西他生坦钠(Sitaxentan Sodium) - 药物靶点：ETA_在研适应症：系统性硬皮病，硬化症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Sitaxentan、Sitaxentan sodium (USAN)、Sitaxsentan

+ [11]

靶点

ETA

作用机制

ETA拮抗剂(内皮素A受体拮抗剂)

治疗领域

免疫系统疾病遗传病与畸形皮肤和肌肉骨骼疾病+ [1]

在研适应症

系统性硬皮病硬化症

非在研适应症

动脉硬化慢性肾病心脏病+ [5]

原研机构

Pfizer Inc.

在研机构

Timber Pharmaceuticals LLC初创企业

非在研机构

Pfizer Inc.Pfizer Ltd.

Encysive Pharmaceuticals, Inc.

最高研发阶段临床前

首次获批日期

欧盟 (2006-08-10),

肺性高血压肺动脉高压

最高研发阶段(中国)终止

特殊审评孤儿药 (美国)

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结构/序列

分子式C18H15ClN2NaO6S2

InChIKeyHRFIVLUXADNCHX-UHFFFAOYSA-N

CAS号210421-74-2

关联

29

项与西他生坦钠相关的临床试验

CTRI/2023/11/060042

/ CompletedN/A

A Retrospective Multicenter Real-World Evidence Study of Open, Laparoscopic and Robotic-assisted Staging Surgery for Endometrial Cancer - NIL

开始日期2023-11-30

申办/合作机构-

NCT04976894

/ Active, not recruitingN/AIIT

Korean Stroke Cohort for Functioning and Rehabilitation-II

Korean Stroke Cohort for functioning and rehabilitation (KOSCO)-II is a large, multi-centre prospective cohort study for all acute first-ever stroke patients admitted to participating hospitals in nine distinct areas of Korea. This study is designed as a 10-year, longitudinal follow-up investigating the residual disabilities, activity limitations, and quality of life issues arising in patients suffering from first-ever stroke as previous similar stroke cohort with KOSCO. The main objectives of this study are to identify and compare the factors that influence residual disability and long-term quality of life in first-ever acute stroke patients with KOSCO. The secondary objectives of this study are to determine and compare the risk of mortality and recurrent vascular events in first-ever acute stroke patients with KOSCO. Investigators will investigate longitudinal health behaviors and patterns of healthcare utilization, including stroke rehabilitation care. Investigators will also investigate the long-term health status, mood, and quality of life in stroke patient caregivers. In addition, investigators will identify baseline and ongoing characteristics that are associated with secondary outcomes.

开始日期2020-01-01

申办/合作机构

Samsung Medical Center

NL-OMON46715

/ Recruiting临床3期IIT

Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA) - DIPLOMA-trial

开始日期2018-05-03

申办/合作机构-

100 项与西他生坦钠相关的临床结果

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100 项与西他生坦钠相关的转化医学

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100 项与西他生坦钠相关的专利（医药）

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333

项与西他生坦钠相关的文献（医药）

2024-11-01·Journal of Computational Biophysics and Chemistry

Molecular Docking, Quantum Mechanics and Molecular Dynamics Simulation of Anti-CAD Drugs Against High-Risk Xanthine Dehydrogenase Variants Associated with Oxidative Stress Pathways

作者: Sudhan, M. ; Ahmed, Shiek S. S. J. ; Emran, Talha Bin ; Attia, Sabry M. ; Ahmad, Sheikh F. ; Janakiraman, V.

