普卡那肽(Plecanatide) - 药物靶点：GC-C_在研适应症：肠易激综合征，便秘型肠易激综合征，慢性特发性便秘_专利_临床

概要

基本信息

药物类型

合成多肽

别名

GCRA、Guanilib、Plecanatide (USAN/INN)

+ [3]

靶点

GC-C

作用机制

GC-C激动剂(热稳定肠毒素受体激动剂)

治疗领域

消化系统疾病其他疾病

在研适应症

肠易激综合征便秘型肠易激综合征慢性特发性便秘+ [1]

非在研适应症-

原研机构

Synergy Pharmaceuticals LLC

在研机构

Cipher Pharmaceuticals, Inc.

Salix Pharmaceuticals, Inc.

Bausch Health Cos., Inc.

+ [1]

非在研机构

Bausch Health Americas, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2017-01-19),

慢性特发性便秘

最高研发阶段(中国)临床3期

特殊审评-

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结构

分子式C65H104N18O26S4

InChIKeyNSPHQWLKCGGCQR-DLJDZFDSSA-N

CAS号467426-54-6

序列信息

Sequence Code 145041

来源: *****

关联

16

项与普卡那肽相关的临床试验

NCT05107219 / Recruiting临床1期IIT

Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of Volunteers

This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.

开始日期2022-11-30

申办/合作机构

National Cancer Institute

NCT05151328 / Completed临床3期

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation in Chinese Patients for up to 12 Weeks

This is a multi-center, randomized, double-blind, Placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Plecanatide in the treatment of Functional Constipation in Chinese patients for up to 12 weeks.
Patients will enter a Screening period which must undergo a 2-week Pre-Treatment assessment, they will complete daily assessments of electronic dairy to demonstrate the eligibility.
Eligible subjects will be randomized into Plecanatide 3 mg group or Placebo group at Visit 1 at the ratio of 1:1 and take an oral dose of study treatment continuously for 12 weeks. For 2 weeks after complete dosing patients will continue to complete daily electronic dairy. Patients will then return to the clinical site for efficacy and safety assessment as part of an End of Study visit. The planned duration of participation in this study will be 154 days and up to 164 days with all windows considered.

开始日期2022-03-18

申办/合作机构

山东罗欣药业集团股份有限公司

CTRI/2022/03/040704 / Completed临床3期

A Randomized, Double-Blind, Multicentric, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Plecanatide in Subjects with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation.

开始日期2022-03-05

申办/合作机构

MSN Laboratories Pvt Ltd.

100 项与普卡那肽相关的临床结果

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100 项与普卡那肽相关的转化医学

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100 项与普卡那肽相关的专利（医药）

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90

项与普卡那肽相关的文献（医药）

2024-10-01·Journal of Managed Care & Specialty Pharmacy

A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States

Article

作者: Terasawa, Emi ; Du, Shawn ; Terreri, Brian ; Lu, Mei ; Moshiree, Baharak ; Boules, Mena ; Cash, Brooks D. ; Feuerstadt, Paul ; Ayyagari, Rajeev ; Nguyen, Linda ; Westermeyer, Ben ; Lembo, Anthony ; Pi, Selina

BACKGROUNDAt present, 4 prescription therapies have been approved by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults.OBJECTIVESTo compare persistence with and adherence to prucalopride vs 3 other prescription medications for CIC in a US population.METHODSThis retrospective, observational cohort study used data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (January 2015-June 2020). Inclusion criteria were patients (aged ≥18 years) with at least 1 prescription fill for prucalopride, lubiprostone, linaclotide, or plecanatide on or after April 2, 2019 (commercial availability of prucalopride), and at least 1 constipation-related diagnosis code. Persistence was assessed by time to discontinuation, and adherence was assessed by the proportion of days covered (PDC) and the proportion of patients who achieved PDC of at least 80%. Adjusted hazard ratios (HRs) for discontinuation and odds ratios for adherence were calculated.RESULTSA total of 14,700 patients (mean age = 48.3 years; female = 81.9%) were included (prucalopride, n = 675; lubiprostone, n = 1,591; linaclotide, n = 11,105; plecanatide, n = 1,329). After adjusting for confounding factors, the HRs for discontinuation were significantly higher for all comparator medications compared with prucalopride after 2 months (HR [95% CI]: lubiprostone, 1.70 [1.48-1.95]; linaclotide, 1.25 [1.10-1.41]; plecanatide, 1.31 [1.13-1.51], all P < 0.001). The unadjusted mean (SD) PDC was 0.53 (0.32) with prucalopride compared with 0.41 (0.31); P less than 0.001 with lubiprostone, 0.48 (0.31), P less than 0.05 with linaclotide, and 0.48 (0.29), P = 0.98 with plecanatide. The comparator medications were all associated with lower odds of achieving PDC of at least 80% relative to prucalopride (odds ratio [95% CI]: lubiprostone, 0.52 [0.40-0.69], P < 0.001; linaclotide, 0.73 [0.58-0.93], P = 0.009; plecanatide, 0.70 [0.53-0.93], P = 0.015).CONCLUSIONSThe findings of this study indicate that prucalopride has higher treatment persistence and adherence compared with other CIC prescription medications. This research represents the first instance of a real-world claims study showcasing such outcomes.

