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 / Active, not recruiting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 a fixed dose of study drug and will be individually and progressively titrated to an optimal dose over a 10 week period, followed by an individualized dosing period up to 16 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. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, and Denmark.

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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项与帕罗培特立帕肽相关的文献（医药）

2024-06-01·ADVANCES IN THERAPY

Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial

Article

作者: Tsourdi, Elena ; Ominsky, Michael S ; Imanishi, Yasuo ; Sprague, Stuart ; Zhao, Carol ; Lai, Bryant ; Sibley, Christopher T ; Palermo, Andrea ; Makita, Noriko ; Gosmanova, Elvira O ; Khan, Aliya A ; Rejnmark, Lars ; Rubin, Mishaela R ; Takeuchi, Yasuhiro ; Makara, Michael A ; Kohlmeier, Lynn ; Ukena, Jenny ; Gagnon, Claudia ; Shoback, Dolores M ; Schwarz, Peter ; Shu, Aimee D

INTRODUCTION:

Individuals with chronic hypoparathyroidism managed with conventional therapy (active vitamin D and calcium) have an increased risk for renal dysfunction versus age- and sex-matched controls. Treatments that replace the physiologic effects of parathyroid hormone (PTH) while reducing the need for conventional therapy may help prevent a decline in renal function in this population. This post hoc analysis examined the impact of palopegteriparatide treatment on renal function in adults with chronic hypoparathyroidism.

METHODS:

PaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period. Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR). A subgroup analysis was performed with participants stratified by baseline eGFR < 60 or ≥ 60 mL/min/1.73 m².

RESULTS:

At week 52, over 95% (78/82) of participants remained enrolled in the OLE and of those, 86% maintained normocalcemia and 95% achieved independence from conventional therapy (no active vitamin D and ≤ 600 mg/day of calcium), with none requiring active vitamin D. Treatment with palopegteriparatide over 52 weeks resulted in a mean (SD) increase in eGFR of 9.3 (11.7) mL/min/1.73 m² from baseline (P < 0.0001) and 43% of participants had an increase ≥ 10 mL/min/1.73 m². In participants with baseline eGFR < 60 mL/min/1.73 m², 52 weeks of treatment with palopegteriparatide resulted in a mean (SD) increase of 11.5 (11.3) mL/min/1.73 m² (P < 0.001). One case of nephrolithiasis was reported for a participant in the placebo group during blinded treatment; none were reported through week 52 with palopegteriparatide.

CONCLUSION:

In this post hoc analysis of the PaTHway trial, palopegteriparatide treatment was associated with significantly improved eGFR at week 52 in addition to previously reported maintenance and normalization of serum and urine biochemistries. Further investigation of palopegteriparatide for the preservation of renal function in hypoparathyroidism is warranted.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT04701203.

2024-04-30·Endocrinology and metabolism (Seoul, Korea)

Treatment of Hypoparathyroidism by Re-Establishing the Effects of Parathyroid Hormone

Review

作者: Rejnmark, Lars

The conventional treatment of hypoparathyroidism (HypoPT) includes active vitamin D and calcium. Despite normalization of calcium levels, the conventional treatment is associated with fluctuations in calcium levels, hypercalciuria, renal impairment, and decreased quality of life (QoL). Replacement therapy with parathyroid hormone (PTH)(1-84) is an option in some countries. However, convincing beneficial effects have not been demonstrated, which may be due to the short duration of action of this treatment. Recently, palopegteriparatide (also known as TransCon PTH) has been marketed in Europe and is expected also to be approved in other countries. Palopegteriparatide is a prodrug with sustained release of PTH(1-34) designed to provide stable physiological PTH levels for 24 hours/day. A phase 3 study demonstrated maintenance of normocalcemia in patients with chronic HypoPT, with no need for conventional therapy. Furthermore, this treatment lowers urinary calcium and improves QoL. Another long-acting PTH analog with effects on the parathyroid hormone receptor (eneboparatide) is currently being tested in a phase 3 trial. Furthermore, the treatment of autosomal dominant hypocalcemia type 1 with a calcilytic (encaleret) is also being tested. All in all, improved treatment options are on the way that will likely take the treatment of HypoPT to the next level.

