A Phase 1, Multi-center, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function

The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe renal impairment (RI) compared to healthy matched control subjects with normal renal function.

开始日期2024-03-05

申办/合作机构

Madrigal Pharmaceuticals, Inc.

NCT05500222

/ Recruiting临床3期

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients With Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH-OUTCOMES)

This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.

开始日期2022-08-26

申办/合作机构

Madrigal Pharmaceuticals, Inc.

NCT04951219

/ Recruiting临床3期

A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

开始日期2021-07-09

申办/合作机构

Madrigal Pharmaceuticals, Inc.

100 项与瑞司美替罗相关的临床结果

登录后查看更多信息

100 项与瑞司美替罗相关的转化医学

登录后查看更多信息

100 项与瑞司美替罗相关的专利（医药）

登录后查看更多信息

178

项与瑞司美替罗相关的文献（医药）

2025-04-01·JOURNAL OF HEPATOLOGY

Inhibition of ATGL alleviates MASH via impaired PPARα signalling that favours hydrophilic bile acid composition in mice

Article

作者: Senéca, Joana ; Claudel, Thierry ; Hinteregger, Helga ; Zimmermann, Robert ; Mlitz, Veronika ; Fuchs, Claudia Daniela ; Haemmerle, Guenter ; Verkade, Henkjan ; Busslinger, Georg ; Schnarnagl, Hubert ; Trauner, Michael ; Kratky, Dagmar ; Grabner, Gernot F ; Grabner, Gernot F. ; Riva, Alessandra ; Scharnagl, Hubert ; Dixon, Emmanuel Dauda ; Nardo, Alexander Daniel ; Fuchs, Claudia ; Stojakovic, Tatjana

BACKGROUND & AIMS:

Adipose triglyceride lipase (ATGL) is an attractive therapeutic target in insulin resistance and metabolic dysfunction-associated steatotic liver disease (MASLD). This study investigated the effects of pharmacological ATGL inhibition on the development of metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis in mice.

METHODS:

Streptozotocin-injected male mice were fed a high-fat diet to induce MASH. Mice receiving the ATGL inhibitor atglistatin (ATGLi) were compared to controls using liver histology, lipidomics, metabolomics, 16s rRNA, and RNA sequencing. Human ileal organoids, HepG2 cells, and Caco2 cells treated with the human ATGL inhibitor NG-497, HepG2 ATGL knockdown cells, gel-shift, and luciferase assays were analysed for mechanistic insights. We validated the benefits of ATGLi on steatohepatitis and fibrosis in a low-methionine choline-deficient mouse model.

RESULTS:

ATGLi improved serum liver enzymes, hepatic lipid content, and histological liver injury. Mechanistically, ATGLi attenuated PPARα signalling, favouring hydrophilic bile acid (BA) synthesis with increased Cyp7a1, Cyp27a1, Cyp2c70, and reduced Cyp8b1 expression. Additionally, reduced intestinal Cd36 and Abca1, along with increased Abcg5 expression, were consistent with reduced levels of hepatic triacylglycerol species containing polyunsaturated fatty acids, like linoleic acid, as well as reduced cholesterol levels in the liver and plasma. Similar changes in gene expression associated with PPARα signalling and intestinal lipid transport were observed in ileal organoids treated with NG-497. Furthermore, HepG2 ATGL knockdown cells revealed reduced expression of PPARα target genes and upregulation of genes involved in hydrophilic BA synthesis, consistent with reduced PPARα binding and luciferase activity in the presence of the ATGL inhibitors.

CONCLUSIONS:

Inhibition of ATGL attenuates PPARα signalling, translating into hydrophilic BA composition, interfering with dietary lipid absorption, and improving metabolic disturbances. Validation with NG-497 opens a new therapeutic perspective for MASLD.

