托伐普坦(Tolvaptan) - 药物靶点：AVPR2_在研适应症：腹水，常染色体显性多囊肾病，心源性水肿_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Jynarque、Tolvaptan (JAN/USAN/INN)、OPC-156

+ [6]

靶点

AVPR2

作用机制

AVPR2拮抗剂(血管加压素V2受体拮抗剂)

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [3]

在研适应症

腹水常染色体显性多囊肾病心源性水肿+ [5]

非在研适应症

急性失代偿性心力衰竭躁郁症慢性低钠血症+ [12]

原研机构

Otsuka Holdings Co., Ltd.

在研机构

Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Development & Commercialization, Inc.Accord Healthcare SLU

+ [3]

非在研机构

Otsuka America Pharmaceutical, Inc.Korea Otsuka Pharmaceutical Co., Ltd.

大冢制药研发（北京）有限公司

+ [2]

最高研发阶段批准上市

首次获批日期

美国 (2009-05-19),

低钠血症

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)

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结构

分子式C26H25ClN2O3

InChIKeyGYHCTFXIZSNGJT-UHFFFAOYSA-N

CAS号150683-30-0

关联

258

项与托伐普坦相关的临床试验

ACTRN12624000191594 / Not yet recruitingN/AIIT

Investigating tolvaptan stimulated copeptin measurements for the differential diagnosis of polyuria-polydipsia syndrome

开始日期2024-05-01

申办/合作机构-

CTRI/2024/03/064070 / Not yet recruitingN/A

efficacy of tolvaptan in prevention of TURP syndrome: A prospective randomised controlled trial

开始日期2024-03-23

申办/合作机构-

NCT06171100 / RecruitingN/AIIT

Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.

This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management.
Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.

开始日期2024-03-15

申办/合作机构

King's College Hospital NHS Foundation Trust

100 项与托伐普坦相关的临床结果

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100 项与托伐普坦相关的转化医学

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100 项与托伐普坦相关的专利（医药）

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1,314

项与托伐普坦相关的文献（医药）

2024-05-01·Pediatric nephrology (Berlin, Germany)

Estimating risk of rapid disease progression in pediatric patients with autosomal dominant polycystic kidney disease: a randomized trial of tolvaptan

Article

作者: Goldstein, Stuart L ; Jadhav, Pravin ; Guay-Woodford, Lisa M ; Mekahli, Djalila ; Debuque, Laurie ; Cadnapaphornchai, Melissa A ; Jiang, Huan ; Dandurand, Ann

Abstract:

Background:

Tolvaptan preserves kidney function in adults with autosomal dominant polycystic kidney disease (ADPKD) at elevated risk of rapid progression. A trial (NCT02964273) evaluated tolvaptan safety and pharmacodynamics in children (5–17 years). However, progression risk was not part of study eligibility criteria due to lack of validated criteria for risk assessment in children. As risk estimation is important to guide clinical management, baseline characteristics of the study participants were retrospectively evaluated to determine whether risk of rapid disease progression in pediatric ADPKD can be assessed and to identify parameters relevant for risk estimation.

Methods:

Four academic pediatric nephrologists reviewed baseline data and rated participant risk from 1 (lowest) to 5 (highest) based on clinical judgement and the literature. Three primary reviewers independently scored all cases, with each case reviewed by two primary reviewers. For cases with discordant ratings (≥ 2-point difference), the fourth reviewer provided a secondary rating blinded to the primary evaluations. Study participants with discordant ratings and/or for whom data were lacking were later discussed to clarify parameters relevant to risk estimation.

Results:

Of 90 evaluable subjects, primary reviews of 69 (77%) were concordant. The proportion considered at risk of rapid progression (final mean rating ≥ 3.5) by age group was: 15–17 years, 27/34 (79%); 12– < 15, 9/32 (28%); 4– < 12, 8/24 (33%). The panelists agreed on characteristics important for risk determination: age, kidney imaging, kidney function, blood pressure, urine protein, and genetics.

Conclusions:

High ratings concordance and agreement among reviewers on relevant clinical characteristics support the feasibility of pediatric risk assessment.