2022-01-01·The Journal of clinical endocrinology and metabolism2区 · 医学

PaTH Forward: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of TransCon PTH in Adult Hypoparathyroidism

2区 · 医学

Article

作者: Pagotto, Uberto ; Karpf, David B ; Rubin, Mishaela ; Vokes, Tamara ; Eriksen, Erik ; Palermo, Andrea ; Brod, Meryl ; Clarke, Bart ; Mourya, Sanchita ; Khan, Aliya A ; Smith, Alden ; Schwarz, Peter ; Pihl, Susanne ; Shu, Aimee D ; Rejnmark, Lars ; Marcocci, Claudio ; Markova, Denka ; Ahmed, Intekhab ; Hofbauer, Lorenz

Abstract:

Context:

Hypoparathyroidism is characterized by insufficient levels of parathyroid hormone (PTH). TransCon PTH is an investigational long-acting prodrug of PTH(1-34) for the treatment of hypoparathyroidism.

Objective:

This work aimed to investigate the safety, tolerability, and efficacy of daily TransCon PTH in adults with hypoparathyroidism.

Methods:

This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism. Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).

Results:

By Week 26, 91% of participants treated with TransCon PTH achieved independence from standard of care (SoC, defined as active vitamin D = 0 μg/day and calcium [Ca] ≤ 500 mg/day). Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while normal serum Ca (sCa) was maintained and serum phosphate and serum calcium-phosphate product fell within the normal range. By Week 26, mean scores on the generic 36-Item Short Form Health Survey domains increased from below normal at baseline to within the normal range. The Hypoparathyroidism Patient Experience Scale symptom and impact scores improved through 26 weeks. TransCon PTH was well tolerated with no treatment-related serious or severe adverse events.

Conclusion:

TransCon PTH enabled independence from oral active vitamin D and reduced Ca supplements (≤ 500 mg/day) for most participants, achieving normal sCa, serum phosphate, uCa, serum calcium-phosphate product, and demonstrating improved health-related quality of life. These results support TransCon PTH as a potential hormone replacement therapy for adults with hypoparathyroidism.

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项与帕罗培特立帕肽相关的新闻（医药）

2024-12-25

·GlobeNewswire-Health Care

YORVIPATH® (Palopegteriparatide) Now Commercially Available in the United States for the Treatment of Hypoparathyroidism in Adults

Dec. 19, 2024 -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide; developed as TransCon PTH) is now commercially available by prescription in the United States. YORVIPATH is a prodrug of parathyroid hormone (PTH [1-34]), administered once-daily, designed to provide continuous exposure to active PTH over the 24-hour dosing period. It is the first and only medicine approved by the U.S. Food & Drug Administration (FDA) for the treatment of hypoparathyroidism in adults. “Members of our community have shared so many stories of positive changes in their lives while participating in clinical trials of YORVIPATH,” said Patty Keating, Executive Director of the HypoPARAthyroidism Association. “We are thrilled that YORVIPATH is now available in the United States, giving patients and physicians here a new approach to treating the underlying cause of this often-debilitating hormone deficiency.” “We are pleased to make YORVIPATH commercially available in the United States, where it is the first and only FDA-approved treatment of hypoparathyroidism in adults,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “We recognize the urgent unmet medical needs of the hypoparathyroidism community and are committed to doing all we can to ensure patients have affordable and broad access to YORVIPATH.” Reflecting this commitment, Ascendis has established a dedicated YORVIPATH team within the U.S. Ascendis Signature Access Program® to support the patient treatment journey, which is staffed by specially trained nurses and offers a full suite of programs designed to help patients, caregivers, and physicians navigate each step of the treatment process. These include clinical education, assistance with prior authorization and appeals, training on proper injection procedures, and co-pay and other related assistance for eligible patients. Hypoparathyroidism 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, 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. Ascendis 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. The content above comes from the network. if any infringement, please contact us to modify.