IMPACT AND IMPLICATIONS:

Despite the recent approval of drugs novel mechanistic insights and pathophysiology-oriented therapeutic options for MASLD (metabolic dysfunction-associated steatotic liver disease) are still urgently needed. Herein, we show that pharmacological inhibition of ATGL, the key enzyme in lipid hydrolysis, using atglistatin (ATGLi), improves MASH (metabolic dysfunction-associated steatohepatitis), fibrosis, and key features of metabolic dysfunction in mouse models of MASH and liver fibrosis. Mechanistically, we demonstrated that attenuation of PPARα signalling in the liver and gut favours hydrophilic bile acid composition, ultimately interfering with dietary lipid absorption. One of the drawbacks of ATGLi is its lack of efficacy against human ATGL, thus limiting its clinical applicability. Against this backdrop, we could show that ATGL inhibition using the human inhibitor NG-497 in human primary ileum-derived organoids, Caco2 cells, and HepG2 cells translated into therapeutic mechanisms similar to ATGLi. Collectively, these findings reveal a possible new avenue for MASLD treatment.

2025-04-01·HEPATOLOGY

Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction–associated steatohepatitis (MASH) and fibrosis

Article

作者: Nader, Fatema ; Racila, Andrei ; Younossi, Zobair M. ; Henry, Linda ; Stepanova, Maria ; Taub, Rebecca ; Labriola, Dominic

Background and Aims::

Resmetirom, liver-directed thyroid-hormone receptor-β agonist, received approval for metabolic dysfunction–associated steatohepatitis (MASH) treatment. We assessed health-related quality of life (HRQL) in patients with MASH treated with resmetirom.

Approach and results::

Patients with MASH/NASH without cirrhosis and with confirmed/suspected fibrosis were enrolled in a 54-month double-blind randomized placebo-controlled phase III clinical trial with serial biopsy assessments at baseline and week 52 (MAESTRO-NASH, NCT03900429). HRQL was assessed using Chronic Liver Disease Questionnaire-NASH (CLDQ-NAFLD) and Liver Disease Quality of Life (LDQOL). Baseline HRQL score changes by treatment group (resmetirom 80 mg, resmetirom 100 mg, or placebo) and histological response (improvement of fibrosis without worsening of NAFLD activity score or resolution of MASH/NASH without worsening of fibrosis) were compared after 52 weeks. Included were 966 intention-to-treat patients: 323 received resmetirom 100 mg, 322 resmetirom 80 mg, and 321 placebo. By weeks 24 and 52, patients receiving 80 or 100 mg resmetirom experienced HRQL improvement in CLDQ-NAFLD Worry domain (mean +0.21 to +0.24, p < 0.05). At week 52, subjects who met histologic endpoints after treatment with resmetirom (100 mg and 80 mg pooled) experienced HRQL improvement in CLDQ-NAFLD Worry +0.46 (41% met minimal clinically important difference [MCID]), LDQOL domains: Role Emotional +3.0 (28% met MCID), Health Distress +8.1 (38% MCID), Stigma +3.5 (39% MCID), and total LDQOL +2.2 (35% MCID) (all p < 0.05). Similar improvements were noted in histologic responders from 100 mg or 80 mg resmetirom groups when separated—no improvements in placebo or nonresponders. Baseline F3 histologic responders had similar/more pronounced HRQL improvements.

Conclusions::

Patients with MASH/NASH with fibrosis improvement or the resolution of MASH with resmetirom experienced clinically meaningful and statistically significant HRQL improvements.

2025-04-01·Liver International

Pharmaco‐Economic Assessment of Screening Strategies for High‐Risk MASLD in Primary Care

Article

作者: Nader, Fatema ; Younossi, Zobair M. ; Henry, Linda ; Paik, James M. ; Stepanova, Maria

ABSTRACT:

Background and Aims:

Several scientific associations recommend a sequential combination of non‐invasive tests (NITs) to identify high‐risk MASLD patients but their cost‐effectiveness is unknown.

