A Phase 3, Multicenter, Single Arm, Open-Label Trial, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Japanese Adult Subjects with Hypoparathyroidism - PaTHway Japan Trial

开始日期2021-11-02

申办/合作机构-

NCT05387070

/ Recruiting临床3期

PaTHway CHINA TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of treatment. All subjects will start with 18 mcg of study drug and will be individually and progressively titrated to an optimal dose over a 26-week double blind period, followed by an open label extension period up to 156 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs.

开始日期2021-07-28

申办/合作机构

维昇药业（上海）有限公司

NCT04701203

/ Completed临床3期

PaTHway TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

During the first 26 weeks of the trial, participants will be randomly assigned to one of two groups: one group will receive TransCon PTH and one group will receive placebo. All subjects will start with study drug at a dose of 18 mcg/day and will be individually and progressively titrated to an optimal dose in dose increments of 3 mcg/day. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in the United States, Canada, Germany, Denmark, Norway, Italy, and Hungary.

开始日期2021-02-16

申办/合作机构

Ascendis Pharma Bone Diseases A/S

100 项与帕罗培特立帕肽相关的临床结果

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100 项与帕罗培特立帕肽相关的转化医学

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100 项与帕罗培特立帕肽相关的专利（医药）

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7,497

项与帕罗培特立帕肽相关的文献（医药）

2025-12-01·Current Pain and Headache Reports

Functional Magnetic Resonance Imaging of Post-Traumatic Headache: A Systematic Review

Review

作者: Christensen, Rune H ; Ashina, Håkan ; Szabo, Edina ; Al-Khazali, Haidar M ; Iljazi, Afrim

PURPOSE OF REVIEW:

To evaluate existing functional magnetic resonance imaging (fMRI) studies on post-traumatic headache (PTH) following traumatic brain injury (TBI).

RECENT FINDINGS:

We conducted a systematic search of PubMed and Embase databases from inception to February 1, 2024. Eligible fMRI studies were required to include adult participants diagnosed with acute or persistent PTH post-TBI in accordance with any edition of the International Classification of Headache Disorders. We identified five eligible fMRI studies: two on acute PTH and three on persistent PTH. These studies assessed resting-state functional connectivity involving comparisons with one or more of the following groups: people with migraine, those with mild TBI but no PTH, and healthy controls. In acute PTH, studies focused exclusively on functional connectivity between the periaqueductal gray or hypothalamus and other brain regions. In persistent PTH, evidence of altered functional connectivity was identified primarily within cingulate, sensorimotor, and visual regions, indicating a hypersensitivity to sensory stimuli in PTH. Despite these insights, the fMRI data remains sparse and is limited by inconsistent results and small samples. The paucity of fMRI studies on PTH limits our understanding of its neurobiological basis. The available evidence suggests that alterations in functional connectivity occur within brain areas involved in emotional and sensory discriminative aspects of pain processing. However, inconsistent results and small sample sizes underscore a critical need for larger, more rigorous fMRI studies. Future studies should also consider using task-based fMRI to investigate possible hypersensitivity to different sensory stimuli in PTH after TBI.

2025-12-01·Current Pain and Headache Reports

The Dual Burden of Post-Traumatic Headache: Health Consequences and Economic Impact

Review

作者: Cohen, Fred

PURPOSE OF REVIEW:

To review the history and impact and burden of post-traumatic headache (PTH).

RECENT FINDINGS:

PTH is a prevalent headache disorder that many healthcare providers encounter. Unlike more extensively researched primary headache disorders like migraines, PTH has not been as thoroughly studied, and there are fewer treatments specifically tested for it. A significant obstacle to conducting detailed population studies on PTH is the need for the headache to occur shortly after a traumatic event. Despite these challenges, PTH is recognized as a disabling condition with considerable effects on quality of life and economic impact. PTH is a distressing and debilitating condition. Although there have been efforts to evaluate its personal and economic effects, these studies are limited compared to the more extensive research conducted on other primary headache disorders. More comprehensive epidemiological studies are needed.

