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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7,518

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 Osteoporosis Reports

PTH Substitution Therapy for Chronic Hypoparathyroidism: PTH 1–84 and Palopegteriparatide

Review

作者: Tabacco, Gaia ; Naciu, Anda Mihaela ; Palermo, Andrea ; Donovan, Yu Kwang Tay ; Zavatta, Guido

PURPOSE OF REVIEW:

to describe and compare the efficacy and safety of the main PTH treatments, namely PTH(1-84) and palopegteriparatide, for the management of hypoparathyroidism.

RECENT FINDINGS:

neither PTH (1-84) nor PTH(1-34) have been shown a clear and consistent favorable impact on the 24 h urinary calcium excretion normalization, while the positive effect on quality of life is still debated. Recently, the Food & Drug Administration and the European Medicines Agency approved palopegteriparatide as the first true replacement therapy for hypoPT management. Palopegteriparatide is a prodrug of PTH(1-34), administered once daily, and designed to provide continuous exposure to released PTH over a 24-h dosing period. According to phase II and phase III studies, palopegteriparatide seems to fill the gaps identified in existing therapies for hypoPT. Palopegteriparatide is the first real replacement therapy for the management of hypoparathyroidism and seems to fill the gaps identified in existing therapies for hypoPT.

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.

195

项与帕罗培特立帕肽相关的新闻（医药）

2025-05-13

·药时空

疗效持续4年！维昇药业特立帕肽前药甲状腺功能减退2期临床长期随访结果

5月12日（当地时间），Ascendis Pharma（中国子公司：维昇药业）宣布Yorvipath（Palopegteriparatide，中文名：帕罗培特立帕肽，研发名称：TransCon PTH）成人甲状腺功能减退2期临床研究（PaTH Forward）214周最新研究结果证实其长期持久的疗效。PaTH Forward研究（NCT04009291)为在4周随机、双盲、安慰剂对照研究后进入为期266周的开放标签扩展研究。214周时，59例患者中的56例（95%)仍在接受治疗。214周研究结果如下：98%患者白蛋白校正血清钙水平继续维持正常范围内,93%患者摆脱现有疗法（定义：钙＜600mg/天&无需Vd）；骨转换标志物CTx（胶原C端肽）和P1NP（总I型胶原氨基端延长肽）从基线正常低端增加，26周到达峰值后下降并在214周维持稳定在基线水平之上；骨骼动力学改善：BMD维持在年龄和性别匹配正常范围内；67.8%患者eGFR（肾小球滤过率）具有临床意义增加（≥5ml/min/1.73m^2),eGFR从第4周明显变化。安全性方面，耐受性良好，无新的安全性信号，TEAE多为轻或中度，无重度或药物相关停药。Yorvipath（Palopegteriparatide，中文名：帕罗培特立帕肽，研发名称：TransCon PTH）为特立帕肽（PTH 1-34）前药，每天一次即可在24h内持续释放PTH。2018年，Ascendis授予Visen（维昇药业）大中华区开发和商业化TransCon hGH、TransCon PTH和TransCon CNP的独家权利。Yorvipath在2023年6月获得欧洲药品管理局批准上市，作为成人慢性甲状腺功能减退患者的替代性疗法。商品名与FDA批准的相同，规格有三种：168μg/0.56ml、294μg/0.98ml、420μg/1.4ml，剂型均为预充笔注射液。FDA的审批过程颇为曲折，2022年8月ascendis Pharma递交NDA申请获FDA受理并获得优先审评，2023年5月FDA下发完整回复函（CRL）提出药械组合的剂量传输控制策略问题，同年12月ascendis Pharma重新递交NDA申请并获FDA受理，而在2024年5月FDA又因审查过程中重大变更导致审评时限延长3月至2024年8月14日。2024年8月，FDA最终批准上市，用于甲状腺功能减退患者的替代性疗法。维昇药业2024年8月公布帕罗培特立帕肽用于治疗成人慢性甲状旁腺功能减退症的中国3期临床试验（PaTHway China），26周随机、双盲、安慰剂对照部分的数据：与安慰剂组相比，帕罗培特立帕肽组达到了主要复合终点的患者比例显著更高。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

