更新于：2024-04-26
Palopegteriparatide
帕罗培特立帕肽
更新于：2024-04-26
概要
基本信息
药物类型 激素 |
别名 TransCon parathyroid hormone、TransCon PTH、TransCon-PTH + [3] |
作用机制 CaSR拮抗剂(钙敏感受体拮抗剂)、PTH1R调节剂(甲状旁腺激素受体调节剂)、骨生成刺激剂 |
治疗领域 |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2023-11-20), |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)、优先审评 (澳大利亚) |
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序列信息
Sequence Code 4953
来源: *****
关联
6
项与 帕罗培特立帕肽 相关的临床试验PaTHway China 试验：评价每日一次皮下注射 TransCon PTH 用于治疗成人甲状旁腺功能减退症的安全性和有效性的随机、双盲、安慰剂对照、平行设计的多中心 III 期临床试验（包含开放性扩展阶段）
评估 TransCon PTH 治疗 26 周后，对控制血钙（sCa）正常且停用常规治疗的有效性。常规治疗指活性维生素 D（骨化三醇）或其类似物（阿法骨化醇），联合钙补充剂>600 mg/天。
开始日期2021-11-03 |
申办/合作机构 |
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- |
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 |
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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8
项与 帕罗培特立帕肽 相关的文献（医药）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.
2021-12-01·Journal of Patient-Reported Outcomes
Psychometric validation of the Hypoparathyroidism Patient Experience Scales (HPES)
Article
作者: Brod, Meryl ; Gianettoni, Jill ; Shu, Aimee ; Smith, Alden ; Markova, Denka ; Lin, Zhengning ; McLeod, Lori ; Mourya, Sanchita
Abstract:
Background:
Hypoparathyroidism (HP) is a rare endocrine disorder characterized by absent or inappropriately low levels of circulating parathyroid hormone with associated significant physical and cognitive symptoms. This study evaluated the psychometric properties of the Hypoparathyroidism Patient Experience Scales (HPES), which were developed as disease-specific, patient-reported outcome (PRO) measures to assess the symptoms and impacts associated with HP in adults.
Methods:
Data from a non-interventional, observational study (N = 300) and a Phase 2 clinical trial (N = 59) were used in the psychometric evaluation. Observational and trial assessments included: an online validation battery (baseline or screening) and retest (approximately 2 weeks after baseline or screening). In the trial, the primary efficacy endpoint was assessed at week 4 through re-administration of the HPES and validation battery subset. The observational study’s larger sample size allowed for evaluation of the HPES descriptive properties, scoring algorithm, test-retest reliability, and construct validity. The trial data examined responsiveness, meaningful within-patient change estimates, and treatment impact on HPES scores.
Results:
Demographic and self-reported medical characteristics results were similar across the 2 studies. Factor analysis confirmed domains in the HPES-Symptom (n = 2) and HPES-Impact (n = 4). For both measures, total and domain scores demonstrated acceptable reliability and validity for both the observational and trial samples. Internal consistency evidence was strong. Test-retest reliability estimates generally approached the recommended 0.70 threshold. The construct validity correlations with other PRO measures were mainly as hypothesized, thus supporting the HPES scores and constructs. Mean scores for both measures also differed as anticipated and significantly across known-groups, thus providing evidence for the scores discriminating between meaningful groups. Trial results supported both HPES total and domain scores’ ability to detect change. The difference in mean total and domain scores for both measures demonstrated statistically significant improvements for TransCon PTH compared to placebo treated subjects despite the small sample and a short 4-week duration on fixed, non-optimized doses.
Conclusions:
The HPES were found to be conceptually sound with adequate evidence supporting their reliability and validity. Incorporation of the HPES into clinical and research settings will help to further elucidate and assess the patient experience of living with HP and identify treatment differences.
