This randomized control trial aims to evaluate the effectiveness of combining resmetirom therapy (first approved pharmacological therapy for treating metabolic dysfunction-associated steatohepatitis (MASH)) with a nutritional intervention compared to resmetirom therapy alone over one year in improving liver health among 120 patients living with non-cirrhotic MASH. We hypothesize that patients receiving resmetirom and nutritional intervention will experience more significant improvements in liver function than those receiving only resmetirom therapy.

开始日期2026-10-01

申办/合作机构

City University of New York

NCT07763015

/ Not yet recruiting临床2期

A Phase 2a, Multicenter, Open-label, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Resmetirom in Pediatric Subjects Ages 6-17 Years With MASH With Fibrosis Stage F1-F3

This study will evaluate the safety, pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates the drug), and pharmacodynamics (how the drug affects the body) of resmetirom in children and adolescents with metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis. Participants will receive oral resmetirom once daily for approximately 14 days at one of several dose levels. The information from this study will help determine appropriate dosing and further evaluate the safety and biological effects of resmetirom in pediatric participants with MASH.

开始日期2026-08-01

申办/合作机构

Madrigal Pharmaceuticals, Inc.

NCT07143968

/ Recruiting临床2期IIT

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Resmetirom for the Treatment of Metabolic Dysfunction- Associated Steatotic Liver Disease (MASLD) in People Living With Human Immunodeficiency Virus (HIV)

The purpose of this research study is to test the safety and effectiveness of the study drug, resmetirom, in participants with MASLD and HIV. This is a research study to test a drug that is already on the market with a population that was not included in the original clinical trials. Participants will be people over age 18 with HIV who are on antiretroviral therapy and have been diagnosed with MASLD.
Researchers will compare resmetirom to placebo (a look-alike substance that contains no drug) to see if resmetirom decreases the amount of fat in the liver.
Participants will:
* Complete 3 screening visits to determine eligibility.
* Take resmetirom or placebo every day for 24 weeks if eligible.
* Have 2 MRI scans to measure the amount of fat on the liver. One will be before treatment starts and one will be at the end of 24 weeks of treatment.
* Attend 3 scheduled clinic visits while on treatment for bloodwork and safety assessments.
* Participate in 3 phone calls while on treatment and one phone call 4 weeks after treatment is completed to check for safety and any health changes.

开始日期2026-04-23

申办/合作机构

Indiana University

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

364

项与瑞司美替罗相关的文献（医药）

2026-09-18·Deutsches Arzteblatt International

Hepatic Steatosis: A Pandemic Disease Causing Serious Secondary Diseases.

Review

作者: Canbay, Ali ; Patsalis, Polykarpos C ; Baars, Theodor ; Figge, Anja ; Götze, Oliver ; Özçürümez, Mustafa K

BACKGROUND:

At least one-quarter of the world's population now suffers from hepatic steatosis (fatty liver disease), which, in current terminology, is called metabolic dysfunction-associated steatotic liver disease (MASLD). This disease and its more dangerous inflammatory variant, metabolic dysfunction-associated steatohepatitis (MASH), promote the development of serious secondary conditions including cardiovascular diseases (CVDs), type 2 diabetes mellitus, and hepatocellular carcinoma (HCC).

METHODS:

This review is based on pertinent publications retrieved from the PubMed-MEDLINE and Google Scholar databases and on current guidelines.

RESULTS:

Conditions that are known to be associated with MASLD and/or MASH include obesity (with or without insulin resistance), dyslipidemia, hypertension, type 2 diabetes mellitus, obstructive sleep apnea, CVDs, and chronic kidney disease (CKD). The frequency of serious secondary diseases (CVDs, CKD, HCC, and extrahepatic malignancies) increases with the degree of fibrosis progression. Cardiovascular events are the main cause of death. Intensive lifestyle changes, including a hypocaloric, low-sugar diet and physical activity and exercise in an adequate amount and intensity, are the first line of treatment and the basis for further treatment options (resmetirom, incretin analogues, bariatric surgery).

CONCLUSION:

In view of its high prevalence and its associated profile of elevated cardiovascular risk, MASLD should be recognized as clinical evidence of the danger of major secondary disease and integrated into a structured, interdisciplinary management program with strict risk stratification. Drugs are part of the therapeutic spectrum but are no substitute for lifestyle modification, which remains the basis of treatment.

