A 26-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Chronic Idiopathic Constipation (CIC) in Adults

This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.

开始日期2026-01-13

申办/合作机构

Ardelyx, Inc.

NCT06810167

/ Recruiting临床3期IIT

An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.

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.

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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130

项与盐酸替那帕诺相关的文献（医药）

2026-03-01·AMERICAN JOURNAL OF GASTROENTEROLOGY

The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis

Review

作者: Busam, Jonathan A. ; Pimentel, Mark ; Rezaie, Ali ; Marshall, Caroline ; Joo, LiJin ; Batta, Nisha ; Shah, Eric D.

INTRODUCTION::

Understanding the safety of pharmacotherapy for irritable bowel syndrome (IBS) enables individuals to make informed treatment decisions. While many studies include the number needed to treat to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.

METHODS::

PubMed, Web of Science, and Cochrane databases were searched through October 2024. Clinical trials investigating IBS pharmacotherapies including discontinuation rates because of adverse events (AEs) were included. Data were pooled using a random-effects model. The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups. Secondary outcomes included the relative risk of withdrawing because of an AE and the most common AEs for each drug.

RESULTS::

Fifty-four trials met inclusion criteria. For constipation-predominant IBS pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 ( P < 0.01), 53 ( P = 0.59), 59 ( P < 0.01), 58 ( P = 0.03), and 16 ( P < 0.01), respectively. For diarrhea-predominant IBS pharmacotherapies, the NNH for alosetron and eluxadoline was 14 ( P < 0.01) and 32 ( P < 0.01) whereas the NNH for both rifaximin and ramosetron was a negative, although statistically insignificant, value. For IBS global symptom pharmacotherapies, the tricyclics, the NNH was 24 ( P < 0.01). Many AEs were transient without long-term sequela.

DISCUSSION::

Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation because of an AE when compared with rifaximin, the safest pharmacotherapy studied.

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.

2026-01-01·Therapeutic Advances in Gastroenterology

Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis

Article

作者: Cangemi, David J. ; Shin, Andrea S. ; Lacy, Brian E. ; Yang, Yang ; Rosenbaum, David P. ; Zhao, Suling

Background::

In patients with irritable bowel syndrome with constipation (IBS-C), rapid, sustained relief from constipation and abdominal symptoms, such as pain, discomfort, and bloating, can improve quality of life.

Objective::

This post hoc analysis evaluates the time to constipation and abdominal symptom relief achieved with tenapanor.

Design::

Post hoc analysis of data pooled from three randomized placebo-controlled studies (phase IIb, T3MPO-1, and T3MPO-2) of tenapanor 50 mg twice daily in patients with IBS-C.

Methods::

The time to first response for complete spontaneous bowel movement (CSBM) frequency, abdominal pain, discomfort, bloating, and 3-item abdominal score (AS3) were assessed. The AS3 was derived as the average of the weekly scores for abdominal pain, discomfort, and bloating. Cumulative incidences of response over time were estimated using the Kaplan–Meier method. A Cox proportional hazards model was used to assess the effect of baseline and demographic characteristics on the time to first response.

Results::

Among 1372 patients with IBS-C (684 tenapanor; 688 placebo), median time to first CSBM response was 2 weeks, and median time to abdominal pain, discomfort, bloating, or AS3 response was 4–5 weeks in those treated with tenapanor, with 67.8%–76.7% achieving first response in CSBM frequency and abdominal symptoms by week 12. These time frames were shorter than those observed with the placebo (4 weeks for CSBM and 6–8 weeks for pain, discomfort, bloating, and AS3), of whom 59.1%–69.4% achieved the first response in CSBM and abdominal symptoms by week 12. Higher weekly response rates were observed with tenapanor than with placebo for all endpoints in each week of the 12-week treatment period.

Conclusion::

This novel post hoc analysis demonstrates that, compared with placebo, tenapanor reduces the time to first response in CSBM frequency and abdominal symptoms and consistently increases the weekly response rate during 12 weeks of treatment.

