Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.

开始日期2025-06-01

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT06460038

/ Recruiting临床2期IIT

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

开始日期2025-01-01

申办/合作机构

Ardelyx, Inc.

NCT06553547

/ Recruiting临床2期

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

开始日期2024-07-24

申办/合作机构

Ardelyx, Inc.

100 项与盐酸替那帕诺相关的临床结果

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100 项与盐酸替那帕诺相关的转化医学

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100 项与盐酸替那帕诺相关的专利（医药）

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127

项与盐酸替那帕诺相关的文献（医药）

2026-01-02·Clinical Kidney Journal

Mechanism of reduced intestinal phosphate absorption by tenapanor: a hypothesis

Review

作者: Nakanishi, Takeshi ; Drueke, Tilman B ; Kuragano, Takahiro

ABSTRACT:

Tenapanor, a selective inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3), was initially developed for the treatment of irritable bowel syndrome with constipation. Subsequent preclinical and clinical studies revealed its ability to reduce gastrointestinal phosphate absorption, leading to effective serum phosphate control with minimal pill burden in patients with kidney failure undergoing dialysis therapy. However, the precise mechanisms underlying NHE3 inhibition, its impact on phosphate handling and the primary site of action within the gastrointestinal tract remain incompletely understood. This review explores the hypothesis that tenapanor-induced NHE3 inhibition elevates the luminal pH via enhanced bicarbonate secretion in the colon, thereby altering phosphate speciation. Phosphate exists in the body as monovalent (H₂PO₄⁻) and divalent (HPO₄²⁻) anions, with the latter predominating under alkaline conditions. Although divalent anions are theoretically more prone to be absorbed from the gut lumen via the paracellular transport route because of the lumen-negative transepithelial potential, on the contrary recent studies have provided evidence that monovalent species are transported more efficiently and that paracellular phosphate permeability is suppressed at high luminal pH. We now propose that the net negative electrostatic environment within the paracellular pore pathway of tight junctions may selectively hinder divalent phosphate transport. This hypothesis aligns with prior findings that tenapanor does not alter the expression of tight junction proteins, suggesting a physicochemical rather than a structural basis for reduced permeability. Further investigations are warranted to determine whether the electrostatic properties of the paracellular pathway contribute to the phosphate-lowering effect of tenapanor.

2025-12-31·CLINICAL AND EXPERIMENTAL HYPERTENSION

High-salt diets provoke phosphorus absorption from the small intestine in mice

Article

作者: You, Huaizhou ; Yang, Mingxin ; Chen, Jing ; Mao, Jianping ; Ni, Li

BACKGROUND:

Recent studies indicate that tenapanor, an inhibitor of sodium/proton exchanger-3 (NHE3), diminishes intestinal phosphorus (Pi) absorption. Given NHE3's pivotal role in sodium (Na+) metabolism, there is a suspected functional link between Na+ and Pi metabolism. High-salt diets (HSD) have been demonstrated to disrupt calcium (Ca2+) metabolism. Since Ca2+ and Pi share analogous metabolic pathways, it is yet to be determined whether HSD also impacts Pi metabolism.

METHODS:

Male C57 mice were randomly assigned to three groups: a standard diet group, HSD groups for 1 week (HSD-1w) and 4 weeks (HSD-4w). Throughout the study, dietary intake and water consumption were monitored using metabolic cages, and urine and feces were collected. Blood pressure was measured using a noninvasive tail vein sphygmomanometer. Upon completion of the intervention, mice were euthanized under anesthesia for blood collection, and intestinal and renal tissues were harvested for molecular analysis.

RESULTS:

Although plasma Pi levels were comparable between HSD groups and the control group, HSD groups exhibited increased urinary Pi excretion and decreased fecal Pi excretion. The HSD-4w group displayed elevated parathyroid hormone levels, reduced fibroblast growth factor 23 levels, and higher renal Cyp27b1 mRNA expression. The expression of sodium-dependent phosphate transporter 2b (Npt2b) and NHE3 was elevated in the intestine of HSD mice.

CONCLUSION:

HSD disrupts Pi metabolism by enhancing urinary Pi excretion and altering hormonal levels. The decrease in fecal Pi excretion, coupled with the upregulation of intestinal Pi transporter expression, suggests that HSD promotes intestinal Pi absorption in mice.