2026-08-09·XENOBIOTICA

Pharmacokinetics, mass balance and metabolic profiling of resmetirom in healthy subjects and nonclinical metabolism and disposition

Article

作者: Solon, Eric ; French, Kevin ; Hennan, James K. ; Chiang, Edward ; Camacho, Raul C. ; Schmidt, Brian ; Taub, Rebecca

Resmetirom is a liver-directed, thyroid hormone receptor-β (THR-β)-selective agonist approved for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis. Disposition in rats and dogs was qualitatively similar to that observed in humans, with high concentrations observed in the liver, kidney, and caecum. The primary circulating metabolite, MGL-3623 (M1), was disproportionate in humans and formed predominantly via CYP2C8. Resmetirom exhibited >99% plasma protein binding in all species and was a substrate for BCRP, OSTα/β, OATP1B1/B3, and, to a lesser extent, MDR1.A [¹⁴C]resmetirom mass balance study in healthy men pre-dosed with 100 mg/d resmetirom (steady-state) demonstrated plasma pharmacokinetics of total radioactivity aligned with unlabelled resmetirom and MGL-3623, with C_max reached within 3-4 h. Radioactivity was largely confined to plasma vs whole blood, with parent compound the predominant radiolabelled species and MGL-3623 the major metabolite. Total recovery was 91.0% (excretion: 67.4% faecal, 23.6% urinary); in excreta, resmetirom was a minor component and no single metabolite exceeded 10% of the dose. Resmetirom inhibited CYP2C8 and weakly induced CYP2B6 and CYP3A4 in vitro.These findings demonstrate the consistent metabolic profile and favourable hepatic disposition of resmetirom across species, supporting its pharmacokinetic properties in humans for the treatment of MASH.

2026-08-01·PATHOLOGY RESEARCH AND PRACTICE

Nitric oxide pathway: Emerging therapeutic strategies for MASLD

Review

作者: Qi, Fangfang ; Zhang, Yanling ; Zhang, Ying ; Chen, Hongjin

Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately 30-40% of the global population, making it the most prevalent chronic liver disorder worldwide. Its progressive form, metabolic dysfunction-associated steatohepatitis (MASH), may advance to fibrosis, cirrhosis, and hepatocellular carcinoma, imposing a substantial socioeconomic and clinical burden. The recent FDA approval of Resmetirom for non-cirrhotic MASH has marked a significant therapeutic milestone; however, the multifactorial nature of MASLD continues to necessitate the identification of complementary therapeutic targets. The nitric oxide (NO) pathway has been increasingly recognized as a context-dependent regulator in MASLD pathogenesis, exhibiting dual and sometimes opposing biological effects. Under physiological conditions, low levels of NO derived from endothelial nitric oxide synthase (eNOS) contribute to hepatic microvascular homeostasis and limit lipid accumulation. In contrast, inducible nitric oxide synthase (iNOS) activity is enhanced during chronic metabolic inflammation, leading to excessive NO production, which may promote nitrosative stress through the formation of reactive nitrogen species including peroxynitrite (ONOO⁻). These processes have been associated with mitochondrial dysfunction, eNOS uncoupling, and progressive tissue injury. Accordingly, a more precise understanding of the spatial, temporal and concentration-dependent regulation of NO signaling is required. This review synthesizes current evidence on the dual role of NO in MASLD and critically evaluates emerging therapeutic strategies targeting this pathway, with the aim of informing future translational research.

1,203

项与瑞司美替罗相关的新闻（医药）

2026-08-12

·BioSpace

Madrigal Appoints John C. Reed, M.D., Ph.D., to its Board of Directors

CONSHOHOCKEN, Pa., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced it has appointed John C. Reed, M.D., Ph.D., to its Board of Directors. Dr. Reed currently serves as Executive Vice President, Innovative Medicine, Research & Development at Johnson & Johnson (“J&J”) and is a member of J&J’s Executive Committee, where he leads research and development across oncology, immunology, neuroscience and other areas of significant unmet medical need. Julian Baker, Chairman of the Board of Directors of Madrigal, stated, “I am pleased to welcome John Reed to Madrigal. John is one of the biopharma industry’s most accomplished physician-scientists and research leaders, with an extraordinary track record of advancing innovative medicines and building premier research organizations. His deep scientific expertise, strategic leadership and global experience developing breakthrough therapies will be invaluable as Madrigal continues to grow and expand its leadership in MASH.” Bill Sibold, Chief Executive Officer of Madrigal, added, “John's appointment reflects Madrigal's continued commitment to scientific excellence and long-term innovation. As we build on the successful launch of Rezdiffra and advance our industry-leading MASH pipeline, John's insights across drug discovery, translational medicine and global R&D strategy will be an important asset to our Board and management team.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Prior to joining Johnson & Johnson in April 2023, Dr. Reed held executive leadership positions at Sanofi and Roche, serving on their respective executive committees. Earlier in his career, he served as President and Chief Executive Officer of Sanford-Burnham Medical Research Institute (now Sanford Burnham Prebys), where he established multiple disease-focused research centers and platform technology organizations. An internationally recognized leader in biomedical research, Dr. Reed has authored more than 900 scientific publications, holds more than 130 patents and has been consistently recognized among the world's most highly cited researchers in life sciences and medicine. He is a Fellow of the American Association for the Advancement of Science and has received numerous awards recognizing his contributions to biomedical research and innovation. He earned a Bachelor of Arts in Chemistry from the University of Virginia and both his M.D. and Ph.D. in Immunology from the University of Pennsylvania School of Medicine. About Madrigal Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit and follow us on LinkedIn . Forward-Looking Statements This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to Madrigal’s growth, Madrigal’s leadership position in the MASH sector and Madrigal’s ability to advance its pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; Madrigal’s ability to successfully commercialize Rezdiffra in the U.S. and Europe; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; Madrigal’s history of operating losses and the possibility that Madrigal may never achieve or maintain profitability; risks associated with meeting the objectives of Madrigal’s clinical trials, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for its trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action or of any other product candidate; market demand for and acceptance of Rezdiffra; Madrigal’s ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; Madrigal’s ability to prevent and/or mitigate cyber-attacks; Madrigal’s ability to protect its intellectual property rights; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to Madrigal’s business and its ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by applicable law, Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s reports filed with the U.S. Securities and Exchange Commission (SEC) for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2025, and as updated from time to time by Madrigal’s other filings with the SEC. Madrigal may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Madrigal’s website in addition to following its press releases, filings with the SEC, public conference calls, and webcasts. Madrigal Pharmaceuticals, Rezdiffra ® and associated logos are trademarks of Madrigal Pharmaceuticals, Inc. Investor Contact Tina Ventura, IR@madrigalpharma.com Media Contact Chris Frates, media@madrigalpharma.com