优先审批上市批准临床2期突破性疗法临床3期

2025-05-05

·GlobeNewswire-Health Care

Ascendis to Share Its Latest Endocrinology Rare Disease Data at ESPE & ESE 2025

COPENHAGEN, Denmark, May 05, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will share the latest data from its hypoparathyroidism, achondroplasia, and growth hormone deficiency (GHD) programs during ESPE & ESE 2025, the joint congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) being held May 10-13, 2025, in Copenhagen. Four oral presentations will feature Ascendis clinical trial results, including 4-year efficacy and safety data from the Phase 2 PaTH Forward Trial of TransCon PTH (palopegteriparatide) in adults with chronic hypoparathyroidism; Week 52 growth and bone morphometry data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with achondroplasia; and efficacy and safety data from the Phase 3 foresiGHt Trial of TransCon hGH (lonapegsomatropin) in adults with growth hormone deficiency. “As new treatments and clinical practices transform the outlook for rare endocrine diseases, we are pleased to partner with trial investigators and leading experts to share new data highlighting clinical benefits of our novel therapies with attendees of ESPE & ESE 2025,” said Aimee Shu, M.D., Executive Vice President of Endocrine & Rare Disease Medical Science and Chief Medical Officer at Ascendis Pharma. The full range of Ascendis Pharma events and updates at ESPE & ESE 2025 include the following: Hypoparathyroidism Sunday, May 1109:55 - 10:25 CEST Congress TheaterFoyer F5Product TheaterRestoring Physiological Levels of PTH in Chronic HypoparathyroidismClick here to see the full session outline.Sunday, May 1116:55-17-55 CEST& Monday, May 1217:15-17:45 CESTPoster HallPoster P238Estimating the Risk of Chronic Kidney Disease Progression in Chronic Hypoparathyroidism: A Restrospective Matched Cohort Study, Using Real-World Data from England Monday, May 1213:00 - 14:30 CESTRoom D5SymposiumBeyond Conventional Care: Redefining Treatment Success in Chronic HypoparathyroidismClick here to see the full session outline.Monday, May 1215:55-16:05 CESTRoom C2Oral PresentationLong-Term Efficacy & Safety of Palopegteriparatide Treatment in Adults with Chronic Hypoparathyroidism: 4-Year Results from the Phase 2 PaTH Forward TrialPresented by Dr. Andrea PalermoAchondroplasiaSunday, May 1115:55-17:25 CESTRoom C2SymposiumAssessing HRQoL in Achondroplasia Across the Life CourseClick here to see the full session outline.Monday, May 1215:15-15:25 CESTRoom C2Oral PresentationEffects of Navepegritide on Bone Morphometry in Children with Achondroplasia: 52-Week Results from the ApproaCH Clinical TrialPresented by Dr. Leanne WardTuesday, May 1315:05-15:15 CESTRoom D2Oral PresentationEffects of Navepegritide on Growth in Children with Achondroplasia: 52-Week Results from the ApproaCH Clinical TrialPresented by Dr. Hanne HoveGrowth Hormone DeficiencyTuesday, May 1314:45-14:55 CESTRoom D2Oral PresentationResults of the foresiGH Trial Support the Efficacy and Safety of Once-Weekly Lonapegsomatropin in Adults with Growth Hormone Deficiency (GHD)Presented by Dr. Aleksandra Gilis-Januszewska More information about the events and presentations listed here is available to registered attendees of the Joint ESPE & ESE 2025 congress. About HypoparathyroidismHypoparathyroidism is an endocrine disease caused by insufficient levels of parathyroid hormone (PTH), the primary regulator of calcium and phosphate balance in the body, acting directly on bone and kidney and indirectly on the intestine. Individuals with hypoparathyroidism may experience a range of severe and potentially life-threatening short-term and long-term complications, including neuromuscular irritability, renal complications, extra-skeletal calcifications, and cognitive impairment. Post-surgical hypoparathyroidism accounts for the majority of cases (70-80%), while other etiologies include autoimmune and idiopathic causes. About AchondroplasiaAchondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 people worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, causing serious muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia vary across different stages of life. Throughout infancy and childhood, observed complications include spinal deformities, enlarged brain ventricles, impaired muscle strength and stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; many of these persist or worsen in adulthood. These medical complications can have detrimental effects on quality of life, physical functioning, and psychosocial function. Individuals with achondroplasia often require multiple surgeries and procedures to alleviate the condition’s many complications. About Adult Growth Hormone DeficiencyGrowth hormone plays an essential role in the health of children and adults, promoting normal growth in children and maintenance of normal body composition and cardiometabolic health throughout adulthood. In adults, growth hormone boosts protein production, promotes fat utilization, enhances muscle mass, and helps regulate blood sugar levels. Adult GHD is a condition in which an individual’s body does not produce enough growth hormone. Symptoms and morbidity can include central obesity, metabolic syndrome, decreased bone density, alterations in lipid profile and markers of cardiovascular risk, fatigue, general weakness, lack of muscle tone, and psychological symptoms such as cognitive impairment, social isolation, lack of motivation, and depression. About Ascendis Pharma A/SAscendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the clinical benefits of Ascendis’ novel therapies, (ii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, and (iii) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. 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 Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © May 2025 Ascendis Pharma A/S. Investor Contacts: Scott Smith Ascendis Pharma ir@ascendispharma.com Media Contact:Melinda BakerAscendis Pharmamedia@ascendispharma.com Patti BankICR Healthcare+1 (415) 513-1284patti.bank@icrhealthcare.com