Graphical abstract:

A higher resolution version of the Graphical abstract is available as Supplementary information

2024-04-26·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Higher beta-hydroxybutyrate ketone levels associated with a slower kidney function decline in ADPKD

Article

作者: Bakker, Stephan J L ; Salih, M ; Gansevoort, Ron T ; Connelly, Margery A ; Geertsema, Paul ; Hoorn, E J ; Meijer, E ; Bais, Thomas ; Drenth, J P H ; Knol, Martine G E ; Nijenhuis, T ; Peters, D J M ; van Gastel, Maatje D A ; de Fijter, J W

ABSTRACT:

Background:

Dysregulated energy metabolism is a recently discovered key feature of autosomal dominant polycystic kidney disease (ADPKD). Cystic cells depend on glucose and are poorly able to use other energy sources such as ketone bodies. Raising ketone body concentration reduced disease progression in animal models of polycystic kidney diseases. Therefore, we hypothesized that higher endogenous plasma beta-hydroxybutyrate (BHB) concentrations are associated with reduced disease progression in patients with ADPKD.

Methods:

We analyzed data from 670 patients with ADPKD participating in the Developing Intervention Strategies to Halt Progression of ADPKD (DIPAK) cohort, a multi-center prospective observational cohort study. BHB was measured at baseline using nuclear magnetic resonance spectroscopy. Participants were excluded if they had type 2 diabetes, were using disease-modifying drugs (e.g. tolvaptan, somatostatin analogs), were not fasting or had missing BHB levels, leaving 521 participants for the analyses. Linear regression analyses were used to study cross-sectional associations and linear mixed-effect modeling for longitudinal associations.

Results:

Of the participants, 61% were female, with an age of 47.3 ± 11.8 years, a height-adjusted total kidney volume (htTKV) of 834 [interquartile range (IQR) 495–1327] mL/m and an estimated glomerular filtration rate (eGFR) of 63.3 ± 28.9 mL/min/1.73 m2. The median concentration of BHB was 94 (IQR 68–147) µmol/L. Cross-sectionally, BHB was associated neither with eGFR nor with htTKV. Longitudinally, BHB was positively associated with eGFR slope {B = 0.35 mL/min/1.73 m2 [95% confidence interval (CI) 0.09 to 0.61], P = .007}, but not with kidney growth. After adjustment for potential confounders, every doubling in BHB concentration was associated with an improvement in the annual rate of eGFR by 0.33 mL/min/1.73 m2 (95% CI 0.09 to 0.57, P = .008).

Conclusion:

These observational analyses support the hypothesis that interventions that raise BHB concentration could reduce the rate of kidney function decline in patients with ADPKD.

2024-03-01·Translational research : the journal of laboratory and clinical medicine

Repurposing calcium-sensing receptor activator drug cinacalcet for ADPKD treatment

Article

作者: Chu, Tifany ; Yottasan, Pattareeya ; Chhetri, Parth D ; Cil, Onur

ADPKD is characterized by progressive cyst formation and enlargement leading to kidney failure. Tolvaptan is currently the only FDA-approved treatment for ADPKD; however, it can cause serious adverse effects including hepatotoxicity. There remains an unmet clinical need for effective and safe treatments for ADPKD. The extracellular Ca²⁺-sensing receptor (CaSR) is a regulator of epithelial ion transport. FDA-approved CaSR activator cinacalcet can reduce cAMP-induced Cl^- and fluid secretion in various epithelial cells by activating phosphodiesterases (PDE) that hydrolyze cAMP. Since elevated cAMP is a key mechanism of ADPKD progression by promoting cell proliferation, cyst formation and enlargement (via Cl^- and fluid secretion), here we tested efficacy of cinacalcet in cell and animal models of ADPKD. Cinacalcet treatment reduced cAMP-induced Cl^- secretion and CFTR activity in MDCK cells as suggested by ∼70 % lower short-circuit current (I_sc) changes in response to forskolin and CFTR_inh-172, respectively. Cinacalcet treatment inhibited forskolin-induced cAMP elevation by 60 % in MDCK cells, and its effect was completely reversed by IBMX (PDE inhibitor). In MDCK cells treated with forskolin, cinacalcet treatment concentration-dependently reduced cell proliferation, cyst formation and cyst enlargement by up to 50 % without affecting cell viability. Cinacalcet treatment (20 mg/kg/day for 7 days, subcutaneous) reduced renal cyst index in a mouse model of ADPKD (Pkd1^flox/flox;Ksp-Cre) by 20 %. Lastly, cinacalcet treatment reduced cyst enlargement and cell proliferation in human ADPKD cells by 60 %. Considering its efficacy as shown here, and favorable safety profile including extensive post-approval data, cinacalcet can be repurposed as a novel ADPKD treatment.

