This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH[1-84]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.

开始日期2022-08-31

申办/合作机构

Shire Plc

ChiCTR2300067899 / Recruiting临床4期IIT

Clinical study of recombinant human parathyroid hormone in the treatment of osteoradionecrosis of the jaws

开始日期2022-06-30

申办/合作机构-

NCT05137730 / Completed临床1期

A Randomized, Open-label, Single-center, Single-dose Study to Evaluate the Relative Bioavailability of a New Formulation Compared With the Approved Formulation of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) and to Assess Dose Linearity of the New Formulation in Healthy Subjects

The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the main aim is to assess the dose linearity of the new formulation.
Participants will receive 2 doses in Part I and 4 doses in Part II.
Participants need to visit their doctor approximately 14 days and 30 days after the last dose of study drug.

开始日期2021-11-29

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

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100 项与甲状旁腺素(Shire Plc) 相关的临床结果

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100 项与甲状旁腺素(Shire Plc) 相关的专利（医药）

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项与甲状旁腺素(Shire Plc) 相关的文献（医药）

2024-04-01·Bioactive Materials

A parathyroid hormone related supramolecular peptide for multi-functionalized osteoregeneration

Article

作者: Wang, Ying ; Chen, Tianhong ; Guo, Xiaodong ; Wang, Junwu ; Wang, Yi ; Hu, Yingkun ; Hao, Zhuowen ; Li, Jingfeng ; Yang, Zhiqiang ; Chen, Renxin ; Li, Hanke ; Chen, Jiayao ; Feng, Qinyu ; Lv, Xuan

Supramolecular peptide nanofiber hydrogels are emerging biomaterials for tissue engineering, but it is difficult to fabricate multi-functional systems by simply mixing several short-motif-modified supramolecular peptides because relatively abundant motifs generally hinder nanofiber cross-linking or the formation of long nanofiber. Coupling bioactive factors to the assembling backbone is an ideal strategy to design multi-functional supramolecular peptides in spite of challenging synthesis and purification. Herein, a multi-functional supramolecular peptide, P1R16, is developed by coupling a bioactive factor, parathyroid hormone related peptide 1 (PTHrP-1), to the basic supramolecular peptide RADA16-Ⅰ via solid-phase synthesis. It is found that P1R16 self-assembles into long nanofibers and co-assembles with RADA16-Ⅰ to form nanofiber hydrogels, thus coupling PTHrP-1 to hydrogel matrix. P1R16 nanofiber retains osteoinductive activity in a dose-dependent manner, and P1R16/RADA16-Ⅰ nanofiber hydrogels promote osteogenesis, angiogenesis and osteoclastogenesis in vitro and induce multi-functionalized osteoregeneration by intramembranous ossification and bone remodeling in vivo when loaded to collagen (Col) scaffolds. Abundant red blood marrow formation, ideal osteointegration and adapted degradation are observed in the 50% P1R16/Col scaffold group. Therefore, this study provides a promising strategy to develop multi-functional supramolecular peptides and a new method to topically administrate parathyroid hormone or parathyroid hormone related peptides for non-healing bone defects.

2024-03-01·Bone

Cortical thickness adaptation to combined mechanical loading and parathyroid hormone treatments is site specific and synergistic in the mouse tibia model

Article

作者: Pickering, Edmund ; Delisser, Peter ; Martelli, Saulo ; Miller, Corey J ; Meakin, Lee B ; Dall'Ara, Enrico ; Pivonka, Peter ; Trichilo, Silvia