2025-10-01·AMERICAN JOURNAL OF KIDNEY DISEASES

Tenapanor: An Update on Evidence of Effectiveness and Guidance on Practical Use

Review

作者: Uribarri, Jaime ; Da Silva Lugo, Ian

Hyperphosphatemia remains a major challenge in managing patients with kidney failure and is associated with significant morbidity and mortality. Traditional approaches such as dietary phosphate restriction, oral phosphate binders, and dialysis modifications, even if combined, often provide insufficient control of serum phosphate levels. Tenapanor, a novel therapy that targets intestinal phosphate absorption, has shown promise in reducing serum phosphate as monotherapy and in combination with binders, even though gastrointestinal side effects may occur. Here, we review the available information about the clinical use of tenapanor, including its safety profile, and provide some clinical suggestions for its practical use.

267

项与盐酸替那帕诺相关的新闻（医药）

2026-01-26

·PRNewswire

Breaking Barriers: How 2026's Top Clinical Leaders Are Disrupting Chronic Disease Markets

Issued on behalf of Avant Technologies Inc. Equity Insider News Commentary VANCOUVER, BC, Jan. 26, 2026 /PRNewswire/ -- The medical world is shifting as the global market for next-gen treatments heads toward $88.85 billion by 2030[1], driven by a surge in funding for high-tech cures for long-term illness. A major FDA move at the beginning of the year[2] is now making it much easier to build these advanced platforms, clearing a path for companies that can treat diseases internally without the harsh side effects of traditional drugs. This regulatory shift positions Avant Technologies, Inc. (OTCQB: AVAI), MannKind (NASAQ: MNKD), Vertex Pharmaceuticals (NASDAQ: VRTX), Fate Therapeutics (NASDAQ: FATE), and Ardelyx (NADSAQ: ARDX) at the center of a massive transformation in chronic healthcare. Smart investors are preparing for a major 2026 rebound as capital flows into the most innovative and results-driven medical platforms[3]. With the total biotech sector projected to reach $9.06 trillion by 2035[4], the biggest opportunities are in companies solving massive issues like diabetes and kidney disease with better clinical execution. In 2026, the market is favoring 'ready-to-go' platforms over early-stage speculation, rewarding the companies that have built the infrastructure to dominate the next generation of medicine. Avant Technologies, Inc. (OTCQB: AVAI) is tackling some of healthcare's biggest challenges with a novel approach: genetically modified cells that produce therapeutic proteins inside the body, protected by a proprietary shield that keeps the immune system from attacking them. The company operates through two joint ventures targeting markets worth hundreds of billions of dollars. The core innovation is a cell encapsulation technology that solves a fundamental problem in regenerative medicine. When doctors transplant therapeutic cells into patients, the immune system typically destroys them within days or weeks. The traditional solution requires lifelong immunosuppressive drugs that cause serious side effects including infection risk, organ damage, and elevated cancer risk. Avant's technology eliminates this problem by creating a protective barrier around the cells while still allowing nutrients, oxygen, and therapeutic proteins to pass through freely. The first venture, Insulinova, Inc., partners with SGAustria Pte. Ltd. to develop treatments for type 1 diabetes and insulin-dependent type 2 diabetes. The approach uses genetically modified cells that produce, regulate and store insulin, essentially creating a bio artificial pancreas that restores natural glucose control without immunosuppressive drugs. The diabetes market opportunity is substantial: 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, projected to reach 853 million by 2050 according to the International Diabetes Federation. "Cell encapsulation is a game changer in the field of regenerative medicine," said Chris Winter, CEO of Avant Technologies. "By partnering with SGAustria, we're ensuring that genetically modified insulin-producing cells can thrive in the body long-term and offer the potential of restoring natural glucose control and dramatically improving patients' quality of life. This technology not only minimizes risks like immune rejection but also prevents potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies." Avant's second venture, Klothonova, partners with Singapore-based Austrianova to develop therapies for both age-related diseases and anti-aging therapies using cells that produce the Klotho protein. Research from the Mayo Clinic links declining Klotho levels to arterial stiffness, endothelial dysfunction, and vascular calcification. Both platforms are backed by over 50 peer-reviewed publications representing decades of development. The addressable markets span multiple areas: Alzheimer's disease ($32.8 billion by 2033), cardiovascular disease (32% of global deaths), and kidney disease (850 million affected worldwide). The strategic advantage lies in platform versatility. The same encapsulation technology that protects insulin-producing cells can theoretically protect cells producing other therapeutic proteins, potentially opening pathways into additional disease indications. This positions Avant at the intersection of multiple high-value healthcare