临床2期临床结果

2025-04-11

·创鉴汇

16家江苏创新药公司Q1获融资！

▎药明康德内容团队编辑江苏作为生物医药产业高地，以苏州、南京、泰州等城市为核心，形成了覆盖研发、临床、制造的全链条产业集群。通过技术突破和生态优化，为患者提供普惠、精准的健康解决方案。2025年第一季度至少16家江苏创新药公司获融资，数量较去年增长60%；已披露融资总额超20亿元，较去年增长14%。值得关注的亮点包括：IPO轮次融资金额高：亚盛医药及维昇药业分别完成约1.26亿美元、6.72亿港元IPO，布局抗肿瘤小分子疗法及内分泌疾病药物。小分子药物最受关注：至少6家获融资公司正在推进小分子药物研发，包括阳光安津、爱科诺、征祥医药等。抗感染药物研发“多技术路径并行”：简达生物、星济生物等7家获融资公司聚焦抗感染领域，覆盖小分子药物、mRNA疫苗、抗体等多种药物类型。亚盛医药：抗肿瘤小分子疗法研发公司亚盛医药宣布于1月24日晚间正式在纳斯达克上市，全球发售所得款项总额预期约为126.4百万美元。亚盛医药致力于在肿瘤等治疗领域开发创新药物，总部位于苏州。成立至今，公司得益于其在基于结构的药物设计方面的技术专长以及其新药发现引擎，致力于透过抑制Bcl-2、MDM2-p53 等细胞凋亡通路关键蛋白的抑制剂；新一代针对癌症治疗中出现的激酶突变体的抑制剂等解决未满足的医疗需求。目前，亚盛医药有11项已完成或进行中的美国及/或国际注册研究。▲亚盛医药在研管线（图片来源：公司官网）公司核心品种奥雷巴替尼是中国首个获批上市的第三代BCR-ABL抑制剂，目前有三项注册3期临床研究正在进行，涉及慢性髓系白血病（CML）、费城染色体阳性（Ph+）急性淋巴细胞白血病（ALL）、琥珀酸脱氢酶（SDH）缺陷型胃肠道间质瘤（GIST）等适应症。公司另一重磅品种Lisaftoclax为新型选择性Bcl-2抑制剂，其新药上市申请（NDA）已于2024年11月获国家药品监督管理局（NMPA）药品审评中心（CDE）受理，并被纳入优先审评，用于治疗难治或复发性（r/r）慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）。维昇药业：内分泌疾病药物研发公司3月21日，维昇药业在港交所IPO，募资约6.72亿港元。维昇药业成立于2018年11月，总部设立于苏州，是一家处于研发后期、产品接近商业化的生物医药公司，专注于在中国为患者提供特定内分泌疾病的治疗方案。该公司目前拥有一款核心产品及两款其他在研候选药物，核心产品每周一次的长效生长激素隆培促生长素已经于2024年3月向中国国家药监局（NMPA）递交上市申请。▲维昇药业在研管线（图片来源：公司官网）该公司研发管线中：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。那韦培肽（navepegritide）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。