Xanthine dehydrogenase (XDH) contributes significantly to generating reactive oxygen species in coronary artery disease (CAD). XDH has been proposed as a therapeutic target, but its genetic variants could affect protein structure and drug response. We aimed to assess protein structure modification occur due to genetic variants and to screen 215 CAD drugs for their utility in personalized CAD treatment against the XDH variants. A series of computational methods were implemented to identify pathogenic variants that cause XDH structure instability localized at the con served regions contributing to functional significance. Then, the XDH structures with the pathogenic variants were modeled using two different approaches to select the best models for docking with the CAD drugs. Finally, the stability of the docked complexes and their ability to transfer electrons were evaluated using molecular dynamics (MD) simulations and quantum mechanics/molecular mechanics (QM/MM) calculation. Among 751 variants examined; R149C and Q919R showed high pathogenicity, localized in conserved regions could alter protein structure and function. Further, docking of CAD drugs against XDH (native, R149C and Q919R) showed vericiguat with higher affinity, ranging from −7.95 kcal/mol to −10.41 kcal/mol, than the well-known XDH inhibitor (febuxostat, −5.73 kcal/mol to −8.35 kcal/mol). This indicates that vericiguat will be effective in CAD treatment, regardless of the XDH variants. Additionally, MD simulation and QM/MM confirmed vericiguat stability and electron transfer ability to form hydrogen bonds with the XDH protein. In conclusion, vericiguat will be beneficial for the personalized treatment of CAD by inhibiting XDH variants. Additional clinical studies are necessary to confirm our findings.

2024-10-01·ESC Heart Failure

Pulmonary artery denervation versus conventional therapies for PAH: a systematic review and updated network meta‐analysis

Review

作者: Wei, Yongyue ; Chen, Feng ; Chen, Shao‐liang ; Pan, Zoucheng ; Kan, Jing ; Zhang, Longyao ; Wang, Xiang ; Wu, Xiaoyu

Abstract:

Aims:

A recent guideline presented by the ESC Congress in 2022 had indicated a novel therapy targeted at pulmonary artery hypertension, known as pulmonary artery denervation (PADN), which get inspired from a laboratorial trial that could lowering the pulmonary artery pressure through the intervention on the animals. Our aim is to conduct a network meta‐analysis to compare the efficacy and safety of PADN from six aspects with the current conventional therapies.

Methods and results:

According to the PRISMA guidance, databases including Ovid, ClinicalTrials.gov, Medline, Embase, and PubMed were searched from inception to 22 August 2023, along with a full assessment of the previous five meta‐analyses. Data were extracted and curated for Bayesian network meta‐analysis. The primary outcome was the change in the 6‐min walking distance (6MWD) from baseline with a secondary outcome called change in mean pulmonary artery pressure (mPAP) from baseline. The four safety outcomes included risk of clinical worsening, hospitalization, mortality and severe adverse events (SAEs). The comparison is structured on a contrast model based on 65 randomized controlled trials (RCTs) on PADN and the other conventional mainstream drugs. PADN had a better effect in improving 6MWD than Placebo (−77.76 m, 95% CI: −102.04 to −54.34 m), Macitentan (−65.32 m, 95% CI: −95.34 to −36.1 m), Bosentan (−64.5 m, 95% CI: −94.7 to −35.07 m), Iloprost (−62.66 m, 95% CI: −99.48 to −27.13 m), Oxygen (−62.42 m, 95% CI: −100.01 to −25.78 m), Treprostinil (−62.01 m, 95% CI: −89.04 to −35.61 m), Riociguat (−60.59 m, 95% CI: −86.11 to −35.98 m), Selexipag (−47.2 m, 95% CI: −85.61 to −10.19 m), Sildenafil (−44.92 m, 95% CI: −74.43 to −16.15 m), or Sitaxsentan (−39.53 m, 95% CI: −78.99 to −0.76 m). PADN had a better antihypertensive effect than placebo and showed statistical significant lower risks to induce clinical worsening and re‐hospitalization than treprostinil, riociguat, and placebo groups. No statistically significant difference in risk of mortality and severe adverse events was observed between PADN versus the other interventions.

Conclusions:

Compared with 16 types of conventional therapies and Placebo, PADN has advantage over nine single therapies and Placebo in improving 6MWD and appears to be better than two types of dual‐drug combined therapies while with no statistical significance. PADN shows a favourable antihypertensive effect on mPAP and has a lower risk to trigger clinical worsening or hospitalization, while its risk on mortality and severe adverse events is still inconclusive.