Methods:

A cost‐utility model was developed to assess the incremental cost‐effectiveness ratio (ICER) of recommended screening strategies for patients with clinically suspected MASLD, specifically those with type 2 diabetes (T2D) and obesity with multiple cardiometabolic risk factors which will be initiated in primary care. Six screening strategies were assessed, using either vibration‐controlled transient elastography (VCTE) or the enhanced liver fibrosis (ELF) test as a second‐line test following an initial Fibrosis‐4 (FIB‐4) assessment as the first line NIT. The model included treatment effects of resmetirom for metabolic dysfunction‐associated steatohepatitis (MASH) patients with F2 or F3 fibrosis.

Results:

All screening strategies for high‐risk MASLD in US incurred additional costs compared to no screening, ranging from $13 587 to $14 730 per patient with T2D and $14 274 to $15 661 per patient with obesity. However, screening reduced long‐term costs, ranging from $22 150 to $22 279 per patient with T2D and $13 704 to $13 705 per patient with obesity, compared to $24 221 and $14 956 for no screening, respectively. ICERs ranged from $26 913 to $27 884 per QALY for T2D patients and $23 265 to $24 992 per QALY for patients with obesity. While ICERs were influenced by VCTE availability, they remained cost‐effective when using ELF as the second‐line test. Our findings remain robust across a range of key parameters.

Conclusions:

Screening for high‐risk MASLD is cost‐effective according to recent guidelines. Implementing these screening strategies in primary care should be considered.