上市批准

2024-12-16

·BiG生物创新社

2024年FDA批准的重磅大分子药物

随着医学科技的迅猛发展和创新药物研发的不断深入，2024年再次见证了FDA在药物审批方面的重大进展。这一年，FDA批准了多种新药上市，这些药物不仅为患者带来了全新的治疗方案，更在疾病治疗领域取得了突破性进展。作者｜momo 相关阅读：2024年FDA批准的重磅小分子药物表1. FDA批准的17种大分子药物截至2024年12月16日，FDA已经批准44款新药上市，其中包括17款生物大分子药物（图1），在获批的生物大分子药物中，单抗药物依旧是创新主力，以59%（10款）的占比遥遥领先；其次是双抗，有3款（占比17%）；蛋白类药物2款（占比12%）；小核酸药物和甲状旁腺激素类似物各1款（分别占比6%）。图1. 2024 年 FDA 批准生物大分子药物类型本文将对2024年FDA批准上市的生物大分子药物进行详细介绍，探讨其在各自疾病领域的重要性及潜在影响。 1.Letybo（letibotulinumtoxinA-wlbg）适应症：中度至重度眉间纹的外观改善靶点：BoNT/A 批准日期：2024年2月29日企业：Hugel Inc. Letybo是一种乙酰胆碱释放抑制剂和神经肌肉阻滞剂，通过肌肉内注射，用于暂时改善成年患者与皱眉肌和/或降眉肌活动相关的中度至重度眉间纹外观。Letybo获得FDA的批准得到了三项已完成的3期试验的积极结果支持，这些试验在美国和欧洲招募了1000多名受试者。Letybo的临床试验结果证明了其在治疗眉间纹方面的有效性和安全性。 2.Tevimbra （tislelizumab-JSGR）适应症：不可切除、局部晚期或转移性食管鳞状细胞癌靶点：PD-1 批准日期：2024年3月13日企业：百济神州 Tevimbra是一款人源化IgG4抗PD-1单克隆抗体，设计目的旨在最大限度地减少与巨噬细胞中的Fcγ受体结合，帮助人体免疫细胞检测和对抗肿瘤细胞。用于治疗既往接受过全身化疗（不包括PD-1或PD-L1类疗法），患有不可切除或转移性食管鳞状细胞癌（ESCC）的成年患者。这是Tevimbra首次在美国获批。Tevimbra于2023年获得欧盟委员会批准用于治疗既往曾接受过化疗的晚期或转移性ESCC患者，并于2024年2月获得欧洲药品管理局（EMA）人用药品委员会的推荐，用于治疗非小细胞肺癌。在中国，该疗法已有12个适应症获得批准。 3.Winrevair （sotatercept-CSRK）适应症：肺动脉高压靶点：INHBA 批准日期：2024年3月26日企业：默克 Winrevair是一款“first-in-class”的IIA型激活素受体（ActRIIA）融合蛋白。它将ActRIIA经过改造的细胞外域与抗体的Fc端融合在一起。它可以阻断激活素与细胞膜上的受体结合，从而降低激活素介导的信号传导。用于治疗肺动脉高压（PAH）患者。Winrevair是默沙东于2021年以约115亿美元收购Acceleron Pharma公司获得的关键疗法。值得一提的是，这款疗法被行业媒体Evaluate评为2024年有望获批的潜在重磅疗法之一。 4.Anktiva （nogapendekin alfa inbakicept-pmln）适应症：膀胱癌靶点：IL-15R 批准日期：2024年4月22日企业：Altor Bioscience Corp. Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。用于治疗对BCG无应答且伴有原位癌（CIS）的非肌层浸润性膀胱癌（NMIBC）成年患者。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。此外，行业媒体Evaluate在今年初将这款疗法列为今年有望获批的10款潜在重磅疗法之一。 