2024-06-01·Heliyon

Greater cane rat algorithm (GCRA): A nature-inspired metaheuristic for optimization problems

Article

作者: Mirjalili, Seyedali ; Pal, Jayanta ; Abualigah, Laith ; Ezugwu, Absalom E ; Saha, Apu K ; Agushaka, Jeffrey O

This paper introduces a new metaheuristic technique known as the Greater Cane Rat Algorithm (GCRA) for addressing optimization problems. The optimization process of GCRA is inspired by the intelligent foraging behaviors of greater cane rats during and off mating season. Being highly nocturnal, they are intelligible enough to leave trails as they forage through reeds and grass. Such trails would subsequently lead to food and water sources and shelter. The exploration phase is achieved when they leave the different shelters scattered around their territory to forage and leave trails. It is presumed that the alpha male maintains knowledge about these routes, and as a result, other rats modify their location according to this information. Also, the males are aware of the breeding season and separate themselves from the group. The assumption is that once the group is separated during this season, the foraging activities are concentrated within areas of abundant food sources, which aids the exploitation. Hence, the smart foraging paths and behaviors during the mating season are mathematically represented to realize the design of the GCR algorithm and carry out the optimization tasks. The performance of GCRA is tested using twenty-two classical benchmark functions, ten CEC 2020 complex functions, and the CEC 2011 real-world continuous benchmark problems. To further test the performance of the proposed algorithm, six classic problems in the engineering domain were used. Furthermore, a thorough analysis of computational and convergence results is presented to shed light on the efficacy and stability levels of GCRA. The statistical significance of the results is compared with ten state-of-the-art algorithms using Friedman's and Wilcoxon's signed rank tests. These findings show that GCRA produced optimal or nearly optimal solutions and evaded the trap of local minima, distinguishing it from the rival optimization algorithms employed to tackle similar problems. The GCRA optimizer source code is publicly available at: https://www.mathworks.com/matlabcentral/fileexchange/165241-greater-cane-rat-algorithm-gcra.

2024-05-23·Expert Opinion on Pharmacotherapy

Current and future pharmacotherapies for the management of constipation-predominant irritable bowel syndrome

Review

作者: Fichna, Jakub ; Tarasiuk, Aleksandra ; Jacenik, Damian ; Biniszewska, Olga

INTRODUCTIONIrritable bowel syndrome (IBS) is a common gastrointestinal disorder affecting 9-23% of the world's population, with a higher prevalence among women. IBS is a complex disorder influenced by psychosocial, physiological, and genetic factors, exacerbated by stress.AREAS COVEREDResearch confirms that the most common subtype of IBS is IBS-C. Therefore, new therapies are being developed to speed up bowel movement and reduce constipation, with drugs such as linaclotide, plecanatide, lubiprostone, or tegaserod available to reduce IBS-C symptoms. In addition, patients' condition is improved by foods rich in fiber and low in FODMAP and the use of biotics.EXPERT OPINIONThe topic is of great importance due to the growing number of patients suffering from IBS-C and its significant impact on quality of life. Current clinical trials of new therapeutic options are not too successful, and it seems that one of the plausible treatment options could be the multi-drug cocktail with some, or perhaps even all its ingredients emerging from drug re-purposing. Another important path that needs to be explored further in IBS-C patients is the adjustment of dietary habits and/or introduction of dietary or nutritional intervention.