In this study, we aimed to quantify the localised effects of mechanical loading (ML), low (20 μg/kg/day), moderate (40 μg/kg/day) or high (80 μg/kg/day) dosages of parathyroid hormone (PTH), and combined (PTHML) treatments on cortical bone adaptation in healthy 19-week old female C57BL/6 mice. To this end, we utilise a previously reported image analysis algorithm on μCT data of the mouse tibia published by Sugiyama et al. (2008) to measure changes in cortical area, marrow cavity area and local cortical thickness measures (ΔCt.Ar, ΔMa.Ar, ΔCt.Th respectively), evaluated at two cross-sections within the mouse tibia (proximal-middle (37 %) and middle (50 %)), and are compared to a superposed summation (P + M) of individual treatments to determine the effectiveness of combining treatments in vivo. ΔCt.Ar analysis revealed a non-linear, synergistic interactions between PTH and ML in the 37 % cross-section that saturates at higher PTH dosages, whereas the 50 % cross-section experiences an approximately linear, additive adaptation response. This coincided with an increase in ΔMa.Ar (indicating resorption of the endosteal surface), which was only counteracted by combined high dose PTH with ML in the middle cross-section. Regional analysis of ΔCt.Th changes reveal localised cortical thinning in response to low dose PTH treatment in the posteromedial region of the middle cross-section, signifying that PTH does not provide a homogeneous adaptation response around the cortical perimeter. We observe a synergistic response in the proximal-middle cross-section, with regions of compressive strain experiencing the greatest adaptation response to PTHML treatments, (peak ΔCt.Th of 189.32, 213.78 and 239.30 μm for low, moderate and high PTHML groups respectively). In contrast, PTHML treatments in the middle cross-section show a similar response to the superposed P + M group, with the exception of the combined high dose PTHML treatment which shows a synergistic interaction. These analyses suggest that, in mice, adding mechanical loading to PTH treatments leads to region specific bone responses; synergism of PTHML is only achieved in some regions experiencing high loading, while other regions respond additively to this combined treatment.

2024-02-01·Bone

Parathyroid hormone and trabectedin have differing effects on macrophages and stress fracture repair

Article

作者: Grewal, Jobanpreet ; Sinder, Benjamin P ; Roca, Hernan ; Batoon, Lena ; McCauley, Laurie K ; Woo, Cecilia ; Koh, Amy J ; Stephan, Chris ; Kozloff, Kenneth ; Do, Justin ; Ulrich, Emily ; Mishina, Yuji ; Zweifler, Laura E

Stress fractures occur as a result of repeated mechanical stress on bone and are commonly found in the load-bearing lower extremities. Macrophages are key players in the immune system and play an important role in bone remodeling and fracture healing. However, the role of macrophages in stress fractures has not been adequately addressed. We hypothesize that macrophage infiltration into a stress fracture callus site promotes bone healing. To test this, a unilateral stress fracture induction model was employed in which the murine ulna of four-month-old, C57BL/6 J male mice was repeatedly loaded with a pre-determined force until the bone was displaced a distance below the threshold for complete fracture. Mice were treated daily with parathyroid hormone (PTH, 50 μg/kg/day) starting two days before injury and continued until 24 h before euthanasia either four or six days after injury, or treated with trabectedin (0.15 mg/kg) on the day of stress fracture and euthanized three or seven days after injury. These treatments were used due to their established effects on macrophages. While macrophages have been implicated in the anabolic effects of PTH, trabectedin, an FDA approved chemotherapeutic, compromises macrophage function and reduces bone mass. At three- and four-days post injury, callus macrophage numbers were analyzed histologically. There was a significant increase in macrophages with PTH treatment compared to vehicle in the callus site. By one week of healing, treatments differentially affected the bony callus as analyzed by microcomputed tomography. PTH enhanced callus bone volume. Conversely, callus bone volume was decreased with trabectedin treatment. Interestingly, concurrent treatment with PTH and trabectedin rescued the reduction observed in the callus with trabectedin treatment alone. This study reports on the key involvement of macrophages during stress fracture healing. Given these observed outcomes on macrophage physiology and bone healing, these findings may be important for patients actively receiving either of these FDA-approved therapeutics.

项与甲状旁腺素(Shire Plc) 相关的新闻（医药）

2024-05-09

·GlobeNewswire-Health Care

Latest Clinical and Quality-of-Life Data for TransCon™ PTH (Palopegteriparatide)-Treated Adults with Chronic Hypoparathyroidism to Be Presented at ECE 2024

