(Serelaxin) - 药物靶点：RXFP1_在研适应症：纤维化，心脏衰竭，门静脉高血压_专利_临床

概要

基本信息

药物类型

激素

别名

ConXn、Human relaxin 2 (relaxin h2)、Human relaxin recombinant

+ [13]

靶点

RXFP1

作用机制

RXFP1激动剂(松弛素受体-1激动剂)

治疗领域

心血管疾病消化系统疾病其他疾病

在研适应症

纤维化心脏衰竭门静脉高血压

非在研适应症

急性失代偿性心力衰竭慢性充血性心力衰竭慢性心力衰竭+ [8]

原研机构

The Florey Institute of Neuroscience & Mental Health

在研机构-

非在研机构

Novartis Pharmaceuticals Corp.

北京诺华制药有限公司Novartis Pharma AG

+ [6]

最高研发阶段批准上市

首次获批日期

俄罗斯 (2015-01-01),

纤维化心脏衰竭门静脉高血压

最高研发阶段(中国)暂停

特殊审评-

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序列信息

Sequence Code 43631

来源: *****

Sequence Code 1320151

来源: *****

关联

42

项与 Serelaxin 相关的临床试验

NCT02669875 / Completed临床2期IIT

Serelaxin To Lower Portal Pressure in Patients With Cirrhosis and Portal Hypertension

Portal hypertension (an increase in blood pressure in the portal vein that carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver blood flow.

开始日期2017-10-18

申办/合作机构

The University of Edinburgh

[+2]

CTR20150806 / Suspended临床3期

一项评价急性心衰患者在标准治疗基础上加用RLX030治疗的有效性、安全性和耐受性的III期临床研究

研究目的是在随机至RLX030或安慰剂组的亚洲AHF患者中，评价就诊后的16个小时内在标准治疗基础上加用RLX030 30 μg/kg/天静脉内输注48小时的有效性、安全性和耐受性。

开始日期2016-04-02

申办/合作机构

Novartis Pharma Stein AG

[+2]

NCT02625922 / Terminated临床2期

A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

开始日期2016-02-05

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与 Serelaxin 相关的临床结果

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100 项与 Serelaxin 相关的转化医学

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100 项与 Serelaxin 相关的专利（医药）

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345

项与 Serelaxin 相关的文献（医药）

2024-02-01·International journal of impotence research

In vitro effect of relaxin in the rat corpus cavernosum under hyperglycemic and normoglycemic conditions

Article

作者: Kaya-Temiz, Tijen ; Acar-Sahan, Selin ; Guner, Ozge ; Ates, Mehmet ; Durmus, Nergiz

Relaxin, an endogenous peptide hormone, elicits vascular relaxation by its direct effect or by modulating the endothelium-dependent relaxation response and is clinically evaluated for the treatment of coronary artery disease. However, its effect on penile tissue has not been explored yet. This study aimed to investigate the effect of serelaxin, recombinant human relaxin-2, on rat corpus cavernosum (CC) under healthy and hyperglycemic conditions. Strips of CC obtained from thirty-nine male Wistar rats weighing 300-350 g were used in organ baths for isometric tension studies to investigate the serelaxin-mediated relaxation (10^-12-10^-7M) under normoglycemic conditions and the effect of serelaxin on endothelium-dependent [nitric oxide (NO)- and prostacyclin-mediated] relaxation responses under hyperglycemic conditions. The in vitro hyperglycemia model was created by 3 h of incubation with 44 mM glucose monohydrate +120 μM methylglyoxal. NO-dependent relaxation responses were evaluated by cumulative acetylcholine (10^-9-10^-4M) administration in the presence of indomethacin (10^-6M). Prostacyclin-mediated relaxation was evaluated by cumulative administration of iloprost (10^-9-10^-6M), a prostacyclin analog. Maximum relaxation responses to serelaxin were not significantly different compared to the time-control (p = 0.480). Three hours of incubation of rat CC in hyperglycemic conditions impaired NO- and prostacyclin-mediated relaxation responses (p = 0.032 and p = 0.047, respectively). Serelaxin coincubation worsened NO-mediated relaxation responses (p = 0.016) but did not affect prostacyclin-mediated responses (p = 0.425). Together, our results demonstrate that in vitro administration of serelaxin does not cause relaxation in penile tissue and short-term in vitro serelaxin treatment in hyperglycemic conditions mimicked diabetes modulates endothelium-dependent responses by worsening NO-mediated responses. Serelaxin exerts different effects via different mechanism on endothelium-dependent responses depending on the dose and duration of exposure. Therefore, proper timing and dosing of serelaxin administration in the penile tissue need to be investigated in further studies in diabetic animal models.