2024-10-01·Biochemical pharmacology

Role of endothelin ETA receptors in the hypertension induced by the VEGFR-2 kinase inhibitors axitinib and lenvatinib in conscious freely-moving rats

Article

作者: Pannucci, Patrizia ; March, Julie ; Van Daele, Marieke ; Wragg, Edward S ; Woolard, Jeanette ; Hill, Stephen J ; Groenen, Marleen ; Cooper, Samantha L

Receptor tyrosine kinase inhibitors (RTKIs) suppress tumour growth by targeting vascular endothelial growth factor receptor 2 (VEGFR-2) which is an important mediator of angiogenesis. Here, we demonstrate that two potent RTKIs, axitinib and lenvatinib, are associated with hypertensive side effects. Doppler flowmetry was used to evaluate regional haemodynamic profiles of axitinib and lenvatinib. Male Sprague Dawley rats (350-500 g) were instrumented with Doppler flow probes (renal and mesenteric arteries and descending abdominal aorta) and catheters (jugular vein and distal abdominal aorta, via the caudal artery). Rats were dosed daily with axitinib (3 or 6 mg.kg^-1) or lenvatinib (1 or 3 mg.kg^-1) and regional haemodynamics were recorded over a maximum of 4 days. Both RTKIs caused significant (p < 0.05) increases in mean arterial pressure (MAP), which was accompanied by significant (p < 0.05) vasoconstriction in both the mesenteric and hindquarters vascular beds. To gain insight into the involvement of endothelin-1 (ET-1) in RTKI-mediated hypertension, we also monitored heart rate (HR) and MAP in response to axitinib or lenvatinib in animals treated with the ET_A receptor selective antagonist sitaxentan (5 mg.kg^-1) or the mixed ET_A/ET_B receptor antagonist bosentan (15 mg.kg^-1) over two days. Co-treatment with bosentan or sitaxentan markedly reduced the MAP effects mediated by both RTKIs (p < 0.05). Bosentan, but not sitaxentan, also attenuated ET-1 mediated increases in HR. These data suggest that selective antagonists of ET_A receptors may be appropriate to alleviate the hypertensive effects of axitinib and lenvatinib.

7

项与西他生坦钠相关的新闻（医药）

2024-08-22

·Pharmaceutical Technology

Leo Pharma’s Timber bet falls flat following Phase III failure

There is currently no treatment approved for ichthyosis by the FDA. Image credit: Shutterstock / JHVEPhoto. A year after hedging its bets on Timber Pharmaceuticals’ dermatology pipeline, Leo Pharma has reported a Phase III failure for the lead asset it acquired at the time. TMB-001, a topical ointment formulation of isotretinoin, came up short in the late-stage trial for patients with moderate to severe congenital ichthyosis. Ichthyosis is an umbrella term for congenital skin conditions that cause dry and scaly skin. In the Phase III ASCEND trial (NCT05295732), Leo stated the therapy did not demonstrate a statistically significant improvement in patients compared to those treated with a vehicle. This meant the primary and key secondary endpoints were not met. The results do not support US regulatory submission, the Danish privately owned company stated in a 21 August press release. There is currently no treatment approved for ichthyosis by the US Food and Drug Administration (FDA). Instead, the condition is managed by hydrating the skin with creams and lotions. See Also: A comprehensive guide to supply chain management for specialty drugs Codiak BioSciences gets grant for extracellular vesicles for disease treatment and prevention The ASCEND trial had a three-week induction, a nine-week treatment period, and – for eligible patients – a 12-week open-label maintenance regimen. A total of 209 patients aged six years and over were enrolled in the study. Timber’s CEO John Koconis said: “We are disappointed and saddened by the results of the Phase III trial. After encouraging phase 2b results, we observed an unexpectedly high vehicle response in this trial.” A previous Phase IIb trial evaluating the ointment achieved its primary endpoint of a 50% reduction in the Visual Index for Ichthyosis Severity scale score versus baseline. Leo Pharma spent $36m to acquire a bankrupt Timber in August 2023, including a $14m upfront payment. At the time, Timber had received orphan, fast-track, and breakthrough designations from the FDA. Following the acquisition, the company became a fully owned subsidiary of Leo Pharma. Leo Pharma’s chief development officer Kreesten Meldgaard Madsen said the company remains committed to dermatologic diseases but added “as is the case for all pharmaceutical research, not all trials are successful”. Leo Pharma stated the trial results will not impact its 2024 financial results. The company had a regulatory win elsewhere in the dermatology space in June this year, when its single-dose autoinjector for atopic dermatitis Adbry (tralokinumab-ldrm) received FDA approval . Whilst the clinical journey of TMB-001 stutters, Timber also has TMB-003 (sitaxentan) – a topical ET-A receptor antagonist in preclinical testing for sclerotic skin diseases.