COPENHAGEN, Denmark, May 09, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that new TransCon PTH (palopegteriparatide) data supporting clinical and quality-of-life benefits in adult patients with chronic hypoparathyroidism will be presented at the European Congress of Endocrinology being held May 11-14, 2024, in Stockholm. Topics include an oral presentation of new 2-year results from a post-hoc analysis of the Phase 3 PaTHway Trial demonstrating sustained improvements in kidney function in adults with chronic hypoparathyroidism treated with TransCon PTH, as well as a symposium presentation on health and quality-of-life improvements in patients switching from rhPTH(1-84) to TransCon PTH as part of a compassionate use program. “We are pleased to partner with leading experts in endocrinology to present this new, groundbreaking data showing the health and quality-of-life benefits of initiating or switching to TransCon PTH treatment,” said Aimee Shu, M.D., Ascendis Pharma’s Senior Vice President of Clinical Development, Endocrine Medical Sciences. The full schedule of Ascendis presentations during ECE 2024 follow: Sunday, May 122:50 pm (2:40 pm session)Rooms A2-A3Oral PresentationSustained Improvement in Renal Function with Palopegteriparatide in Adults with Chronic Hypoparathyroidism: 2-Year Results from the Phase 3 PaTHway TrialDr. Peter SchwarzMonday, May 1312:40 – 1:55 pmRoom A7SymposiumReplacing What’s Missing in Chronic Hypoparathyroidism – Treatment with Palopegteriparatide Hypoparathyroidism, Current Management and Palopegteriparatide Dr. Andrea PalermoBone Metabolism & New 2-Year Renal Data Dr. Peter SchwarzPatient-Reported Outcomes & Initial Data from Compassionate Use of PalopegteriparatideDr. Heide Siggelkow 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 kidneys and indirectly on the intestines. 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 TransCon PTHTransCon PTH (palopegteriparatide) is a prodrug of parathyroid hormone (PTH 1-34) administered once daily, designed to provide parathyroid hormone levels within the normal physiological range across the 24-hour dosing period. TransCon PTH was granted marketing authorization under the brand name YORVIPATH® by the European Commission (EC) and the European Economic Area in November 2023 and by the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) in Great Britain in April 2024 as a PTH replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. In the United States, the U.S. Food & Drug Administration (FDA) has set a PDUFA date of May 14, 2024 to complete their review of Ascendis Pharma’s New Drug Application for TransCon PTH for adults with chronic hypoparathyroidism. TransCon PTH is also in development in Japan through Teijin Ltd. and in China through VISEN Pharmaceuticals. About Ascendis Pharma A/SAscendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. 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) TransCon PTH’s PDUFA date of May 14, 2024, (ii) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company and (iii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. 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. 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 7, 2024 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, TransCon, and YORVIPATH® are trademarks owned by the Ascendis Pharma group. © May 2024 Ascendis Pharma A/S. Investor Contacts: Media Contact:Tim Lee Melinda BakerAscendis Pharma Ascendis Pharma+1 (650) 374-6343 +1 (650) 709-8875tle@ascendispharma.com media@ascendispharma.com ir@ascendispharma.com Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com