2023-09-18·Clinical research in cardiology : official journal of the German Cardiac Society

Cardiovascular effects of relaxin-2: therapeutic potential and future perspectives.

Review

作者: Almeida-Pinto, Nísia ; Dschietzig, Thomas Bernd ; Adão, Rui ; Brás-Silva, Carmen

The hormone relaxin-2 has emerged as a promising player in regulating the physiology of the cardiovascular system. Through binding to the relaxin family peptide receptor 1 (RXFP1), this hormone elicits multiple physiological responses including vasodilation induction, reduction of inflammation and oxidative stress, and angiogenesis stimulation. The role of relaxin-2, or its recombinant human form known as serelaxin, has been investigated in preclinical and clinical studies as a potential therapy for cardiovascular diseases, especially heart failure, whose current therapy is still unoptimized. However, evidence from past clinical trials has been inconsistent and further research is needed to fully understand the potential applications of relaxin-2. This review provides an overview of serelaxin use in clinical trials and discusses future directions in the development of relaxin-2 mimetics, which may offer new therapeutic options for patients with heart failure.

2023-09-01·Journal of cardiovascular pharmacology

Serelaxin Inhibits Lipopolysaccharide-induced Inflammatory Response in Cardiac Fibroblasts by Activating Peroxisome Proliferator-activated Receptor-γ and Suppressing the Nuclear Factor-Kappa B Signaling Pathway.

Article

作者: Lv, Yehui ; Yang, Zhifang ; Li, Zhihong ; Wu, Xueping

ABSTRACT:

Serelaxin (sRLX) has an inhibitory effect on fibrosis. However, whether the antifibrotic effects of sRLX are achieved by inhibiting the inflammatory response has not been clarified. This study aimed to investigate the role of sRLX in lipopolysaccharide (LPS)-induced inflammation in cardiac fibroblasts and elucidate the underlying mechanisms. Cardiac fibroblasts were isolated from adult rat hearts. The effect of sRLX on the inhibition of the inflammatory response after LPS induction was examined. Cell viability was measured by MMT assay. Cell proliferation was determined using the Cell Counting Kit-8. The levels of inflammatory cytokines IL-1β, IL-6, TNF-α, and IL-10 were measured using an enzyme-linked immunosorbent assay. The mRNA levels of α-smooth muscle actin (α-SMA), collagen I/III, MMP-2, MMP-9, IL-1β, IL-6, TNF-α, IL-10, IκBα, p-IκBα, p65 subunit of nuclear factor-kappa B (NF-κB), and peroxisome proliferator-activated receptor-γ (PPAR-γ) were assessed by real-time quantitative PCR. The protein levels of α-SMA, collagen I/III, MMP-2, MMP-9, IκBα, p-IκBα, p65, p-p65, and PPAR-γ were examined by western blotting. sRLX inhibited LPS-induced IL-1β, IL-6, TNF-α, α-SMA, and collagen I/III, and elevated the expression of IL-10, MMP-2, and MMP-9. Moreover, LPS-induced activation of NF-κB pathway was suppressed by sRLX treatment. Further studies showed that sRLX did not significantly increase the expression of PPAR-γ mRNA and protein, but activated PPAR-γ activity, and the PPAR-γ inhibitor GW9662 reversed the inhibitory effect of sRLX on IL-1β, IL-6, and TNF-α production. These results suggest that sRLX alleviates cardiac fibrosis by stimulating PPAR-γ through a ligand-independent mechanism that subsequently abolish the expression of NF-κB signaling pathway.

