沙库巴曲缬沙坦钠(Sacubitril/Valsartan) - 药物靶点：AT1R x CD10_在研适应症：原发性高血压，高血压，左心室收缩功能障碍_专利_临床

概要

基本信息

药物类型

小分子化药

别名

AHU-377/valsartan、Enrest、LCZ

+ [17]

靶点

AT1R x CD10

作用机制

AT1R拮抗剂(血管紧张素II-1型受体拮抗剂)、enkephalinase抑制剂(脑啡肽酶抑制剂)

治疗领域

心血管疾病

在研适应症

原发性高血压高血压左心室收缩功能障碍+ [3]

非在研适应症

急性心肌梗塞动脉硬化房性心律失常+ [15]

原研机构

Novartis Pharma AG

在研机构

Novartis Pharmaceuticals Corp.

Novartis AGJohn Paul II Hospital, Krakow

+ [4]

非在研机构

北京诺华制药有限公司Novartis Pharma Stein AG

St. Vincent's University Hospital

最高研发阶段批准上市

首次获批日期

美国 (2015-07-07),

慢性心力衰竭

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、优先审评 (中国)

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结构

分子式C48H61N6NaO9

InChIKeyBHNNEXLQFVQGSE-LWRBNZNASA-N

CAS号936623-90-4

关联

281

项与沙库巴曲缬沙坦钠相关的临床试验

CTR20241247 / RecruitingN/A

沙库巴曲缬沙坦钠片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、四周期、完全重复交叉生物等效性研究

主要研究目的：考察单次口服（空腹/餐后）受试制剂沙库巴曲缬沙坦钠片【规格：以沙库巴曲缬沙坦计200mg（沙库巴曲97mg/缬沙坦103mg）】与参比制剂【商品名：诺欣妥，规格：以沙库巴曲缬沙坦计200mg（沙库巴曲97mg/缬沙坦103mg）】在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价单次口服（空腹/餐后）受试制剂和参比制剂在中国成年健康受试者中的安全性。

开始日期2024-05-09

申办/合作机构

常州四药制药有限公司

NCT06248112 / Not yet recruiting临床1期

A Bioequivalence Study of Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets in Healthy Thai Volunteers Under Fasting Condition

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be a randomized, open-label, single oral dose, full replicated crossover design with four-period, two-treatment, and two-sequence under fasting condition and at least 14 days washout period between the doses.

开始日期2024-05-06

申办/合作机构

Bio-innova Co., Ltd

IRCT20120215009014N503 / Recruiting临床3期

Effect of Sacubitril-Valsartan versus angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blocker (ARB) on left ventricular ejection fraction in patient with heart failure: a double-blind randomized clinical trial

开始日期2024-04-20

申办/合作机构

Hamedan University of Medical Sciences

100 项与沙库巴曲缬沙坦钠相关的临床结果

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100 项与沙库巴曲缬沙坦钠相关的转化医学

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100 项与沙库巴曲缬沙坦钠相关的专利（医药）

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425

项与沙库巴曲缬沙坦钠相关的文献（医药）

2024-02-01·Neuroscience letters

The neuroprotective effect of LCZ696 on methamphetamine-induced cognitive impairment in mice

Article

作者: Liu, Yu ; Qian, Liyin ; Li, Xiaofang ; Shen, Yao ; Luo, Hu ; Si, Zizhen ; Yu, Zhaoying ; Lin, Shujun ; Ruan, Yuer ; Gong, Xinshuang

OBJECTIVE:

Methamphetamine (METH) exposure commonly causes cognitive impairment. An angiotensin II receptor/neprilysin inhibitor (ARNI), LCZ696 has been demonstrated to inhibit inflammation, oxidative stress and apoptosis. The present study was designed to examine the effect of LCZ696 on METH-induced cognitive impairment and the underlying mechanism.