2020-12-01·Journal of Bone and Mineral Research
Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial
Article
作者: Vokes, Tamara ; Abbott, Lisa G ; Gagnon, Claudia ; Ukena, Jenny ; Eng, Walter Frank ; Khan, Aliya A ; Sibley, Christopher T ; Rubin, Mishaela R ; Schwarz, Peter ; Clarke, Bart L ; Rejnmark, Lars ; Shu, Aimee D ; Marcocci, Claudio ; Kohlmeier, Lynn ; Pihl, Susanne ; An, Xuebei ; Smith, Alden R ; Palermo, Andrea ; Hofbauer, Lorenz C ; Shoback, Dolores M
ABSTRACT:
Conventional therapy for hypoparathyroidism consisting of active vitamin D and calcium aims to alleviate hypocalcemia but fails to restore normal parathyroid hormone (PTH) physiology. PTH replacement therapy is the ideal physiologic treatment for hypoparathyroidism. The double-blind, placebo-controlled, 26-week, phase 3 PaTHway trial assessed the efficacy and safety of PTH replacement therapy for hypoparathyroidism individuals with the investigational drug TransCon PTH (palopegteriparatide). Participants (n = 84) were randomized 3:1 to once-daily TransCon PTH (initially 18 μg/d) or placebo, both co-administered with conventional therapy. The study drug and conventional therapy were titrated according to a dosing algorithm guided by serum calcium. The composite primary efficacy endpoint was the proportion of participants at week 26 who achieved normal albumin-adjusted serum calcium levels (8.3–10.6 mg/dL), independence from conventional therapy (requiring no active vitamin D and ≤600 mg/d of calcium), and no increase in study drug over 4 weeks before week 26. Other outcomes of interest included health-related quality of life measured by the 36-Item Short Form Survey (SF-36), hypoparathyroidism-related symptoms, functioning, and well-being measured by the Hypoparathyroidism Patient Experience Scale (HPES), and urinary calcium excretion. At week 26, 79% (48/61) of participants treated with TransCon PTH versus 5% (1/21) wiplacebo met the composite primary efficacy endpoint (p < 0.0001). TransCon PTH treatment demonstrated a significant improvement in all key secondary endpoint HPES domain scores (all p < 0.01) and the SF-36 Physical Functioning subscale score (p = 0.0347) compared with placebo. Additionally, 93% (57/61) of participants treated with TransCon PTH achieved independence from conventional therapy. TransCon PTH treatment normalized mean 24-hour urine calcium. Overall, 82% (50/61) treated with TransCon PTH and 100% (21/21) wiplacebo experienced adverse events; most were mild (46%) or moderate (46%). No study drug-related withdrawals occurred. In conclusion, TransCon PTH maintained normocalcemia while permitting independence from conventional therapy and was well-tolerated in individuals with hypoparathyroidism. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).AbstractTransCon PTH is an investigational once-daily prodrug providing sustained release of active PTH designed to maintain stable PTH levels in the physiological range for 24 hours/day. The PaTHway trial met all primary and key secondary endpoints with statistically significant differences from placebo. Most adverse events (AEs) were mild/moderate. Injection-site reactions and headaches were the most common treatment-related AEs.