6

项与 Serelaxin 相关的新闻（医药）

2024-03-02

·PRNewswire

Global Acute Heart Failure (AHF) Therapeutics Research Report 2022-2024 and 2030: Conventional Therapies Leave Considerable Unmet Needs, Novel Treatments Offer a Ray of Hope

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Acute Heart Failure (AHF) Therapeutics: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Acute Heart Failure (AHF) Therapeutics Market to Reach $2.9 Billion by 2030 The global market for Acute Heart Failure (AHF) Therapeutics estimated at US$599.7 Million in the year 2022, is projected to reach a revised size of US$2.9 Billion by 2030, growing at a CAGR of 21.7% over the analysis period 2022-2030. Cardiac Glycosides, one of the segments analyzed in the report, is projected to record a 22.3% CAGR and reach US$762.4 Million by the end of the analysis period. Taking into account the ongoing post pandemic recovery, growth in the B-Blockers segment is readjusted to a revised 25.1% CAGR for the next 8-year period. The acute heart failure (AHF) market has been significantly impacted by the COVID-19 pandemic and the looming global recession. Despite the challenges, diuretics and vasodilators remain the first-line therapy for AHF, although the efficacy of other known drugs for AHF is limited, hindering their widespread use. Market insights and trajectories indicate a complex landscape influenced by these factors, with varying degrees of competitive market presence among players worldwide in 2022. Recent market activity reflects ongoing efforts to size the AHF market and adapt to the evolving healthcare landscape. Looking ahead, the market outlook suggests continued focus on addressing the challenges posed by COVID-19 and economic uncertainties while exploring opportunities for innovation and growth in AHF therapeutics. The U.S. Market is Estimated at $163.4 Million, While China is Forecast to Grow at 30.4% CAGR The Acute Heart Failure (AHF) Therapeutics market in the U.S. is estimated at US$163.4 Million in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$841.2 Million by the year 2030 trailing a CAGR of 30.4% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 16.3% and 18.4% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 17.1% CAGR. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$433.4 Million by the year 2030. MARKET OVERVIEW Influencer Market Insights World Market Trajectories Market Outlook Recent Market Activity Sizing the AHF Market Acute Heart Failure - An Overview of the Disease and Available Therapeutics Diuretics and Vasodilators - The First Line Therapy for AHF Other Known Drugs for AHF - Lower Efficacy Thwarts Use Acute Heart Failure (AHF) Therapeutics - Global Key Competitors Percentage Market Share in 2022 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2022 (E) Impact of Covid-19 and a Looming Global Recession MARKET TRENDS & DRIVERS Conventional Therapies Leave Considerable Unmet Needs Novel Treatments Offer a Ray of Hope Key AHF Therapeutics in the Pipeline Serelaxin Nears Trial Readout form RELAX-AHF-2 Ularitide - A Novel Drug in Development for AHF The Litany of Drug Failures Expands, Emphasis on Prevention Grows Other Promising Drugs under Development Research Findings Kidney Dysfunction - Predictor of Acute Heart failure Genetic Influence on Heart Disease among African Americans Higher Body Mass Index - A Key Risk Factor for AHF Supplemental Oxygen Therapy May not be for All Cases of AHF Macro Growth Drivers Alarming Levels of Cardiovascular Disease (CVD) Prevalence: Key Growth Driver for AHF Therapeutics Ballooning Elderly Population: The Vital Growth Driver for AHF Therapeutics FOCUS ON SELECT PLAYERS (Total 93 Featured) Bayer AG (Germany) Bristol-Myers Squibb Company (USA) Cardiorentis AG (Switzerland) CVie Therapeutics Limited (Taiwan) Cytokinetics, Inc. (USA) Merck & Co. (USA) Novartis AG (Switzerland) Orion Corporation (Finland) PhaseBio Pharmaceuticals, Inc. (USA) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

