董事，并当选为第九届董事会董事长。此外，关晓晖担任第九届董事会联席董事长（不再担任副董事长），文德镛担任第九届董事会副董事长。这些任职变动均自4月29日起正式生效。陈玉卿出生于1975年12月，拥有上海大学工学学士学位。在加入复星医药之前，他在多个领域积累了丰富的工作经验。1997年7月至1999年7月，陈玉卿担任上海大学材料学院教师。此后，从1999年7月至2005年3月，他历任延锋伟世通汽车饰件系统有限公司（现更名为延锋汽车饰件系统有限公司）、延锋伟世通（北京）汽车饰件系统有限公司、上海延锋江森座椅有限公司人力资源经理。2005年6月至2006年4月，他出任上海埃力生（集团）有限公司人力资源部发展经理；2006年7月至2006年11月，担任迅达（中国）电梯有限公司中国中区人力资源经理；2006年12月至2009年4月，任职购宝商业集团高级人力资源整合经理；2009年4月至2009年10月，出任酷宝信息技术（上海）有限公司人力资源总监。自2010年1月加入复星医药所在集团，他曾任公司总裁助理兼人力资源部总经理等职，2015年4月至2016年6月任公司副总裁，2016年6月至2020年10 月任高级副总裁，2020年10月至2022年6月任联席总裁，2022年6月至 2023年6月任公司联席首席执行官。2020年8月至2021年5月及2022年10 月至今，陈玉卿还担任复星健康董事长；2023年7月起，他出任复星国际（股票代码：00656）副总裁。在2024年12月，国家金融监督管理总局核准了陈玉卿复星联合健康保险股份有限公司董事的任职资格。在陈玉卿履新之前，复星医药在其与其他管理层的共同努力下已取得了不少成果。就在4月29日，复星医药公布2025年首季度业绩报告。第一季度，复星医药实现营业收入人民币94.20亿元，归母净利润人民币7.65亿元，经营活动现金流人民币10.56亿元。报告期内，复星医药持续推进创新转型和创新产品的开发落地，自主研发的斯鲁利单抗注射液（欧盟商品名：Hetronifly）于欧盟获批、许可引进的全球首款磷吸收抑制剂万缇乐 ®（盐酸替那帕诺片）于中国境内获批，多项在研创新管线进入关键临床/审批阶段。2025年2月，控股子公司复宏汉霖授予Dr.Reddy's就其自主研发的达雷妥尤单抗生物类似药 HLX15两种剂型在美国及42个欧洲国家和地区的独家商业化权益，加速自研产品进入欧美市场。近期，复星医药也有其他高管变动情况。2025年3月31日，公司高级副总裁包勤贵因个人原因向董事会请辞，从即日起不再担任公司高级副总裁一职。包勤贵1984年出生，2010年7月加入复星集团，在复星医药的发展堪称惊艳，十余年间升至顶层团队，年薪一度逼近千万。但近三年间，其薪酬从969.63 万骤减至520.13 万，再陡降至269.63 万。此次离职前，他已卸任复星诊断（复星医药全资子公司）的董事长及法定代表人。另外，4月23日，公司董事会收到李东久的书面辞职函，因到龄退休，李东久申请辞去高级副总裁职务，自2025年4月23日起不再担任该职。包勤贵与李东久的离职，为陈玉卿的新团队“让路”，陈玉卿或许将借此机会组建更贴合公司当下战略发展的管理班底。此次陈玉卿出任复星医药董事长，无疑为公司的未来发展注入了新的活力与思路。在他的带领下，复星医药将如何在激烈的市场竞争中持续创新、拓展全球布局，值得市场密切关注。来源：一度医药作者：Mandy点击 阅读原文 了解更多