2025-04-01·CHEMOSPHERE

Association of perfluoroalkyl substance (PFAS) on vitamin D biomarkers in a highly exposed population of the Veneto Region in Italy

Article

作者: Di Falco, Achille ; Sabovic, Iva ; Ferlin, Alberto ; Canova, Cristina ; Foresta, Carlo ; Berti, Mirko ; Zolin, Rinaldo ; De Toni, Luca ; Di Nisio, Andrea ; Bettega, Anna Maria

Perfluoroalkyl substances (PFASs) raise concerns about their environmental accumulation. Experimental data have suggested that PFASs interfere with bone metabolism from the early stages of life. However, mechanisms underlying this association are unclear. The aim of this study was to evaluate the possible association between environmental exposure to PFAS and vitamin D (VitD), serum calcium and parathyroid hormone (PTH) levels in subjects residing in high-exposure area of the Veneto Region of Italy. In this cross-sectional observational study, 1174 subjects who previously adhered to the 2016-2018 Regional Surveillance Plan for plasma levels of PFASs were recalled in 2023 and evaluated for demographic, anthropometrics and blood analyses. Data on nutritional habits and VitD supplementation were obtained by a dedicated questionnaire. Serum concentrations of PFASs, calcium, 25-hydroxy-vitamin D (25OH-VitD) and PTH were determined from blood sampling. Perfluorooctanoic acid (PFOA), perfluorooctanesulfonate (PFOS) and perfluorohexanesulfonic acid (PFHxS) were the only three PFASs, of 12, quantifiable in at least 90% of the samples and considered for further analyses. Generalized additive models, using linear regression and smoothing thin plate splines, detected a positive association between serum calcium and all considered PFAS (PFOA: β = 0.03; CI 95% 0.01-0.06; PFOS: β = 0.06; CI 95% 0.02-0.09, PFHxS: β = 0.04; CI 95% 0.01-0.06). Estimated degrees of freedom (EDF) analysis showed the approximately linear association between serum calcium with PFOA (EDF = 1.89) and PFHxS (EDF = 1.21), but not for PFOS (EDF = 3.69). Differently, PFAS levels showed no association with either 25-hydroxy-vitamin D or PTH, except for ln-transformed 25OH-D and PFOS (β = 0.04; CI 95% 0.00-0.08). Stratified analyses confirmed the positive association between all considered PFAS and calcium in subjects not taking a VitD supplementation. Results show that high exposure levels to PFAS may interfere with calcium metabolism, independently of lifestyle and dietary factors. Further elucidation on the mechanisms underlying calcium homeostasis disruption, including multiple binding-equilibrium with serum albumin, remains to be addressed.

191

项与帕罗培特立帕肽相关的新闻（医药）

2025-03-24

·CPHI制药在线

维昇药业上市背后，不止是“生长发育第一股”