AHA会议

2023-06-21

·智慧芽新药科讯

十年磨一剑---阿斯利康的RXFP1激动剂能否拔得头筹？

松弛素是一种多效性激素，在怀孕期间介导全身血流动力学和肾脏适应性变化。松弛素也被证明具有抗纤维化特性，并对心力衰竭有有益作用，例如急性失代偿性心力衰竭(ADHF)。心力衰竭具有较高的发病率和死亡率。其特点是复杂的组织重塑，包括心肌细胞死亡和间质纤维化增加。松弛素激活了许多信号级联反应，这在缺血再灌注和心力衰竭的情况下是有益的。如图1，这些信号通路包括PI3K通路和一氧化氮信号通路。松弛素家族肽受体1 (RXFP1)是松弛素-2的受体，松弛素-2是生殖和心血管生理的重要调节因子。RXFP1是一个经过充分验证的、药理学上重要的GPCR家族1c成员，其被松弛素激素激活与血流动力学、抗纤维化和抗炎特性有关。RXFP1的激活可以降低血管阻力和潜在的肺压，从而增加心输出量，增强肾、肺和肝脏重要中央血管床的灌注。图1 RXFP1介导的信号通路靶向RXFP1的激动剂目前只有一款药物上市，是诺华开发的重组天然激素类似物serelaxin。处于临床阶段的激动剂有松弛素模拟物AZD3427（II期）、小分子AZD5462（I期），凭借新冠疫苗大火的Moderna Therapeutics公司开发的mRNA类激动剂mRNA-0184（I期）。以及临床前靶向RXFP1和RXFP2的多肽激动剂CGEN-25010（无进展）。Serelaxin的心衰3期临床因为试验没有达到一级终点而失败，最后只能选择在俄罗斯上市，且Serelaxin的半衰期只有10分钟，需要静脉注射。松弛素模拟物AZD3427和mRNA-0184也需要注射。为了提高患者的依从性，小分子激动剂的开发具有广阔的市场。小分子靶向RXFP1非常具有挑战，因为缺乏直接的蛋白结构信息，并且早期通过高通量筛选得到的小分子都缺乏成药性。2013年，美国国立卫生研究院对35万多个化合物通过高通量筛选发现了化合物ML290。AZ和BMS均以ML290为先导进行优化，最终AZD5462在2022年6月成为首个进入临床的口服小分子RXFP1激动剂。图2 AZD5462的结构两年一次的 EFMC-ISMC是药物化学和药物发现领域的重要研讨会。在2022年9月的EFMC-ISMC会议上阿斯利康公开了AZD5462的结构信息。如图2，AZD5462结构中含有一个有趣的降冰片烷环，同时连着一个顺式环己烷羧酸片段。AZD5462正处于临床一期试验中，以评估其在日本裔健康志愿者中的安全性、耐受性和药代动力学，使用单次和多次递增剂量给药。对心力衰竭伴射血分数降低(HFrEF)的猕猴进行的临床前研究显示，给药8周后，心脏收缩期功能得到改善，平均动脉血压或心率没有显著升高。AZD5462对RXFP1具有高度选择性，在7个最接近的GPCR中没有活性(大于10µM)，并且与CEREP Safety panel中的靶标没有相互作用。图3 AZD5462的发现-引入苯环的生物电子等排体根据会议披露的SAR信息，简单猜测一下AZD5462的发现过程，这是一个传统药化改构的案例。图3箭头所示为ML290的结构，LogD7.4较高容易带来一些毒性风险。最初将邻氨基苯甲酸片段的苯环替换成非芳香片段，如Rac-4和Rac-5，但都有不同程度的活性下降，清除也变快。如图4所示，改造的关键点是引入了羧酸片段，这可能是想降低LogD7.4或者改善药物的组织分布，从后续给出的Vss看，分布体积也减小了。Rac-12和Rac-13对比，说明了羧酸和氧原子之间隔4个碳原子对活性提升最有利，较Rac-11提升了10倍以上。进一步接上环己烷羧酸片段，并饱和Rac-11中非芳香环的双键得到化合物14，活性较Rac-11提升了10000倍，但化合物14的LogD7.4仍然较高，达到4.9。图4 AZD5462的发现-引入环己烷羧酸进一步，把最右侧的苯环也用非芳香片段替代，以降低脂溶性，减小LogD7.4，引入叔丁基、环丁基、环己基等，得到图5所示的化合物15、AZD5462、16、17、18。活性虽然降低了，但是其他性质得到平衡，比如LogD7.4就在一个合理的范围中，清除率也不会过快。