Trial registration::

NCT01923428; NCT02621892; NCT02686138.

312

项与盐酸替那帕诺相关的新闻（医药）

2026-04-02

·复星医药

创新引领！复星医药荣登2026全球药企研发管线规模TOP 20

近日，全球知名咨询机构Citeline发布《2026年医药研发年度回顾》白皮书（Pharma R&D Annual Review 2026），评选出全球管线规模排名前25的制药公司。根据本年度最新的统计方法，复星医药成功入选该榜单，位列第20位。为了更精准的展现全球药企的活跃管线数量，今年开始，排名统计将采用全新的统计方法，着重展现企业当前仍在推进的活跃管线数量，以此真实反映企业的研发活跃度与未来发展潜力。复星医药入选该国际权威榜单，标志着公司创新研发实力与管线质量获得国际专业认可。深耕核心治疗领域，构建差异化临床管线作为一家创新驱动的全球化医药健康产业集团，复星医药已形成开放式、全球化的创新研发体系，围绕未满足临床需求，深度布局肿瘤、免疫炎症、神经退行性疾病等核心治疗领域，积极拓展慢病及罕见病等领域，打造具有长期竞争力的产品管线与综合解決方案。同时，复星医药持续夯实抗体/ADC、小分子、细胞治疗等核心技术平台，拓展核药、小核酸等前沿技术，强化早期创新能力，加速科研成果转化。 2025年，复星医药全年研发总投入共计59.13亿元，同比增长6.46%，其中，创新药品相关研发投入达43.03亿元、同比增长15.98%，占制药业务研发投入的80.26%。2025年复星医药共有7个创新药品共16项适应症于境内外获批上市，6个创新药品种的上市申请获受理，近40项创新药临床试验获中美欧批准，多个核心产品进入关键临床阶段，为后续商业化增长奠定了坚实的管线基础。在肿瘤领域，自研小分子创新药复迈宁（芦沃美替尼片）双适应症国内获批，填补国内罕见肿瘤治疗空白；CDK4/6抑制剂复妥宁（枸橼酸伏维西利胶囊）2项适应症上市，为乳腺癌患者带来全新治疗选择。抗PD-1单抗斯鲁利单抗注射液在欧洲及多个新兴市场获批，成为全球首个在欧盟获批用于一线治疗广泛期小细胞肺癌的抗PD-1单抗，截至2025年末，斯鲁利单抗注射液累计已在全球超过40个国家和地区获批上市，联合化疗一线治疗ES-SCLC的美国桥接试验已完成患者入组，计划2026年向FDA递交相应生物制品许可申请（BLA）。HLX43、HLX22等抗体/ADC药物已进入关键临床阶段，第二款CAR-T产品布瑞基奥仑赛的上市申请也已获受理。2026年3月31日，复星医药宣布与梯瓦合作开发的肿瘤免疫治疗创新疗法FXB0871在中国获批开展I期临床，将加速这一全球前沿创新疗法落地中国，让患者尽早受益于全球领先的创新疗法。在免疫炎症与慢病领域，许可引进的First-in-Class创新药万缇乐（盐酸替那帕诺片）获批上市，为中国慢性肾脏病透析患者提供全新治疗方案；FXS7553等核心产品临床进展稳步推进。在神经退行性疾病领域，帕金森病治疗药物奥吡卡朋胶囊通过“先行先试”政策在海南博鳌落地；甘露特钠胶囊纳入阿尔茨海默病创新药管线，并推进上市后确证性临床试验；许可引进的AR1001已进入全球多中心III期临床。此外，复星医药前瞻性布局核药、小核酸等前沿赛道，核药项目SRT-007顺利启动I期临床试验，初步建立“影像诊断 - 靶向治疗”的诊疗一体化研发路径；细胞治疗领域自体双靶点CAR-T产品FKC289临床试验申请获国家药监局受理，为后续创新产品储备持续赋能。展望未来，复星医药将继续以患者为中心，围绕未被满足的临床需求，持续加大创新投入，高效推进全球领先技术和创新产品的研发与转化落地。同时，以全球视野整合创新资源，以数字智能驱动运营升级，致力于成为全球领先的医疗创新整合者，为全球患者提供更多优质、可及的医疗健康解决方案。联系方式媒体：pr@fosunpharma.com 投资人：ir@fosunpharma.com