markets with a single core technology that addresses the immune rejection challenge across different applications. CONTINUED... Read this and more news for Avant Technologies at: MannKind (NASDAQ: MNKD) provided business updates outlining anticipated growth drivers for 2026, including progress across commercial programs and clinical development initiatives following a record-setting fourth quarter surpassing $100 million in net revenue. The company expects two high-potential launches on the horizon with FDA decisions anticipated for Afrezza label updates and FUROSCIX ReadyFlow Autoinjector. "MannKind closed 2025 on a high note, marked by milestones that reinforce our growth trajectory—including the acquisition of scPharmaceuticals and a record-setting fourth quarter surpassing $100 million in net revenue," said Michael Castagna, PharmD, CEO of MannKind Corporation. "With two high-potential launches on the horizon, 2026 is shaping up to be a catalyst-rich year that positions MannKind for long-term value creation." Major catalysts include an FDA decision on Afrezza dose conversion with PDUFA date of January 23, 2026, and review of the supplemental BLA for Afrezza in pediatric patients with PDUFA date of May 29, 2026. MannKind also continues advancing its pipeline including nintedanib DPI with first patient enrollment in the INFLO-1 Phase 1b study completed in December. Vertex Pharmaceuticals (NASDAQ: VRTX) provided pipeline and business updates ahead of the J.P. Morgan Healthcare Conference, highlighting strong commercial execution and rapid R&D progress setting up continued growth and important milestones for 2026. The company increased estimates for people with CF in all target markets to approximately 112,000 including approximately 97,000 in core markets, while CASGEVY realized greater than $100 million revenue in 2025 reflecting more than 60 patient infusions. "2025 was a year of strong commercial execution and rapid R&D progress, setting up the company for continued growth and many important milestones in 2026," said Reshma Kewalramani, M.D., CEO and President of Vertex. "Building on this momentum, we are focused on expanding our commercial reach in multiple disease areas; advancing the emerging renal franchise, including the potential near-term launch of povetacicept; and progressing our mid- and late-stage clinical pipeline." Vertex expects to complete the rolling BLA filing for U.S. accelerated approval of povetacicept in IgAN in the first half of 2026 using a priority review voucher to expedite review from ten months to six months. The company also plans to complete enrollment in both Phase 3 studies of suzetrigine in diabetic peripheral neuropathy by end of 2026, with more than 500,000 JOURNAVX prescriptions written and filled in 2025. Fate Therapeutics (NASDAQ: FATE) presented updated Phase 1 clinical data of FT819 off-the-shelf CAR T-cell product candidate demonstrating meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus patients now treated and first systemic sclerosis patient dosed. The company continues to advance preparations for a pivotal study and is engaged in discussions with the FDA under its RMAT designation regarding plans to initiate registrational trial in 2026. "We are very pleased with the accelerating patient enrollment, the expansion of U.S. clinical sites, and the addition of international clinical sites, which together are enabling broader access to FT819 for patients suffering with lupus," said Bob Valamehr, Ph.D., M.B.A., President and CEO of Fate Therapeutics. "The updated FT819 clinical data continue to demonstrate meaningful and durable responses with the use of less-intensive conditioning chemotherapy and a differentiated safety profile." Preliminary data in Regimen A showed mean SLEDAI-2K score decreased progressively from baseline with DL1 dropping 50% at month 3 and 70% at month 6, while DL2 decreased 65% at month 3 and 78% at month 6. Clinical SLEDAI-2K of 0 was achieved in 5 out of 10 patients with no Grade >2 CRS, ICANS, or GVHD reported. Ardelyx (NASDAQ: ARDX) presented real-world evidence studies of XPHOZAH (tenapanor) demonstrating patient satisfaction and reduction in serum phosphate at the American Society of Nephrology's Kidney Week. The first real-world study showed patients prescribed tenapanor experienced a reduction in serum phosphate of nearly 1 mg/dL on average, with 45.3% experiencing at least 1 mg/dL reduction. "We are excited to present new data on XPHOZAH at ASN's Kidney Week, including the first results from our prospective, observational cohort study designed to evaluate the impact of an XPHOZAH-based regimen in a real-world setting," said Edward Conner, Chief Medical Officer. "Our results show the impact XPHOZAH can have in reducing serum phosphorus levels for these patients." Real-world survey data collected through the ArdelyxAssist patient services program showed that 63% of patients reported their phosphate levels were better since starting tenapanor. Among patients who reported a change in serum phosphate levels, 69% indicated their outlook on serum phosphate control was better, with improvements attributed to better control, improved bowel movements, and lower pill burden. Source: need-to-know/ CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: Logo: 21% more press release views with Request a Demo