78

项与托伐普坦相关的新闻（医药）

2024-05-31

·赛柏蓝

日本10大药企最新排位分析

特约作者 | 春胡责任编辑 | 郑瑶2024年5月，AnswersNews 发布统计的日本药企排名，其中Top10的基本情况整理如下表。时间周期2023年04月-2024年03月01日本Top10药企及产品分析截至 2024 年 3 月的财年最新财务业绩显示：武田药品工业株式会社的销售收入稳居第一，约为4.3万亿日元。其治疗炎症性肠病的明星药物Entyvio（8009亿日元，比上一财年增长14.0%）等支柱产品表现良好，其中日元疲软也有所帮助，导致销售额比上一财年增长5.9%。位居第二的是大冢控股（HD），其营收首次突破2万亿日元。大冢的四款全球产品（Abilify Maintena、Rexulti、Samsca/JinArc 和 Lonsurf）贡献了两位数的销售额增长，销售额增长 17.4%，达到 7269 亿日元。安斯泰来制药（Astellas Pharma）保持第三位，安斯泰来前列腺癌治疗药物Xtandi的销售额增长13.5%，达到7505亿日元。第一三共（Daiichi Sankyo）紧随其后，位居第四。其抗癌药物Enhertz收入为4492亿日元，增长73.9%，其中包括里程碑式的收入，抗凝血药物Lixiana也增长至2877亿日元（增长17.9%）。其销售额增速在受访的39家企业中最高，表明经营状况良好。排在第五位的是中外制药，销售额 11114 亿日元（下降 11.8%）。这是前五名公司中唯一一家因新型冠状病毒治疗药物 Ronapriv 的政府交付销售下降而导致销售额下降的公司。前五名企业阵容与去年相同。卫材以 7418 亿日元排名第六（下降 0.4%）。但目前其阿尔茨海默病治疗药物Lecanemab已在美、日、中、韩获批上市，未来表现可期。排名第7位的小野制药株式会社，由于抗癌药Opdivo和SGLT2抑制剂Farxiga的销售增长，营收突破5000亿日元，比上一年的第9位上升了两位。排在第八位的是 Kyowa Kirin，该公司将 FGF 相关疾病治疗药物 Creasevita 扩展到全球，自 2022 年以来首次进入前十。另一方面，排名第9位的三菱化学集团（制药业务＝田边三菱制药）的排名较去年有所下降。由于上一财年一次性记录了多发性硬化症药物 Gilenya 的几年特许权使用费，三菱化学的销售额下降了两位数。 02利润表现分析中外制药以4392亿日元的营业利润位居榜首，营业利润率为39.5%，比上年下降2.8个百分点。武田制药以 2141 亿日元位居第二，由于再生医学产品“Aloficel”和抗癌药物“Exquiviti”相关的减值损失约1306亿日元，武田的利润大幅下降（环比下降 56.4%）。第三位是第一三共（Daiichi Sankyo），约 2116 亿日元。第一三共在专利侵权诉讼中与诺华公司和解后，利润有所增加（环比增长 75.5%）。由于收购美国Iberic Bio以及在研基因治疗药物计提减值损失，安斯泰来利润下降80.8%。营业利润率下降至1.6%。03海外销售情况分析武田制药，以海外销售额38124亿日元（增长8.4%）的表现位居榜首。位居第二的是大冢HD，销售额为13477亿日元，增长24.4%，反映出四款全球产品的增长。去年排名第二的安斯泰来增长了6.2%，达到13336亿日元。排名第四的第一三共（Daiichi Sankyo）由于 Enhearts 的扩张，销售额增长了 34.4%，超过 1 万亿日元。04研发费用分析武田制药的研发投入最高，达 7299 亿日元。第二名是积极投资ADC（抗体药物偶联物）开发的第一三共（3643亿日元，增长8.2%）。第三名是大冢HD（3078亿日元，增长11.8%）。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

并购专利侵权基因疗法财报

2024-05-28

·PRNewswire

Rege Nephro CO., Ltd. Announces Patient Enrollment for Phase II Clinical Trial of Tamibarotene for ADPKD