抗体药物偶联物免疫疗法细胞疗法上市批准

2026-04-01

·GlobeNewswire-Health Care

Rajani Dinavahi, MD, Appointed Chief Medical Officer of Ardelyx

WALTHAM, Mass., April 01, 2026 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs, today announced the appointment of Rajani Dinavahi, MD, as Chief Medical Officer (CMO). Dr. Dinavahi brings more than two decades of experience in healthcare and biotechnology, spanning multiple therapeutic areas and modalities. She has extensive experience across immuno-oncology, autoimmune diseases, metabolic disease, nephrology and transplantation, with a track record of advancing programs from early development through Phase 3 and regulatory approval. Dr. Dinavahi most recently served as Senior Vice President, Chief Medical Officer at Atara Biotherapeutics. “I am delighted to welcome Rajani as our new Chief Medical Officer. She brings a rare combination of scientific rigor, clinical expertise and proven leadership in advancing innovative therapies from development to patients,” said Mike Raab, president and chief executive officer of Ardelyx. “As we enter an important phase of growth and execution, Rajani’s experience and vision will be instrumental in strengthening our pipeline, deepening our medical capabilities, and ensuring we continue to deliver meaningful outcomes for patients. I look forward to partnering closely with her as we build on our momentum and shape the next chapter of our company.” “I am thrilled to join Ardelyx at such a pivotal time in its evolution,” said Dr. Dinavahi. “The company’s commitment to advancing innovative therapies and its focus on patients strongly align with my own values and experience. I’ve been deeply impressed by the strength of the science, the dedication of the team and the opportunity to meaningfully impact patients’ lives. I look forward to working alongside this talented organization to advance the pipeline, build on the company’s momentum and help deliver important new medicines to patients who need them.” As Chief Medical Officer at Atara Biotherapeutics, Dr. Dinavahi’s responsibilities spanned leading pre-clinical and translational sciences through global development and medical affairs of their lead T-cell directed therapy asset and allo-CART program. Prior to becoming CMO, Dr. Dinavahi held senior leadership positions at Atara across clinical sciences, program team leadership and medical affairs, where she built and led global teams to deliver on the first allogeneic T-cell therapy to be approved and launched globally. Earlier, she spent seven years at Amgen, contributing to multiple global development programs and regulatory filings for products approved across the U.S., Europe and Japan. Dr. Dinavahi began her career in academic medicine as an Assistant Professor of Medicine (Nephrology) at Mount Sinai School of Medicine and a principal investigator in transplant research. She is board-certified in Internal Medicine and Nephrology, a Fellow of the American Society of Nephrology, and has authored numerous scientific publications and presentations. She earned a Bachelor of Science and Doctor of Medicine from the University of Miami and completed her Internal Medicine residency and Nephrology fellowship training at Thomas Jefferson University Hospital, followed by a clinical transplant and post-doctoral fellowship focusing on translational immunology at Mount Sinai Hospital in New York City. About ArdelyxArdelyx is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative 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 tenapanor for chronic idiopathic constipation, 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. Investor Contact:Lisa Caperellilcaperelli@ardelyx.com