92
项与 帕罗培特立帕肽 相关的新闻（医药）2024-04-24
COPENHAGEN, Denmark, April 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH® (palopegteriparatide; developed as TransCon™ PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has also granted YORVIPATH orphan drug status. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily. “With today’s MHRA approval of YORVIPATH, we are expanding our global geographic reach to meet the needs of adults with chronic hypoparathyroidism in Great Britain,” said Camilla Harder Harvig, Executive Vice President and Chief Commercial Officer at Ascendis Pharma. MHRA approval of YORVIPATH is based on the same dossier submitted with Ascendis Pharma’s Marketing Authorisation Application to the European Medicines Agency, which led to European Commission authorization of YORVIPATH in the European Union in November 2023. Orphan status provides 10 years of market exclusivity in Great Britain with respect to similar medicinal products in the approved orphan indication of chronic adult hypoparathyroidism. TransCon PTH is also in development for the treatment of adults with chronic hypoparathyroidism in the United States, Japan, and other countries. About HypoparathyroidismHypoparathyroidism is an endocrine disease caused by insufficient levels of PTH, the primary regulator of calcium and phosphate balance in the body, acting directly on bone and kidneys and indirectly on the intestine. Hypoparathyroidism is considered chronic if it persists >6 months following surgery per the 2016 Endocrine Society Guidelines, 2019 Canadian and International Consensus Statement, and 2022 European Society of Endocrinology Consensus Statement. 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, genetic, and idiopathic causes. 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) Ascendis’ ability to meet the needs of adults with chronic hypoparathyroidism in Great Britain, (ii) Ascendis’ ability to apply its innovative platform technology 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. © April 2024 Ascendis Pharma A/S. Investor Contacts:Media Contact:Tim LeeMelinda BakerAscendis PharmaAscendis Pharma+1 (650) 374-6343+1 (650) 709-8875tle@ascendispharma.commedia@ascendispharma.comir@ascendispharma.com Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com