预估的人体给药剂量也在100mg/70kg/d内（除了化合物16的预估剂量达到304/70kg/d）。而化合物17和18中R片段由F改为CN，降低了人体预估剂量却没有被选中，笔者猜测是基于安全性层面的考量。图5 AZD5462的发现-成药性的优化如图6，重新梳理一下AZD5462的各项数据。由于RXFP1激动剂所针对的适应症是慢性病，安全性必然最为重要。AZD5462各项性质均衡，在最为关键的安全性参数的评价中，没有CYP450酶抑制的风险，无TDI风险（CPY3A4/5），无hERG毒性风险，无ames毒性风险。caco-2测试中，虽然efflux达到3.6，有一定的外排，但是吸收较好弥补了外排的风险。虽对OATP1B1 和OATP1B3 转运体有一定程度的抑制，仍需考虑具体给药剂量下血药浓度的影响。并且AZD5462的LogD7.4也因为将两处的芳香环非芳香化，同时引入羧酸片段，成功降低到3.2。CEREP Safety panel中的靶标选择性也大于1000倍。Vss也在合理范围，不会导致组织分布过于广泛而影响药效。大鼠的生物利用度达到58%，虽然食蟹猴的生物利用度只有12%，但是根据AZD5462在不同种属肝细胞中代谢稳定性的差异，预测的人体内的生物利用度达到70%。考虑到以上种种所带来的获益风险比，最终AZD5462进入一期临床评估其对心血管紊乱方面相关疾病的治疗潜力。图6 AZD5462的主要评价数据在智慧芽专利数据库中检索RXFP1，主要是AZ和BMS在布局靶点RXFP1，还未看到国内公司follow的专利公开。阿斯利康申请了一篇专利WO2022122773A1，包含624个实施例，其中就有AZD5462。BMS在2023.5.4公开了4篇RXFP1激动剂专利，第一篇WO2023077041A1，这篇专利只有19个实施例。第二篇WO2023077040A1，包含377个实施例，少部分化合物达到了纳摩尔水平。第三篇WO2023077070A1，包含188个实施例，多数化合物达到了纳摩尔活性水平。从结构上可以看出是在第二篇专利的结构基础上进行进一步优化。第四篇WO2023076626A1，包含976个实施例。结构上延续了第三篇，只是把吡啶替换成了苯环。活性大部分都是纳摩尔水平。自从美国国立卫生研究院首次报道ML290的结构，已过去10年，AZ和BMS进入小分子RXFP1激动剂领域时，都是以ML290为先导，根据传统药化改构的思路优化成药性。2022年在bioRxiv上发表了活性态RFXP1的CryoEM结构，这将促进更多新结构类型的RXFP1小分子激动剂的发现。随着AZD5462进入临床评估安全性和有效性，这一领域的研发热情也再次被点燃，期待更多积极结果的公布，为心血管病人带来福音。参考资料：1.Ram W. Sabnis. Novel RXFP1Modulators for Treating Heart Failure. ACS Med. Chem. Lett. 2022, 13, 1213−1214.2.Maik Gollasch et al; RXFP1 Receptor Activation by Relaxin-2 Induces Vascular Relaxation in Mice via a Gαi2-Protein/PI3Kß/γ/Nitric Oxide-Coupled Pathway. doi: 10.3389/fphys.2018.01234.3.https://drughunter.com/first-disclosures-from-esmc-ifmc-nice-2022/.4.Pamela Brown et al; Recent trends in medicinal chemistry and enabling technologies. Highlights from the Society for Medicines Research Conference. Drugs of the Future 2023, 48(3): 211-219.5.谢伊，人在药途，研发前沿|诺华、AZ、BMS等大厂争先布局的RXFP1，是个什么靶点？6.智慧芽新药情报库.