高管变更上市批准临床3期免疫疗法细胞疗法

2026-03-30

·雪球

创新药+出海：10家核心企业解析

前言：从“仿制药大国”到“创新药强国”，中国生物医药产业的转型之路，正伴随着“出海”的浪潮加速前行。曾经，中国药企的海外布局多停留在仿制药出口的初级阶段，而如今，越来越多具备核心研发实力的企业，带着自主创新的原研药、突破性技术，叩开了全球市场的大门，从“产品出海”迈向“技术出海”“品牌出海”的高阶阶段。在这条充满机遇与挑战的赛道上，有这样10家企业，它们深耕创新药研发，布局全球化布局，凭借差异化的管线优势、硬核的技术突破和灵活的海外合作模式，成为中国创新药出海的“主力军”。它们中，有龙头引领、全面开花的标杆企业，有聚焦特色、实现技术突围的黑马企业，也有深耕细分、加速追赶的潜力企业。今天，我们就一起来深度拆解这10家企业，看看它们如何以创新为帆、以出海为桨，书写中国生物医药的全球化篇章。当前，创新药出海已成为中国生物医药产业高质量发展的核心赛道，一批具备核心研发实力、全球化布局能力的企业脱颖而出。以下10家公司深度布局创新药研发与海外市场拓展，凭借差异化管线、核心技术突破及海外合作优势，成为“创新药+出海”赛道的核心参与者，具体解析如下：一、核心出海标杆企业（研发与商业化双领先）1.恒瑞医药作为国内创新药龙头，恒瑞医药以持续高额研发投入为根基，累计研发投入已超500亿元，2025年前三季度研发费用达49.45亿元，已在中国获批上市24款1类创新药和5款2类新药，同时拥有100多个自主创新产品在临床开发、400余项国内外临床试验正在推进。国际化进程全面提速，海外BD合作成果丰硕，2025年三季度达成3项海外BD授权，包括与GSK合作共同开发至多12款创新药物，潜在总金额约120亿美元，同时有5款创新药获得FDA孤儿药资格认定，多款研究成果亮相ESMO等国际顶尖学术会议，进一步扩大全球影响力，中高层中拥有海外或跨国药企经验者占比超30%，为全球化布局提供坚实支撑。2.百济神州聚焦肿瘤领域的全球化创新药企，自创立以来坚持国际化发展理念，已在六大洲组建超11000人团队，在美国纳斯达克、香港联交所和上交所科创板三地上市。拥有超过1100名科研人员，构建了覆盖血液肿瘤、实体肿瘤、免疫治疗和炎症三大领域的丰富管线，80%的商业化产品和在研管线覆盖全球80%的癌症种类。核心产品百悦泽（泽布替尼）已在70多个市场获批，全球超180000例患者接受治疗；百泽安（替雷利珠单抗）已在45个国际市场获批，全球超130万患者接受治疗。同时布局全球生产基地，在美国新泽西州、中国苏州和广州建有生产基地，符合FDA、NMPA、EMA的GMP标准，实现“研发-生产-商业化”全链条全球化覆盖。3.复星医药以创新研发与全球化为双引擎，2025年境外收入达129.77亿元，同比增长14.87%，创新药品收入98.93亿元，同比增长29.59%。持续深化创新药布局，2026年3月自研创新药FXS0683获批临床，聚焦血液系统恶性肿瘤领域，同时引进全球首个且唯一获批的磷吸收抑制剂万缇乐®（盐酸替那帕诺片）并实现商业上市。