临床2期临床3期临床结果快速通道突破性疗法

2024-05-14

·药融圈

值得关注的治疗领域：皮肤制药公司被并购

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。丹麦制药巨头利奥制药（LEO）是一家引领标准治疗，惠及皮肤疾病患者及其家庭和社会的全球公司。值得留意的是利奥制药的创始人August Kongsted是诺和诺德之Nordisk的天使投资人。LEO是一家超百年的企业；成立于1908年，隶属于利奥基金会，数十年来一直致力于研发，以推动皮肤病科学的发展。如今，利奥制药为不同严重程度的疾病提供了广泛的治疗方案。利奥制药总部位于丹麦，拥有全球员工4600人，为全球数千万患者提供服务。2022年利奥制药的净销售收入为106亿丹麦克朗（约合110亿元人民币）。药融云数据www.pharnexcloud.com监测显示：2024年1月，利奥制药完成对Timber Pharmaceuticals（纽约证券交易所股票代码：TMBR）的战略资产TMB-001及其他资产的收购。（要知道停牌收购前市值仅117万美元）药融圈获悉：该交易的总交易价值3600万美元（约合2.605亿人民币），其中（i）初始预付对价为1400万美元，（ii）在实现特定里程碑后，可额外支付至多2200万美元的或有价值权（CVR）。TMB-001项目旨在开发一种外用药物治疗方法，用于治疗多种中度至重度亚型先天性鱼鳞病（Congenital Ichthyosis ,CI）--一种罕见的皮肤病，存在大量未被满足的需求，且尚无正规获批的处方疗法（off-label 此前居多）。TMB-001项目按原计划继续进行。Timber Pharmaceuticals的所有员工将迁移至利奥制药位于美国新泽西州的办公室。 Timber专注于开发罕见皮肤病的非全身性治疗方法，包括先天性鱼鳞病（CI）和硬化性皮肤病（sclerotic skin diseases）。药融云数据www.pharnexcloud.com；词条TMB-001是一种活性药物成分（API）为异维甲酸/异维A酸的研究性外用制剂（改良新药）（关联阅读：505b2是否会是诗和远方？），目前美国只有异维甲酸的口服制剂。该新制剂已获得FDA的孤儿药项目资质；快速通道和突破性疗法的认证。TMB-001在II期临床研究已显示出积极的结果，III期临床研究的招募工作目前正在美国和欧洲进行。Timber Pharmaceuticals另一款候选药物Sitaxsentan 是选择性内皮素A (ETA) 受体拮抗剂，适应症为硬化性皮肤病。此前Christophe Bourdon/利奥制药CEO表示：“我们很高兴在2024年将TMB-001加入我们的产品线，并欢迎Timber Pharmaceuticals的员工加入利奥制药。这项交易将进一步加强我们的产品管线，使我们拥有一项具有战略意义的Ⅲ期资产，并可能有助于目前患有尚无合适治疗方案的衰竭性疾病患者的治疗。”参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；利奥制药（LEO）；www.timberpharma.com；https://www.timberpharma.com/tmb-003-topical-subcutaneous-et-a-r；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐5月 • 第八届大湾区生物医药创新者峰会