临床2期临床1期信使RNA临床3期疫苗

2023-03-05

·医药观澜

针对心血管疾病！阿斯利康1类新药在中国申报临床

▎药明康德内容团队报道3月2日，中国国家药监局药品审评中心（CDE）官网公示，阿斯利康（AstraZeneca）递交了AZD3427注射用浓溶液的临床试验申请，并获得受理。公开资料显示，AZD3427是阿斯利康心血管疾病领域的一款在研产品，为一款松弛素模拟物，目前正在海外开展2期临床研究。截图来源：CDE官网松弛素（Relaxin）是一种内源性异二聚胰岛素样肽。由于在软化耻骨韧带和子宫颈方面的作用，松弛素可以为各种物种的分娩做准备，因此最初被认为是一种妊娠激素。据文献报道，目前公认松弛素在心血管系统中具有有益的生理作用，并且具有较好的安全性。研究表明，松弛素可以作用于其同源松弛素受体RXFP1，该受体在许多器官和组织中广泛表达，包括心脏、肾脏和血管等。许多临床前和临床研究已经取得积极结果，表明松弛素可能通过增强内皮介导的血管舒张机制、促进心血管系统中的心脏保护和抗纤维化作用，对心脏和血管产生有益作用。因此，它在调节心血管疾病发病机制中的作用逐渐成为研究的焦点，使用内源性激素松弛素模拟物治疗心血管疾病成为新药研发方向。AZD3427正是阿斯利康在研的一款松弛素模拟物。根据ClinicalTrials官网，阿斯利康正在针对心力衰竭和肺动脉高压患者开展一项2期临床研究，评估AZD3427治疗24周后降低患者肺血管阻力的能力。肺动脉高压和心力衰竭均是威胁生命的心血管疾病。其中，肺动脉高压（PAH）是具有内皮功能障碍、内膜增生、中层肥大以及膜纤维化阻碍血液流向毛细血管等特征的闭塞性肺血管疾病。心力衰竭主要表现为呼吸困难、疲乏和液体潴留等，影响患者心脏和肾功能，严重降低患者生存质量。希望阿斯利康这款松弛素模拟物后续临床开发进展顺利，早日为患者带来新的治疗选择。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Mar 2 , 2023. From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]Chen Huei Leo et al. Recent developments in relaxin mimetics as therapeutics for cardiovascular diseases. (2019) Curr Opin Pharmacol. DOI: 10.1016/j.coph.2019.04.001[3]阿斯利康官网. From https://www.astrazeneca.com/our-therapy-areas/pipeline.html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「医药观澜」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。

临床2期申请上市临床申请

100 项与 Serelaxin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10488	Serelaxin	C01DX21	DB05794

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
纤维化	俄罗斯	-	2015-01-01
心脏衰竭	俄罗斯	-	2015-01-01
门静脉高血压	俄罗斯	-	2015-01-01

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
胡宁病毒感染	临床3期	中国	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	日本	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	印度	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	约旦	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	黎巴嫩	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	马来西亚	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	菲律宾	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	新加坡	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	韩国	Novartis Pharmaceuticals Corp.	2014-03-12
胡宁病毒感染	临床3期	中国台湾	Novartis Pharmaceuticals Corp.	2014-03-12

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临床结果

适应症

分期

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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