5.Imdelltra （tarlatamab-dlle）适应症：广泛期小细胞肺癌靶点：CD3E、DLL3 批准日期：2024年5月16日企业：安进 Imdelltra是一款“first-in-class”双特异性抗体（bsAbs），通过结合肿瘤细胞上的 DLL3 蛋白和 T 细胞上的 CD3 抗原，激活人体的免疫细胞并诱导表达 DLL3 的癌细胞被破坏。用于治疗铂类化疗期间或之后疾病进展的广泛期小肺癌（SCLC）患者。Imdelltra在今年5月获FDA加速批准用于治疗ES-SCLC成人患者，他们在接受化疗时或之后出现疾病进展。值得一提的是，Imdelltra是首款用于治疗实体瘤的获批BiTE疗法。 6.Rytelo （imetelstat）适应症：低危骨髓增生异常综合征伴输血依赖性贫血靶点：Telomerase 批准日期：2024年6月6日企业：Geron Corp. Rytelo是一款“first-in-class”的寡核苷酸端粒酶抑制剂，通过抑制端粒酶活性，抑制癌变干细胞和祖细胞不可控制的增殖，导致癌变细胞的凋亡。用于治疗患有低风险至中等-1风险的骨髓增生异常综合征（MDS）成年患者。Rytelo是40年来首个获美国FDA批准的端粒酶靶向疗法。Rytelo被行业媒体Evaluate列为今年10大潜在重磅疗法之一。 7.Piasky （crovalimab-akkz）适应症：阵发性睡眠性血红蛋白尿症靶点：C5 批准日期：2024年6月20日企业：Sino-Foreign Pharmaceutical Co., Ltd. Piasky是一款靶向补体蛋白C5的可循环使用人源化单克隆抗体，能够阻止C5裂解为C5a和C5b，阻止终末补体通路，从而防止红细胞在阵发性睡眠性血红蛋白尿症（PNH）等疾病中的破坏。用以治疗阵发性睡眠性血红蛋白尿症（PNH）患者。Piasky是PNH的首个每月皮下注射治疗药物，且患者可以选择在受监督的医疗机构之外进行自我给药。 8.Kisunla（Donanemab-azbt）适应症：阿尔茨海默病靶点：pGlu3Aβ 批准日期：2024年7月2日企业：礼来 Kisunla是一款靶向β淀粉样蛋白（Aβ）的单克隆抗体，它能与N3pG的淀粉样蛋白亚型特异性结合，从而促进淀粉样斑块的清除。用于治疗出现早期症状的阿尔茨海默病（AD）的成年人。Kisunla是首个有证据表明在淀粉样斑块清除后可停止治疗的淀粉样斑块靶向疗法。2021年6月，Donanemab被FDA授予突破性疗法认定。 9.Yorvipath（palopegteriparatide）适应症：甲状旁腺功能亢进靶点：PTH1R 批准日期：2024年8月9日企业：Ascendis Pharma. Yorvipath是一种长效甲状旁腺激素（PTH）前药，旨在将甲状旁腺功能减退（HP）患者的PTH恢复至生理水平，以解决HP导致的血钙含量降低、血液磷酸盐水平升高等问题。用于治疗成人慢性甲状旁腺功能减退。该产品为甲状旁腺功能减退的首款激素替代疗法。 10.Nemluvio（nemolizumab-ilto）适应症：结节性痒疹靶点：IL-31 批准日期：2024年8月12日企业：Galderma Pharma. Nemluvio是一种”first-in-class”单克隆抗体，它通过与IL-31受体α相结合，可以阻断IL-31的信号通路，用于治疗成人结节性痒疹（prurigo nodularis）患者。Nemluvio是首款获得FDA批准用以抑制IL-31信号的单克隆抗体，它曾在2019年获得美国FDA授予突破性疗法认定，并在今年2月获得治疗结节性痒疹的优先审评资格。 11.Niktimvo（axatilimab-csfr）适应症：慢性移植物抗宿主病靶点：CSF-1R 批准日期：2024年8月14日企业：Incyte/Syndax制药 Niktimvo是一种靶向集落刺激因子-1受体（CSF-1R）的单克隆抗体，用于治疗慢性移植物抗宿主病（cGVHD）成人和体重40公斤以上的儿科患者。