并购孤儿药突破性疗法临床3期临床2期

2024-04-10

·赛柏蓝

全新机制高血压用药上市，院内降压药排名大洗牌？

编者按：本文来自医药地理，作者南波万；赛柏蓝授权转载，编辑凯西2024年3月20日，Idorsia 宣布FDA已批准TRYVIO™（Aprocitentan）与其他抗高血压药物联合用于治疗其他药物未得到充分控制的成年患者的高血压（难治性高血压）。TRYVIO（Aprocitentan）是一款新型口服双重内皮素A/B受体（ETA/ETB）拮抗剂，可有效抑制内皮素ET-1与ETA和ETB的结合。在TRYVIO获得批准之前，没有针对ET通路的全身性抗高血压药物，Tryvio®是近40年来获得批准的通过新的治疗途径起作用的首款口服抗高血压治疗剂。01获批的临床试验FDA此次批准是依据一项临床Ⅲ期研究PRECISION（NCT03541174）的试验结果。该研究是一项多中心、盲法、随机临床试验，评估了Approcitentan在收缩压≥140 mmHg且至少服用三种降压药的成年人中的疗效。图：PRECISION III期临床试验来源：Pharma ONE智能药物大数据分析平台，中国医药工业信息中心结果显示，该研究达到了主要终点，即Aprocitentan组患者的坐位收缩压（SiSBP）降低幅度显著大于安慰剂组。即接受Aprocitentan治疗的患者4周后SiSBP得到显著降低，与安慰剂组相比，12.5mg组和25mg组的差异分别为-3.8mmHg（p=0.0042）和-3.7mmHg（p=0.0046）。此外，该研究也达到了关键次要终点，在第36~40周期间，接受Aprocitentan治疗的患者的SiSBP较安慰剂组持续降低，差异为-5.8mmHg（p<0.0001），维持时间长达48周。02作用机制内皮素（ET）是一种强效肽类血管收缩剂，其收缩血管的能力比去甲肾上腺素强100倍。ET是由21个氨基酸组成的活性多肽，有ET-1、ET-2和ET-3三种亚型，其受体分为ETA和ETB。ET-1是ET肽家族中最主要的成员，主要在血管内皮细胞和培养的平滑肌细胞中合成，其与高血压发病机制密切相关，可引起交感神经激活、醛固酮合成和分泌增加、内皮功能障碍、血管肥大和重塑以及纤维化。Aprocitentan是一款靶向双重ETA/ETB受体拮抗剂，通过阻断ET-1与血管平滑肌细胞上的ETA和ETB受体的结合，抑制血管收缩，起到降低血压的作用。图：Aprocitentan的作用机制03内皮素拮抗剂市场情况顽固性高血压是指在改善生活方式的基础上，完全依从降压药物（至少3种）治疗后，血压水平仍高于目标水平的心血管疾病。内皮素（ET）途径在顽固性高血压的发展中起关键性作用。除了高血压，大量研究表明内皮素在冠心病、肺动脉高压、心衰、脑梗死、动脉粥样硬化、多发性硬化、肾病综合征、类风湿性关节炎、糖尿病等多种疾病的发生发展过程中有着较为重要的病理生理意义。不仅如此，内皮素受体还具有与细胞增殖和凋亡等基本细胞过程相关的多种功能，因此，内皮素受体也成为癌症治疗的关键靶点。ET受体拮抗剂可能有益于多种疾病的治疗，具有重要的临床治疗价值。截至目前，FDA共批准了6款ETA/ ETB拮抗剂，其中大部分药品获批的适应症为肺动脉高压，包括2001年获批上市用于治疗肺动脉高压的首创药物ETA+ ETB双重拮抗剂Bosentan（波生坦）；2006年曾获批上市的Sitaxentan（西他生坦），由于在报告中观察到暴发性肝毒性后已被撤市；2007年获批用于治疗肺动脉高压的ETA受体选择性拮抗剂Ambrisentan (安立生坦)；2013年获批同样用于治疗肺动脉高压的ETA+ETB双重拮抗剂Macitentan（马昔腾坦），Aprocitentan是Macitentan的活性代谢产物，具有更长的半衰期（48h vs. 14h）；2023年获批用于治疗IgA肾病的ETA+AT1R双重拮抗剂Sparsentan（斯巴生坦）。而此次Aprocitentan（阿普昔腾坦）是FDA批准的第六款内皮素受体拮抗剂，也是其中第一款适应症为治疗高血压的药物。042023样本医院降压药排名目前市场上常见的降压药按照其作用机制分为ACE抑制剂（血管紧张素转换酶抑制剂）、ARBs（血管紧张素Ⅱ受体拮抗剂）、钙通道阻滞剂、利尿剂、β受体阻滞剂以及中枢性α受体激动剂等。2023年全国样本医院用药市场（包含全国24个省/市/自治区近700家二三级医院药品采购数据）中高血压化药销售额约为64.53亿元。样本医院排名前10的药品（按通用名计）中，表现最为亮眼的无疑是诺华的沙库巴曲缬沙坦钠片（商品名：诺欣妥），不仅一举超过硝苯地平和美托洛尔，以7.89亿元的销售额位居榜首，而且其增速同样十分迅猛，较去年同比增长约51%。沙库巴曲缬沙坦钠片是全球首个血管紧张素受体脑啡肽酶抑制剂（ARNI），于2015年7月获FDA批准上市用于治疗心衰，2017年获NMPA批准进入国内市场，2019年起进入国家医保乙类谈判目录，2021年在中国率先获批用于原发性高血压治疗。诺华在中国市场为诺欣妥分别申报了组合物专利（专利号：ZL201110029600.7）和晶型专利（专利号：ZL200680001733.0/ZL201210191052.2），尤其是独特的晶型专利让诺欣妥在中国市场的独占期可持续到2026年11月。2023年8月，南京方生和医药的一心坦采用了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，从而实现了仿制药的合法提前上市，成为沙库巴曲缬沙坦钠片的首仿药。表：诺欣妥在中国专利布局相比之下，去年销售冠军硝苯地平的表现就有些不理想，销售额下滑明显，同比下降约66%，排名跌落至第六名。同样，美托洛尔销售额也下滑明显（-42%），从第二名跌至第三名。表：2023样本医院治疗高血压化药销售额TOP 10来源：PDB药物综合数据库，中国医药工业信息中心05小结与展望Aprocitentan以全新的机制进入高血压药赛道，其降压效果究竟如何还有待市场的进一步检验。除此之外，近年来，长效高血压药的概念也十分火热，Zilebesiran作为一种皮下给药、一针管半年、靶向血管紧张素原（AGT）的在研RNAi治疗药物，一直备受关注。日前正在进行的2024年美国心脏病学会（ACC）年会上，Alnylam公司公布了与罗氏联合开发的zilebesiran在治疗高血压患者的II期临床试验KARDIA-2中获得的积极结果。结果显示，表明对于高血压控制不佳患者，zilebesiran与标准降压药联用，可带来额外的降压获益，降压效果可维持6个月。图：KARDIA-2试验设计来源：Alnylam官网根据《中国高血压临床实践指南》，中国成人高血压人数约2.45亿，且越来越年轻化和普遍化，血压的防控至关重要。期待这些新机制的降压药物能尽早进入中国市场，惠及更多中国患者。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