临床3期上市批准

2024-05-03

·医药观澜

5月4款创新药有望获FDA批准，来自恒瑞医药等

▎药明康德内容团队编辑根据PDUFA的预期目标日期，预计5月，美国FDA将对4款创新药物的批准做出监管决定，本文将对这些疗法进行相关介绍。▲5月美国FDA可能批准的新药（药明康德内容团队制图，点击可见大图）活性成分：palopegteriparatide适应症：甲状旁腺功能减退症公司名称：Ascendis PharmaPalopegteriparatide是一种甲状旁腺激素（PTH）前药，它旨在每天将PTH恢复至生理水平24小时，以解决甲状旁腺功能减退的短期症状和长期并发症。去年12月，Ascendis Pharma宣布美国FDA已经接受了该公司为palopegteriparatide重新递交的新药申请（NDA），PDUFA目标日期为5月14日。此前公布的随机双盲、含安慰剂对照的3期临床试验结果包括82位慢性甲状旁腺功能减退成人患者。试验结果显示，接受palopegteriparatide治疗的患者中，78.7%的患者实现不依赖常规治疗，保持血清钙水平在正常范围内（8.3–10.6 mg/dL），在安慰剂组此数值仅有4.8%（p<0.0001）。此外，通过甲状旁腺功能减退患者体验量表（HPES）检测的患者身体症状和认知症状，均获得统计学显著减少。Palopegteriparatide已经在去年11月获得欧盟委员会批准上市，商品名为Yorvipath。它在今年4月还获得了英国监管机构的批准。活性成分：prademagene zamikeracel适应症：营养不良性大疱性表皮松解症公司名称：Abeona TherapeuticsPrademagene zamikeracel（pz-cel）是Abeona Therapeutics公司开发的一款基因疗法，旨在将功能性、产生胶原的COL7A1转基因递送到患者自身的皮肤细胞中，并通过使用逆转录病毒载体稳定整合到分裂的靶细胞DNA中，实现长期基因表达。去年11月，Abeona Therapeutics宣布美国FDA已接受为pz-cel递交的生物制品许可申请（BLA），并授予其优先审评资格，PDUFA目标日期为2024年5月25日。该BLA申请主要获得关键性3期临床试验VIITAL以及另一项1/2a期研究的临床疗效和安全性数据支持。两项研究均显示，在大型和慢性伤口上单次应用pz-cel治疗可实现持续伤口愈合和疼痛减轻。分析显示，该疗法在VIITAL试验中达成两项主要终点，大多数（81%）pz-cel治疗的伤口显示出≥50%的愈合程度，并且与对照伤口相比，pz-cel治疗的伤口中观察到疼痛严重程度有更大程度的减轻。即使在较早的时间点，与对照伤口相比，使用pz-cel治疗的伤口显示愈合的百分比和疼痛严重程度的降低也更大。▲接受pz-cel治疗后，显示出≥75%愈合程度的伤口（图片来源：参考资料[3]）活性成分：camrelizumab，rivoceranib适应症：肝细胞癌公司名称：Elevar Therapeutics，恒瑞医药卡瑞利珠单抗（camrelizumab）是恒瑞医药研发的人源化抗PD-1单克隆抗体，于2019年5月在中国获批上市，此前已在肺癌、肝癌、食管癌、鼻咽癌以及淋巴瘤五大瘤种中获批了9个适应症。阿帕替尼（rivoceranib）是恒瑞医药开发的一款针对血管内皮生长因子受体（VEGFR）的小分子酪氨酸激酶抑制剂，于2014年10月在中国获批上市，目前有3个适应症获批，分别为单药用于晚期胃腺癌或胃食管结合部腺癌、既往接受过至少一线系统性治疗后失败或不可耐受的晚期肝细胞癌、联合卡瑞利珠单抗用于不可切除或转移性肝细胞癌。2021年4月，卡瑞利珠单抗联合阿帕替尼一线治疗不可切除或转移性肝细胞癌适应症获得FDA孤儿药资格。2023年7月31日，恒瑞医药宣布，该公司提交的注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片（“双艾”组合）用于不可切除或转移性肝细胞癌患者的一线治疗的生物制品许可申请获得了美国FDA正式受理。2023年7月在《柳叶刀》发表的3期临床试验结果显示，在中位随访时间为7.8个月时，与对照组相比，“双艾”组合中位无进展生存期（mPFS）显著改善（5.6个月比3.7个月）；在总生存期中分析，中位随访时间为14.5个月，与对照组相比，“双艾”组合中位总生存期（mOS）显著延长（22.1个月比15.2个月）。试验中最常见的3级或4级治疗相关不良事件是高血压、手掌-足底红血病综合征、天冬氨酸转氨酶升高和丙氨酸转氨酶升高。去年10月，Elevar Therapeutics公司与恒瑞医药达成授权协议，获得卡瑞利珠单抗与阿帕替尼联合用于治疗肝细胞癌，除大中华区和韩国以外全球范围内开发及商业化的独家权利。参考资料：[1] FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism. Retrieved April 29, 2024, from https://investors.ascendispharma.com/news-releases/news-release-details/fda-accepts-review-resubmitted-nda-transcon-pth[2] Elevar Therapeutics and Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC. Retrieved April 29, 2024, from https://elevartherapeutics.com/2023/10/17/elevar-therapeutics-and-jiangsu-hengrui-pharma-announce-global-commercialization-licensing-agreement-for-pd-1-inhibitor-camrelizumab-in-combination-with-rivoceranib-for-uhcc/[3] International Societies for Investigative Dermatology (ISID) Meeting. Retrieved November 27, 2023 from https://d1io3yog0oux5.cloudfront.net/_f9f4f56b4e0fc6c658b01f45fca61800/abeonatherapeutics/db/440/4098/presentation/VIITAL+ISID+2023+Oral+Presentation_Dr+Jean+Tang+Final.d3.pdf本文来自药明康德内容团队，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载至其他平台。转载授权请在「药明康德」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。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。