关注并星标CPHI制药在线 3月21日，维昇药业在第四次向港交所递交IPO文件后，终于顺利“敲钟”，成为“港股生长发育第一股”。事实上，无论是运营模式还是管线产品，维昇药业都有值得业界学习的地方。　反向Newco标杆维昇药业成立于2018年，由丹麦药企Ascendis Pharma A/S（下称Ascendis）、维梧资本和Sofinnova Ventures共同在上海创立。其中Ascendis以产品入股，维梧资本和Sofinnova Ventures出资支持。这一模式与近两年来国内涌现的NewCo模式不同。作为一种复杂的创新药资产交易模式，传统NewCo是指新公司由境外资本出资设立，在获得中国药企许可的管线权益后，向NewCo公司提供资金并负责经营管理，中国药企除了获得管线的授权许可费外，还可以获得NewCo公司的部分股权，NewCo公司今后独立在境外IPO或公司/管线被MNC并购。而维昇药业这种借助海外药企技术+本土化运营的模式，与传统NewCo模式恰恰相反，这一新颖模式被形象地称为反向NewCo。　专注内分泌领域，避开红海市场根据维昇药业与Ascendis的达成独家许可协议，公司能够在相关地区开发、生产和商业化隆培促生长素（lonapegsomatropin）、那韦培肽（navepegritide）及帕罗培特立帕肽（palopegteriparatide）等内分泌领域的候选药物，这三款药物也是维昇药业的核心产品。与扎堆内卷PD-1、GLP-1等大赛道的药企不同，维昇药业从一开始就避开这些红海市场，专注内分泌疾病领域。据弗若斯特沙利文数据，预计到2026年，中国的非糖尿病类内分泌药物市场规模将增至68亿美元；到2030年将增至115亿美元。与此同时，目前至少有近一半的内分泌疾病缺乏有效的治疗手段。以隆培促生长素为例，这是一款每周一次的长效生长激素替代疗法。已获FDA及欧盟EMA批准上市，用于治疗儿童生长激素缺乏症（PGHD）。 GHD是一种因下丘脑-垂体轴的器质性病变或功能性异常导致生长激素缺乏引起的疾病，患者表现为身材矮小、代谢异常、认知缺陷和生活质量差等问题。据相关媒体报道，我国4-15岁的人群矮小症发病人数有700万，但每年就诊人数预估不足30万人，接受规范治疗的患者渗透率仍然远远低于欧美国家。对于PGHD来说，补充生长激素是目前公认的最有效方法之一。生长激素是由脑垂体前叶嗜酸性细胞分泌的一种长度为191个氨基酸的肽类激素，通过刺激肝脏等组织产生胰岛素样生长因子（IGF -1）发挥生理功能，促进骨骼生长，促进蛋白质合成，调节脂肪、糖、矿物质代谢等。目前，国内已上市的生长激素产品，还是以短效类产品为主，高端的长效类产品仅获批一款——金赛增（金赛药业，长春高新子公司），患者的需求远没有得到充分满足。预计2030年，长效生长激素将是PGHD的主要疗法，市场份额占比可达74%。隆培促生长素基于维昇药业的暂时连接技术（TransCon），被设计为每周一次给药方案，并在体内释放未经修饰的与人内源性生长激素相同的分子，保留了原始作用机制。据国内III期临床试验数据显示，隆培促生长素的年化生长速率为10.66厘米/年，优于传统短效制剂的9.75厘米/年，达到研究主要终点。基于该III期临床试验，2024年3月，隆培促生长素在国内的上市许可申请（BLA）获得中国国家药监局受理，预计于2025年在中国上市。值得一提的是，隆培促生长素海外上市以来，销量一路攀升。2024年，其销售额达到2.02亿欧元（约14.7亿元人民币），同比增长高达84%。另一款核心产品那韦培肽，是一款C型利钠肽的长效前药，每周一次给药，拟开发用于治疗2至10岁软骨发育不全患者，该患者群体在国内有超过5万人。据国内II期临床试验显示，在治疗第52周时，剂量为100μg/kg/周的队列的那韦培肽的AGV（5.939厘米/年）较安慰剂（4.760厘米/年）高。帕罗培特立帕肽是一种甲状旁腺激素替代疗法，每日一次，拟开发用于治疗慢性甲状旁腺功能减退症，该病由于甲状旁腺激素分泌减少或功能缺陷，引起钙磷代谢异常。在一项III期关键试验中，经过长达156周的治疗，77.6%（45/58）接受帕罗培特立帕肽治疗的患者达到了主要终点（界定为在治疗第26周时，符合下列要求的受试者比例：白蛋白校正血清钙浓度在正常范围内，停用骨化三醇或阿法骨化醇活性维生素D，且停用治疗剂量的钙，在26周随访前的4周内未增加研究药物的剂量），而对照组中0.0%（0/22）的患者达到了主要终点。早在2023年9月，国家卫生健康委等6部门联合制定了《第二批罕见病目录》，软骨发育不全和遗传性甲状旁腺功能减退症均被纳入其中，意味着该类疾病将得到全方位的政策支持。除了在内分泌蓝海市场布局产品管线外，维昇药业的TransCon（Transient Conjugation，暂时连接）平台深受药企关注。　独一无二的技术平台，引诺和诺德押注为了攻克肽类激素（如生长激素等）长效化的壁垒，维昇药业开发了TransCon（Transient Conjugation，暂时连接）技术平台，TransCon分子包括三个部分：未经修饰的原型药物，保护原型药物的惰性载体分子和将两者暂时连接起来的连接体。当3部分结合后，形成前药，其载体分子可以使得原型药物以无活性状态存在，不被机体清除。当前药注射至人体内，在生理条件的PH和体温下，有活性的、未经修饰的原型药物将以可控的方式释放出来，从而实现了从短效到长效的突破。 2024年11月，维昇药业宣布授予诺和诺德TransCon技术平台的全球独家许可，以开发、制造和商业化诺和诺德在代谢性疾病（包括肥胖和2型糖尿病）方面的产品等。维昇药业将有资格获得高达2.85亿美元的预付款、开发和监管里程碑付款，以及基于销售额的里程碑付款和全球净销售额的分层特许权使用费等。该合作的达成肯定了TransCon在长效化技术方面的优势。维昇药业通过反向NewCo落地中国，如今凭借核心产品和技术平台在港股上市，未来公司将有望以全方位的优势，缔造内分泌赛道全新的传奇。参考资料：　 1.维昇药业招股书 https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0313/2025031300018_c.pdf. 2.https://www.hsppharma.com/news/pfizer-once-a-week-long-acting-drug-somatrogon-38750405.html. 3.Miller BS, Yuen KCJ. Spotlight on Lonapegsomatropin Once-Weekly Injection and Its Potential in the Treatment of Growth Hormone Deficiency in Pediatric Patients. Drug Des. END 2025金笔奖征文活动开启，来投稿吧！领取CPHI & PMEC China 2025展会门票智药研习社直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