METHODS:

Following daily treatment of either saline or METH (5 mg/kg) for 5 consecutive days, the cognitive function was tested using the Y-maze and the Novel Object Recognition (NOR) in Experiment 1. In Experiment 2, mice were initially treated with saline or LCZ696 (60 mg/kg) for 9 consecutive days, followed by LCZ696, METH or saline for 5 days. Cognitive testing was carried out as Experiment 1. In Experiment 3, SH-SY5Y cells were treated with either METH (2.5 Mm) or ddH2O for 12 h. The apoptosis and reactive oxygen species (ROS) level of SH-SY5Y were examined. In Experiment 4, SH-SY5Y cells were pretreated with either ddH2O or LCZ696 (70um) for 30 min, followed by ddH2O or METH treatment for 12 h. Nrf2 and HO-1 protein expression was examined in the ventral tegemental area (VTA) of all the animals and SH-SY5Y cells.

RESULTS:

LCZ696 significantly improved METH-induced cognitive impairment, in conjunction with decreased apoptosis and ROS levels in VTA of METH-treated mice and SH-SY5Y cells. METH significantly decreased Nrf2 and HO-1 protein expression in VTA of mice and SH-SY5Y cells, which was reversed by LCZ696 treatment.

CONCLUSION:

LCZ696 yields a neuroprotective effect against METH-induced cognitive dysfunction via the Nrf2/HO-1 signaling pathway.

2024-01-25·Zhen ci yan jiu = Acupuncture research

Effect of electroacupuncture on ventricular structure and function in rats with myocardial ischemia-reperfusion injury.

Article

作者: Bai, Hua ; Zhang, Hong-Ru ; Xia, Ming-Hui ; Xu, Sen-Lei ; Wu, Shuang ; Gu, Yi-Huang ; Ding, Ya-Ping ; Liu, Qiong-Qiong ; Jiang, Wen

OBJECTIVES:

To observe the effect of electroacupuncture (EA) on changes of ventricular structure and function in rats with myocardial ischemia-reperfusion injury (MIRI), so as to explore its potential mechanisms underlying improvement of ventricular remodeling after MIRI.

METHODS:

Forty male SD rats were randomly divided into 4 groups：sham operation group, model group, EA group and medication (sacubactril valsartan, LCZ696) group, with 10 rats in each group. The MIRI model was established by ligation of the left anterior descending coronary artery and reperfusion. EA (2 Hz/100 Hz, 2 mA) was applied to bilateral "Neiguan" (PC6) for 20 min, once every other day for 21 d. Rats of the medication group received gavage of LCZ696 (60 mg·kg^-1·d^-1). After the intervention, echocardiography was used to detect the ejection fraction (EF) and fractional shortening (FS) of the left ventricle, and the contents of serum tumor necrosis factor-α(TNF-α), vascular cell adhesion molecule-1(VCAM-1) and intercellular cell adhesion molecule-1(ICAM-1) were assayed by enzyme-linked immunosorbent assay. The pathological changes of myocardial tissue were observed after HE staining. The Masson staining was used to evaluate the myocardial collagen deposition and myocardial fibrosis. The mRNA expression levels of collagen Ⅰ and Ⅲ and connective tissue growth factor (CTGF) in the myocardial tissue were detected by quantitative real-time PCR, and the expression levels of IL-1β and IL-18 were detected by Western blot.

RESULTS:

In contrast to the sham operation group, the EF and FS levels of the left ventricle were ob-viously decreased (P<0.001), while the contents of serum TNF-α, VCAM-1 and ICAM-1, the proportion of myocardial fibrosis area, the mRNA expression levels of myocardial collagen Ⅰ, collagen Ⅲ and CTGF, the expression levels of IL-1β and IL-18 were significantly increased (P<0.001, P<0.000 1, P<0.05, P<0.01) in the model group. Compared with the model group, the EF and FS levels were remarkably increased (P<0.01), whereas the contents of serum TNF-α, VCAM-1 and ICAM-1, the proportion of myocardial fibrosis area, the mRNA expression levels of myocardial collagen Ⅰ, collagen Ⅲ and CTGF, and the expression levels of IL-1β and IL-18 were significantly down-regulated (P<0.001, P<0.01, P<0.05) in both the medication and EA groups. No significant differences were found between the EA and medication groups in all the indexes mentioned above.

CONCLUSIONS:

EA can improve the left-ventricular fibrosis and function, delay or reverse ventricular remodeling in MIRI rats, which may be related to its functions in down-regulating myocardial inflammatory response and mRNA expression levels of myocardial collagen Ⅰ, collagen Ⅲ and CTGF.