KYOTO, Japan, May 28, 2024 /PRNewswire/ -- Rege Nephro CO., Ltd. () has announced that patient enrollment began in April for the second stage of its Phase II clinical trial of tamibarotene as a developmental product for the treatment of autosomal dominant polycystic kidney disease (ADPKD) under the code RN-014. After reviewing all available safety data from the first stage, which started in December of last year, the decision was made to advance to the second stage. The company aims to complete patient enrollment by the end of 2024. Public Clinical Trial Information jRCT (Japan Registry of Clinical Trials): A system for the submission and publication of clinical research () ClinicalTrials.gov: A public website provided by the U.S. National Library of Medicine () Tolvaptan is the only approved drug for the treatment of ADPKD. Since the launch of tolvaptan, pharmaceutical companies worldwide have been developing numerous clinical trials of new drugs to treat ADPKD, but most of these drugs have already been discontinued due to inefficacy, highlighting the strong need for new treatment options. RN-014 is currently at the most advanced stage of development among the drugs in development for patients with ADPKD. About ADPKD Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary cystic kidney disease. It is characterized by the gradual development and enlargement of multiple cysts in both kidneys, leading to progressive renal dysfunction. Cysts can also occur in the liver and pancreas, and vascular abnormalities throughout the body are common, including high blood pressure, cerebral aneurysms, and heart valve abnormalities. Currently, tolvaptan, which inhibits cyst growth, is the only approved treatment for ADPKD, but there is no curative treatment available. About RN-014 Tamibarotene, under development for ADPKD, is a retinoic acid receptor (RAR) agonist expected to potently inhibit cyst formation and improve renal function. The clinical trial dose identified in multiple mouse model experiments is 4mg/day, and its safety has been confirmed in past studies. With advice from the Pharmaceuticals and Medical Devices Agency (PMDA), the Phase II clinical trial began in December 2023. This trial includes a pharmacokinetic (PK) phase and a randomization phase. Various safety measures have been established, including phased patient enrollment, periodic independent safety monitoring, strict criteria for dose reduction and discontinuation of the investigational drug, and criteria for discontinuation of the entire trial. About Rege Nephro CO., Ltd. Rege Nephro CO., Ltd. is a clinical-stage biotech company utilizing induced pluripotent stem cell (iPSC)-based technology from the Center for iPS Cell Research and Application (CiRA), Kyoto University. It is developing therapeutics and cell therapy for kidney, liver, and pancreas diseases. Media Inquiries: Katsuhisa Yamaguchi, CFO Rege Nephro CO., Ltd. TEL: 075-744-6858 E-mail: [email protected] SOURCE Rege Nephro CO., Ltd.

临床2期上市批准细胞疗法

2024-04-19

·赛柏蓝

60亿美元大品种，「无缘」第十批集采？

编者按：本文来自新康界，作者慧玲；赛柏蓝授权转载，编辑凯西近日，国家药监局信息显示，天宇股份全资子公司浙江诺得的沙库巴曲缬沙坦钠片获批上市，适用于治疗慢性心力衰竭，射血分数降低的慢性心力衰竭的成人患者和用于治疗原发性高血压。0155个仿制上市申请提交近30家企业提前布局沙库巴曲缬沙坦钠片原研来自诺华，是由沙库巴曲和缬沙坦两种成分以1:1摩尔比例结合而成的盐复合物晶体，为驱动诺华业绩增长的核心药物之一。该品种最早于2015年获FDA批准上市，是全球首款心衰治疗领域的突破性创新药物。前不久，诺华披露的2023年财报显示，全年营收454.4亿美元，同比增长10%。其中，明星产品沙库巴曲缬沙坦钠片（诺欣妥，Entresto）实现60.35亿美元营收，同比增长31%。2023年高血压药在等级医院销售额约达242亿元。在高血压药的细分赛道中，排在市场份额首位的作用于肾素-血管紧张素系统的药物销售额在2023年约109亿元，而沙库巴曲缬沙坦钠片突破30亿元，稳坐该细分赛道第一的宝座。沙库巴曲缬沙坦钠片于2017年进入中国市场，用于治疗心衰，后被纳入2020年国家医保目录，2021年6月，在中国率先获批用于原发性高血压治疗。2021年，院内销售额一举突破20亿元，同比增长170%。国家药审中心（CDE）信息显示，截至目前CDE共承办了55个关于沙库巴曲缬沙坦钠片的仿制上市申请，来自近30家药企。除开此次获批的浙江诺得，也不乏华润双鹤、科伦、倍特、正大天晴、齐鲁等明星药企。沙库巴曲缬沙坦钠片仿制上市申请企业名单来源：国家药审中心去年8月，南京方生和医药子公司南京一心和与石药欧意的沙库巴曲缬沙坦钠片获批上市，视同通过一致性评价。至此，该品种的首仿之争落下帷幕。而原研沙库巴曲缬沙坦钠的中国专利是在2026年11月到期。在已获批上市的仿制药产品中，一心和的沙库巴曲缬沙坦钠片（一心坦）率先进入市场与原研药争抢国内份额。因为一心坦含有3个结晶水的新晶型，规避了原研含有2.5 个结晶水的晶型专利障碍，从而让这款药物可以合法地提前3年获批上市。另据南京方生和医药相关公告，一心坦将通过复星医药向全国销售，这是我国首家申报的沙库巴曲缬沙坦钠片仿制药，也是全球法规市场首个通过自主创新突破原研专利壁垒成功获批上市的该品种药物。02这些品种大概率赶不上第十批集采如果按照过往九批国采的规律推测，今年第十批国家集采大概率会在5月份前后启动。来源：易联招采事实上，过往9次国家药品集采基本上涵盖了高血压、心脏病、糖尿病等慢病领域的常用大品种。目前还未被集采的慢病药大多都是专利保护期内的药品，如沙库巴曲缬沙坦钠、托伐普坦片、达格列净、苯甲酸阿格列汀、西格列汀片、西格列汀二甲双胍等药品都还处于专利保护期。值得注意的是，虽然一些明星产品过评企业数量已经足够，但第十批国家集采明显不会纳入。其中，专利最快到期的是西格列汀，作为国内年销超20亿的大品种，其药物活性成分专利将在今年6月到期，但大概率赶不上第十批国采。此外，值得关注的是利格列汀，在2023年8月核心专利过期后，原本因侵权被撤网的东阳光仿制药利格列汀片被广东、上海等地恢复了挂网资格，但勃林格殷格翰的利格列汀多项专利的保护期可到2030年，其能否参加第十批国采同样要看在专利上是否有障碍。来源：上海医药集中招标采购事务管理所同样受限于专利，达格列净片仿制药上市受阻。其中化合物专利已于2023年5月份到期，其余组合物和用途专利尚在有效期内，且保护期最早为2027年6月21日，最迟至2041年4月1日。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