通过产学研融合强化创新实力，与中国药科大学签署战略合作协议，同时依托全球化布局，推动创新药在海外市场的落地，形成“自研+引进”双轮驱动、国内外协同发展的出海格局，海外市场影响力持续提升。二、技术突破型出海企业（聚焦特色管线与核心技术）4.百利天恒以双抗ADC为核心技术优势，创新实力获得国际巨头认可，2023年12月与百时美施贵宝（BMS）达成总额高达84亿美元的合作协议，授予BMS其核心产品BL-B01D1在中国以外地区的开发和商业化权利，刷新国产ADC药物出海授权纪录，该药物也成为首款成功出海的国产双抗ADC新药。目前BMS已在美国启动该药物一线晚期三阴性乳腺癌的II/III期临床试验及多项早期研究，公司在美国西雅图和中国成都布局研发中心，协同推进全球多中心临床试验，秉持“扎根中国、走向全球”的战略，致力于成为肿瘤用药领域具有全球领先优势的跨国药企。5.荣昌生物聚焦创新生物药研发，以双抗、ADC等核心技术为支撑，2026年1月与全球制药巨头艾伯维签署RC148的独家授权许可协议，艾伯维获得该药物大中华区以外地区的开发、生产和商业化独家权利，交易涉及6.5亿美元首付款及最高49.5亿美元的里程碑付款，彰显其研发实力获得国际顶级药企认可。RC148是自主研发的PD-1/VEGF双特异性抗体，临床数据表现优异，在ESMO-IO大会上公布的单药一线治疗非小细胞肺癌客观缓解率达61.9%，已获得中国突破性治疗药物资格认定及FDAII期临床批准，依托自主Hibody双功能抗体平台，持续推进创新药全球化布局，同时保留大中华区权益，兼顾本土与海外市场发展。6.科伦药业依托“三发驱动、创新增长”战略，在创新药领域重点布局肿瘤、自身免疫等重大疾病领域，旗下科伦博泰搭建了享誉国际的ADC研发平台，2022年与默沙东达成总金额超100亿美元的授权合作，奠定国内创新药研发第一方阵地位。核心产品佳泰莱®（TROP2ADC）、科泰莱®（全球首款鼻咽癌PD-L1单抗）陆续获批上市，多个创新药项目处于临床阶段，其中多个为全球多中心研究，与欧美合作伙伴携手布局全球临床，同时主导产品已批量出口至50多个国家和地区，在输液领域拥有全球影响力，形成“仿制药出海打底、创新药出海突破”的全球化格局。三、潜力成长型出海企业（聚焦细分赛道，加速海外突破）7.诺诚健华聚焦肿瘤与自身免疫性疾病领域，核心产品奥布替尼是全球首个进入Ⅲ期临床的中枢神经系统强渗透性BTK抑制剂，已在中国获批四个血液瘤适应症，其中三个纳入医保。2025年10月与美国ZenasBioPharma达成潜在总金额超20亿美元的全球授权合作，聚焦奥布替尼在多发性硬化症（MS）领域的开发及其他自身免疫性疾病管线，Zenas获得相关领域全球或区域独家权利，奥布替尼针对原发进展型多发性硬化症的全球Ⅲ期试验已启动，同时公司持续布局自身免疫性疾病领域全球前沿靶点，推动创新药出海实现重大突破。8.