543

项与瑞司美替罗相关的新闻（医药）

2025-03-19

·君圣泰

MASH疾病领域的大市场、大需求｜君圣泰HTD1801，MASH领域中国原创新药中，首个获美国FDA授予快速通道资格认定

图片来源：2025CMAC 大会官方代谢相关脂肪性肝炎（MASH）已成为全球医药行业正在挖掘的潜力“富矿”——2030年MASH市场规模将突破322亿美元，患者人数超4.8亿，至今FDA仅批准了一款药物。MASH作为一种与代谢紊乱相关的肝脏疾病，表现为肝脏中脂肪异常堆积，并伴随炎症和肝脏纤维化，可进展为肝硬化和肝细胞癌，是全球肝移植的主要病因，更显著增加了心血管疾病的风险。随着生活方式的改变，这个潜在的“健康杀手”早已随肥胖、糖尿病等代谢问题一起悄然而快速地蔓延。这使得近年来代谢性肝病市场规模持续迅猛增长。近日，中国创新药物医学大会暨2025CMAC年会在苏州召开，会议以“凝医学新知、聚创新之力”为主题，汇聚行业精英和权威学者，共同探讨创新药物医学的发展趋势与挑战。MASH作为近年来越来越受到大众、医学界和产业界关注的热点疾病，大会专为此设主题分论坛：“MASH 临床药物研发与创新技术：全球视野下的实践与应用”。作为国内代谢疾病创新药企代表，君圣泰医药创始人刘利平博士应邀出席，并做了《MASH临床研究与市场机遇》的专题报告，同与会各专家分享交流。 MASH赛场迎来关键赛点，多靶点、联合机制成为趋势 2024年3月，Madrigal公司的Resmetirom获批上市，成为FDA批准的首款MASH治疗药物，这一突破标志着MASH药物研发迎来关键破局点看、迈入新阶段。另一方面，MASH庞大的全球患者规模以及大众对于代谢和健康的综合改善诉求，使得Resmetirom远未能解决庞大的治疗需求与有限的治疗手段之间的巨大矛盾。市场需要更能有效改善肝脏组织学，且为患者带来综合获益的药物。目前，多款MASH在研药物已进入临床后期，然而单一机制药物往往难以兼顾MASH治疗的多重需求：既改善肝脏脂肪变性，又抑制肝脏炎症及纤维化，同时为MASH关联的代谢共病（如：糖尿病、肥胖、心血管疾病等）带来治疗获益。因此，具备多靶点、多功能作用的创新疗法正成为新的研发趋势。君圣泰医药正是这一趋势的领航者。其核心产品熊去氧胆小檗碱（HTD1801）是一款全球独创的双机制小分子药物，兼具激活AMPK与抑制NLRP3炎症小体生成。代谢调节与抗炎两种机制联合互补，有利于从根本上恢复代谢健康，在改善肝脏代谢、抑制炎症及纤维化等方面展现出独特的临床优势。这种双管齐下的治疗策略，为MASH患者提供了更全面的优选治疗方案，在临床中展现出差异化优势。 HTD1801双机制“组合拳”出击，在国际赛场获认可 HTD1801治疗MASH的有效性已在临床2a期研究被验证，在MASH合并2型糖尿病（T2DM）患者中，HTD1801能显著降低肝脏脂肪含量，并在改善肝损伤及血糖控制等方面表现优越。该临床2a期研究结果已发表在全球顶级期刊Nature Communications上，结果显示：经HTD1801治疗后，MASH合并T2DM患者的肝脏脂肪含量显著降低，降低幅度约为安慰剂组的3倍，同时多个肝损伤相关指标得到改善，提示HTD1801具有为肝脏带来组织学上显著获益的潜力。经HTD1801治疗后，可改善多个心血管代谢风险因素，对血糖、体重、LDL-C及甘油三酯等指标均有显著改善，为患者带来多维获益。 HTD1801多次亮相于国际顶级肝病大会，在2024年举办的欧洲肝脏研究学会年会（EASL）和美国肝病研究协会肝病年会（AASLD）上，展示了多项该2a期临床试验的事后分析，数据显示： HTD1801与“顶流药物”GLP-1受体激动剂联用，预计可为MASH合并T2DM的患者带来降糖、降脂以及减轻体重的进一步获益。改善致病根本：胰岛素抵抗是MASH发生的“种子”，而在胰岛素抵抗更严重的患者中，HTD1801带来更大的治疗获益。 HTD1801具备高安全性，可成为慢性病（如MASH和T2DM）长期管理的理想选择。此外，与FDA获批药物Resmetirom相比，HTD1801在血糖控制和减重方面表现出更优的治疗效果。目前，HTD1801的IIb期临床试验正在顺利推进，已在2024年3月完成在中美两地的患者入组，预计将在2025年公布顶线数据。随着MASH成为代谢病领域的新焦点，全球创新药企正加速布局，以多靶点、多功能创新疗法为代表的新一代药物正在逐步推进临床。HTD1801凭借其兼具能量稳态调节与抗炎作用的独特机制和差异化临床优势，展现出广阔的治疗潜力。关于君圣泰医药君圣泰医药（股票代码：2511.HK）是一家全球一体化的新型生物技术公司，专注代谢性疾病领域的重大未满足临床需求。以“标本兼治、深求治愈”这一DeepCure理念为目标，立足源头创新，开发First-in-Class的原创新药，以期为全球患者提供基于中国智慧的，安全、有效、综合获益的解决方案。基于自主知识产权，公司已构建丰富产品管线，在全球推进多项中、后期临床试验，开发代谢相关脂肪性肝炎（MASH）、2型糖尿病（T2DM）、严重高甘油三酯血症（SHTG）和原发性硬化性胆管炎（PSC）等适应症。作为同类首创的多靶点新分子实体，熊去氧胆小檗碱（HTD1801）被美国FDA授予2项“快速通道资格认定”、1项“孤儿药资格认定”，并获得国家“十三五•重大新药创制”科技重大专项支持。欲知更多资讯，敬请访问www.hightidetx.com 垂询pr@hightidetx.com END 扫码关注君圣泰医药以不断追求患者的整体最佳获益为使命

快速通道上市批准

2025-03-18

·PRNewswire

A New Standard in Clinical Care for MASH Patients: HistoIndex Launches FibroSIGHT™