帕罗培特立帕肽（palopegteriparatide)是一款每日一次的甲状旁腺激素替代疗法，拟开发用于治疗慢性甲状旁腺功能减退症。阳光安津：新型镇痛药物研发公司1月15日，阳光安津宣布完成超亿元pre-A轮融资。本轮融资由启明创投领投，博行资本和清控银杏跟投。阳光安津成立于2021年，总部位于南京。该公司由雷晓光教授与杨勇教授共同创立，公司以新型镇痛药的研发为目标，专注于Nav1.8和Nav1.7这两个与机体疼痛感受高度相关的钠离子通道。其中，Nav1.8抑制剂已展现了较好的镇痛效果和安全性，该产品预计于2025年启动IND。未来，阳光安津将持续聚焦于疼痛领域有潜力的离子通道靶标，以自研为主导兼顾合作开发的方式，打造疼痛治疗研发管线，并通过灵活的临床试验策略进一步加速其全球临床开发，使患者早日获得远离疼痛的新手段，同时拓展其在全球市场的影响力。爱科诺生物：新型小分子药物研发公司3月15日，爱科诺生物（Accropeutics）宣布完成近亿元B+轮融资，本轮融资由深创投领投，晨兴创投（Morningside Ventures）、领军创投和合肥创新投跟投。所筹资金将用于加速针对炎症性肠病、银屑病、非感染性葡萄膜炎及急性移植物抗宿主病等炎症与自身免疫疾病的临床阶段的药物开发。爱科诺官网地址位于苏州，专注于炎症、自身免疫性疾病和肿瘤的创新药物研发。爱科诺生物医药深耕“细胞死亡-炎症”回路，建立了独特的“调节性细胞死亡”新药研发平台。爱科诺研发团队在药物化学、生物学、转化医学等领域积累了丰富的新药研发经验，快速高效地推进多款原创药物进入到临床开发阶段。▲爱科诺在研管线（图片来源：公司官网）该公司目前已有三款产品进入临床阶段，包括选择性RIPK2抑制剂AC-101、选择性TYK2/JAK1抑制剂AC-201、选择性RIPK1抑制剂AC-003，分别正在开发治疗溃疡性结肠炎、银屑病、急性移植物抗宿主病。简达生物：疫苗研发公司1月14日，简达生物宣布完成由汇鼎投资独家投资的近亿元Pre-A轮融资。本轮融资将用于创新型佐剂带状疱疹疫苗1-2期临床试验、重组流感疫苗临床申报以及相关技术平台的扩展建设。简达生物成立于2018年，官网地址位于南京，是一家临床阶段创新疫苗研发企业，公司以自主创新技术为驱动，聚焦于创新疫苗及新型佐剂研发，建立了具有自主知识产权的新型佐剂和DC靶向疫苗技术平台。目前，创新型佐剂带状疱疹疫苗、重组流感疫苗、改进型两针剂狂犬疫苗、治疗性肿瘤疫苗等一系列项目，分别处于临床试验、IND（中美）申报、中试生产各个阶段。结语江苏生物医药产业创新生态持续优化，产业生态链环环相扣，为区域发展注入强劲动能。作为产业链的关键一环，“原料药”受到关注。目前，江苏已形成多个特色原料药聚集区，吸引全球药企开设生产基地或采购中心，带动上下游企业融资活力。近期，药明康德位于江苏常州及泰兴的两个原料药基地于3月相继以零缺陷成功通过了美国食品药品监督管理局（FDA）检查，再次为产业树立标杆，以高质量标准“出圈”，吸引更多目光关注。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