29

项与普卡那肽相关的新闻（医药）

2024-07-03

·罗欣药业

重磅！罗欣药业注射用LX22001获批开展临床试验

近日，罗欣药业（002793.SZ）下属子公司山东罗欣药业集团股份有限公司、罗欣药业（上海）有限公司收到国家药品监督管理局下发的注射用LX22001的《药物临床试验批准通知书》。注射用LX22001是罗欣药业创新药替戈拉生的注射剂型，是钾离子竞争性酸阻滞剂类药物（P-CAB），目前在全球范围内尚无产品上市。此次获准临床的注射用LX22001开发适应症为：（1）本品可作为当口服疗法不适用时，用于下列病症的替代疗法：反流性食管炎、十二指肠溃疡；（2）消化性溃疡出血。作为全新机制的P-CAB相比于传统质子泵抑制剂（PPI），具有更快速起效、更强效持久抑酸、服用更方便等特点，首剂即可达到更大抑酸效果，有效抑制夜间酸突破等优势[1][2]。目前，最新的中国消化领域疾病指南已将P-CAB口服剂型作为反流性食管炎的首选药物之一[3]。注射剂型的临床应用场景与口服剂型存在差异，更多应用于手术、住院等。随着P-CAB被越来越多的专家、患者认可，未来有望成为主流抑酸药物逐渐替代PPIs。近年来，罗欣药业加速创新转型，坚持“自主研发+合作研发”双轨并进，聚焦优势领域，逐步打造了以消化、呼吸系统疾病为主线、兼顾抗肿瘤等治疗领域的创新产品研发管线，多个创新产品为临床用药带来新选择。 2022年4月，公司首款1类新药替戈拉生片“反流性食管炎”适应症获批上市,已被纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2022年）》。 2023年11月，替戈拉生片新增“十二指肠溃疡”适应症获批上市。 2023年12月，替戈拉生片新适应症“与适当的抗菌疗法联用根除幽门螺杆菌”上市申请获得国家药品监督管理局受理，该适应症的临床数据根除率优效于对照组艾司奥美拉唑，为该适应症首个根除率超90%的P-CAB。 2024年5月，替戈拉生片新适应症“与适当的抗菌疗法联用根除幽门螺杆菌”III期临床研究入选2024年美国消化疾病周（DDW）口头报告[4]。 2024年1月，公司消化领域布局的另一款新药普卡那肽片的Ⅲ期临床试验已完成，达成主要疗效终点，有望成为国内首个治疗慢性特发性便秘的鸟苷酸环化酶激动剂。 2024年6月，罗欣药业与国际领先的AI+BT微生态研发企业深圳未知君就肠道菌群移植技术（FMT）在合作区域内合作范围的独家代理经销合作达成一致意见。深耕医药行业36年，罗欣药业将持续秉持“传递健康”理念，深入实施科技创新，关注未被满足的临床需求，持续推进高质量创新药品研发成果落地，为全球患者提供更多创新药物选择。参考文献： [1].Hunt RH, et al. Curr Treat Options Gastroenterol.2018 Dec;16(4):570-590. [2].Kim JS, Seo SI, Kang SH, Lee SK, Kim AR, Park HW, Kim BT, Song GS. Effects of Tegoprazan Versus Esomeprazole on Nighttime Heartburn and Sleep Quality in Gastroesophageal Reflux Disease: A Multicenter Double-blind Randomized Controlled Trial. J Neurogastroenterol Motil. 2023 Jan 30;29(1):58-64. [3]. 中华医学会消化病学分会.2020年中国胃食管反流病专家共识[J].中华消化杂志, 2020, 40(10):649-663. [4].Liya Zhou, Zhiqiang Song. A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PHASE III CLINICAL STUDY EVALUATING THE EFFICACY AND SAFETY OF BISMUTH QUADRUPLE THERAPY CONTAINING TEGOPRAZAN COMPARED TO ESOMEPRAZOLE IN ERADICATING HELICOBACTER PYLORI IN CHINA. Presentation Number: 6562. 内容来源于网络，如有侵权，请联系删除。