IPO上市批准并购申请上市

2025-03-21

·FiercePharma

Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO

Visen Pharmaceuticals is designed to develop and commercialize Ascendis’ endocrinology therapies in greater China. Endocrine-disease-focused Visen Pharmaceuticals is making its public market debut in Hong Kong, filing papers for an $86.5 million IPO.The China-based biotech was formed in 2018 by Ascendis Pharma and an investor syndicate led by Vivo Capital. The biotech is designed to develop and commercialize Ascendis’ endocrinology therapies in greater China.Now, Visen is going public, with expected gross proceeds of $100 million, according to March 20 regulatory filings (PDF). The company has previously raised about $190 million, closing a $150 million series B financing in early 2021. That fundraise included OrbiMed, Logos Capital, Ascendis Pharma, Vivo Capital and Sofinnova Investments, among others.The company hosts three programs in its pipeline: Yorvipath (palopegteriparatide) for adults with chronic hypoparathyroidism; Skytrofa (lonapegsomatropin) for pediatric growth hormone deficiency; and navepegritide, an investigational prodrug of C-type natriuretic peptide for achondroplasia.

IPO

2025-03-21

·贝壳社

今日，生长发育第一股登陆港交所

▲点击图片，了解详情作者：米朵资本市场一直以来都似一块大磁铁，对医药企业有着“万有引力”，今日港股市场再迎“稀缺标的”——维昇药业。凭借在内分泌治疗领域的领先布局，维昇药业历经4次递表的坎坷，最终通过香港主板成功挂牌上市，并摘得“生长发育第一股”桂冠。生长激素赛道这几年逐渐升温，维昇药业也站上风口，如今登陆资本市场，能走多远呢？ 01 依托License in，坐拥“BIC”或“FIC”的潜力候选物维昇药业成立于2018年，专注于内分泌领域创新药的开发及商业化，为生长激素缺乏症、甲状旁腺功能减退症、软骨发育不全等内分泌罕见病提供全新、专业和高效的治疗方案。与其他IPO的企业相比，维昇药业的管线简单明了，只拥有一款核心产品及两款在研候选药物，且三款产品均从合作伙伴及控股股东之一Ascendis Pharma授权引入，但这三款在研药物却都具备了“BIC”或“FIC”的潜力。维昇药业管线，图源：招股书其中，核心产品隆培促生长素（Lonapegsomatropin）是一款每周一次的长效生长激素替代疗法，用于治疗儿童生长激素缺乏症（「PGHD」，一种生长激素不足导致的18岁以下患者中常见的矮小症），有潜力成为用于治疗儿童生长激素缺乏症（“PGHD”）的同类最佳候选药物，已经完成的全球Ⅲ期关键试验（该试验支持了美国食品药品监督管理局（“FDA”）及欧洲药品管理局（“EMA”）对其治疗PGHD的上市批准）所验证，其国内上市申请已于2024年3月获国家药监局受理。另外一款关键候选物那韦培肽，是一款C型利钠肽的长效前药，用于治疗软骨发育不全（一种短肢型矮小症，可导致严重的骨骼并发症及合并症），是潜在同类首创药物，已完成中国II期临床试验。最后一款候选物帕罗培特立帕肽是一款每日一次的甲状旁腺激素替代疗法，用于治疗慢性甲状旁腺功能减退症（一种由甲状旁腺激素分泌减少或功能缺陷所引起的钙磷代谢异常综合症），目前在国内的III期临床试验双盲期也已完成，并达到主要研究终点，预计将于2025年上半年向国家药监局提交NDA，有望成为国内首款甲状旁腺激素替代疗法。 2 亏损收窄，基石投资加持由于目前并无产品实现商业化，维昇药业承担着一定的资金流动性的压力，自成立以来每年均产生经营亏损，绝大部分经营亏损由研发开支、管理费用及其他收益及亏损净额所致，不过，纵观近三年的财务数据，维昇药业的亏损在收窄。