高管变更上市批准临床3期

2026-08-11

·今日头条

重磅！国产MASH创新药48周实现抗纤维化、降脂、降酶“三重获益”

近期，广东众生药业的一纸公告在医药圈激起涟漪：其控股子公司广东众生睿创生物科技有限公司（下称“众生睿创”）自主研发的1类创新药ZSP1601片，在治疗代谢功能障碍相关脂肪性肝炎（MASH，原称NASH）的IIb期临床试验中，顶线数据初步分析结果积极，两个剂量组主要疗效终点应答率均显著优于安慰剂组，且展现出逆转肝纤维化的潜力。公司表示，该结果有力支持继续开展III期临床试验有力支持继续开展III期临床试验。这则消息不仅是众生药业在创新药征途上的一座里程碑，更为国内数以千万计的MASH患者带来了新的曙光。这款长跑了多年的国产FIC（First-in-Class）新药，究竟有何特殊之处？本文将为您抽丝剥茧。靶向“沉默的肝脏杀手”，MASH治疗缺口巨大在解读药物之前，我们有必要认识它要攻克的疾病——MASH。它是非酒精性脂肪性肝病（NAFLD）的严重类型，可以理解为肝脏因脂肪过度堆积而产生炎症，进而引发肝细胞损伤、纤维化，最终可能走向肝硬化甚至肝癌。由于早期几乎没有明显症状，MASH常被称为“沉默的杀手”。过去数十年，全球MASH药物研发可谓“九死一生”，直到2024年3月，首款疗法Resmetirom才在美国获批上市，打破了四十余年无药可医的僵局。根据弗若斯特沙利文数据，全球MASH患病人数预计将在2030年达到4.86亿人；中国MASH患者人数已从2019年的3710万攀升至2024年的4400万，预计到2034年将增至6110万。北京地坛医院成军教授的调查显示，北京市成人非酒精性脂肪性肝病患病率已达31%。更令人警醒的是，MASH患者预期寿命缩短，死因主要为代谢综合征相关恶性肿瘤和心脑血管疾病。正是在此背景下，ZSP1601被寄予厚望。 ZSP1601从“第一”到“唯一”，一路领跑的国产新锐 ZSP1601之所以备受瞩目，源于其鲜明的“首创”标签。 ZSP1601是国内首个获批临床试验、用于治疗NASH（现称MASH）的小分子创新药。 ZSP1601是一种泛磷酸二酯酶（pan-PDE）抑制剂，主要作用于PDE3、PDE4、PDE5等多个靶点。用通俗的话讲，它能同时踩下几重“刹车”，调节肝脏细胞内的信使分子水平，从而改善肝脏脂质代谢、抑制炎症反应并延缓纤维化进程。与单一靶点药物相比，这种多靶点协同作用有望为复杂病因的MASH带来更全面的治疗效果。除了MASH这一核心赛道，ZSP1601因作用机制广谱，其适应症布局还扩展到了特发性肺纤维化（IPF）和银屑病，这些领域的临床试验均已在推进中，展现了这款分子成为重磅“基石药物”的潜力。这一机制的独特性在于它不是像GLP-1类药物那样通过减重"间接"改善肝脏，也不像THR-β激动剂那样聚焦脂代谢调节，而是直接作用于肝内炎症与肝星状细胞（HSC）激活，从源头同时阻断炎症和纤维化进程。根据发表在《Nature Communications》上的Ib/IIa期研究结果，ZSP1601对PDE2的半数最大抑制浓度（IC50）为2.82μM，显著优于传统PDE抑制剂己酮可可碱（PTX，IC50=34.0μM）。从实验室到临床：ZSP1601的研发之路 ZSP1601的研发历程，堪称中国MASH创新药从0到1的缩影。 2017年10月获NMPA批准开展I期临床试验，成为国内首个获批用于NASH/MASH治疗的小分子创新药； I期临床：在中国健康人群中完成药代动力学和安全性研究，结果显示药物快速吸收（达峰时间1.25-2.50小时），安全性良好； Ib/IIa期临床：共纳入36例NAFLD患者，治疗28天后，50mg BID和100mg BID剂量组血清转氨酶及肝脏脂肪含量（MRI-PDFF）较安慰剂组显著降低，无创纤维化指标及生物标志物均呈下降趋势。