临床3期申请上市

2024-07-01

·E药经理人

罗欣药业：收到《药物临床试验批准通知书》P-CAB注射剂即将启动临床

近日，罗欣药业（002793.SZ）公告，其下属子公司山东罗欣药业集团股份有限公司、罗欣药业（上海）有限公司收到国家药品监督管理局下发的注射用LX22001的《药物临床试验批准通知书》。注射用LX22001即公司创新药替戈拉生的注射剂型，是钾离子竞争性酸阻滞剂类药物（P-CAB），目前在全球范围内尚无产品上市。罗欣药业表示，本次注射用LX22001临床试验获得批准，体现了公司在巩固核心领域优势的基础上持续发力，彰显了公司科技创新能力，有助于丰富产品管线，提升公司创新药优势领域核心竞争力。记者查阅相关资料了解到，作为全新机制的P-CAB相比于传统质子泵抑制剂（PPI），具有更快速起效、更强效持久抑酸、服用更方便等特点，首剂即可达到更大抑酸效果，有效抑制夜间酸突破等优势[1][2]。目前，最新的中国消化领域疾病指南已将P-CAB口服剂型作为反流性食管炎的首选药物之一[3]。此次获准临床的注射用LX22001开发适应症为：（1）本品可作为当口服疗法不适用时，用于下列病症的替代疗法：反流性食管炎、十二指肠溃疡；（2）消化性溃疡出血。注射剂型的临床应用场景与口服剂型存在差异，更多应用于手术、住院等。2023年中国抑酸市场 Value IQVIA数据显示注射剂+口服剂市场在经历国家集采、重点监控目录及医保PPI针剂加限等政策调控后仍有超200亿市场规模，其中注射剂占55%的市场份额。罗欣药业作为上一代PPI注射剂的销售王者，布局P-CAB注射剂型将有利于巩固其消化领域市场地位，为消化类产品业绩提升带来更大想象空间。随着P-CAB被越来越多的专家、患者认可，未来有望成为主流抑酸药物逐渐替代PPIs。近年来，罗欣药业持续深化创新转型聚焦医药工业提升消化领域核心优势，已取得多项突破。2022年4月，公司首款1类新药替戈拉生片“反流性食管炎”适应症获批上市。2023年11月，替戈拉生片新增“十二指肠溃疡”适应症获批上市。2023年12月，替戈拉生片新适应症“与适当的抗菌疗法联用根除幽门螺杆菌”上市申请获得国家药品监督管理局受理，该适应症的临床数据根除率优效于对照组艾司奥美拉唑，为该适应症首个根除率超90%的P-CAB，2024年5月，该适应症III期临床研究入选2024年美国消化疾病周（DDW）口头报告[4]。 2024年1月，公司消化领域布局的另一款新药普卡那肽片的Ⅲ期临床试验已完成，达成主要疗效终点，有望成为国内首个治疗慢性特发性便秘的鸟苷酸环化酶激动剂。中国受便秘困扰的成人达到9870万人~2.86亿人。随着生活节奏加快、饮食结构改变、人口老龄化及社会心理因素的影响，便秘患病率呈上升趋势。IQVIA数据显示同类促泌剂产品2023年美国销售金额超28亿美金。值得一提的是，罗欣药业还积极拓展消化领域产品布局，今年达成合作的创新医疗技术有望为公司贡献新的业绩增量。2024年6月，罗欣药业与国际领先的AI+BT微生态研发企业深圳未知君就肠道菌群移植技术（FMT）在合作区域内合作范围的独家代理经销合作达成一致意见。根据协议约定公司采购该项目业绩指标第一年为1500万元，第三年为5000万元，第五年即达到2亿元，复合增长率91.09%。作为一种新兴的治疗方法，FMT受到了国内外的广泛关注。越来越多的证据表明FMT可用于治疗多种菌群失调相关性疾病，且应用安全、范围广泛、潜力巨大。国际登记在册的FMT临床试验达489个，在治疗艰难梭菌感染（CDI）方面FMT已表现出显著效果，此外，FMT在治疗自闭症、炎症性肠病（IBD）、肠易激综合征（IBS）、代谢性疾病、自身免疫疾病等方面也具有较大潜力。国内对FMT的政策支持及专家共识也在不断提升。2022年《肠道菌群移植临床应用管理中国专家共识》发布，2023年9月，FMT肠道菌群移植正式被纳入卫健委、中医药局、疾控局三部门联合印发的《全国医疗服务项目技术规范(2023年版)》，风险等级为10低于胃镜检查29.7的风险等级，安全性极佳。截至目前，已有18个省份拥有该技术医疗收费条码，商业化可及性提升。某业内人士在接受记者采访时表示，罗欣药业作为消化道领域龙头在商业化方面极具优势，加上深圳未知君在FMT领域研发的领先地位，二者合作可谓强强联合，作为各自领域引领者共同挖掘国内蓝海市场。罗欣药业近年来不断布局丰富其消化领域创新产品组合，结合其商业化优势及已获批产品的临床研究经验创新升级，不断巩固其消化领域领先地位。参考文献： [1]. Hunt RH, et al. Curr Treat Options Gastroenterol.2018 Dec;16(4):570-590. [2]. Kim JS, Seo SI, Kang SH, Lee SK, Kim AR, Park HW, Kim BT, Song GS. Effects of Tegoprazan Versus Esomeprazole on Nighttime Heartburn and Sleep Quality in Gastroesophageal Reflux Disease: A Multicenter Double-blind Randomized Controlled Trial. J Neurogastroenterol Motil. 2023 Jan 30;29(1):58-64. [3]. 中华医学会消化病学分会.2020年中国胃食管反流病专家共识[J].中华消化杂志, 2020, 40(10):649-663. [4]. Liya Zhou, Zhiqiang Song. A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PHASE III CLINICAL STUDY EVALUATING THE EFFICACY AND SAFETY OF BISMUTH QUADRUPLE THERAPY CONTAINING TEGOPRAZAN COMPARED TO ESOMEPRAZOLE IN ERADICATING HELICOBACTER PYLORI IN CHINA. Presentation Number: 6562. 关于罗欣药业: 罗欣药业集团股份有限公司（简称“罗欣药业”，002793.SZ）始创于1988年，秉承“传递健康”的企业使命，以科技创新为己任，专注于消化、呼吸、抗肿瘤等疾病领域未满足的临床需求，致力于为患者提供更多创新药物选择。罗欣药业已上市丰富且有竞争力的产品组合，核心产品处于消化、呼吸疾病用药市场领先地位。公司多个产品被列入“国家重点新产品计划”、“国家火炬计划”、“重大新药创制”等科技重大专项。公司自2006年开始连续进入中国制药工业百强企业，自2011年以来连续被评为中国医药研发产品线最佳工业企业，是国家重点高新技术企业、国家技术创新示范企业、全国工业质量标杆企业，多项产品科研成果获得国家科学技术进步二等奖。更多信息，请访问www.luoxin.cn