临床结果临床1期

2026-01-08

·医时代观察

2025年全球肾病治疗领域新药突破性进展全景

肾脏疾病因其高发病率、高致残率及复杂的治疗逻辑，长期以来是全球医疗领域的攻坚重点。据《全球疾病负担研究2023》数据显示，慢性肾脏病（CKD）已成为第九大死亡原因，其相关并发症更是严重影响患者生活质量。2025年，在肾病治疗领域迎来了多项突破性进展，多款针对性新药相继获批，涵盖慢性肾脏病核心并发症管理、免疫性肾病靶向治疗、特殊肾病精准干预等多个细分领域，为广大肾病患者带来了全新的治疗选择与生存希望。本文将对2025年肾病领域获批的关键新药进行全面汇总，梳理其核心临床价值与行业影响。 PART.01 慢性肾脏病核心并发症治疗新药慢性肾脏病进展过程中，常伴随高磷血症、瘙痒等并发症，严重影响患者预后与生活质量。2025年两款针对性新药的获批，填补了相关治疗领域的需求空白。 1. 盐酸替纳帕诺片：透析患者高磷血症的新选择 2025年2月20日，国家药品监督管理局（NMPA）批准盐酸替纳帕诺片上市，适应症为控制对磷结合剂疗效不充分或不耐受的慢性肾脏病（CKD）成人透析患者的血清磷水平。作为一种局部作用于小肠和结肠上皮顶端的钠/氢交换体3（NHE3）抑制剂，其作用机制精准靶向磷吸收的关键环节。在中国血液透析患者中开展的III期研究证实，该药具有显著的降磷疗效，研究期间40%-50%的患者血磷可达到中国透析质控达标标准（< 1.78 mmol/L），为不耐受传统磷结合剂的患者提供了全新的治疗方案。 2. 安瑞克芬注射液：终结透析患者瘙痒困扰 2025年9月9日，NMPA批准安瑞克芬注射液上市，用于治疗成人维持性血液透析患者的慢性肾脏疾病相关中度至重度瘙痒。慢性肾病相关瘙痒（CKD-aP）是终末期肾病患者的常见并发症，发生率超60%，且传统治疗手段有限。作为外周κ阿片受体（KOR）激动剂，安瑞克芬在III期试验中展现出优异疗效：治疗第12周，患者每日最严重瘙痒强度数字评分（WI-NRS）周平均值较基线改善≥4分的比例达37.2%，显著高于安慰剂组的15.0%（P< 0.001），同时患者生活质量评分（Skindex-10和5-D量表）也得到显著改善，且长期使用安全性稳定。 PART.02 IgA肾病靶向治疗药物密集获批，开启精准治疗时代原发性免疫球蛋白A肾病（IgAN）是全球最常见的原发性肾小球疾病，疾病进展风险高，此前缺乏针对性靶向药物。2025年，多款不同机制的IgA肾病新药获批，构建了多元化的治疗体系。 1. 布地奈德肠溶胶囊：靶向肠道黏膜的免疫调节新方案 2025年5月7日，NMPA批准布地奈德肠溶胶囊用于治疗具有疾病进展风险的原发性IgA肾病成人患者，以减少肾功能损失。该药作为靶向肠道黏膜B细胞的免疫调节剂，通过调节肠道免疫微环境，降低致病性IgA1的产生。NefIgArd III期临床试验结果显示，与安慰剂相比，其能减少肾功能衰退达50%；尤其在我国人群中，可延缓肾功能衰退达66%，预计将疾病进展至透析或肾移植的时间延缓12.8年，为我国IgA肾病患者带来了突破性治疗选择。 2. 盐酸阿曲生坦片：非免疫机制的降蛋白尿新武器 2025年8月20日，NMPA通过优先审评程序附条件批准盐酸阿曲生坦片上市，适用于降低有疾病快速进展风险的原发性IgA肾病成人患者的蛋白尿（尿蛋白肌酐比值UPCR≥ 1.5 g/g）。作为高选择性内皮素A（ETA）受体拮抗剂，其通过抑制内皮素通路，降低肾小球内压、抑制肾脏纤维化。III期ALIGN研究显示，治疗组患者最早在第6周即可观察到尿总蛋白肌酐比值（UPCR）的降低，36周时较安慰剂组24小时UPCR降幅达36.1%（P< 0.0001），成为首个非免疫机制获批的IgA肾病靶向治疗药物。 3. 盐酸伊普可泮胶囊：补体替代途径抑制新突破 2025年9月10日，NMPA批准盐酸伊普可泮胶囊上市，用于降低有疾病快速进展风险的原发性IgA肾病成人患者的蛋白尿水平（UPCR> 1.5 g/g）。作为口服形式的B因子抑制剂，伊普可泮精准靶向补体替代途径，阻断补体过度激活对肾脏的损伤。