Niktimvo是全球首个获得批准用于治疗慢性移植物抗宿主病（GVHD）的CSF-1R单克隆抗体疗法。 12.Ebglyss（lebrikizumab-lbkz）适应症：中度至重度特应性皮炎靶点：IL-13 批准日期：2024年9月13日企业：礼来 Ebglyss是一种单克隆抗体，能高亲和力结合IL-13，有效阻止IL-13Rα1/IL-4Rα异二聚体复合物的形成及其后续信号传导。用于治疗中度至重度特应性皮炎（AD）成年和青少年患者。Ebglyss于2023年获得欧盟委员会批准，并于2024年1月在日本获得批准。 13.Hympavsi（marstacimab-hncq）适应症：预防或减少与血友病A或B相关的出血事件靶点：BCMA 批准日期：2024年10月11日企业：辉瑞 Hympavsi是一种靶向TFPI的人源IgG1单克隆抗体，通过靶向TFPI的Kunitz-2结构域，重新建立出血和凝血之间的平衡；用于预防或减少患有 A 型血友病（先天性第 VIII 因子缺乏症）和B 型血友病（先天性第 IX 因子缺乏症）成人和 12 岁及以上儿童患者的出血发作频率。Hympavzi是FDA批准治首款只需每周一次皮下注射的血友病B疗法。 14.Vyloy（Zolbetuximab-clzb）适应症：胃或胃食管结合部腺癌靶点：Claudin 18.2 批准日期：2024年10月18日企业：安斯泰来 Vyloy是一种“first-in-class”的靶向CLDN18.2的单克隆抗体，被美国FDA批准与氟尿嘧啶和铂类化疗联合用于一线治疗HER2阴性、其肿瘤经FDA批准的检测确定为Claudin18.2阳性的局部晚期不可切除或转移性胃或胃食管交界处（GEJ）腺癌。Vyloy是全球首个获批的靶向Claudin 18.2的治疗药物。 15.Ziihera（zanidatamab）适应症：HER2阳性（IHC 3+）的经治无法切除或转移性胆道癌靶点：HER2 批准日期：2024年11月20日企业：Jazz Pharmaceuticals Ziihera是一种具有新作用机制的HER2靶向双特异性抗体，可靶向HER2蛋白上两个不重复的抗原表位，用于治疗经FDA批准检测确诊为HER2阳性（IHC 3+）的经治无法切除或转移性胆道癌（BTC）成人患者。FDA曾授予Ziihera突破性疗法认定，快速通道资格、孤儿药资格。 16.Bizengri（zenocutuzumab）适应症：胰腺导管腺癌或非小细胞肺癌靶点：HER2、HER3 批准日期：2024年12月4日企业：Merus Bizengri是一种双特异性抗体，能结合表达在细胞（包括肿瘤细胞）表面的HER2和HER3的细胞外结构域，抑制HER2与HER3形成二聚体并阻止NRG1与HER3的结合，用于治疗携带NRG1基因融合（NRG1+）的晚期不可切除或转移性胰腺导管腺癌或非小细胞肺癌（NSCLC）成年患者。Bizengri是FDA批准的首款治疗这一患者群体的靶向疗法，FDA也曾授予Bizengri突破性疗法认定。 17.Unloxcyt（cosibelimab）适应症：皮肤鳞状细胞癌靶点：PD-L1 批准日期：2024年12月14日企业：Checkpoint Therapeutics Unloxcyt是一种完全人源化、具有高亲和力的单克隆抗体，可直接与PD-L1结合，从而阻断其与PD-1以及B7.1受体的相互作用，进而除去PD-L1对CD8阳性T细胞的抑制效果，恢复其毒杀性T细胞反应。用于治疗转移性皮肤鳞状细胞癌（cSCC）或不适合治愈性手术或放疗的局部晚期cSCC成年患者。Unloxcyt是首个获批用于治疗晚期cSCC患者的PD-L1靶向抗体。参考资料 [1] https://www.fda.gov/ [2]各种公开资料共建Biomedical创新生态圈！如何加入BiG会员？