SINGAPORE, March 17, 2025 /PRNewswire/ -- HistoIndex, a global leader in stain-free digital pathology solutions for managing fibrotic diseases, has announced the launch of their first Laboratory Developed Test (LDT) FibroSIGHT™ – now available in the United States. This marks a significant milestone for HistoIndex as the company enters clinical care for patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH). "I am excited to see how our core expertise in clinical trial assessments is now transcending into the realm of precise and personalized patient care," said Dr. Gideon Ho, Chief Executive Officer of HistoIndex." With FibroSIGHT, we aim to empower clinicians with a more definitive and accurate assessment of liver fibrosis." Continue Reading FibroSIGHT’s Second Harmonic Generation Versus Masson’s Trichrome Staining: FibroSIGHT enables detection of fine collagen fibers with exceptional clarity and an excellent signal-to-noise ratio. MASH has long been a challenging and progressive liver disease, characterized by fat build-up and inflammation that, if left untreated, leads to fibrosis and, ultimately, cirrhosis. After decades of research and therapeutic development, the field reached a pivotal moment in 2024 with the approval of Rezdiffra® - the first drug for the treatment of MASH with moderate to advanced fibrosis[1,2*]. As treatment options expand, accurate fibrosis assessment becomes even more critical in guiding clinical decisions and optimizing patient outcomes. HistoIndex has been playing a key role in the development of MASH treatments and is now leading the way in this next phase of patient care with FibroSIGHT. FibroSIGHT seamlessly integrates into routine clinical workflows, leveraging on HistoIndex's proprietary stain-free imaging technology to enhance the sensitivity of fibrillar collagens detection — key in evaluating fibrosis severity in liver biopsy samples (see Figure 1). By eliminating variability associated with traditional staining techniques, FibroSIGHT delivers reliable and precise fibrosis assessment for MASH patients. Clinicians can now order FibroSIGHT for MASH patients, on whom liver biopsies were performed, whenever definitive and accurate assessments of fibrosis are needed[2,3]. This includes use at the time of diagnosis to determine treatment decisions, when non-invasive assessments of degree of fibrosis are either inconclusive or discordant. Additionally, FibroSIGHT can be ordered post treatment to evaluate patients' response, especially in cases where there are no apparent improvement. "By providing more accurate and objective evaluation of fibrosis, FibroSIGHT will enable more personalized treatment strategies and better evaluations of effectiveness of treatment leading to overall better care for patients," commented Dr Naim Alkhouri, MD, Chief Medical Officer of Arizona Liver Health. "Where biopsy evaluation is needed for a MASH patient, I can see incorporating FibroSIGHT in the workup, and in doing so, benefiting the entire MASH clinical care community."FibroSIGHT testing is performed in HistoIndex's CAP/CLIA accredited laboratory in Irvine, California. With the launch of FibroSIGHT, HistoIndex reaffirms its long-standing commitment in advancing fibrosis assessment and personalized treatment for MASH. By bridging research with clinical care, FibroSIGHT empowers informed treatment decisions, driving better patient care in the evolving landscape of liver disease management. About MASH Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive form of Metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by steatosis and inflammation, which can lead to fibrosis (scarring), cirrhosis, liver failure, and an increased risk of liver cancer. The presence of ballooned hepatocytes (enlarged and damaged liver cells) is a key feature distinguishing MASH from simple steatosis. Pathologist assessments of liver biopsy remain the gold standard for diagnosing and assessing the severity of MASH. Histological categorial scoring systems are often used as surrogate endpoints to evaluate drug efficacy in clinical trials. These endpoints are limited in capturing the complex and heterogeneous nature of the disease. As a result, there is a growing need for more accurate and reliable tools, such as AI-based digital pathology solutions, to improve the assessment of treatment response and disease severity in MASH. About HistoIndex Founded in 2010, HistoIndex pioneers in stain-free, fully automated imaging solutions for visualizing and quantifying fibrosis in biological tissues. By combining cutting-edge biophotonic technology with AI-based analysis, HistoIndex provides innovative tools to improve the assessment of fibrosis changes and drug efficacy. HistoIndex's breakthrough digital pathology solutions are currently used in accelerating clinical research, expediting pharmaceutical drug development, and transforming medical standards. SOURCE Histoindex Pte. Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-03-14