三生国健国内首批专注于抗体药物的创新药企，拥有研产销一体化成熟平台，2025年5月与辉瑞达成关于PD-1/VEGF双抗SSGJ-707的授权协议，辉瑞获得该药物全球（不包括中国内地）的独家开发、生产、商业化权利，交易涉及12.5亿美元首付款及最高48亿美元的里程碑付款。SSGJ-707基于CLF2专利平台开发，II期临床数据优异，已获得中国突破性治疗药物认定及FDAIND批准，目前多项适应症处于临床II、III期阶段，此次合作标志着公司双抗研发平台获得国际认可，加速推动创新药全球化落地。9.艾力斯专注于肿瘤治疗领域的创新型制药企业，2020年在科创板上市，核心布局KRASG12C等关键靶点。2024年8月与加科思药业签订许可协议，获得KRASG12C靶向药物戈来雷塞及SHP2抑制剂在中国地区的独家开发和商业化权利，戈来雷塞已在中国、美国及欧洲多国启动多项晚期实体瘤临床试验，其胰腺癌适应症在美国和欧洲获得孤儿药认定，在中国被纳入突破性治疗药物认定程序。公司组建专业化营销团队，同时积极推动核心产品的全球化临床布局，逐步实现创新药出海突破，聚焦肿瘤领域打造具有全球竞争力的产品管线。10.百奥泰全球性生物制药企业，聚焦创新药与生物类似药研发，产品覆盖肿瘤、自身免疫性疾病等领域，多款药物实现中美欧等多地获批上市，其中托珠单抗成为首个由中国药企研发、生产且获得美国FDA批准上市的单克隆抗体药物。2025年以来，核心产品乌司奴单抗相继获得美国FDA、欧盟委员会、英国MHRA上市批准，公司与吉瑞医药签署协议，授权其在欧盟、英国等市场的商业化，同时推动多款候选药物进入后期临床试验，聚焦PD-1后时代肿瘤免疫治疗和ADC靶向药物开发，持续拓展全球生物类似药与创新药业务布局，海外市场覆盖持续扩大。总结：创新为核，出海为翼，中国药企的全球化未来可期回望中国创新药出海的历程，从早期的艰难探索，到如今的多点开花，这10家企业的成长与突破，正是中国生物医药产业崛起的缩影。它们或许所处赛道不同、发展阶段各异，但都有一个共同的特质——以创新为根本，以全球化为目标，在核心技术上持续深耕，在海外布局上稳步推进。恒瑞、百济神州、复星医药等标杆企业，凭借全链条布局和强大的商业化能力，引领中国创新药出海走向成熟；百利天恒、荣昌生物、科伦药业等技术型企业，以双抗、ADC等特色技术为突破口，实现了国产创新药的高端出海；诺诚健华、三生国健等潜力企业，聚焦细分赛道，凭借差异化管线逐步打开全球市场。当然，创新药出海之路从来不是一帆风顺的，面临着海外临床试验壁垒、市场竞争加剧、合规要求严苛等诸多挑战。但我们可以看到，中国药企正以更成熟的姿态、更硬核的实力，应对这些挑战——从自主研发到海外合作，从产品输出到技术授权，中国创新药的全球话语权正在逐步提升。未来，随着研发投入的持续加大、核心技术的不断突破，相信这10家企业，以及更多中国创新药企，将继续扛起“创新+出海”的大旗，推动更多国产原研药走向全球，让中国生物医药产业真正实现从“跟跑”向“并跑”“领跑”的跨越，为全球患者带来更多中国方案、中国力量。