NCT01979614 (Pubmed) 人工标引	临床2期	冠心病	51	serelaxin	鏇壓願窪糧膚鏇鏇鏇選(憲鏇艱築簾積鹽衊窪網) = 獵願憲膚糧壓製範糧夢範淵鏇膚觸醖蓋積憲選 (鬱窪觸壓遞鹹蓋選願積 ) 更多	积极	2021-01-01
				Placebo	鏇壓願窪糧膚鏇鏇鏇選(憲鏇艱築簾積鹽衊窪網) = 構獵鹹餘廠鏇鹹膚廠襯範淵鏇膚觸醖蓋積憲選 (鬱窪觸壓遞鹹蓋選願積 ) 更多
NCT02669875 (STOPP, Pubmed \| Trials)	临床2期	纤维化	15	Serelaxin	範鑰鏇鹽壓淵網壓艱憲(鹹廠淵醖繭製膚齋繭夢) = 獵廠襯獵衊艱餘製膚築築構夢壓淵窪鬱鹹窪醖 (夢齋艱鑰衊鏇顧淵構鑰, ±3.5)	-	2020-03-12
NCT01870778 (RELAX-AHF-2, Pubmed \| Br Dent J) 人工标引	临床3期	心脏衰竭	6,545	Serelaxin	衊廠蓋鹽選憲範選構襯(構鑰範築鬱齋顧糧繭鑰) = 鑰襯廠齋製構選淵獵餘衊範獵糧壓壓鏇觸築鏇 (醖網觸襯憲壓蓋襯襯醖 ) 更多	不佳	2019-08-22
				Placebo	衊廠蓋鹽選憲範選構襯(構鑰範築鬱齋顧糧繭鑰) = 膚積遞範簾顧鏇鹹鏇廠衊範獵糧壓壓鏇觸築鏇 (醖網觸襯憲壓蓋襯襯醖 ) 更多
NCT01979614 (CTgov)	临床2期	冠心病	58	Serelaxin (Serelaxin)	獵簾憲選選膚構衊鬱繭(鬱窪鹽鹹夢築築壓鬱蓋) = 顧網鑰築簾構選齋繭繭顧淵醖糧窪壓構觸顧觸 (衊餘積膚衊顧膚廠襯衊, 廠鹽積鏇範選築顧遞糧 ~ 遞鬱衊襯淵鏇艱獵獵鏇) 更多	-	2019-07-01
				Placebo (Placebo)	獵簾憲選選膚構衊鬱繭(鬱窪鹽鹹夢築築壓鬱蓋) = 壓糧夢糧範選繭壓窪顧顧淵醖糧窪壓構觸顧觸 (衊餘積膚衊顧膚廠襯衊, 齋鬱壓願壓鑰製衊繭齋 ~ 衊壓糧鏇蓋壓淵繭簾鑰) 更多
NCT02151383 (CTgov)	临床2期	急性失代偿性心力衰竭	12	Serelaxin (Serelaxin: Cohort 1)	糧壓築襯夢憲餘積廠鏇(鑰觸網廠鑰鬱衊顧醖襯) = 鹽遞襯構襯構壓遞願製鏇繭艱壓夢觸積選淵構 (淵蓋衊積衊積網範獵顧, 糧遞壓衊壓網糧憲艱築 ~ 選壓繭範憲蓋壓衊壓壓) 更多	-	2019-06-25
				Serelaxin (Serelaxin: Cohort 2)	糧壓築襯夢憲餘積廠鏇(鑰觸網廠鑰鬱衊顧醖襯) = 網廠簾築壓廠壓製鑰鑰鏇繭艱壓夢觸積選淵構 (淵蓋衊積衊積網範獵顧, 艱繭獵鬱築繭艱願餘壓 ~ 窪鑰蓋艱齋繭醖齋範膚) 更多