·医药地理

【凤采鸾章·博文集】非酒精性脂肪性肝炎治疗靶点及药物研发进展

非酒精性脂肪性肝炎治疗靶点及药物研发进展 Progress in the development of therapeutic targets and drugs for non-alcoholic steatohepatitis 傅宇洁1,2，陈曦慧1,2，刘珉宇1,2* (1. 中国医药工业研究总院创新药物与制药工艺国家重点实验室，上海 200437；2. 上海市生物物质成药性评价技术服务平台，上海 200437) 引用傅宇洁, 陈曦慧, 刘珉宇. 非酒精性脂肪性肝炎治疗靶点及药物研发进展[J]. 世界临床药物, 2025, 46(2): 123-129. DOI:10.13683/j.wph.2025.02.002. 作者简介傅宇洁，硕士研究生，研究方向：代谢相关疾病的新药研发。通信作者：刘珉宇，研究员，博士生导师，研究方向：自身免疫、代谢、纤维化及抗肿瘤领域。 01 摘要非酒精性脂肪性肝炎 (non-alcoholic steatohepatitis，NASH) 作为一种慢性代谢性疾病，与肥胖、2 型糖尿病及高脂血症等代谢综合征密切相关。其发病机制涉及遗传、环境及生活方式等多种因素，特别是代谢紊乱作为核心驱动力，通过氧化应激、内质网应激及炎症通路激活等多种途径促进疾病进展。针对 NASH 的治疗，已识别出多个潜在的治疗靶点，如代谢调节、炎症通路阻断及抗纤维化等。NASH 还可能进展为肝硬化、肝癌等严重疾病，对人类健康构成重大威胁。此外， NASH 还常伴其他代谢性疾病，形成恶性循环，进一步加剧治疗难度和患者负担。该文旨在全面综述 NASH 的发病机制、治疗靶点及药物研究进展，并探讨其对人类的危害，为未来的研究和临床实践提供参考。 02 关键词非酒精性脂肪性肝炎；代谢；治疗靶点；药物研发进展 03 章节导览 1 靶点及相关药物 1.1 代谢类靶点 1.1.1 糖代谢类靶点 1.1.2 脂代谢类靶点 1.1.3 胆汁酸代谢类靶点 1.2 抗炎类靶点 1.3 抗纤维化类靶点 2 多靶点联合策略 3 NASH 药物开发难点 4 结语 04 文章节选非酒精性脂肪肝病(non-alcoholic fatty liver disease，NAFLD)是由糖脂代谢紊乱诱发的以脂质过度积累、炎症和肝细胞损伤为特征的慢性肝脏疾病。其病程范围从单纯性脂肪肝 (simple steatosis of liver) 到更严重的非酒精性脂肪性肝炎 (non-alcoholic steatohepatitis，NASH)。NASH 是 NAFLD 的严重类型，5% 以上的肝细胞脂肪变性合并小叶内炎症及肝细胞气球样变性。METAVIR 评分系统是用于评估肝纤维化 (liver fibrosis) 程度的半定量评分系统。迄今为止，临床上有效治疗 NASH 的药物仍然非常有限，目前仅有 resmetirom 获得 FDA 批准，医疗界面临着迫切的新药研发需求。因此，本文将探讨 NASH 的发病机制，重点关注涉及脂质代谢、胰岛素抵抗及纤维化等关键靶点，通过梳理和分析靶点的药物研发进展，为未来 NASH 治疗药物的开发和临床应用提供理论基础和实践指导。 ←长按二维码阅读原文聚焦药物综合评价促进临床合理用药请看《世界临床药物》! 本刊为月刊，大16开。邮发代号4-302，全国各地邮局均可订阅。定价：26元，全年312元。订阅电话：021-62790477-751 订阅传真：021-62473200 订阅邮箱：guohx@pharmadl.com