优先审批临床3期临床结果基因疗法申请上市

2024-04-30

·药明康德

5月4款创新药有望获FDA批准

▎药明康德内容团队编辑根据PDUFA的预期目标日期，预计5月，美国FDA将对4款创新药物的批准做出监管决定，本文将对这些疗法进行相关介绍。▲5月美国FDA可能批准的新药（药明康德内容团队制图，点击可见大图）活性成分：palopegteriparatide适应症：甲状旁腺功能减退症公司名称：Ascendis PharmaPalopegteriparatide是一种甲状旁腺激素（PTH）前药，它旨在每天将PTH恢复至生理水平24小时，以解决甲状旁腺功能减退的短期症状和长期并发症。去年12月，Ascendis Pharma宣布美国FDA已经接受了该公司为palopegteriparatide重新递交的新药申请（NDA），PDUFA目标日期为5月14日。此前公布的随机双盲、含安慰剂对照的3期临床试验结果包括82位慢性甲状旁腺功能减退成人患者。试验结果显示，接受palopegteriparatide治疗的患者中，78.7%的患者实现不依赖常规治疗，保持血清钙水平在正常范围内（8.3–10.6 mg/dL），在安慰剂组此数值仅有4.8%（p<0.0001）。此外，通过甲状旁腺功能减退患者体验量表（HPES）检测的患者身体症状和认知症状，均获得统计学显著减少。Palopegteriparatide已经在去年11月获得欧盟委员会批准上市，商品名为Yorvipath。它在今年4月还获得了英国监管机构的批准。活性成分：prademagene zamikeracel适应症：营养不良性大疱性表皮松解症公司名称：Abeona TherapeuticsPrademagene zamikeracel（pz-cel）是Abeona Therapeutics公司开发的一款基因疗法，旨在将功能性、产生胶原的COL7A1转基因递送到患者自身的皮肤细胞中，并通过使用逆转录病毒载体稳定整合到分裂的靶细胞DNA中，实现长期基因表达。去年11月，Abeona Therapeutics宣布美国FDA已接受为pz-cel递交的生物制品许可申请（BLA），并授予其优先审评资格，PDUFA目标日期为2024年5月25日。该BLA申请主要获得关键性3期临床试验VIITAL以及另一项1/2a期研究的临床疗效和安全性数据支持。两项研究均显示，在大型和慢性伤口上单次应用pz-cel治疗可实现持续伤口愈合和疼痛减轻。分析显示，该疗法在VIITAL试验中达成两项主要终点，大多数（81%）pz-cel治疗的伤口显示出≥50%的愈合程度，并且与对照伤口相比，pz-cel治疗的伤口中观察到疼痛严重程度有更大程度的减轻。即使在较早的时间点，与对照伤口相比，使用pz-cel治疗的伤口显示愈合的百分比和疼痛严重程度的降低也更大。▲接受pz-cel治疗后，显示出≥75%愈合程度的伤口（图片来源：参考资料[3]）活性成分：camrelizumab，rivoceranib适应症：肝细胞癌公司名称：Elevar Therapeutics，恒瑞医药卡瑞利珠单抗（camrelizumab）是恒瑞医药研发的人源化抗PD-1单克隆抗体，于2019年5月在中国获批上市，此前已在肺癌、肝癌、食管癌、鼻咽癌以及淋巴瘤五大瘤种中获批了9个适应症。阿帕替尼（rivoceranib）是恒瑞医药开发的一款针对血管内皮生长因子受体（VEGFR）的小分子酪氨酸激酶抑制剂，于2014年10月在中国获批上市，目前有3个适应症获批，分别为单药用于晚期胃腺癌或胃食管结合部腺癌、既往接受过至少一线系统性治疗后失败或不可耐受的晚期肝细胞癌、联合卡瑞利珠单抗用于不可切除或转移性肝细胞癌。2021年4月，卡瑞利珠单抗联合阿帕替尼一线治疗不可切除或转移性肝细胞癌适应症获得FDA孤儿药资格。2023年7月31日，恒瑞医药宣布，该公司提交的注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片（“双艾”组合）用于不可切除或转移性肝细胞癌患者的一线治疗的生物制品许可申请获得了美国FDA正式受理。2023年7月在《柳叶刀》发表的3期临床试验结果显示，在中位随访时间为7.8个月时，与对照组相比，“双艾”组合中位无进展生存期（mPFS）显著改善（5.6个月比3.7个月）；在总生存期中分析，中位随访时间为14.5个月，与对照组相比，“双艾”组合中位总生存期（mOS）显著延长（22.1个月比15.2个月）。试验中最常见的3级或4级治疗相关不良事件是高血压、手掌-足底红血病综合征、天冬氨酸转氨酶升高和丙氨酸转氨酶升高。去年10月，Elevar Therapeutics公司与恒瑞医药达成授权协议，获得卡瑞利珠单抗与阿帕替尼联合用于治疗肝细胞癌，除大中华区和韩国以外全球范围内开发及商业化的独家权利。▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism. Retrieved April 29, 2024, from https://investors.ascendispharma.com/news-releases/news-release-details/fda-accepts-review-resubmitted-nda-transcon-pth[2] Elevar Therapeutics and Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC. Retrieved April 29, 2024, from https://elevartherapeutics.com/2023/10/17/elevar-therapeutics-and-jiangsu-hengrui-pharma-announce-global-commercialization-licensing-agreement-for-pd-1-inhibitor-camrelizumab-in-combination-with-rivoceranib-for-uhcc/[3] International Societies for Investigative Dermatology (ISID) Meeting. Retrieved November 27, 2023 from https://d1io3yog0oux5.cloudfront.net/_f9f4f56b4e0fc6c658b01f45fca61800/abeonatherapeutics/db/440/4098/presentation/VIITAL+ISID+2023+Oral+Presentation_Dr+Jean+Tang+Final.d3.pdf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：本文来自药明康德内容团队，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载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期优先审批基因疗法临床结果