III期APPLAUSE-IgAN研究纳入443例使用足量RAS阻断剂后尿蛋白依然＞1 g的IgA肾病患者，结果显示伊普可泮组治疗9个月时，平均24小时尿蛋白肌酐比下降38.3%，为补体异常激活相关IgA肾病患者提供了新的治疗方向。 4. 斯贝利单抗：FDA批准的全球首个APRIL抑制剂 2025年11月25日，美国食品药品监督管理局（FDA）批准斯贝利单抗（sibeprenlimab）上市，用于降低存在疾病进展风险的成人原发性IgA肾病患者的蛋白尿水平。该药是一种靶向抑制增殖诱导配体（APRIL）的人源化IgG2单克隆抗体，通过调节B细胞功能减少致病性IgA的产生。III期VISIONARY研究中期分析结果显示，在优化支持治疗基础上，斯贝利单抗400 mg每月一次皮下注射，治疗9个月可使24小时UPCR较基线降低50.2%，较安慰剂组减少51.2%（P < 0.0001），且不良事件发生率低于安慰剂组，为全球IgA肾病患者提供了新的免疫靶向治疗选择。 PART.03 糖尿病肾病与特殊肾病治疗领域新突破 1. 司美格鲁肽注射液：开启GLP-1RA糖尿病肾病综合管理新时代 2025年7月18日，NMPA批准司美格鲁肽注射液新增适应症，用于降低2型糖尿病合并慢性肾病成人患者因心血管疾病而恶化、肾衰竭（终末期肾病）和死亡的风险。我国约1.48亿糖尿病患者中，近三分之一合并慢性肾病，且疾病进展快、死亡风险高。作为中国首个且唯一同时具有降糖、心血管和肾脏三大适应症的GLP-1受体激动剂，司美格鲁肽的获批基于III期FLOW研究结果：中位随访3.4年时，其较安慰剂组降低肾脏疾病进展及心肾死亡风险24%，同时降低主要心血管事件风险18%、全因死亡风险20%，且一周一次给药、不增加低血糖风险，为糖尿病肾病患者提供了“一药多效”的综合管理方案。 2. Pegcetacoplan：FDA批准用于C3肾小球病精准治疗 2025年7月28日，FDA批准Pegcetacoplan用于12岁及以上C3肾小球病（C3G）或原发性免疫复合物膜增生性肾小球肾炎（IC-MPGN）患者，以减少蛋白尿。作为合成的环肽类补体抑制剂，其通过抑制补体C3转化酶，阻断补体系统过度激活对肾脏的损伤。III期VALIANT研究显示，治疗26周后，Pegcetacoplan组患者尿蛋白/肌酐比（UPCR）较基线下降67.3%，而安慰剂组为上升3.2%，相对下降幅度达68.3%（P< 0.0001）；52周长期数据显示，持续治疗患者UPCR平均下降67.2%，估算肾小球滤过率（eGFR）仅轻微下降，为这类罕见肾病患者带来了首个针对性治疗药物。 3. 瑞玛比嗪注射液：肾功能评估精准化工具 2025年10月14日，NMPA批准瑞玛比嗪注射液上市，需与经皮肾小球滤过率测量设备（TGFR）配合使用，用于评估患者的肾小球滤过率（GFR）。GFR是评估肾功能的核心指标，传统检测方法存在一定局限性。瑞玛比嗪注射液的获批，为肾功能评估提供了更精准、便捷的工具，有助于肾病的早期筛查、病情监测及治疗方案优化，为肾病全程管理提供了重要支撑。 PART.04 年肾病新药研发趋势与行业意义 2025年肾病领域新药的集中获批，呈现出三大显著趋势：一是靶向治疗成为主流，从补体系统、内皮素通路、肠道免疫到APRIL等多个靶点的精准干预，打破了传统非特异性治疗的局限；二是治疗领域不断细分，从常见的慢性肾脏病、IgA肾病，到罕见的C3肾小球病，再到透析并发症，实现了对肾病全病程、多场景的覆盖；三是心肾代谢综合管理理念深化，如司美格鲁肽的多适应症获批，体现了从单一器官治疗向系统疾病综合干预的转变。更为重要的是，2025年世界卫生组织首次将肾脏疾病列为全球优先关注的重大非传染性疾病，这些新药的获批不仅填补了多个治疗空白，更推动了肾病治疗指南的更新与临床实践的变革。从中国本土药物的快速获批到全球创新药的同步引进，我国肾病患者的治疗可及性显著提升，为实现肾病早诊早治、延缓疾病进展、提高生存质量奠定了坚实基础。未来，随着更多靶点的发现与临床试验的推进，肾病治疗将迎来更精准、更有效的新时代。