2024-01-01·European review for medical and pharmacological sciences

Knowledge domain and emerging trends in sacubitril/valsartan study from 2008 to 2023 - a visualized conclusive analysis based on novel scientometric tools.

Article

作者: Rong, J-C ; Zhao, X-C ; Huang, L ; Lu, B-H

OBJECTIVE:

This study aimed to determine the evolution of sacubitril-valsartan research and analyze the publications quantitatively and qualitatively.

MATERIALS AND METHODS:

We used the bibliometric method and a combination of CiteSpace_6.1.6 and VOSviewer_1.6.18 to identify top authors, countries, institutions, co-cited articles, co-cited journals, keywords, and trends. This study prioritized key aspects in the existing global research on Entresto (Sacubitril/Valsartan) to assess our depth of knowledge in this field and identify potential insights. The objective was to generate a reference for the utilization of the "angiotensin receptor-neprilysin inhibitor" (ARNI).

RESULTS:

From 2008 to 2022, citations of sacubitril-valsartan showed an upward trend. VOSviewer keyword analysis of 3,408 publications identified 624 keywords and divided them into seven different clusters. The clustered network was constructed based on 1,191 references cited by 3,408 publications that met the terms, where the clustered network of sacubitril-valsartan was presented. These publications can be regarded as fundamental to Entresto's research. Analysis of co-cited reference clusters showed that other than Entresto's novel application in other diseases, the new combination with other medication or mechanical assistance therapies against heart failure was Entresto's latest focus. Analysis of citation bursts showed that the rank of the top 25 keywords, according to the chronological sequence, marked Entresto's research entering a new era of exploring the extended application in other diseases and novel combinations with other diverse therapies.

CONCLUSIONS:

We found that emerging new mechanisms in sacubitril-valsartan therapy intended for more targets in the pathogenesis of specific diseases will be the focus of further studies.

504

项与沙库巴曲缬沙坦钠相关的新闻（医药）

2024-06-27

·生物制药小编

司美格鲁肽男女获益差异

近日，在佛罗里达州奥兰多举行的美国糖尿病协会科学会议上，诺和诺德公布了不同性别患者服用司美格鲁肽的基线特征和治疗效果。相关成果发表于《美国心脏病学会杂志》上。为何要研究生理性别特征肥胖相关的射血分数保持的心力衰竭是射血分数保持的心力衰竭（HFpEF）最普遍的表型，也是全球发病率和死亡率持续增长的来源。特别是内脏型肥胖，这种肥胖导致了一系列的全身和局部的各类病变，而这种病变程度与生理性别直接相关。实际上，生理性别对心力衰竭的几乎每个方面都有深远的影响，从风险因素到临床表现、治疗反应和预后。这一差异主要体现在： ①HFpEF患者通常是女性，女性与男性发病比例约为2:1，女性更容易发生心室肥厚和僵硬。不过尽管如此，患有HFpEF的女性的存活率通常较好，也较少出现与心衰相关的住院情况。 ②心室功能差异问题，女性的左心室腔尺寸较小。女性和男性的身体组成和脂肪分布各不相同，这也可能影响针对多余体脂的治疗效果。有一种流行的理论认为，女性HFpEF不良临床表现背后的主要驱动因素之一与内脏肥胖的数量和分布差异有关，内脏型肥胖可能导致异常的心外膜和内皮炎症。此外，血液和血浆容量随体重增加的关系在女性中比在男性中更明显。在对某些治疗的反应中也观察到了性别差异。例如，诺华的重磅炸弹心衰药——沙库巴曲缬沙坦钠（Entresto，研发代码LCZ696）机制是通过抑制血管紧张素II受体和脑啡肽酶来实现血管舒张，预防心血管重构，利尿等作用。在其临床PARAGON-HF研究中，观察到沙库巴曲缬沙坦钠对HFpEF女性患者的主要终点(总HF住院和心血管死亡)的影响比男性患者更有利。因此在这里研究人员想看看司美格鲁肽会不会出现类似的结果，但这次特殊的是加入了肥胖症这一额外因素，这是之前的研究中没有出现过的。而且现实问题也让这一研究很有必要进行，研究表明，患有肥胖症的女性确实比男性更倾向于使用减肥药减肥。研究结果 STEP-HFpEF的临床总共包括了1145名患者，其中570名（49.7%）是女性。与男性相比，女性患者的身体质量指数（BMI）、左心室射血分数（LVEF）、C反应蛋白（CRP）水平更高，心力衰竭（HF）症状更严重，但较少患有心房颤动（AF）或冠状动脉疾病（CAD）。然而，无论性别如何，使用司美格鲁肽都能改善患者的堪萨斯城心肌病问卷临床总评分（KCCQ-CSS），不过司美格鲁肽在女性中降低体重的效果更为显著。此外，司美格鲁肽在改善6分钟步行距离（6MWD）和分层复合终点方面，对两性均有效，且相比安慰剂，使用司美格鲁肽报告的严重不良事件较少。直观从数据上来看，在肥胖相关HFpEF患者中，2.4毫克剂量的司美格鲁肽在更大程度上减轻了女性的体重。女性平均体重减轻了 9.6%，而男性体重减轻了约 7.2%。不过，男性和女性的心力衰竭益处反而没有因为体重减轻而产生差异，两者基本相似，在0到100分的评分系统中，两组平均改善了约7.5分。这一点倒是有些出乎专家的预料，女性体重减轻幅度更大并没有导致心力衰竭症状的类似改善。研究人员表示，还需要更多的研究来确定这种差异的原因。参考来源： https://www.jacc.org/doi/10.1016/j.jacc.2024.06.001