财务状况，图源：招股书根据招股书，2022年维昇药业亏损2.88亿元人民币，主要因研发投入1.79亿元及管理费用1.77亿元；2023年，由于部分临床试验接近完成，研发开支降至5,769万元（同比减少68%），同时管理费用降至7,994万元（同比减少54.4%），全年亏损收窄至2.49亿元，同比缩减13.5%；2024年前九个月，亏损节奏进一步放缓，亏损1.29亿元，低于2022年同期。虽然无产品商业化，还陷在亏损泥潭，但维昇药业的IPO基石阵容为其成功叩开港交所大门增分不少。本次引入的5名基石投资者，既有老股东维梧资本（Vivo capital）继续增持，也有药明生物、安科生物，苏州工业园区产业投资基金，以及新引入的财务投资者瑞凯集团。根据招股书，5名基石计共认购7200万美元的发售股份，其中安科生物认购3000万美元，苏州工业园区产业投资基金子公司园丰认购1800万美元、现有股东维梧资本Vivo Capital认购1000万美元，药明生物旗下WuXi Biologics认购1000万美元，瑞凯集团Reynold Lemkins认购400万美元。在港股IPO市场中，基石投资者的选择往往被视为企业价值与资本信心的指示灯，维昇药业本次IPO基石占比较高，且老股东持续追投，确实是对其管线优势及商业潜力的高度认可。 3 百亿级市场，维昇胜算多大？现阶段维昇药业的核心产品隆培促生长素最接近收获期，且是极具战斗力的独家武器。隆培促生长素背靠的是数百亿级的人生长激素市场。据弗若斯特沙利文，中国的人生长激素市场规模从2018年的40亿元增长至2023年的116亿元，复合年增长率达到23.9%，预计到2030年增长至286亿元。生长激素疗法可分为短效（hGH）和长效（LAGH）。使用短效生长激素的儿童每天都需要打针，因其过于频繁的给药对于患儿及其家庭的依从性要求非常高，从而导致其在市场上销售受限，而长效生长激素由于只需一周注射一次，降低给药频率，提高了依从性，正在成为许多患者及家长的新宠。尽管当下短效hGH占据大部分人生长激素市场，但是由于长效剂型的优势，LAGH有望迅速发展，并逐渐成为主流治疗方案。据弗若斯特沙利文，中国LAGH的市场规模2018年的3亿元增至2023年的29亿元，复合年增长57.4%，预计到2030年增至211亿元。纵观目前的人生长激素市场，竞争格局并不复杂，主要由长春高新旗下金赛药业主导，市占率超75%，剩余市场主要由安科生物粉针、联合赛尔粉针分割。而与维昇的隆培促生长素一样属于长效生长激素的只有金赛药业的聚乙二醇重组人生长激素注射液（金赛增）一款在售。据悉，在安全性相当的前提下，隆培促生长素的疗效不仅优于短效剂型，而且25周和52周的数据均优于金赛增，根据长春高新财报，2024年三季度累计总营收已达到103.88亿人民币，金赛药业的长效生长素的市场渗透率目前在30%左右。隆培促生长素此前已经在欧美上市，且拥有良好的市场表现，2024年欧美销售额达2.02亿欧元（约15.36亿元），中国生长激素这几年都很火，市场远大于欧美。不过，当前国内的长效生长激素赛道已经开始燃起硝烟，除了隆培促生长素，2024年以来，国家药监局还受理了另外3款长效生长激素产品的上市申请，分别是特宝生物的怡培生长激素注射液、诺和诺德的帕西生长素注射液以及天境生物的伊坦长效生长激素，值得一提的是，伊坦长效生长激素是首款且唯一一款融合蛋白长效生长激素。据悉，维昇药业的隆培促生长素有望于2025年下半年率先突围，获批上市。结语整体来看，当前长效生长激素的开发已逐渐突破技术瓶颈，正在逐步替代短效生长激素成为用药主流，且目前整个赛道已进入收获期，这一数百亿的蓝海市场正在逐步被开启，但蛋糕大的同时，竞争者也多，虽然维昇药业的生长激素商业化箭在弦上，但是能否快速“产奶”还不得而知。不过，此次能顺利登陆资本市场，对于维昇药业而言，已经迈出了至关重要的一步，至于能走多远，拭目以待。参考资料： 1、招股书 2、《维昇药业-B（02561.HK）开启招股，基石占比近8成，预计于3月21日登陆港交所主板》IPO聚焦 3、《百亿生长激素市场变局！天境生物长效新药报产，长春高新迎考》医学经济报关于贝壳社贝壳社是国内领先的医健创新创业服务平台，为医健创业者提供全路径创业服务。通过产业空间运营、创业教育、投资孵化、数字化赋能、企业价值增长等服务体系，给医健创业企业提供产业空间、人才战略培养、投融资、产业生态资源、数字化转型等服务。同时，贝壳社布局澳洲，帮助国内生物医药企业加速走向海外；成立“泰格-泰珑-贝壳社企业经营服务中心”为企业成长提供全生命周期的增值服务，提高企业运营效率，加快企业成长发展。我们深度链接政府、科研院所、临床机构、投资机构、第三方服务商、CXO等行业资源，致力于赋能医疗健康创业公司成长，推动创新技术造福人类生命健康。往期推荐 1 百济神州也“NewCo” 2 百济神州，正在走安进曾经的路 _ 3 头对头击败奥希替尼，这款大药将起飞？ _ *声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐。投稿请添加小助手：bioclub666