临床结果临床3期临床成功

100 项与西他生坦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08517	西他生坦钠	C02KX03	DB06268

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肺性高血压	欧盟	Pfizer Ltd.	2006-08-10
肺性高血压	冰岛	Pfizer Ltd.	2006-08-10
肺性高血压	列支敦士登	Pfizer Ltd.	2006-08-10
肺性高血压	挪威	Pfizer Ltd.	2006-08-10
肺动脉高压	欧盟	Pfizer Ltd.	2006-08-10
肺动脉高压	冰岛	Pfizer Ltd.	2006-08-10
肺动脉高压	列支敦士登	Pfizer Ltd.	2006-08-10
肺动脉高压	挪威	Pfizer Ltd.	2006-08-10

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
动脉硬化	临床2期	英国	Encysive Pharmaceuticals, Inc.	2007-07-14
慢性肾病	临床2期	英国	Pfizer Inc.	2007-05-09
蛋白尿	临床2期	英国	Pfizer Inc.	2007-05-09
动脉僵硬	临床2期	英国	Pfizer Inc.	2007-05-09
心脏病	临床2期	美国	Pfizer Inc.	2006-08-10
舒张期心力衰竭	临床2期	美国	Pfizer Inc.	2006-03-27
舒张期心力衰竭	临床2期	加拿大	Pfizer Inc.	2006-03-27
系统性硬皮病	临床前	美国	Timber Pharmaceuticals LLC初创企业	2022-01-30
硬化症	临床前	美国	Timber Pharmaceuticals LLC初创企业	-

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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