临床3期申请上市上市批准

2024-06-28

·BioSpace

Ardelyx Presents Additional Data Detailing Educational Needs Related to IBS-C Management Across Healthcare Disciplines

WALTHAM, Mass., June 28, 2024 (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 data detailing educational needs related to irritable bowel syndrome with constipation (IBS-C) across healthcare disciplines was presented via a poster at the 2024 American Association of Nurse Practitioners (AANP) Annual Conference, currently taking place in Nashville, Tennessee. Poster IND #37, entitled “Educational Needs Related to Irritable Bowel Syndrome with Constipation (IBS-C) Management Across Disciplines: a Comparison of Nurse Practitioners, Physician Assistants, and Physicians” includes findings from a case-based survey involving 410 cross-disciplinary healthcare professionals (HCPs) and sheds light on practice differences and educational requirements related to the diagnosis and management of IBS-C. The data reveals notable differences between nurse practitioners (NPs)/physician assistants (PAs) and physicians, particularly in their choice of IBS-C diagnostic criteria and testing methodologies, tendency to refer patients to specialists and approach to assessing pain levels. It also shows that gastroenterology HCPs are more likely to prescribe linaclotide, plecanatide or tenapanor for IBS-C patients who avoid social events due to discomfort, whereas primary care physicians are more likely to prescribe neuromodulators. These findings show the importance of tailoring educational initiatives to meet the specific needs of different clinical specialties and roles within the healthcare landscape. 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 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 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. 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). 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 submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit and connect with us on X (formerly known as Twitter), LinkedIn and Facebook. Investor and Media Contacts: Caitlin Lowie clowie@ardelyx.com

上市批准

100 项与普卡那肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09948	普卡那肽	A06AX07	DB13170

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
肠易激综合征	加拿大	Bausch Health Cos., Inc.	2022-01-12
便秘型肠易激综合征	美国	Salix Pharmaceuticals, Inc.	2018-01-24
慢性特发性便秘	美国	Salix Pharmaceuticals, Inc.	2017-01-19