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○ 动脉网“供需对接”产业链接平台，高效对接行业资源，助力业绩增长 ○ 现已上线供需信息近千条，累计实现企业成功对接次数超2千次 ○ 持续精选供需信息合集发布，并精准推送到动脉网相关领域社群（总覆盖人数超3W+）我们每周精选一批最热门、最具价值的供需链接，为您提供深度的行业洞察，助您把握行业动态和商业先机。欢迎大家通过下方小程序进入详情页咨询： 01 维昇药业-内分泌疾病产品和治疗方案项目亮点： 1.隆培促生长素隆培促生长素是目前唯一一款可在体内持续释放未经修饰的生长激素分子、具有“天然作用”的长效生长激素； 2.那韦培肽那韦培肽（TransCon C-型利钠肽）是维昇药业一款用于儿童软骨发育不全（ACH）的在研创新疗法；3.帕罗培特立帕肽维昇药业在研的帕罗培特立帕肽，就是一款可用于甲旁减激素替代治疗的创新药物。点击小程序查看详情： 02 曦健科技-便携式骨骼肌结构与力学性能融合成像仪项目亮点：软组织力学定量检测仪是一种针对软组织在体、无创的力学定量检测的创新产品，能够从“结构”“性能”“功能”等多个维度对肌肉和肌腱进行力学评估，可广泛应用于人体各部位肌肉的力学定量评估场景，包括肌力和肌张力的定量评估、肩颈疼痛及腱鞘炎的诊断、肌肉疲劳评估，以及肌少症的评估和筛查等。点击小程序查看详情： 03 诺一迈尔-闻诺®明胶-聚己内酯分层牙龈修复膜项目亮点： 1.口服小分子治疗IBD及其他自免疾病。目前中重度IBD治疗主要靠生物药，口服小分子药物存在巨大的市场需求。2.同靶点小分子药物全球前三位，目前已完成PCC，专利已申请；3.肠道限制性分布（浓度高于血液1000倍以上），对肠道以外的免疫系统影响极小。在动物模型上疗效等同或优于Jak抑制剂和S1P调节剂，但临床感染风险远远低于这些药物，且在临床上有望降低疾病复发。点击小程序查看详情： 04 赛德欧-磁牵引术野暴露系统项目亮点： 1.无需额外穿刺，可随时灵活调整牵拉位置，对手术部位周围组织的作用力更为轻柔、均匀，避免了因过度牵拉造成的组织撕裂、挫伤等机械性损伤。 2.由于减少了组织损伤的可能性，相应地降低了因组织损伤引发的局部炎症反应和感染风险，有助于患者减轻术后疼痛与不适、加速组织愈合、实现更快恢复、更轻疼痛、更少疤痕。 3.推动了术式的创新。医生可根据手术方式、时间、进程、患者因素及个人经验，灵活应用该系统。点击小程序查看详情： 05 集思鸣智-全球首款大脑生理与认知功能辅助评估系统项目亮点： 1.三位顶尖科学家联合创办2.国产自主知识产权3.国内最大规模高精度眼动数据库4.拥有全球首款基于眼动对轻度认知功能障碍进行辅助诊断的创新医疗器械并取得医疗器械注册证点击小程序查看详情：您也可以点击下方图片进入小程序，自主发布，高效对接：近期推荐搜索组件错误占位声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