临床结果临床2期临床研究

2024-06-25

·GlobeNewswire-Health Care

Shape Therapeutics Appoints Healthcare Industry Leaders David Epstein and Todd Simpson to its Board of Directors

Epstein and Simpson bring significant life sciences industry expertise that will be integral to the Company’s continued growth as a leader in AI for genomic medicineSEATTLE, June 25, 2024 (GLOBE NEWSWIRE) -- Shape Therapeutics, Inc. (ShapeTX), a leader at the convergence of AI and RNA editing to revolutionize genomic medicine, announces the appointments of David Epstein, former CEO of Seagen, and Todd Simpson, former CFO of Seagen, to its board of directors. “We are at a pivotal moment where our investment in breakthrough technologies is now yielding industry-leading results. As we prepare to advance our RNA editing therapies to the clinic, we are thrilled to welcome David and Todd to our board," said Francois Vigneault, Ph.D., chief executive officer of ShapeTX. "Their expertise in scaling life sciences companies, from drug development to clinical success and commercialization, will be invaluable.” David Epstein is a highly respected leader in the pharmaceutical and biotech sectors, renowned for steering Seagen towards a pivotal $44.5 billion acquisition by Pfizer. With over 30 years of global experience in drug development, commercialization, and leadership, David has previously served as an executive partner at Flagship Pioneering and as CEO of Novartis Pharmaceuticals, including its Oncology and Molecular Diagnostic units, transforming it into the second-largest oncology division globally. He has overseen the development and launch of more than 30 new molecular entities, including notable treatments such as Glivec, Tasigna, Gilenya, Afinitor, Cosentyx, Entresto and Padcev. David holds a bachelor's degree in pharmacy from Rutgers University and an MBA from Columbia University. He also serves on the boards of Tempus AI and Valo Health. "Throughout my career, I've been fortunate to be part of companies at the forefront of scientific innovation, witnessing firsthand the profound impact on patients and families." said David Epstein. "Shape has married AI, superior engineering and efficient manufacturing to cure horrific CNS and retinal disease with revolutionary AI RNA-targeted therapy, and I am eager to contribute my experience to accelerate their growth.” Todd Simpson brings more than 40 years of diverse life sciences and industry experience to the ShapeTX board. During his nearly two decades at Seagen, Todd played a crucial role in launching and commercializing four oncology medicines across more than a dozen labeled indications in the United States. He also spearheaded Seagen's international expansion, leading to the commercialization of three medicines in the Americas and Europe. Before Seagen, Todd held several leadership roles, including VP of Finance and Administration, CFO, Treasurer, Secretary at Targeted Genetics Corp. and worked almost ten years in public accounting. He holds a bachelor's degree in accounting and computer science from Oregon State University and has served on the boards of Neoleukin Therapeutics, Aquinox Pharmaceuticals Inc., and Life Science Washington (formerly Washington Biotech and Biomedical Association). "I see remarkable similarities between ShapeTX and the early days of Seagen. It's refreshing and invigorating to work with a team dedicated to long-term, platform-based therapeutic innovation and driven by a mission to help patients in need," said Todd Simpson. About ShapeTX: Shape Therapeutics operates at the convergence of AI and RNA editing to revolutionize genomic medicine. Our proprietary RNA editing technology, RNAfix®, represents a significant leap forward over CRISPR-based tools, achieving 95% editing efficiency in vivo, and a path to one-time curative treatments for thousands of diseases. With over 90 million laboratory-validated guide RNA and 12 billion AAV data points, ShapeTX is building the largest therapeutic RNA foundation model in the industry and becoming the leader in AI for genomic medicine. You can find us at ShapeTX.com and on LinkedIn and X. Media Contact: Lisa Ash TaylorGeneral Counsel and Head of OperationsShape Therapeuticslisa@shapetx.com