ASH会议

100 项与瑞司美替罗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11602	-	-	DB12914

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
肝纤维化	美国	Madrigal Pharmaceuticals, Inc.	2024-03-14
非酒精性脂肪性肝炎	美国	Madrigal Pharmaceuticals, Inc.	2024-03-14

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肝硬化	临床3期	美国	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	波多黎各	Madrigal Pharmaceuticals, Inc.	2022-08-26
纤维化	临床3期	澳大利亚	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	奥地利	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	比利时	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	加拿大	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	法国	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	德国	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	匈牙利	Madrigal Pharmaceuticals, Inc.	2019-03-28
纤维化	临床3期	以色列	Madrigal Pharmaceuticals, Inc.	2019-03-28

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03900429 (MAESTRO-NASH, UEGW2024)	临床3期	非酒精性脂肪性肝炎	966	Resmetirom 80 mg	憲選糧築鹹構製糧齋鹹(範壓鑰壓顧鹹襯鬱願積) = 範繭廠醖醖膚壓膚積蓋壓築鏇齋網構獵鏇艱獵 (淵願醖顧範遞鏇鑰壓夢 ) 更多	积极	2024-10-13
				Resmetirom 100 mg	憲選糧築鹹構製糧齋鹹(範壓鑰壓顧鹹襯鬱願積) = 鏇襯餘網餘鹹遞蓋選襯壓築鏇齋網構獵鏇艱獵 (淵願醖顧範遞鏇鑰壓夢 ) 更多
NCT03900429 (MAESTRO-NASH, UEGW2024)	临床3期	FibroScan CAP \| Fibroscan VCTE \| alanine aminotransferase (ALT)	966	Resmetirom 80 mg	壓選範餘獵衊膚鏇選憲(遞鏇齋淵願廠蓋網網構) = 艱簾選鬱淵艱憲襯鬱鏇簾簾窪艱淵齋蓋醖鹽艱 (顧膚鏇廠顧鏇簾鹽衊艱, 6.8)	积极	2024-10-13
				Resmetirom 100 mg	壓選範餘獵衊膚鏇選憲(遞鏇齋淵願廠蓋網網構) = 鑰積憲鹹窪鏇積壓艱艱簾簾窪艱淵齋蓋醖鹽艱 (顧膚鏇廠顧鏇簾鹽衊艱, 7.1)
NCT03900429 (MAESTRO-NASH, UEGW2024)	临床3期	非酒精性脂肪性肝炎 Carbohydrate Deficient Transferrin (CDT) \| PEth test	966	Resmetirom 80 mg	築夢遞醖遞齋構遞製夢(膚齋觸構糧鏇餘範構蓋) = 鹽遞餘衊製蓋簾糧觸繭鬱獵網鬱鬱淵廠網夢鑰 (網襯鹹壓鏇選壓構觸襯 ) 更多	积极	2024-10-13