一致性评价专利到期财报上市批准

100 项与托伐普坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01213	托伐普坦	C03XA01	DB06212

研发状态

批准上市

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适应症	国家/地区	公司	日期
腹水	日本	Otsuka Pharmaceutical Co., Ltd.	2017-02-28
常染色体显性多囊肾病	日本	Otsuka Holdings Co., Ltd.	2014-03-24
心源性水肿	日本	Otsuka Pharmaceutical Co., Ltd.	2011-01-05
水肿	日本	Otsuka Holdings Co., Ltd.	2010-10-27
ADH分泌不当综合征	欧盟	Otsuka Pharmaceutical Co., Ltd.	2009-08-02
ADH分泌不当综合征	冰岛	Otsuka Pharmaceutical Co., Ltd.	2009-08-02
ADH分泌不当综合征	列支敦士登	Otsuka Pharmaceutical Co., Ltd.	2009-08-02
ADH分泌不当综合征	挪威	Otsuka Pharmaceutical Co., Ltd.	2009-08-02
低钠血症	美国	Otsuka Pharmaceutical Co., Ltd.	2009-05-19

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适应症	最高研发状态	国家/地区	公司	日期
常染色体隐性遗传性多囊肾	临床3期	-	Otsuka Pharmaceutical Development & Commercialization, Inc.	2021-04-01
音量过载	临床3期	日本	Otsuka Pharmaceutical Co., Ltd.	2018-02-13
慢性肾病	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	阿根廷	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	澳大利亚	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	比利时	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	加拿大	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	捷克	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	丹麦	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01
慢性肾病	临床3期	法国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01

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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