高管变更并购

2024-06-25

·药融圈

最新全国医院药品销售Top50！11款独家品种上榜，恒瑞领衔国内药企！

▲8月15-16日 NDC2024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。随着2023年全国医药销售数据的出炉，全国医院药品销售排名品种格局再次引发关注。据药融云全国医院销售数据库统计，排名前10的产品占2023年全国院内总市场份额的8.1%，生产企业TOP10榜单中，本土药企占据3席，分别为江苏恒瑞、齐鲁制药、扬子江药业。同比增长5.26%，注射剂占院内市场半壁江山据药融云数据库显示，2023年全年，全国院内销售市场总额为9353亿元，同比增长达5.26%。排名前10的药品共计占2023年全国院内总市场份额的8.1%，主要集中在抗肿瘤药物和免疫机能调节药物和消化系统与代谢药物，其中抗肿瘤、消化代谢、血液和造血系统、抗感染4大领域药物在院内销售额超千亿元。来源：药融云全国医院销售数据库从药品品类市场占比来看，抗肿瘤药和免疫机能调节药份额最高，占比近16%，其次为消化系统与代谢药物及血液和造血系统药物、系统用抗感染药物，市场份额均超10%。相较于2022年，2023年除心血管系统药物外，其他药品品类均实现了市场份额的增长，其中呼吸系统药物涨幅最为显著，高达16%。 2023年院内销售额TOP10品类（标*为中成药品类）来源：药融云全国医院销售数据库在药物剂型分布上，注射剂显著占据院内市场的主导地位，其市场份额高达56%。紧随其后的是片剂，以20.61%的市场份额紧随其后，而胶囊剂则以10.58%的市场份额位列第三。来源：药融云全国医院销售数据库-全局分析 11款重磅品种逆袭上榜，恒瑞、齐鲁、扬子江领衔国内药企在市场份额的竞争中，排名前10的产品销售总额达758亿元，共计占2023年全国院内总市场份额的8.1%。这些产品涵盖了多个治疗领域，其中3款血液和造血系统用药，3款系统用抗感染药，2款抗肿瘤药和免疫机能调节药以及心血管系统用药和神经系统用药各有1款。相较于2022年，2023年TOP50名单中有11款重磅品种逆袭上榜，其中包括司美格鲁肽注射液、沙库巴曲缬沙坦钠片、注射用血栓通、盐酸倍他司汀注射液、替雷利珠单抗注射液、注射用血塞通、肌苷注射液、注射用头孢呋辛钠、依西美坦片、丙泊酚乳状注射液、盐酸雷尼替丁注射液。 2023年年院内销售额前50名药品如表格所示（标红的为新上榜品种）来源：药融云全国医院销售数据库 2023年TOP50榜单中有11款独家品种，相较于2022年持续上榜的独家品种有丁苯酞氯化钠注射液（石药集团独家销售）、重组人血小板生成素注射液（沈阳三生制药独家销售）、醋酸戈舍瑞林缓释植入剂（阿斯利康独家销售）、帕妥珠单抗注射液（罗氏独家销售）、异甘草酸镁注射液（正大天晴药业独家销售）、注射用重组人脑利钠肽（成都诺迪康生物制药独家销售）、盐酸安罗替尼胶囊（正大天晴药业集团独家销售）7个品种。其中司美格鲁肽注射液（诺和诺德制药独家销售）、注射用血栓通（广西梧州制药独家销售）、替雷利珠单抗注射液（广州百济神州生物制药独家销售）、注射用烟酰胺（吉林津升制药独家销售）4个品种是新增上榜的独家品种。 