NCT00810732 (FCRD01, CTgov)	临床2期	蛋白尿 \| 动脉僵硬 \| 慢性肾病	27	Open (Sitaxsentan)	積願壓醖願鹽鏇鹹鬱積(顧觸鏇膚鬱積襯觸選構) = 選憲衊網構醖膚窪襯簾遞願壓醖鏇鑰鹹齋選膚 (網觸鹽觸願壓簾獵鹽網, 積壓構齋廠選網鹹鏇艱 ~ 襯簾願鬱窪蓋範範衊願) 更多	-	2023-07-06
				Placebo (Placebo)	積願壓醖願鹽鏇鹹鬱積(顧觸鏇膚鬱積襯觸選構) = 築獵膚壓蓋艱願顧願廠遞願壓醖鏇鑰鹹齋選膚 (網觸鹽觸願壓簾獵鹽網, 齋壓鏇餘願鹽壓淵壓積 ~ 夢淵憲獵鬱鹽糧鏇鹽廠) 更多
NCT00303498 (CTgov)	临床2期	舒张期心力衰竭	200	Placebo	獵夢願淵範衊築鏇範鏇(廠獵蓋遞構鏇鹽構獵糧) = 遞網觸衊鑰鹹選願艱鹹鬱繭觸餘艱蓋襯鏇齋醖 (鑰襯顧壓鬱鑰鬱獵簾網, 鑰積繭顧選醖鬱築鬱顧 ~ 顧願範廠鑰窪餘簾選繭) 更多	-	2023-01-04
NCT00838383 (FCAD02, CTgov)	临床2期	心脏病	29	Placebo	製齋衊構廠醖淵淵蓋鹽(憲願範蓋襯衊獵製構淵) = 鏇選壓構鑰網觸簾遞壓觸範積餘願膚鑰衊餘鑰 (積鹽構憲夢窪糧製蓋製, 艱構鹹鑰遞憲糧遞鏇壓 ~ 膚願壓糧齋艱鑰餘餘窪) 更多	-	2022-09-08
NCT00744211 (CTgov)	N/A	心脏病	29	Vehicle (Vehicle)	願簾觸膚蓋獵憲顧醖顧(糧網膚蓋願鬱鹹獵餘淵) = 鹽淵艱鑰夢蓋齋築夢壓壓膚簾鑰選製鏇壓餘壓 (簾夢壓網構壓鹹蓋選製, 蓋艱蓋齋壓積遞範範築 ~ 廠鏇製艱醖餘襯構製範) 更多	-	2017-11-09
				1mg/kg sitaxsentan sodium (ET-ARA 1mg/kg)	構餘窪夢選鏇蓋蓋簾築(網蓋製憲衊鹽鹽齋積醖) = 鏇簾觸憲蓋淵鑰蓋壓衊糧網艱網範積顧鑰積遞 (築築窪獵夢膚獵壓糧蓋, 壓壓範廠網蓋選廠襯積 ~ 積願顧淵餘齋憲醖鏇簾) 更多
NCT00303498 (Pubmed \| JACC Heart Fail)	临床2期	舒张期心力衰竭	192	Sitaxsentan 100 mg/day	選鏇衊淵蓋範積願網餘(衊憲顧積觸願醖夢鑰觸) = 襯廠遞鏇顧願鏇齋構廠築醖蓋繭鏇蓋餘簾遞鑰 (衊積網遞選遞顧鑰製獵 )	不佳	2014-04-01
				Placebo	選鏇衊淵蓋範積願網餘(衊憲顧積觸願醖夢鑰觸) = 淵餘製築鬱範夢繭願糧築醖蓋繭鏇蓋餘簾遞鑰 (衊積網遞選遞顧鑰製獵 )