AASLD2023	N/A	肝硬化 neutrophil gelatinase-associated lipocalin (uNGAL)	86	Tolvaptan	鑰獵範廠繭網襯繭鹹窪(膚艱壓壓艱願顧蓋觸醖) = 築鹹鏇餘選築築鹹構構淵鑰網鏇膚繭鏇壓選繭 (窪鏇夢繭簾網範繭遞鹽 ) 更多	-	2023-11-10
ESC2023	N/A	心脏衰竭	846	tolvaptan	齋選繭選蓋觸膚顧網築(壓壓鹽廠憲衊鏇廠夢網) = 網鬱遞簾構醖遞膚壓糧鏇鬱構鑰壓憲膚壓衊構 (遞壓鏇餘製憲蓋選繭築 ) 更多	-	2023-08-27
ERA2023	N/A	常染色体显性多囊肾病	41	Tolvaptan	願築蓋憲繭選鹹觸衊襯(鑰淵餘觸觸選淵鹽顧觸) = 淵觸衊製鏇憲獵艱獵鏇簾範憲顧糧衊餘鑰積簾 (淵憲積醖繭獵鬱鬱衊構 ) 更多	-	2023-06-15
ERA2023	N/A	常染色体显性多囊肾病	40	Tolvaptan	襯鏇鑰網膚繭憲鹽製糧(醖選構醖醖廠範顧繭構) = recorded in all our patients (100%), with a median diuresis 6000 ml/day (7000-5500) 膚艱繭願襯簾鑰襯膚願 (網衊艱積鑰淵網範鏇蓋 ) 更多	-	2023-06-15
ERA2023	N/A	常染色体显性多囊肾病	41	Tolvaptan treatment	簾艱構觸艱憲製廠製積(積淵壓簾鬱壓鏇遞顧醖) = 鏇範積糧衊蓋夢醖積簾艱簾膚窪夢願醖遞窪簾 (鹽獵衊衊壓願範壓廠醖, 0, 2) 更多	-	2023-06-15
#5783 (ERA2023)	N/A	常染色体显性多囊肾病	523	Tolvaptan	醖廠鹹遞遞範繭襯壓選(窪廠製鑰獵糧襯獵膚鏇) = 51% 願繭願繭衊鑰網築襯膚 (願淵窪鹹鏇憲餘觸構觸 ) 更多	积极	2023-06-14
#5783 (ERA2023)	N/A	常染色体显性多囊肾病	523	No Tolvaptan	醖廠鹹遞遞範繭襯壓選(窪廠製鑰獵糧襯獵膚鏇) = 51% 願繭願繭衊鑰網築襯膚 (願淵窪鹹鏇憲餘觸構觸 ) 更多	积极	2023-06-14
#4377 (ERA2023)	N/A	常染色体显性多囊肾病	75	Tolvaptan 45/15 mg	壓夢壓醖糧憲簾鬱鏇簾(構窪遞淵鏇選鬱鑰鏇築) = A significant increase (p< 0.0001) in 24-h urine volume (138%) occurred only immediately after therapy initiation with no further significant increase during updosing in the complete and longitudinal cohort 餘壓膚壓衊築鏇膚願壓 (廠襯構願鏇淵顧夢廠鹹 ) 更多	积极	2023-06-14
#4377 (ERA2023)	N/A	常染色体显性多囊肾病	75	Tolvaptan 60/30 mg		积极	2023-06-14
NCT02964273 (#3034, ERA2023)	临床3期	常染色体显性多囊肾病	83	Tolvaptan	繭醖壓築憲壓鬱遞顧獵(築網積膚築蓋鹽積艱鏇) = 12%, 31% 製淵製壓獵鏇網選衊淵 (鏇選鹽壓廠廠鬱範鏇築 ) 更多	积极	2023-06-14
NCT02964273 (#3034, ERA2023)	临床3期	常染色体显性多囊肾病	83	Placebo		积极	2023-06-14
NCT02160145 \| NCT00413777 \| NCT01885559 \| NCT01430494 \| NCT01336972 \| NCT01214421 \| NCT02251275 (REPRISE, Pubmed)	N/A	常染色体显性多囊肾病	-	Tolvaptan	鹹網膚積製獵廠膚糧窪(鹽憲繭鏇遞鏇觸鬱膚鏇) = 鑰襯壓獵醖蓋齋憲獵構觸積繭齋鏇鹽構築網獵 (網範廠簾壓淵積簾構網 )	-	2023-06-01
	N/A	常染色体显性多囊肾病	-	Non-tolvaptan standard of care	鹹網膚積製獵廠膚糧窪(鹽憲繭鏇遞鏇觸鬱膚鏇) = 製淵夢繭醖顧觸廠構網觸積繭齋鏇鹽構築網獵 (網範廠簾壓淵積簾構網 )	-	2023-06-01
NCT03541447 (TOOL, Pubmed)	临床2期	常染色体显性多囊肾病追加	19	Tolvaptan	築齋廠觸遞醖醖鹽觸構(範遞鹹築範鹽顧簾鹹鬱) = 獵製觸選選顧廠簾顧淵餘窪築築艱遞構築齋觸 (遞願艱鑰獵鏇廠鬱鑰蓋 )	-	2023-02-01