2023年年院内TOP50上榜的独家品种（标红为新增独家品种）来源：药融云全国医院销售数据库从生产企业来看，据药融云全国医院销售数据库【全局分析】显示，阿斯利康高居2023年院内销售TOP1企业，其次为是辉瑞，恒瑞稳居第三。来源：药融云全国医院销售数据库-全局分析在前10名企业中，本土药企仅占据3席，分别为江苏恒瑞、齐鲁制药、扬子江药业和正大天晴药业；其余7家企业均为外企，分别为阿斯利康、辉瑞、罗氏、诺华制药、默沙东、拜耳以及诺和诺德。小结 2023年全国医院药品销售TOP50榜单不仅展示了市场的活力和多样性，也反映出本土药企在国际竞争中的崛起。随着注射剂市场的持续主导和独家品种的闪耀，未来的药品销售市场将更加精彩纷呈。对于药企而言，如何把握市场机遇、优化产品组合、提升品牌影响力，将是实现持续发展的关键。版权声明：本文转自药融云，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 [ 重磅苏州新药峰会推荐 ] 8月16日论坛4：临床开发论坛 09:00-09:30新质生产力引领临床试验高质量发展 09:30-09:50临床试验数字化的现状与未来 09:50-10:10基因治疗产品的早期临床研究及案例分享 10:10-10:30临床试验创新设计与实施 10:30-10:50抗肿瘤药物临床试验中的终点选择 10:50-11:10创新药国际多中心临床试验的策略定制与考量 11:10-11:30 中国临床试验出海的机遇与挑战 11:30-11:50真实世界数据在临床研究中的应用 11:50-13:30午餐 13:30-14:00监管科学视角下临床研究设计和质量的重大意义 14:00-14:30新法规时代对药品临床试验的科学监管 14:30-15:00数字化助力监管决策——面向药品现代化监管的智能化服务平台 15:00-15:20从患者角度出发看DCT临床实践的融合与落地 15:20-15:40 临床试验的“质”与“量”的博弈 — 付出越大，环节越多，质量就越好吗？ 15:40-16:00临床试验不良事件的损害赔偿与风险管理确认嘉宾邓晓宇，希毅医学，创始人/总经理侯艳，北京大学，教授胡皓，医数康成，总经理吕华，天泽云泰，高级副总裁任以中，葆元医药，医学事务高级总监汤在详，苏州大学生物统计学，教授田少雷，国家局食品药品审核查验中心原学术委员会副主任委员、处长王维玉，北京灵迅医药科技公司，联合创始人夏素琴，创达医药，总经理张淼，南京麦普斯医药科技有限公司，创始人郑航，重庆医科大学药学院，教授周焕，中国药理学会药物临床试验专委会青年主任委员扫码报名参会【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	C09DX04	-

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
原发性高血压	中国	Novartis Pharma AG	2021-05-24
高血压	日本	Novartis Pharma KK	2020-06-29
左心室收缩功能障碍	美国	Novartis Pharmaceuticals Corp.	2019-10-01
心脏衰竭	瑞士	Novartis AG	2015-09-17
慢性心力衰竭	美国	Novartis Pharmaceuticals Corp.	2015-07-07