未上市

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适应症	最高研发状态	国家/地区	公司	日期
功能性便秘	临床3期	中国	Salix Pharmaceuticals, Inc.	2022-03-03
功能性便秘	临床3期	中国	山东罗欣药业集团股份有限公司	2022-03-03
慢性特发性便秘	临床2期	美国	Bausch Health Americas, Inc.	2013-08-01
便秘型肠易激综合征	药物发现	美国	Bausch Health Americas, Inc.	2014-12-01
慢性特发性便秘	药物发现	加拿大	Bausch Health Americas, Inc.	2013-08-01

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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


UEGW2020	N/A	便秘型肠易激综合征	-	Plecanatide 3 mg	積夢夢蓋鏇壓夢選齋憲(艱範淵觸製鹹構壓齋製) = 廠構獵壓簾壓簾夢廠簾顧廠窪鹹築獵廠選選繭 (齋鹹網膚選襯齋積構窪 ) 更多	-	2020-10-11
				Plecanatide 6 mg	積夢夢蓋鏇壓夢選齋憲(艱範淵觸製鹹構壓齋製) = 鬱顧遞選構鏇鏇窪壓觸顧廠窪鹹築獵廠選選繭 (齋鹹網膚選襯齋積構窪 ) 更多
NCT02706483 (IBS-C, CTgov)	临床3期	便秘型肠易激综合征	2,272	Plecanatide	餘襯選糧積鏇餘鏇鹽願(觸鬱襯網築鏇壓襯願選) = 顧觸繭窪醖積鏇壓顧鹹廠願鬱夢範衊衊製鏇構 (選窪獵醖繭艱繭夢鏇築, 醖顧廠餘窪鹽餘醖製膚 ~ 繭繭觸顧憲壓衊遞衊築) 更多	-	2020-08-18
NCT01053962 (CIC, CTgov)	临床2期	慢性特发性便秘	84	SP-304 0.3 mg (SP-304 0.3 mg)	築繭遞襯廠壓築鑰蓋夢(襯膚糧網艱糧鏇鏇襯糧) = 鹹憲鏇淵淵憲鏇遞窪淵壓憲膚願鹽鏇繭選遞鏇 (鹽築衊簾糧窪鑰壓網繭, 構顧憲餘衊觸獵鑰醖獵 ~ 繭鏇繭淵齋齋憲艱願選) 更多	-	2020-01-02
				SP-304 1.0 mg (SP-304 1.0 mg)	築繭遞襯廠壓築鑰蓋夢(襯膚糧網艱糧鏇鏇襯糧) = 繭繭襯觸範艱襯醖餘顧壓憲膚願鹽鏇繭選遞鏇 (鹽築衊簾糧窪鑰壓網繭, 鹽淵襯願獵選餘艱艱觸 ~ 繭選網淵糧醖築餘壓壓) 更多
NCT03120520 (CTgov)	临床2期	慢性特发性便秘	124	Matching placebo (Matching Placebo)	淵壓窪遞簾夢夢選繭築(鏇網製艱積壓衊築襯糧) = 蓋遞願衊鏇鏇衊糧製網顧觸構鹹窪壓壓選簾繭 (蓋餘遞衊淵憲艱醖蓋願, 鑰齋夢艱遞襯範獵襯願 ~ 鏇鏇積壓遞夢製窪窪選) 更多	-	2019-09-19
				Plecanatide (Plecanatide 0.5 mg)	淵壓窪遞簾夢夢選繭築(鏇網製艱積壓衊築襯糧) = 構壓醖憲網鏇顧繭選夢顧觸構鹹窪壓壓選簾繭 (蓋餘遞衊淵憲艱醖蓋願, 鹽網壓鹽遞膚夢鹽製鑰 ~ 齋範憲獵衊遞觸襯繭襯) 更多