2026-01-08

·ir.ardelyx.com

Ardelyx Reports Preliminary 2025 Revenue and Provides 2026 Strategic Outlook

Company achieved significant commercial progress in 2025, generating approximately $378 million in product revenue1 IBSRELA achieved $274 million in revenue in 2025, representing 73% growth vs. 20241 IBSRELA expected to achieve $410-430 million in revenue in 2026 IBSRELA revenue expected to reach $1 billion in 2029 WALTHAM, Mass., Jan. 08, 2026 (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 provided its preliminary and unaudited fourth quarter and full year 2025 product revenue, currently expected product revenue for 2026 and updated long-term outlook for IBSRELA, along with recent business updates. “For Ardelyx, 2025 was a remarkable year characterized by outstanding commercial execution and performance. IBSRELA delivered significant revenue growth of 73% over 2024, and we successfully protected patient access to XPHOZAH. We advanced our pipeline by commencing a Phase 3 program for IBSRELA in chronic idiopathic constipation and began development of a next generation NHE3 inhibitor with RDX10531, creating momentum behind our efforts to continue positioning Ardelyx for durable long-term growth,” said Mike Raab, president and chief executive officer. “We enter 2026 exceptionally well positioned to deliver significant growth and long-term value creation as we invest in our business to accelerate our commercial opportunities. We have first-in-class medicines in areas of unmet need, an innovative commercial strategy that continues to deliver exceptional results, strong development capabilities and a robust cash position that will enable us to further advance our portfolio, achieve our vision of bringing important medicines to patients who need them and create meaningful value for shareholders.” Financial Highlights1: 2025 total product revenue was approximately $378 million, representing 18% year-over-year growth. IBSRELA finished 2025 with full year revenue totaling approximately $274 million, 73% growth compared to 2024, generating revenue of approximately $87 million in the fourth quarter. XPHOZAH finished 2025 with revenue totaling approximately $104 million, generating approximately $28 million in revenue in the fourth quarter. The company had $265 million in cash, cash equivalents and investments as of December 31, 2025, sufficient to support high impact investments to grow adoption of its commercial products and advance its pipeline. Financial Guidance and Outlook: Full-year 2026 revenue for IBSRELA is expected to be between $410 and $430 million, representing growth of at least 50% compared to 2025. 2029 IBSRELA revenue is expected to be $1 billion with continued growth through loss of exclusivity. Full-year 2026 XPHOZAH revenue is expected to be between $110 and $120 million. Corporate and Pipeline Updates: A Phase 3 clinical trial evaluating IBSRELA in patients with chronic idiopathic constipation (CIC) has commenced and is expected to be completed in the second half of 2027. A Notice of Allowance has been received for a patent that, when issued, will extend the intellectual property protection for IBSRELA and XPHOZAH. The patent covers the commercial formulations of IBSRELA and XPHOZAH and will have an expiration date of December 6, 2041. Development of RDX10531, a next generation sodium/hydrogen exchanger 3 (NHE3) inhibitor, continued. IMPORTANT SAFETY INFORMATION (IBSRELA) WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA 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. CONTRAINDICATIONS IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration. IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. WARNINGS AND PRECAUTIONS Risk 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. IMPORTANT SAFETY INFORMATION (XPHOZAH) CONTRAINDICATIONS XPHOZAH is contraindicated in: Pediatric patients under 6 years of age Patients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONS Diarrhea Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea. MOST COMMON ADVERSE REACTIONS Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials. INDICATION XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. For additional safety information, please see full Prescribing Information. About Ardelyx Ardelyx 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). The company’s pipeline includes the Phase 3 development of IBSRELA for chronic idiopathic constipation (CIC) and RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. 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. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, Ardelyx’s current expectations regarding: product revenue for IBSRELA and XPHOZAH for full year 2025 and the fourth quarter ended December 31, 2025; its cash position at December 31, 2025; the year in which IBSRELA will achieve U.S. product revenue of $1 billion; product revenue for IBSRELA and XPHOZAH for 2026; its ability to deliver significant growth and long-term value creation, advance its portfolio and deliver meaningful value for shareholders; and the timing for the completion of the Phase 3 CIC trial. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control, that could cause actual outcomes or results to differ materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to the preparation and audit of financial statements; clinical development and regulatory approval; commercialization, market acceptance and payer coverage; manufacturing and supply; competition; pricing and regulatory changes; intellectual property and exclusivity; reliance on third parties; and macroeconomic conditions in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements, except as required by law. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 30, 2025, and its future current and periodic reports to be filed with the Securities and Exchange Commission. Investor and Media Contacts: Caitlin Lowie clowie@ardelyx.com 1 Financial results for the fourth quarter and full year 2025 reported are preliminary, unaudited and are subject to change, perhaps materially, upon the audit of the Company’s financial statements for the year ended December 31, 2025. Source: Ardelyx, Inc.