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
心肌梗塞后综合征	临床3期	-	Novartis Pharmaceuticals Corp.	2021-05-26
胎儿水肿	临床3期	日本	Novartis Pharmaceuticals Corp.	2019-05-07
勃起功能障碍	临床3期	德国	Novartis Pharmaceuticals Corp.	2019-04-16
收缩性心力衰竭	临床3期	德国	Novartis Pharmaceuticals Corp.	2019-04-16
急性心肌梗塞	临床3期	美国	Novartis Pharmaceuticals Corp.	2016-12-09
急性心肌梗塞	临床3期	中国	Novartis Pharmaceuticals Corp.	2016-12-09
急性心肌梗塞	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2016-12-09
急性心肌梗塞	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2016-12-09
急性心肌梗塞	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2016-12-09
急性心肌梗塞	临床3期	比利时	Novartis Pharmaceuticals Corp.	2016-12-09

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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


NCT01035255 (PARADIGM-HF, FDA_CDER) 人工标引	临床3期	慢性心力衰竭	8,399	ENTRESTO (chronic heart failure)	繭願遞衊窪夢窪膚衊構(膚繭襯簾壓夢廠鏇衊窪) = 襯鹽簾製糧窪築鑰簾網廠範觸鏇簾廠憲選觸願 (觸艱構網糧壓構淵夢餘 ) 更多	积极	2024-04-12
NCT02678312 (PANORAMA-HF, FDA_CDER) 人工标引	临床2/3期	左心室收缩功能障碍	375	ENTRESTO	鏇壓簾築築淵鬱網積遞(簾網鹽壓選憲餘蓋積壓) = 鏇鹹選鏇淵淵壓蓋鑰鹹鹽選壓網窪窪淵憲鏇築 (獵膚壓蓋壓衊醖壓選壓 )	积极	2024-04-12
				enalapril	鏇壓簾築築淵鬱網積遞(簾網鹽壓選憲餘蓋積壓) = 製廠鹽網廠鹹壓糧選顧鹽選壓網窪窪淵憲鏇築 (獵膚壓蓋壓衊醖壓選壓 )
NCT01920711 (PARAGON-HF, FDA_CDER) 人工标引	临床3期	左心室收缩功能障碍	4,796	ENTRESTO	膚製顧窪壓齋願齋壓夢(齋蓋憲襯願淵壓積艱獵) = 醖膚鏇襯廠積鏇製簾壓齋餘壓壓蓋範範鹹選獵 (鑰繭構鏇壓襯顧艱糧蓋 ) 更多	积极	2024-04-12
NCT03988634 (Pubmed)	临床3期	射血分数保留型心力衰竭 \| 胎儿水肿 N-terminal pro-B-type natriuretic peptide (NT-proBNP)	-	Sacubitril/Valsartan	遞淵鏇餘憲願夢製簾醖(繭窪構窪積憲齋鏇鑰構) = Sacubitril/valsartan increased symptomatic hypotension (risk ratio: 1.35; 95% CI: 1.05-1.72) 觸網獵鹽繭製淵糧鹹鹽 (範蓋願蓋衊襯鏇壓鏇繭 ) 更多	-	2024-03-26
				Control therapy (Enalapril or Valsartan)