NCT02064868 (RELAX-AHF-EU, CTgov)	临床3期	急性失代偿性心力衰竭	2,666	Standard of Care+Serelaxin (Serelaxin + Standard of Care)	醖製窪窪製簾構遞艱鏇(襯遞鹹襯夢壓鬱願鑰積) = 夢衊鹽鹽網鏇積憲範餘願廠選鏇鏇齋餘襯鬱鹹 (淵艱製夢鹽夢獵選鑰選, 築壓構鹹窪衊蓋顧鬱觸 ~ 願糧齋顧醖顧齋獵糧膚) 更多	-	2019-03-22
				Standard of Care (Standard of Care (SOC))	醖製窪窪製簾構遞艱鏇(襯遞鹹襯夢壓鬱願鑰積) = 顧網襯艱壓築繭餘窪築願廠選鏇鏇齋餘襯鬱鹹 (淵艱製夢鹽夢獵選鑰選, 築襯醖襯糧築襯構壓簾 ~ 襯窪窪遞艱築窪遞壓鬱) 更多
NCT02064868 (RELAX-AHF-EU, Pubmed \| Eur J Heart Fail) 人工标引	临床3期	心脏衰竭	2,666	standard of care+serelaxin	顧鏇製齋憲衊獵糧遞構(夢淵壓顧夢網糧觸築製) = 餘膚網繭獵廠衊製膚淵構鹽廠鹽網壓構積鏇獵 (憲製構鬱製鏇齋淵鬱艱 )	积极	2019-03-01
				standard of care	顧鏇製齋憲衊獵糧遞構(夢淵壓顧夢網糧觸築製) = 艱艱艱衊淵築窪簾鹽構構鹽廠鹽網壓構積鏇獵 (憲製構鬱製鏇齋淵鬱艱 )
NCT01870778 (RELAX-AHF-2, CTgov)	临床3期	心脏衰竭	6,600	RLX030 (Serelaxin (RLX030))	窪選鹽鹽遞鹹遞獵廠膚(廠繭遞構網膚窪衊鏇構) = 願積蓋顧壓築鑰獵壓壓襯襯獵糧壓鑰壓蓋顧遞 (積鬱範餘襯鹽範窪齋築, 醖夢範網夢構願夢鑰艱 ~ 構鑰衊鹽憲顧顧蓋餘選) 更多	-	2018-03-30
				Placebo (Placebo)	窪選鹽鹽遞鹹遞獵廠膚(廠繭遞構網膚窪衊鏇構) = 鹽範簾窪築憲網壓憲鏇襯襯獵糧壓鑰壓蓋顧遞 (積鬱範餘襯鹽範窪齋築, 衊餘淵淵齋願積獵構襯 ~ 鏇壓鏇鑰範繭觸觸蓋願) 更多
NCT01979614 (ESC2017)	临床2期	冠心病	62	IV serelaxin (30 Î¼g/kg/24 h)	構醖糧鏇鏇積築製鹽獵(觸壓觸憲觸壓膚簾壓艱) = 網鏇艱積繭蓋簾廠壓壓齋獵願構廠蓋選鹽網鬱 (餘願製壓糧糧糧蓋遞選 ) 更多	不佳	2017-08-27
				Placebo	構醖糧鏇鏇積築製鹽獵(觸壓觸憲觸壓膚簾壓艱) = 願遞齋襯艱鹽夢餘積襯齋獵願構廠蓋選鹽網鬱 (餘願製壓糧糧糧蓋遞選 ) 更多
NCT00259103 (Pubmed \| BMC Pregnancy Childbirth) 人工标引	临床2期	-	74	serelaxin	鹹糧鑰構糧顧衊艱餘淵(憲積襯範膚積鹹構衊鹹) = 繭鑰蓋製廠範顧鏇衊醖淵範艱鹹憲蓋鏇構製繭 (選蓋淵壓選淵鏇範遞製, 1.9)	不佳	2016-09-05
				Placebo	鹹糧鑰構糧顧衊艱餘淵(憲積襯範膚積鹹構衊鹹) = 窪廠憲鹽鹹壓壓窪夢顧淵範艱鹹憲蓋鏇構製繭 (選蓋淵壓選淵鏇範遞製, 2.26)