100 项与甲状旁腺素(Shire Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲状旁腺素(Shire Plc)	H05AA03	DB05829

研发状态

适应症	最高研发状态	国家/地区	公司
甲状旁腺功能减退症	批准上市	欧盟更多	Takeda Pharmaceuticals International AG 更多
绝经期后骨质疏松	撤市	欧盟更多	NPS Pharma Holdings Ltd. 更多
骨质疏松症	无进展	美国更多	Shire Plc 更多
家族性高钙尿症性低钙血症	无进展	美国更多	Shire Plc 更多
骨折	无进展	加拿大更多	Shire Plc 更多

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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


NCT05137730 (CTgov)	临床1期	-	96	rhPTH(1-84) (Part I: Treatment A)	襯衊鬱艱醖襯襯網鑰繭(憲夢願襯鹽壓壓衊壓築) = 選築積網窪築艱顧鬱範鏇獵鹽淵選願繭衊願廠 (觸艱鏇艱築齋範淵淵餘, 願繭簾鏇積醖鬱衊醖遞 ~ 願積壓壓繭鬱遞淵襯鬱) 更多	-	2023-12-15
				rhPTH(1-84) (Part I: Treatment B)	襯衊鬱艱醖襯襯網鑰繭(憲夢願襯鹽壓壓衊壓築) = 製衊窪範鏇淵襯夢艱鏇鏇獵鹽淵選願繭衊願廠 (觸艱鏇艱築齋範淵淵餘, 糧鬱廠糧網餘網鏇繭鏇 ~ 選膚鑰鑰艱網願夢衊蓋) 更多
NCT03324880 (CTgov)	临床4期	甲状旁腺功能减退症	93	Placebo (Placebo)	齋壓獵憲獵餘壓齋齋衊(築鑰憲繭艱顧齋積鑰膚) = 繭齋網鹹衊鬱選願糧鹽齋鹽構餘遞壓蓋膚構構 (鏇艱築齋選襯鹽壓醖齋, 蓋鑰鹽製壓築壓鏇積獵 ~ 淵廠餘繭壓夢艱願餘鬱) 更多	-	2023-06-09
				rhPTH (1-84) (rhPTH (1-84))	齋壓獵憲獵餘壓齋齋衊(築鑰憲繭艱顧齋積鑰膚) = 糧繭鬱簾淵製製蓋廠餘齋鹽構餘遞壓蓋膚構構 (鏇艱築齋選襯鹽壓醖齋, 憲憲繭鑰簾鹽網醖鏇艱 ~ 鹽醖壓淵範範選餘範糧) 更多
Pubmed	N/A	甲状旁腺功能减退症	72	rhPTH(1-84)	醖膚積壓鏇遞膚淵觸廠(製積鹹製鹽憲簾襯襯鏇) = 壓鹹顧憲餘窪壓鏇衊網遞襯淵遞顧廠蓋願淵淵 (簾膚積壓醖窪繭襯觸願 )	积极	2022-08-26
				rhPTH(1-84) (Control)	醖膚積壓鏇遞膚淵觸廠(製積鹹製鹽憲簾襯襯鏇) = 糧淵選遞鹹窪蓋廠構膚遞襯淵遞顧廠蓋願淵淵 (簾膚積壓醖窪繭襯觸願, 1.67 mL/min/1.73 m^2 per year)
REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) (Pubmed)	N/A	甲状旁腺功能减退症	113	rhPTH(1-84)	鑰襯鑰艱艱窪鹽積餘範(鬱築獵繭鬱衊顧簾襯選) = 鏇鏇鏇糧夢醖獵鹽觸鬱築窪鹽構襯蓋艱蓋製衊 (構窪淵壓築鹽觸鏇蓋廠 )	-	2022-06-11
				rhPTH(1-84) (Control)	鑰襯鑰艱艱窪鹽積餘範(鬱築獵繭鬱衊顧簾襯選) = 衊鑰襯獵製襯簾醖願糧築窪鹽構襯蓋艱蓋製衊 (構窪淵壓築鹽觸鏇蓋廠 )
ESC2021	N/A	肺性高血压 PTH	20	PTH treatment	簾餘遞艱齋鑰簾餘鹽衊(獵餘構襯選選積鏇範網) = 鑰壓願衊壓簾積積選繭齋構窪膚繭繭蓋蓋糧夢 (鏇衊鹽鬱觸窪壓淵願淵 )	-	2021-08-27
				Parathyroid hormone	簾餘遞艱齋鑰簾餘鹽衊(獵餘構襯選選積鏇範網) = 範鏇艱製簾築繭窪廠獵齋構窪膚繭繭蓋蓋糧夢 (鏇衊鹽鬱觸窪壓淵願淵 )
NCT02910466 (CTgov)	临床4期	甲状旁腺功能减退症	39	rhPTH(1-84)	鏇齋艱襯鹽願鹹獵積蓋(鏇範築齋遞獵窪獵鏇膚) = 鹹淵夢鏇獵構鏇積夢鏇鏇顧醖鹹遞襯簾壓淵繭 (夢鬱糧獵糧顧鑰獵鬱鏇, 醖範鏇膚衊窪鬱鑰鏇鑰 ~ 顧壓選顧壓淵窪積願網) 更多	-	2021-07-28
NCT03364738 (CTgov)	临床3期	甲状旁腺功能减退症	22	rhPTH(1-84)	膚範築鏇顧鏇鹹廠艱襯(壓鏇鑰獵簾鹽糧醖襯觸) = 鹹廠觸積鬱鹹艱選範窪鑰廠觸膚壓艱壓醖製鏇 (齋繭齋築網醖餘餘築築, 膚艱淵壓獵顧網憲顧膚 ~ 網網壓顧糧膚蓋選醖簾) 更多	-	2021-06-16
NCT01268098 \| NCT02910466 \| NCT01297309 \| NCT00732615 (Pubmed \| J Clin Endocrinol Metab)	N/A	甲状旁腺功能减退症	-	rhPTH(1-84) cohort	襯鏇鏇築觸夢繭繭鹹鑰(遞鏇憲窪鹽選鹹築淵範) = 憲顧艱鬱鑰製鹽憲獵遞鹽餘糧構衊艱鑰蓋構醖 (鹹蓋膚範糧遞憲衊鑰獵 )	-	2020-08-01
NCT02204579 (Pubmed \| N Engl J Med) 人工标引	临床2期	低钙血症，常染色体显性遗传 1	-	SHP635	夢淵窪鑰壓衊艱積網壓(鬱蓋壓憲淵糧糧鬱夢夢) = 遞齋窪觸構鹽鑰選窪壓鹽襯築顧窪鬱鹹壓遞繭 (鬱選鹽廠獵膚窪窪鑰膚 )	积极	2019-09-01
NCT01297309 (CTgov)	临床3期	甲状旁腺功能减退症	51	rhPTH (1-84)	網窪築鹹構夢觸壓壓簾(願齋積繭鏇積廠遞膚憲) = 積鹽憲壓衊齋獵窪願願艱壓遞壓壓壓選襯襯齋 (積壓範鬱願淵鏇簾鬱鏇, 鑰觸窪齋網觸鏇簾齋膚 ~ 艱構積鹹糧網築鬱艱構) 更多	-	2019-08-06