上市批准临床3期财报临床结果

100 项与盐酸替那帕诺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11653	盐酸替那帕诺	A06AX	DB11761

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高磷血症	日本	Kyowa Kirin Co., Ltd.	2023-09-25
便秘型肠易激综合征	美国	Ardelyx, Inc.	2019-09-12

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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
慢性特发性便秘	临床3期	美国	Ardelyx, Inc.	2026-01-13
终末期肾脏病	临床3期	美国	Ardelyx, Inc.	2016-01-01
白蛋白尿	临床2期	美国	Ardelyx, Inc.	2013-05-01
白蛋白尿	临床2期	美国	AstraZeneca PLC	2013-05-01

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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


NCT02675998 (BLOCK, ASN2025)	临床3期	终末期肾脏病 \| 便秘	84	Tenapanor 3 mg	選糧窪鹽蓋鬱鏇醖鏇醖(鏇廠願衊鑰襯簾遞醖獵) = 窪範繭醖壓憲夢範積鏇醖齋簾製艱顧獵鏇廠網 (範繭襯餘構糧鹹鏇鹹遞 ) 更多	积极	2025-11-06
				Tenapanor 10 mg	簾醖廠構範構鹹壓願獵(壓範網淵壓範獵築蓋顧) = 願窪鹹觸範簾遞觸糧淵製觸餘膚夢憲鑰觸網鏇 (構餘糧鑰簾襯艱築積蓋 ) 更多
ASN2025	N/A	高磷血症	13	Tenapanor	餘鹹遞網構顧鬱憲壓壓(壓製繭憲構夢齋願顧鹹) = Diarrhea or loose stools occurred in 7 patients, and 4 required dose reductions. 鏇窪糧夢遞淵憲艱鬱艱 (觸糧製鏇襯網製鹹鑰蓋 )	不佳	2025-11-06
NCT03824587 (AMPLIFY, ASN2024)	临床2/3期	慢性肾病	308	Tenapanor + Sevelamer-based PB	構築選淵夢構製製製淵(鑰襯蓋簾鑰選鏇獵淵願) = 鏇衊願鬱餘衊壓艱鏇衊艱壓壓獵顧窪顧鏇製選 (糧窪窪廠艱鹹廠醖膚齋 ) 更多	积极	2024-10-24
				Tenapanor + Non-Sevelamer based PB	構築選淵夢構製製製淵(鑰襯蓋簾鑰選鏇獵淵願) = 繭齋遞鹹鹹襯窪範鏇築艱壓壓獵顧窪顧鏇製選 (糧窪窪廠艱鹹廠醖膚齋 ) 更多
NCT04549597 (OPTIMIZE, Pubmed \| Kidney360) 人工标引	临床4期	高磷血症维持	333	Tenapanor in combintenapanorh phosphate binders	鏇壓構遞醖構憲衊繭蓋(襯憲衊積願築選膚醖衊) = 顧範獵蓋範積膚鑰鏇窪壓餘願選積鬱餘襯獵獵 (醖艱網願觸構齋衊構製 ) 更多	积极	2024-02-07