孤儿药上市批准
2024-03-22
·药研网
3月21日，据港交所披露，维昇药业再次向港交所主板提交上市申请。该公司曾于2022年11月17日、2023年8月16日向港交所递交过上市申请。01维昇药业维昇药业于2018年成立，是一家处于研发后期、产品接近商业化的创新生物制药公司，聚焦开发新一代内分泌疗法，致力于提供同类首创或同类最优的内分泌疾病产品和治疗方案。02融资历史维昇药业由Vivo Capital携手Ascendis孵化成立，成立6年就获得了两轮融资。2018年A轮融资4000万美元，投后估值8000万美元。2021年，由红杉中国基金领投，维昇药业完成1.5亿美元B轮融资，投后估值10.3亿美元。03管线布局维昇药业已建立包含三款候选药物的产品管线，首发管线隆培生长激素是一款长效生长激素。隆培促生长素是同类首创在美国和欧盟被批准用于治疗PGHD的LAGH，已分别于2021年及2022年获得FDA及EMA的上市批准。后续管线还有TransCon CNP、帕罗培特立帕肽，分别针对儿童和成人内分泌疾病，亦已在全球范围内进入后期临床试验阶段。几款产品均从Ascendis引进。核心产品-隆培促生长素基于已完成的中国3期关键性试验验证，隆培促生长素为唯一一款在与短效(每日注射)人生长激素的阳性药物对照及平行组试验比较中显示出优效性及同等安全性的长效生长激素，有潜力成为用于治疗儿童生长激素缺乏症的同类最佳候选药物。隆培促生长素是同类首创在美国和欧盟被批准用于治疗PGHD的LAGH，已分别于2021年及2022年获得FDA及EMA的上市批准。2023年12月18日，维昇药业宣布，已与药明生物签署合作协议，赋能隆培促生长素本地商业化生产。近期，用于治疗PGHD的核心产品的生物制品上市许可申请已获国家药监局受理。隆培促生长素是首个在美国及欧洲获批上市的长效生长激素，商品名为Skytrofa，用于治疗儿童生长激素缺乏症。据统计，Skytrofa 2023年销售额1.79亿欧元，预计2024年销售额将达到3.2-3.4亿欧元。04长效生长激素市场潜力&布局后续市场空间方面，于2022年，经估算中国在全球人生长激素市场占据最大份额，超过美国，占全球市场的34%。根据弗若斯特沙利文的资料，中国的人生长激素市场规模于2022年为17亿美元，预计到2026年将增至31亿美元，自2022年至 2026年的年复合增长率为16.7%，并且到2030年将增至48亿美元，自2026 年至2030年的年复合增长率为11.5%。面对丰厚的盈利空间，国内企业也在积极推进长效产品的研发与上市。除维昇药业外，特宝生物，安科生物、天境生物等均已进入临床III 期。国内主要临床在研的长效生长激素图源凯莱英药闻细胞系产品查询投稿丨商务合作转载丨加交流群往期推荐一国产GLP-1药企递交IPO招股书，估值约8.3亿元人民币超40亿美元：上海Argo与Novartis达成多项目RNAi独家合作17 亿美元！强生与LegoChem就Trop2 靶向ADC的达成许可协议完整版：2023 全年药企裁员汇总点击下方“药研网”，关注更多精彩内容
IPO临床3期上市批准
2024-03-17
近年来，得益于分子生物学的发展和多肽合成技术的进步，多肽产业发展迅速。多肽药物已经在肿瘤治疗、免疫调节、内分泌代谢类疾病治疗等领域取得了一定的成功。目前全球已经有100多种多肽药物获批上市并取得了良好的市场表现。此外，多肽产品还可广泛应用于疫苗制备、功能食品以及化妆品领域中，随着科技的持续进步和市场需求的不断增长，多肽产业必将迎来更加广阔的发展空间。随着司美格鲁肽、度拉糖肽等 GLP-1多肽药物销售额的快速增长 ，全球肽类药物市场规模加速扩容，根据Frost&Sullivan预测，全球肽类药物市场规模有望从2020年的628亿美元增长到2025年的960亿美元，其中，中国肽类药物市场规模从2020年85亿美元增长到2025年的182亿美元。2020-2025年，全球和中国肽类药物市场规模在CAGR将分别达到8.9%和16.4%，增速较快。全球多肽产业进入快速发展期。2022年全球销售额Top25的多肽药物全球GLP1管线：司美格鲁肽在已上市减肥药中减重疗效脱颖而出获得FDA 批准可以长期使用的六种减重药物分别是：安非他酮-纳曲酮、利拉鲁肽、奥利司他、芬特明-托吡酯、司美格鲁肽、塞美拉肽。其中GLP GLP-1受体激动剂司美格鲁肽（长效）和利拉鲁肽（短效）由于副作用小，被广大群众接受，逐渐成为一线用药方案，其他减重药物如奥利司他、安非他酮-纳曲酮、芬特明-托吡酯皆因副作用影响，治疗人群受限制。表：FDA已获批“减肥”药国内GLP1管线：国内减重创新药加速推进，司美格鲁肽生物类似药研发竞速2024年1月26日，诺和诺德司美格鲁肽片获国家药品监督管理局（NMPA）批准上市，用于治疗2型糖尿病。这将进一步增大GLP-1类药物市场规模。目前国内已有多家企业布局 GLP-1药物，其当前核心布局市场为减重市场，已经有二十余家企业的GLP-1药物进入减重适应症临床开发阶段，此外还有多款药物处在临床前阶段。