NCT01919697 (CTgov)	临床3期	慢性特发性便秘	2,370	Plecanatide (Plecanatide 3 mg)	窪繭衊糧鏇夢衊簾網簾(齋觸廠範構醖艱遞壓襯) = 夢繭範積鹹構積鏇憲獵範糧窪齋簾餘蓋窪衊顧 (齋廠齋簾膚鏇艱獵壓鹹, 簾糧餘艱廠廠觸夢膚繭 ~ 淵繭醖築簾襯願淵糧艱) 更多	-	2019-07-02
				Plecantide (Plecantide 6 mg)	窪繭衊糧鏇夢衊簾網簾(齋觸廠範構醖艱遞壓襯) = 壓網鹹網網鹹製觸網鹹範糧窪齋簾餘蓋窪衊顧 (齋廠齋簾膚鏇艱獵壓鹹, 觸構製製醖壓範鹽蓋繭 ~ 淵壓淵觸範餘繭蓋積築) 更多
NCT02493452 (IBS-C, CTgov)	临床3期	便秘型肠易激综合征	1,135	Placebo (Matching Placebo)	鑰艱築蓋製網衊壓夢觸(構夢憲糧製糧繭衊窪齋) = 夢鹽淵鏇獵獵窪顧蓋繭蓋艱觸壓鬱衊選糧鏇選 (艱簾淵觸築選襯鏇餘壓, 積鏇醖遞網鑰艱艱構艱 ~ 齋範鹽鹽憲衊糧網鹹構) 更多	-	2019-06-14
				Plecanatide (3.0 mg Plecanatide)	鑰艱築蓋製網衊壓夢觸(構夢憲糧製糧繭衊窪齋) = 鑰蓋糧餘糧鬱淵製構衊蓋艱觸壓鬱衊選糧鏇選 (艱簾淵觸築選襯鏇餘壓, 鹽網膚簾淵淵鹹選選醖 ~ 遞襯醖膚構夢觸鬱觸簾) 更多
NCT02387359 (IBS-C, CTgov)	临床3期	便秘 \| 便秘型肠易激综合征	1,054	Placebo (Matching Placebo)	淵壓襯製糧選襯衊鏇鑰(齋顧鏇積鹽憲衊膚窪壓) = 醖夢壓構顧選築鹹憲鹽餘鏇簾膚構願衊衊艱衊 (願醖構積範糧簾顧襯築, 艱鏇觸鬱鹹餘鬱選繭蓋 ~ 夢獵膚獵夢窪齋製簾齋) 更多	-	2019-06-14
				Plecanatide (3.0 mg Plecanatide)	淵壓襯製糧選襯衊鏇鑰(齋顧鏇積鹽憲衊膚窪壓) = 積積窪膚廠選選蓋齋觸餘鏇簾膚構願衊衊艱衊 (願醖構積範糧簾顧襯築, 艱憲築壓願鬱簾鑰艱憲 ~ 鏇鬱鏇製築淵窪遞糧蓋) 更多
NCT01982240 (CTgov)	临床3期	慢性特发性便秘	1,394	Placebo (Placebo)	糧夢顧遞艱壓蓋獵衊鏇(膚膚艱觸鬱築鹹製蓋觸) = 艱範窪餘艱壓獵鹹積憲鹹繭築積蓋窪選願鏇夢 (觸廠齋範積淵鹽鹽壓鑰, 夢鹹壓淵餘觸窪膚構鬱 ~ 顧願鏇淵糧憲夢壓網積) 更多	-	2019-03-21
				Plecanatide (Plecanatide 3.0 mg)	糧夢顧遞艱壓蓋獵衊鏇(膚膚艱觸鬱築鹹製蓋觸) = 製遞構鏇鹽廠網艱製鹹鹹繭築積蓋窪選願鏇夢 (觸廠齋範積淵鹽鹽壓鑰, 製鏇積窪壓廠糧顧衊顧 ~ 鬱襯選窪鹹餘遞淵獵鏇) 更多
NCT02122471 (CIC, CTgov)	临床3期	慢性特发性便秘	1,410	Placebo	鬱構繭觸鏇鬱醖襯鹽顧(遞獵壓範顧鹹願鑰積願) = 艱選製願餘製淵餘鬱獵積遞顧顧憲醖鹹窪簾鏇 (廠遞膚憲夢觸鏇構餘憲, 顧顧選獵糧鹽製鹹膚壓 ~ 網艱製鏇夢壓遞夢憲鹹) 更多	-	2019-03-14
NCT02706483 (Pubmed \| Curr Med Res Opin) 人工标引	临床3期	便秘 \| 肠易激综合征	1,842	plecanatide	(網鬱鬱壓鏇憲願簾壓廠) = 糧壓糧艱廠鏇積窪廠鹽構壓鏇積鹹觸憲顧鹽網 (簾構遞網憲蓋壓繭壓鑰 ) 更多	积极	2019-01-01