IPO引进/卖出临床3期临床2期

100 项与帕罗培特立帕肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	H05AA	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
甲状旁腺功能减退症	欧盟	Ascendis Pharma Bone Diseases A/S	2023-11-17
甲状旁腺功能减退症	冰岛	Ascendis Pharma Bone Diseases A/S	2023-11-17
甲状旁腺功能减退症	列支敦士登	Ascendis Pharma Bone Diseases A/S	2023-11-17
甲状旁腺功能减退症	挪威	Ascendis Pharma Bone Diseases A/S	2023-11-17

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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


NCT04701203 (PaTHway, CTgov)	临床3期	甲状旁腺功能减退症	84	TransCon PTH (TransCon PTH)	獵獵糧遞鑰築壓憲廠糧 = 膚糧蓋鑰選鏇憲艱鏇壓範淵蓋襯製願糧積網獵 (衊鹹鏇淵鏇遞構鬱顧餘, 壓衊築膚鹽憲醖網膚憲 ~ 齋繭齋鹽夢鹹繭繭醖網) 更多	-	2025-02-28
				Placebo (Placebo)	獵獵糧遞鑰築壓憲廠糧 = 構壓構齋繭餘遞築醖窪範淵蓋襯製願糧積網獵 (衊鹹鏇淵鏇遞構鬱顧餘, 鑰網製窪繭壓積獵範餘 ~ 製衊壓遞醖衊鏇衊範鑰) 更多
NCT05387070 (PaTHway, PRNewswire) 人工标引	临床3期	甲状旁腺功能减退症	-	Palopegteriparatide	觸遞鏇遞鹹願鬱膚餘廠(鏇鬱範鹹簾艱積願選憲) = 鏇衊觸構壓餘壓膚廠顧窪蓋醖積觸鏇夢觸網夢 (簾鹽觸壓築餘繭鑰鑰顧 ) 更多	积极	2024-08-12
				Placebo	觸遞鏇遞鹹願鬱膚餘廠(鏇鬱範鹹簾艱積願選憲) = 觸網艱觸鏇齋願獵衊範窪蓋醖積觸鏇夢觸網夢 (簾鹽觸壓築餘繭鑰鑰顧 )
NCT04701203 (FDA_CDER) 人工标引	临床3期	甲状旁腺功能减退症	82	YORVIPATH	鹽膚選廠衊簾餘顧遞選(簾蓋製蓋膚淵憲簾鹹襯) = 膚積夢願夢艱鑰蓋淵獵網觸鑰獵觸觸積遞鏇壓 (願糧遞衊窪獵製積醖膚 ) 更多	积极	2024-08-09
				Placebo	鹽膚選廠衊簾餘顧遞選(簾蓋製蓋膚淵憲簾鹹襯) = 築膚糧膚淵願蓋簾願鹽網觸鑰獵觸觸積遞鏇壓 (願糧遞衊窪獵製積醖膚 ) 更多
NCT04701203 (PaTHway, GlobeNewswire) 人工标引	临床3期	甲状旁腺功能减退症	82	TransCon PTH (palopegteriparatide)	廠鏇齋蓋構積艱憲製襯(鬱窪觸積鏇願廠壓窪獵) = 淵選鏇窪繭築製蓋壓窪鑰齋醖夢醖簾製窪夢膚 (鹽繭鬱鹽鑰鹹夢憲遞糧 ) 更多	积极	2024-05-13