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
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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


NCT05387070 (PaTHway, PRNewswire) 人工标引	临床3期	甲状旁腺功能减退症	-	Palopegteriparatide	鏇鏇膚網蓋糧鏇淵壓顧(夢觸壓鑰淵襯鑰鏇蓋糧) = 齋窪齋醖簾壓窪廠獵鹹積憲繭廠窪獵選觸鏇鹽 (襯繭鏇鬱艱淵網範壓夢 ) 更多	积极	2024-08-12
				Placebo	鏇鏇膚網蓋糧鏇淵壓顧(夢觸壓鑰淵襯鑰鏇蓋糧) = 觸醖積齋範夢憲鹽蓋積積憲繭廠窪獵選觸鏇鹽 (襯繭鏇鬱艱淵網範壓夢 )
NCT04701203 (FDA_CDER) 人工标引	临床3期	甲状旁腺功能减退症	82	YORVIPATH	簾獵糧齋範蓋衊繭鏇廠(觸鹹壓簾獵獵構淵餘構) = 顧壓餘築鏇鬱夢積構蓋簾鹽醖鹽積遞壓選襯艱 (網範壓憲膚廠憲獵糧鹹 ) 更多	积极	2024-08-09
				Placebo	簾獵糧齋範蓋衊繭鏇廠(觸鹹壓簾獵獵構淵餘構) = 願淵鹹齋獵襯艱憲鹽醖簾鹽醖鹽積遞壓選襯艱 (網範壓憲膚廠憲獵糧鹹 ) 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)	醖夢製襯鬱簾餘鑰齋鑰(糧築鏇蓋築繭範齋蓋鬱) = 鏇壓窪觸鹽鹹鹹壓淵襯遞積糧顧簾襯夢築範選 (蓋顧鑰鏇願簾遞窪顧鬱 ) 更多	积极	2024-05-13
				TransCon PTH (palopegteriparatide) (eGFR < 60 mL/min/1.73m2)	醖夢製襯鬱簾餘鑰齋鑰(糧築鏇蓋築繭範齋蓋鬱) = 構鹹鏇遞膚廠壓鬱構範遞積糧顧簾襯夢築範選 (蓋顧鑰鏇願簾遞窪顧鬱 ) 更多
PaTHway (ENDO2023)	临床3期	甲状旁腺功能减退症	82	TransCon PTH	鹹簾壓膚觸憲顧觸簾壓(獵衊鹹鬱醖鑰遞鑰積遞) = trended toward norms from baseline to Weeks 26 and 52 夢窪顧範壓願壓觸淵鬱 (簾窪鏇網鏇製衊鑰廠範 ) 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)	製衊鑰遞壓窪憲艱範鏇(鹹觸糧築鬱願淵網簾範) = 繭蓋膚選夢襯鬱獵鹹艱網範鏇網製壓選蓋壓窪 (鑰蓋衊築選鏇選願遞衊, 鏇網鏇襯衊觸獵醖鏇衊 ~ 膚壓遞鹽衊艱憲廠醖簾) 更多	-	2023-09-01
				TransCon PTH (TransCon PTH 18 mcg)	製衊鑰遞壓窪憲艱範鏇(鹹觸糧築鬱願淵網簾範) = 窪廠構遞顧壓艱鹽夢鹹網範鏇網製壓選蓋壓窪 (鑰蓋衊築選鏇選願遞衊, 憲淵網獵遞積夢構獵獵 ~ 糧鹽觸鏇襯鬱鑰膚願淵) 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	淵夢網構簾鑰網鹹壓蓋(糧鑰築遞淵齋獵鑰觸遞) = 網膚鹽糧衊壓遞積範憲構築窪築衊夢遞憲壓觸 (醖選齋鏇膚願鹹觸鏇餘 ) 更多	积极	2022-11-01
				TransCon PTH 18 mcg/d	淵夢網構簾鑰網鹹壓蓋(糧鑰築遞淵齋獵鑰觸遞) = 窪廠蓋繭選簾製遞憲壓構築窪築衊夢遞憲壓觸 (醖選齋鏇膚願鹹觸鏇餘 ) 更多
PaTHway (ENDO2022)	临床3期	-	82	TransCon PTH 18 mcg/d	襯夢製積積齋顧衊願艱(願鹽醖鏇壓衊廠顧觸壓) = The most commonly reported study drug-related AEs were headaches 鏇積繭膚衊齋廠範餘鬱 (鏇顧艱簾艱遞顧構繭積 ) 更多	积极	2022-11-01
				Placebo
NCT04009291 (PaTH Forward, Corporate Publications) 人工标引	临床2期	-	57	TransCon™ PTH	憲簾淵夢願襯鏇鹹餘積(網廠鹹鹽範鏇繭膚鹹蓋) = 獵齋淵築艱窪繭淵顧淵夢艱鬱醖衊鏇獵蓋構構 (窪網艱積觸製願顧構選 ) 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)	積觸淵窪遞鹽醖鏇網憲(衊獵鹹齋觸壓鑰衊積觸) = lower baseline levels 壓憲艱壓醖蓋蓋艱餘蓋 (鬱鹹積廠窪製積選簾鹹 ) 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	夢膚積襯鹽鑰膚蓋顧顧(鹽壓淵蓋簾餘製艱糧鏇) = 製鹹願鬱膚糧鬱積積蓋壓蓋膚窪簾觸鹽遞鏇窪 (餘鬱製夢窪鬱鹹繭範構, 66.3 ~ 88.1) 更多	积极	2022-03-13
				Placebo	夢膚積襯鹽鑰膚蓋顧顧(鹽壓淵蓋簾餘製艱糧鏇) = 顧壓襯鹽範繭艱鹹顧鹽壓蓋膚窪簾觸鹽遞鏇窪 (餘鬱製夢窪鬱鹹繭範構, 0.1 ~ 23.8) 更多