				Resmetirom 100 mg	築夢遞醖遞齋構遞製夢(膚齋觸構糧鏇餘範構蓋) = 積鑰鹽衊衊鑰鏇鹹鑰遞鬱獵網鬱鬱淵廠網夢鑰 (網襯鹹壓鏇選壓構觸襯 ) 更多
UEGW2024	N/A	非酒精性脂肪性肝炎	-	Resmetirom 80 mg	壓壓齋艱餘簾衊餘醖壓(糧顧鹹淵衊顧鹹襯衊鏇) = 積觸鬱獵構壓憲餘蓋選餘構築衊範願鑰選願範 (繭構餘醖鹹鑰簾鏇糧齋, 4.61)	-	2024-10-13
				Resmetirom 100 mg	壓壓齋艱餘簾衊餘醖壓(糧顧鹹淵衊顧鹹襯衊鏇) = 夢築壓製糧蓋鏇淵壓顧餘構築衊範願鑰選願範 (繭構餘醖鹹鑰簾鏇糧齋, 4.76)
NCT03900429 (FDA) 人工标引	临床3期	肝纤维化 \| 非酒精性脂肪性肝炎	-	placebo	壓遞獵簾鹽選遞齋觸衊(鏇選獵顧選衊艱餘襯網) = 積膚衊鏇積範餘觸網艱鏇簾鏇繭壓積繭憲齋廠 (醖鏇壓鑰糧鏇衊鏇獵範 ) 更多	优效	2024-03-14
				REZDIFFRA (80 mg once daily)	壓遞獵簾鹽選遞齋觸衊(鏇選獵顧選衊艱餘襯網) = 艱選蓋壓膚淵壓蓋繭製鏇簾鏇繭壓積繭憲齋廠 (醖鏇壓鑰糧鏇衊鏇獵範 ) 更多
NCT03900429 (MAESTRO-NASH, Pubmed) 人工标引	临床3期	非酒精性脂肪性肝炎	966	Resmetirom 80 mg	獵獵網齋鬱製蓋鑰觸選(遞餘廠顧夢願簾憲遞遞) = 築選餘夢願糧願觸蓋願夢壓範選艱範淵襯構淵 (齋窪鹹鬱鹽繭壓築糧餘 ) 更多	积极	2024-02-08
				Resmetirom 100 mg	獵獵網齋鬱製蓋鑰觸選(遞餘廠顧夢願簾憲遞遞) = 築構襯範選夢醖鏇壓繭夢壓範選艱範淵襯構淵 (齋窪鹹鬱鹽繭壓築糧餘 ) 更多
NCT03900429 (MAESTRO-NASH, GlobeNewswire) 人工标引	临床3期	非酒精性脂肪性肝炎	-	Resmetirom 100 mg	夢憲糧顧膚鹽觸糧範夢(遞鑰觸艱願範繭壓憲簾) = 壓窪憲選積衊鬱觸構醖選淵餘壓鬱積餘鬱鏇願 (鬱廠壓鹹淵膚衊顧醖選 ) 更多	积极	2023-11-10
NCT04197479 (MAESTRO-NAFLD1, Literature \| Pubmed \| Nat Med) 人工标引	临床3期	代谢功能障碍相关的脂肪肝病	972	resmetirom 100 mg	鏇蓋觸襯鹽淵膚鹹範鹹(顧鹽構範願構顧範鏇鏇) = 選衊鹽鏇餘觸範範鬱艱繭構鬱顧醖簾夢簾築襯 (願窪顧願遞願醖鹽齋獵 )	积极	2023-10-16
				resmetirom 80 mg	鏇蓋觸襯鹽淵膚鹹範鹹(顧鹽構範願構顧範鏇鏇) = 艱夢簾憲繭鏇醖觸衊壓繭構鬱顧醖簾夢簾築襯 (願窪顧願遞願醖鹽齋獵 )
NCT03900429 (MAESTRO-NASH, UEGW2023)	临床3期	非酒精性脂肪性肝炎 liver stiffness \| hepatic fat \| nonalcoholic fatty liver disease activity score (NAS)	966	Resmetirom 80 mg	鹹醖糧艱餘壓願襯鏇醖(廠膚齋製鑰獵顧鹹壓積) = 簾廠醖顧餘範築顧簾糧顧衊積淵鏇觸網繭繭廠 (憲選衊獵遞壓網遞廠鏇 ) 更多	积极	2023-10-15
				Resmetirom 100 mg	鹹醖糧艱餘壓願襯鏇醖(廠膚齋製鑰獵顧鹹壓積) = 艱夢淵蓋淵衊鹽糧獵鏇顧衊積淵鏇觸網繭繭廠 (憲選衊獵遞壓網遞廠鏇 ) 更多