				TransCon PTH (palopegteriparatide) (eGFR < 60 mL/min/1.73m2)	廠鏇齋蓋構積艱憲製襯(鬱窪觸積鏇願廠壓窪獵) = 鹹鏇膚淵齋範構夢鹽願鑰齋醖夢醖簾製窪夢膚 (鹽繭鬱鹽鑰鹹夢憲遞糧 ) 更多
NCT04009291 \| NCT04701203 \| NCT05387070 (PaTHway, ENDO2023)	临床3期	甲状旁腺功能减退症	82	TransCon PTH	繭簾廠鏇蓋築糧廠壓淵(觸齋觸鏇膚壓餘製衊選) = trended toward norms from baseline to Weeks 26 and 52 夢鹹壓蓋鹹獵齋糧餘壓 (選範鹽醖膚鬱獵夢襯艱 ) 更多	积极	2023-10-05
NCT04009291 (PaTHway \| PaTH Forward, CTgov)	临床2期	甲状旁腺功能减退症	59	TransCon PTH (TransCon PTH 15 mcg)	憲積窪膚鏇襯製醖鑰膚 = 膚築膚鏇鑰範鹽醖積糧蓋網構壓願觸餘積範夢 (積壓網遞膚夢淵獵鹽艱, 淵顧夢築製窪襯簾繭壓 ~ 範繭繭築鏇鏇淵淵壓糧) 更多	-	2023-09-01
				TransCon PTH (TransCon PTH 18 mcg)	憲積窪膚鏇襯製醖鑰膚 = 憲廠餘餘襯築鹽廠憲積蓋網構壓願觸餘積範夢 (積壓網遞膚夢淵獵鹽艱, 鑰遞簾壓範艱艱繭遞壓 ~ 積簾糧網範遞鏇鹽構窪) 更多
PaTH Forward Trial (ENDO2022)	临床2期	甲状旁腺功能减退症	59	TransCon PTH 15 mcg/d	糧壓廠齋積獵網壓鹹鹽(齋積蓋壓糧鏇憲簾製範) = 齋選襯膚獵壓醖蓋窪構構鏇餘顧網壓醖鹽鬱壓 (鏇積鹽顧構鹹鏇廠糧鬱 ) 更多	积极	2022-11-01
				TransCon PTH 18 mcg/d	糧壓廠齋積獵網壓鹹鹽(齋積蓋壓糧鏇憲簾製範) = 憲廠鬱鑰醖觸齋壓簾範構鏇餘顧網壓醖鹽鬱壓 (鏇積鹽顧構鹹鏇廠糧鬱 ) 更多
NCT04009291 \| NCT04701203 \| NCT05387070 (PaTHway, ENDO2022)	临床3期	甲状旁腺功能减退症	82	TransCon PTH 18 mcg/d	艱齋顧網簾築鹽獵積範(鏇鹽齋膚壓範憲遞齋醖) = The most commonly reported study drug-related AEs were headaches 鹹蓋觸繭願範範鏇淵衊 (鹹簾糧壓築顧繭襯顧膚 ) 更多	积极	2022-11-01
				Placebo
NCT04009291 (PaTH Forward, Corporate Publications) 人工标引	临床2期	-	57	TransCon™ PTH	鏇襯窪製構壓襯憲願糧(獵壓鹹鹽齋蓋鹹網艱糧) = 選壓壓獵遞壓壓齋膚積鹹積糧築製簾鏇遞網壓 (夢鏇鹽簾願膚壓蓋餘獵 ) 更多	积极	2022-09-12
WCO_IOF_ESCEO2022	N/A	肢端肥大症 PTH \| serum vitamin D metabolites	-	PTH (Acromegaly group)	窪憲選鑰廠繭餘齋膚蓋(鏇簾鏇蓋齋築襯襯遞糧) = lower baseline levels 鹹範願簾艱鹹膚網醖壓 (壓艱積夢膚壓衊網願製 ) 更多	-	2022-03-24
				PTH (Control group)