				reduce PB dosage by ≥50% and add tenapanor (Binder Reduction)	鏇壓構遞醖構憲衊繭蓋(襯憲衊積願築選膚醖衊) = 艱醖壓淵壓艱選壓構糧壓餘願選積鬱餘襯獵獵 (醖艱網願觸構齋衊構製 ) 更多
ASN2023	临床3期	高磷血症	212	Tenapanor 5 mg BID	齋鹹餘襯範遞積憲淵淵(鏇艱構鏇選鑰醖遞夢齋) = 襯衊壓鑰廠淵鹽網鹽淵壓襯淵鏇觸範餘選網襯 (築鏇選網蓋願壓膚憲襯 ) 更多	积极	2023-11-02
ASN2023	临床3期	高磷血症	54	Tenapanor	襯餘鹹鹽淵襯觸襯選範(壓齋網簾蓋壓構範遞糧) = diarrhea (74.1%, 40/54). All were mild or moderate in severity and only three subjects (5.6%) discontinued due to diarrhea 窪積襯構窪蓋醖艱衊鹽 (願窪壓鏇鏇壓鹹襯鏇觸 )	积极	2023-11-02
NCT03427125 (PHREEDOM, ASN2023)	临床3期	高磷血症	556	Tenapanor 30 mg bid	遞製願齋觸製範選觸鬱(醖構積淵鏇醖膚顧膚鑰) = 窪醖膚選繭壓鏇醖廠製鬱蓋遞繭鑰觸廠繭鑰願 (鬱願窪願繭繭糧築鹽築 ) 更多	积极	2023-11-02
				Sevelamer Carbonate	遞製願齋觸製範選觸鬱(醖構積淵鏇醖膚顧膚鑰) = 夢憲構獵淵觸觸壓廠膚鬱蓋遞繭鑰觸廠繭鑰願 (鬱願窪願繭繭糧築鹽築 ) 更多
NCT02621892 \| NCT02727751 \| NCT02686138 (T3MPO-3, Pubmed \| Neurogastroenterol Motil)	临床3期	便秘型肠易激综合征	312	Tenapanor 50 mg	廠廠醖夢糧齋糧範範構(遞獵醖餘壓願艱襯選廠) = 糧醖膚鹹壓選壓構遞壓膚淵憲鹹膚衊觸構積選 (淵繭齋窪積鏇壓簾醖廠 ) 更多	积极	2023-11-01
NCT03988920 (NORMALIZE, Pubmed \| Kidney360)	临床3期	高磷血症维持 serum intact fibroblast growth factor-23 \| serum intact parathyroid hormone	172	Tenapanor 30 mg twice daily	網齋壓鬱蓋網窪積憲醖(積顧醖選觸艱製鏇憲鹹) = The most commonly reported treatment-emergent adverse event was diarrhea in 38 of 172 patients (22%), which led to tenapanor discontinuation in four patients (2%) 醖夢艱鏇顧蓋夢蓋憲糧 (顧遞廠製鹹夢壓餘積憲 )	积极	2023-11-01
NCT02675998 \| NCT03427125 \| NCT03824587 (TEN-02-202 , FDA) 人工标引	临床2/3期	高磷血症	964	XPHOZAH (TEN-02-301)	鑰製膚壓壓蓋廠遞鏇鬱(齋願範築襯繭簾蓋餘廠) = 願蓋遞夢選夢鬱艱鑰積襯廠獵襯觸夢構鏇鹽窪 (範鹽鏇廠築壓膚鏇餘鹽, 0.2 ~ 1.1)	积极	2023-10-17
				placebo (TEN-02-301)	-