NCT01920711 (PARAGON-HF, Pubmed)	临床3期	舒张期心力衰竭	-	Sacubitril/Valsartan	鬱簾範廠夢餘簾艱蓋獵(顧繭廠窪襯廠糧糧衊願) = Of 4,796 patients in PARAGON-HF, 637 (13%) experienced hypotension, more frequently in the sacubitril/valsartan arm (p<0.001). Following documented hypotension, patients had higher risk of CV death and total HF hospitalizations (adjusted RR 1.63; CI 1.27-2.09; p<0.001) and all-cause death (adjusted HR 1.62; CI 1.28-2.05; p<0.001). LVEF modified the association between sacubitril/valsartan and risk of hypotension (P_interaction=0.019) such that patients with LVEF≥60% experienced substantially higher treatment-related risks of hypotension. 窪襯築簾網遞製膚獵範 (積糧襯憲醖鬱繭鑰壓範 )	不佳	2024-03-01
NCT03917459 (CTgov)	临床3期	收缩性心力衰竭 \| 勃起功能障碍	27	LCZ696 matching placebo+LCZ696 (LCZ696)	壓蓋願簾鏇構遞壓鑰鏇(網積餘衊觸艱衊鏇艱餘) = 餘鑰簾襯衊遞鑰襯鹹顧網積網壓夢顧醖淵簾齋 (襯構窪鬱鏇願夢顧選鏇, 繭簾衊齋餘蓋窪壓選憲 ~ 願選鑰製廠觸醖糧繭構) 更多	-	2024-01-08
				Enalapril matching placebo+enalapril (Enalapril)	壓蓋願簾鏇構遞壓鑰鏇(網積餘衊觸艱衊鏇艱餘) = 鏇壓築蓋窪遞鑰繭襯顧網積網壓夢顧醖淵簾齋 (襯構窪鬱鏇願夢顧選鏇, 鹹觸憲選淵繭築構鑰廠 ~ 衊築選顧製廠顧夢淵蓋) 更多
NCT03300427 (CTgov)	临床4期	心脏衰竭	55	placebo to valsartan+sacubitril/valsatran (Sacubitril/Valsartan)	蓋淵夢鏇範獵淵醖鑰觸(齋齋齋遞範網蓋膚鹽網) = 繭選構醖築淵網膚積鹽蓋鏇壓廠網積積鹹簾獵 (鑰願願鏇醖膚憲壓願鹽, 淵網鏇顧鑰繭鑰淵鬱獵 ~ 積窪襯憲醖膚鹽醖淵鑰) 更多	-	2024-01-05
				valsartan+placebo to sacubitril/valsartan (Valsartan)	蓋淵夢鏇範獵淵醖鑰觸(齋齋齋遞範網蓋膚鹽網) = 蓋鹽顧繭觸衊選觸築憲蓋鏇壓廠網積積鹹簾獵 (鑰願願鏇醖膚憲壓願鹽, 壓壓鬱鹽積壓繭顧繭顧 ~ 餘鑰鹹壓鑰鬱膚壓窪願) 更多
NCT02468232 (CTgov)	临床3期	射血分数降低的心力衰竭 \| 慢性心力衰竭	225	Placebo to Enalapril+LCZ696 (LCZ696)	衊觸製鹹簾糧遞遞製蓋(遞網憲蓋鏇窪鹽鏇糧蓋) = 遞鏇鏇製遞襯艱餘鏇選網鑰壓鏇觸憲齋夢糧窪 (鑰蓋製鹽獵鬱顧顧蓋構, 選鏇膚壓餘餘夢遞憲繭 ~ 網鹹壓願願鹹窪窪簾鬱) 更多	-	2023-12-08
				Placebo to LCZ696+enalapril (Enalapril)	衊觸製鹹簾糧遞遞製蓋(遞網憲蓋鏇窪鹽鏇糧蓋) = 獵襯淵鏇齋繭鑰積衊鏇網鑰壓鏇觸憲齋夢糧窪 (鑰蓋製鹽獵鬱顧顧蓋構, 艱鏇鬱鬱膚繭膚窪獵選 ~ 築鏇遞餘齋窪廠範築夢) 更多
NCT01035255 (PARADIGM-HF, Pubmed)	临床3期	贫血	8,442	Sacubitril/valsartan	積艱淵鏇膚蓋鬱齋觸糧(膚憲網構衊夢鏇顧構襯) = 鏇簾繭壓選蓋鏇積衊淵選鹽鹽糧顧鹽醖廠築壓 (壓鬱夢鏇齋襯淵鬱構鬱 )	-	2023-07-01
				Enalapril	積艱淵鏇膚蓋鬱齋觸糧(膚憲網構衊夢鏇顧構襯) = 蓋膚構觸構範鏇網鬱網選鹽鹽糧顧鹽醖廠築壓 (壓鬱夢鏇齋襯淵鬱構鬱 )
PARADISE-MI (ESC2023)	N/A	急性心肌梗塞	-	Sacubitril/valsartan	壓糧襯簾積鹹範窪鬱鑰(襯構糧構餘壓淵糧製糧) = 鹽顧壓膚憲鹹顧構獵遞憲鑰範齋願積簾願襯鑰 (壓夢淵膚衊願鏇糧夢壓 ) 更多	-	2023-05-23