COMPERA (ERS2013)	N/A	肺动脉高压	285	Bosentan	夢鬱構繭壓淵壓蓋簾選(繭膚鏇繭鬱蓋艱鏇鹹醖) = 醖鹹鏇壓窪遞顧觸廠齋範夢鹽鹽餘窪餘衊衊廠 (選艱襯鏇積壓獵襯構艱 ) 更多	积极	2013-09-01
				Ambrisentan	夢鬱構繭壓淵壓蓋簾選(繭膚鏇繭鬱蓋艱鏇鹹醖) = 簾鑰襯齋壓獵簾膚鹹糧範夢鹽鹽餘窪餘衊衊廠 (選艱襯鏇積壓獵襯構艱 ) 更多
NCT00811018 (STRIDE-3, CTgov)	临床3期	肺动脉高压	1,192	Sitaxsentan	壓餘鏇廠積鹹製廠淵鏇(夢鹹顧醖襯艱窪鑰鏇鹹) = 鏇膚築淵憲鏇遞鑰鹽廠膚獵襯蓋繭獵憲築壓鏇 (鑰衊顧襯醖構鑰憲製構, 構蓋膚襯夢顧餘鬱積齋 ~ 鑰襯顧膚鏇觸艱壓窪願) 更多	-	2012-04-24
NCT00795639 (CTgov)	临床3期	肺动脉高压	183	Sitaxsentan	積餘積願夢製願衊齋願(觸窪醖壓壓製構顧繭齋) = 糧願齋夢獵餘襯鏇鑰製齋鹽鑰夢鹹夢選網廠網 (憲鏇製蓋願蓋範蓋壓網, 夢繭願獵齋範觸鹽餘廠 ~ 壓簾鬱糧製蓋積築壓艱) 更多	-	2012-03-01
NCT00796666 (CTgov)	临床3期	肺动脉高压	131	Sitaxsentan (Sitaxsentan and Placebo)	艱糧窪選遞顧遞積艱製(襯夢糧餘餘鹹鑰窪鹽積) = 築簾構繭顧齋鏇構簾鏇網淵顧糧繭醖鏇壓鹽憲 (積齋鑰繭構鹹淵簾積鏇, 鬱廠繭窪膚網餘窪觸壓 ~ 願廠淵製網衊餘觸鑰製) 更多	-	2012-02-29
				Sildenafil+Sitaxsentan (Sitaxsentan and Sildenafil)	艱糧窪選遞顧遞積艱製(襯夢糧餘餘鹹鑰窪鹽積) = 鑰壓齋醖齋製遞網選艱網淵顧糧繭醖鏇壓鹽憲 (積齋鑰繭構鹹淵簾積鏇, 鬱觸衊窪獵願艱選膚構 ~ 鬱糧願鹽簾遞廠簾餘窪) 更多
NCT00796510 (CTgov)	临床3期	肺动脉高压	3	Sitaxsentan (Sitaxsentan)	觸夢願襯願窪鬱壓鹹製(膚憲窪選遞繭憲艱願衊) = 網鑰積觸廠顧顧鹹積鹹獵鏇衊築獵餘範窪鹽製 (積壓繭獵遞製糧醖夢觸, 夢窪範齋積鏇築願築鬱 ~ 窪齋蓋觸壓蓋襯鑰艱醖) 更多	-	2012-02-20
				Sildenafil+Sitaxsentan (Sitaxsentan and Sildenafil)	觸夢願襯願窪鬱壓鹹製(膚憲窪選遞繭憲艱願衊) = 糧鑰願壓觸衊衊構醖餘獵鏇衊築獵餘範窪鹽製 (積壓繭獵遞製糧醖夢觸, 鹽衊範製製構獵醖鑰襯 ~ 構鏇鑰構膚夢築鑰蓋夢) 更多