临床进展上联邦制药、华东医药、 丽珠集团、九源基因以及齐鲁制药等公司进展最快，已将产品推至III期临床。表：国内GLP1药物管线情况概览展望未来，多肽药物市场的发展趋势主要有：市场规模继续保持增长，多肽药物市场预计2023年至2032年将以7%-8%左右的复合年增长率大幅增长，并于2032年达到826亿美元的规模。越来越多的多肽类药物将获批上市，Ascendis Pharma宣布已向FDA重新递交TransCon PTH用于治疗成人甲状旁腺功能减退症(HP)的新药申请(NDA)。TransCon PTH（palopegteriparatide）是一种长效甲状旁腺激素（PTH）前药，旨在将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。多肽与其他疗法的结合，将多肽药物与其他治疗方法，如化疗药物、免疫疗法等结合使用，以实现协同效应，提高治疗效果。多肽药物产业链迎来发展良机，多肽药物产量增加，带动上游设备、耗材、合成试剂等需求量增长。原料药、多肽CDMO公司将迎来新机遇。基于多肽产业蓬勃发展的需求，“多肽产业创新与发展大会”将于2024年4月17-18日在南京举办。大会旨在搭建对接合作平台，汇聚业内专家、企业家、研究学者以及投资机构代表，探讨多肽产业的最新发展动态，未来发展趋势及研发创新方向，以推动我国多肽产业的快速发展。名称：多肽产业创新与发展大会时间：2024年4月17日-18日（周三-周四）地点：南京国际展览中心主办单位：四叶草会展、生物制品圈、抗体圈、乘风济海媒体支持：药时空、细胞基因研究圈报名方式：扫描下方二维码或点击文章最底部“阅读原文”→ 填写表格 → 报名成功组委会获得报名信息后，根据报名信息进行初筛，并进一步与报名者沟通确认，实现精准邀请（严格审核通过）。大会日程注：大会日程以会议现场为准。中国医药全产业链新资源大会（CBC大会）是一场将“政、产、学、研、用、管、投”各方精英围绕全产业链新资源展开的合作大会，将于2024年4月16日-18日在南京国际展览中心举办。大会将主打“全产业链新资源对接”，围绕投资、立项、临床前研发、临床研究、生产、供应链国产化、销售、MAH合作、国际品种合作、公司股权合作与并购全产业链，为中国医药同仁带来全新的资源与商机。大会下设的同期会议包括：宠物药品、食品、保健品新资源大会兽用生物制品研发和产业化大会透皮技术研发生产与注册开年分享会吸入制剂研发、生产与注册新机遇新进展分享会中国改良新药与缓控释制剂全产业链合作大会多肽产业创新与发展大会新药典新型辅料与包材产品与技术交流会新药典新型实验室仪器与耗材实操演示交流会陆续更新中......识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。
临床3期生物类似药上市批准疫苗
100 项与 帕罗培特立帕肽 相关的药物交易
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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 |
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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 |
|---|
临床2期 | 59 | (TransCon PTH 15 mcg) | 鹹襯繭齋齋窪蓋窪艱餘(淵蓋鹽糧遞窪壓築壓膚) = 構夢獵夢願艱衊膚遞範 鹹觸淵艱築齋積選鏇鹹 (範鑰糧積鬱糧廠鑰鹽憲, 築壓糧鑰鏇窪廠積壓選 ~ 鹽顧製獵製網製壓鬱夢) 更多 | - | 2023-09-01 | ||
(TransCon PTH 18 mcg) | 鹹襯繭齋齋窪蓋窪艱餘(淵蓋鹽糧遞窪壓築壓膚) = 夢構糧願簾製構糧獵艱 鹹觸淵艱築齋積選鏇鹹 (範鑰糧積鬱糧廠鑰鹽憲, 壓製範齋構衊簾築糧憲 ~ 衊鑰餘範醖齋獵鹹糧壓) 更多 | ||||||
临床2期 | - | 57 | 餘廠醖艱簾鹽網獵製憲(鬱壓壓糧廠簾觸觸壓構) = 鬱窪願顧簾膚廠襯廠艱 鏇襯憲鹽鑰簾鏇膚簾壓 (壓淵餘醖遞選憲範衊艱 ) 更多 | 积极 | 2022-09-12 | ||
临床3期 | 82 | 糧糧蓋範築鹹壓醖鏇襯(遞艱醖艱遞鑰願壓壓醖) = 獵廠構願鏇齋鏇憲蓋襯 鏇鹹憲鬱遞襯構齋獵壓 (鹹鹹壓鏇淵構鏇積構蓋, 66.3 ~ 88.1) 更多 | 积极 | 2022-03-13 | |||
Placebo | 糧糧蓋範築鹹壓醖鏇襯(遞艱醖艱遞鑰願壓壓醖) = 憲製淵艱築鑰鬱觸構壓 鏇鹹憲鬱遞襯構齋獵壓 (鹹鹹壓鏇淵構鏇積構蓋, 0.1 ~ 23.8) 更多 | ||||||
临床2期 | 59 | 築襯選獵構蓋範淵觸繭(顧構憲糧遞鹹遞築鬱夢) = 鏇構觸廠襯願觸窪積衊 窪獵獵憲膚蓋夢獵範齋 (糧糧糧憲鑰齋襯艱醖網 ) | 积极 | 2021-08-04 | |||
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