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

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
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

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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临床结果

适应症

分期

评价

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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


NCT01923428 \| NCT02621892 \| NCT02686138 (T3MPO-2, Pubmed \| Ther Adv Gastroenterol)	临床2期	便秘型肠易激综合征	1,372	Tenapanor 50 mg	鬱廠範襯遞鹽醖壓選鹽(憲憲網窪築餘鏇夢壓鹹) = 觸蓋願積構齋憲糧窪衊範獵艱獵顧糧願夢糧憲 (襯積構淵壓鏇鹽窪夢築 )	积极	2026-01-01
				Placebo	鬱廠範襯遞鹽醖壓選鹽(憲憲網窪築餘鏇夢壓鹹) = 糧襯範簾繭襯範壓艱蓋範獵艱獵顧糧願夢糧憲 (襯積構淵壓鏇鹽窪夢築 )
NCT02675998 (BLOCK, ASN2025)	临床3期	终末期肾脏病 \| 便秘	84	Tenapanor 3 mg	餘憲艱醖鹽構淵齋繭淵(衊憲鑰憲齋積鏇糧淵觸) = 遞選鹹鹽繭壓艱鏇積繭鬱鏇鬱憲繭壓窪鑰壓淵 (鹹鏇壓齋淵廠製鬱築遞 ) 更多	积极	2025-11-06
				Tenapanor 10 mg	鏇壓鹽鑰艱襯網範窪衊(鹹繭範壓艱選願糧築淵) = 鬱簾蓋網獵鹽淵夢選餘顧觸繭簾製餘鏇範繭範 (鬱壓繭製廠壓觸遞選顧 ) 更多
ASN2025	N/A	高磷血症	13	Tenapanor	選糧鹽蓋顧膚鹽鑰繭醖(憲顧襯餘範醖製願積鬱) = Diarrhea or loose stools occurred in 7 patients, and 4 required dose reductions. 齋鬱構網憲繭觸鬱蓋鬱 (願齋淵遞糧獵簾齋淵衊 )	不佳	2025-11-06
NCT03824587 (AMPLIFY, ASN2024)	临床2/3期	慢性肾病	308	Tenapanor + Sevelamer-based PB	簾鬱膚鬱簾壓鏇蓋築顧(顧簾範範範壓鹽衊膚築) = 鹽繭壓醖鏇觸獵鏇衊齋製觸鹽鹽顧顧廠糧淵築 (繭艱獵衊獵網齋簾艱範 ) 更多	积极	2024-10-24
				Tenapanor + Non-Sevelamer based PB	簾鬱膚鬱簾壓鏇蓋築顧(顧簾範範範壓鹽衊膚築) = 範鏇顧顧鹽艱鬱衊遞壓製觸鹽鹽顧顧廠糧淵築 (繭艱獵衊獵網齋簾艱範 ) 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	淵願淵壓鏇艱鏇憲蓋遞(衊齋淵範顧鹽繭齋繭簾) = 窪積願網夢艱衊選襯膚憲網繭齋鹽遞淵鹽製憲 (願鬱鹹壓淵壓鹽艱選鏇 ) 更多	积极	2024-02-07
				reduce PB dosage by ≥50% and add tenapanor (Binder Reduction)	淵願淵壓鏇艱鏇憲蓋遞(衊齋淵範顧鹽繭齋繭簾) = 齋艱繭窪壓襯構選積艱憲網繭齋鹽遞淵鹽製憲 (願鬱鹹壓淵壓鹽艱選鏇 ) 更多
NCT03427125 (PHREEDOM, ASN2023)	临床3期	高磷血症	556	Tenapanor 30 mg bid	簾醖鏇憲醖蓋鹹選齋憲(製壓繭顧範觸繭願簾膚) = 繭鑰選鹽願網蓋鹹夢遞獵繭鑰艱鹽醖獵壓壓築 (製衊壓鹽餘築鹹蓋淵憲 ) 更多	积极	2023-11-02
				Sevelamer Carbonate	簾醖鏇憲醖蓋鹹選齋憲(製壓繭顧範觸繭願簾膚) = 鏇鑰製廠艱廠糧顧鹹簾獵繭鑰艱鹽醖獵壓壓築 (製衊壓鹽餘築鹹蓋淵憲 ) 更多
ASN2023	临床3期	高磷血症	212	Tenapanor 5 mg BID	積齋膚選鹽膚襯觸觸艱(襯積襯餘蓋蓋襯鹹觸築) = 簾夢製獵製獵鑰製繭憲鬱範淵憲膚蓋選範積壓 (積簾餘網蓋積願憲齋鏇 ) 更多	积极	2023-11-02
ASN2023	临床3期	高磷血症	54	Tenapanor	蓋膚糧廠鏇構壓製選鹹(齋窪願憲餘遞艱鬱糧蓋) = diarrhea (74.1%, 40/54). All were mild or moderate in severity and only three subjects (5.6%) discontinued due to diarrhea 衊廠齋獵築餘網鑰顧鏇 (壓獵簾繭鹽夢齋壓範願 )	积极	2023-11-02
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	鹹齋膚範餘糧膚鹹糧壓(衊淵網齋簾願鹽鹹醖膚) = 艱鏇鹽網窪鬱壓夢壓餘鹽鬱鹽繭糧鹹遞選顧艱 (簾艱積鏇範膚範範繭鏇 ) 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	餘襯範廠夢艱鏇糧積觸(鹽積蓋壓網糧範鹽顧膚) = 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%) 鏇壓鏇顧鹹獵淵鬱網觸 (簾鬱夢鏇顧顧構憲艱糧 )	积极	2023-11-01