IPO疫苗信使RNA临床3期优先审批

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)	鏇鑰範遞範選襯廠廠鬱 = 願築顧積願蓋鏇觸繭範顧網範獵構鬱蓋構壓選 (蓋選醖壓憲鏇願鬱積築, 鹹積膚築鑰網構膚築鹹 ~ 願選鏇餘願窪壓壓願遞) 更多	-	2025-02-28
				Placebo (Placebo)	鏇鑰範遞範選襯廠廠鬱 = 廠齋顧鏇餘壓鏇築壓顧顧網範獵構鬱蓋構壓選 (蓋選醖壓憲鏇願鬱積築, 繭願顧鹹鏇齋構醖願遞 ~ 鏇繭繭壓網範積遞網蓋) 更多
NCT05387070 (PaTHway, PRNewswire) 人工标引	临床3期	甲状旁腺功能减退症	-	Palopegteriparatide	衊簾遞衊鹹襯夢積艱鏇(淵衊鹽醖壓衊壓壓選築) = 壓獵廠襯鬱簾鹽繭醖醖獵窪壓齋齋選衊窪製蓋 (製鬱齋製顧鏇窪簾鏇構 ) 更多	积极	2024-08-12
				Placebo	衊簾遞衊鹹襯夢積艱鏇(淵衊鹽醖壓衊壓壓選築) = 顧構憲壓築範繭範網觸獵窪壓齋齋選衊窪製蓋 (製鬱齋製顧鏇窪簾鏇構 )
NCT04701203 (FDA_CDER) 人工标引	临床3期	甲状旁腺功能减退症	82	YORVIPATH	壓簾鏇艱餘餘衊製積齋(鏇網範遞壓繭蓋選簾鏇) = 齋鏇獵壓積觸繭窪鏇範艱膚製遞襯顧積鑰衊艱 (淵網壓襯鏇夢繭廠鏇衊 ) 更多	积极	2024-08-09
				Placebo	壓簾鏇艱餘餘衊製積齋(鏇網範遞壓繭蓋選簾鏇) = 網襯淵壓鹹艱鹽膚糧製艱膚製遞襯顧積鑰衊艱 (淵網壓襯鏇夢繭廠鏇衊 ) 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)	淵繭觸餘憲鬱艱憲鹹襯(蓋製鏇醖鹽鏇獵製網築) = 觸餘夢鏇衊鬱蓋餘簾遞築鏇遞鬱淵遞顧糧鑰遞 (顧範願衊餘製膚憲願窪 ) 更多	积极	2024-05-13
				TransCon PTH (palopegteriparatide) (eGFR < 60 mL/min/1.73m2)	淵繭觸餘憲鬱艱憲鹹襯(蓋製鏇醖鹽鏇獵製網築) = 壓襯憲壓憲積網壓製鏇築鏇遞鬱淵遞顧糧鑰遞 (顧範願衊餘製膚憲願窪 ) 更多
NCT04009291 \| NCT04701203 \| NCT05387070 (PaTHway, ENDO2023)	临床3期	甲状旁腺功能减退症	82	TransCon PTH	構襯製窪蓋餘繭壓獵繭(壓製願鬱糧積網鹽壓襯) = trended toward norms from baseline to Weeks 26 and 52 壓網醖憲艱膚遞窪廠積 (遞齋範築夢夢衊膚鏇繭 ) 更多	积极	2023-10-05
PaTH Forward Trial (ENDO2022)	临床2期	甲状旁腺功能减退症	59	TransCon PTH 15 mcg/d	範鑰範鬱顧製壓網膚簾(構醖鑰膚構遞壓積憲憲) = 願廠壓繭積壓淵構顧獵獵觸窪觸鏇鑰餘願憲鹹 (淵鬱夢膚憲夢範窪獵遞 ) 更多	积极	2022-11-01
				TransCon PTH 18 mcg/d	範鑰範鬱顧製壓網膚簾(構醖鑰膚構遞壓積憲憲) = 選築鏇觸選積襯製壓觸獵觸窪觸鏇鑰餘願憲鹹 (淵鬱夢膚憲夢範窪獵遞 ) 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	壓願齋醖醖積衊構鹹壓(淵範襯餘鬱壓膚餘觸獵) = The most commonly reported study drug-related AEs were headaches 衊壓鹹築廠範獵夢網衊 (築鏇獵鑰範鬱艱製醖鬱 ) 更多	积极	2022-11-01
				Placebo
NCT04009291 (PaTH Forward, Corporate Publications) 人工标引	临床2期	-	57	TransCon™ PTH	襯艱獵顧鏇醖鏇膚獵廠(膚鑰鏇憲鬱淵憲壓鏇壓) = 廠蓋鹹積淵繭繭憲夢選膚製範襯顧範範願鹽醖 (顧鑰獵膚醖選顧淵夢鹽 ) 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)	構繭築構遞顧齋膚鬱築(壓選積窪網築齋鬱襯憲) = lower baseline levels 艱鏇憲衊鹹簾鹽蓋選鑰 (選遞顧鹹醖網餘獵選積 ) 更多	-	2022-03-24
				PTH (Control group)
NCT04701203 (Corporate Publications) 人工标引	临床3期	甲状旁腺功能减退症	82	Palopegteriparatide	製鏇鏇鹹淵夢顧醖遞鏇(膚鑰糧鹽顧鹹憲餘築鏇) = 觸鏇繭糧餘鑰蓋壓網鬱鹽構觸觸衊繭鑰網顧範 (觸繭築膚構積繭鏇糧構, 66.3 ~ 88.1) 更多	积极	2022-03-13
				Placebo	製鏇鏇鹹淵夢顧醖遞鏇(膚鑰糧鹽顧鹹憲餘築鏇) = 觸艱願淵壓餘簾蓋餘衊鹽構觸觸衊繭鑰網顧範 (觸繭築膚構積繭鏇糧構, 0.1 ~ 23.8) 更多