研究结果发表于国际知名期刊《Nature Communications》； IIb期临床：2024年完成入组，2026年5月7日公布顶线数据，181例活检确诊患者治疗48周，主要终点达成，抗纤维化、降脂、降酶三重获益，支持推进III期临床。值得一提的是，ZSP1601曾获国家"重大新药创制"科技重大专项立项支持，具有全球自主知识产权，这为其未来的国际化布局提供了坚实基础。未来展望：III期临床是关键一跃尽管IIb期数据令人振奋，但ZSP1601距离最终上市仍有关键一步——III期临床试验。根据众生药业公告，公司将积极推进与监管部门的沟通，计划基于IIb期结果推进关键性III期临床试验。 MASH药物的III期临床通常需要更大样本量（数百至上千例）、更长随访周期，并以肝活检组织学改善作为主要终点，研发投入巨大。此外，完整的有效性和安全性结果仍需以最终的临床总结报告为准，顶线数据（Top Line）仅为初步统计分析结果。从市场维度看，全球MASH药物市场规模预计将从2025年的约107亿美元增长至2035年的超7000亿美元，年复合增长率达15%以上。中国MASH市场渗透率目前极低，随着诊断率提升和医保政策支持，ZSP1601若成功上市，有望凭借疗效、安全性和口服便利性率先打开市场。结语众生药业ZSP1601的IIb期积极数据，不仅是一款药物的阶段性胜利，更是中国创新药在MASH这一"研发黑洞"中实现差异化突破的标志性事件。从全球首创的pan-PDE机制，到抗纤维化、降脂、降酶的三重获益，再到口服给药的便利性，ZSP1601展现出的FIC（First-in-Class）与BIC（Best-in-Class）双重潜力，值得行业持续关注。当然，创新药的研发从来不是百米冲刺，而是马拉松。 IIb期的亮眼成绩只是通往终点的又一个里程碑，III期临床的验证、监管审批的闯关、商业化落地的挑战，仍在前方等待。但对于数千万MASH患者而言，每多一个有效的治疗选择，就多一份逆转肝纤维化、回归正常生活的希望。参考文献： [1]众生药业官网 [2]NMPA官网胶囊与细胞背景3D渲染抗生素的作用机制包括抑制细胞壁合成、蛋白质合成和DNA复制

2026-08-11

·药研途

重磅！国产MASH创新药ZSP1601 IIb期阳性：48周实现抗纤维化、降脂、降酶“三重获益”

近期，广东众生药业的一纸公告在医药圈激起涟漪：其控股子公司广东众生睿创生物科技有限公司（下称“众生睿创”）自主研发的1类创新药ZSP1601片，在治疗代谢功能障碍相关脂肪性肝炎（MASH，原称NASH）的IIb期临床试验中，顶线数据初步分析结果积极，两个剂量组主要疗效终点应答率均显著优于安慰剂组，且展现出逆转肝纤维化的潜力。公司表示，该结果有力支持继续开展III期临床试验有力支持继续开展III期临床试验。这则消息不仅是众生药业在创新药征途上的一座里程碑，更为国内数以千万计的MASH患者带来了新的曙光。这款长跑了多年的国产FIC（First-in-Class）新药，究竟有何特殊之处？本文将为您抽丝剥茧。靶向“沉默的肝脏杀手”，MASH治疗缺口巨大在解读药物之前，我们有必要认识它要攻克的疾病——MASH。它是非酒精性脂肪性肝病（NAFLD）的严重类型，可以理解为肝脏因脂肪过度堆积而产生炎症，进而引发肝细胞损伤、纤维化，最终可能走向肝硬化甚至肝癌。由于早期几乎没有明显症状，MASH常被称为“沉默的杀手”。过去数十年，全球MASH药物研发可谓“九死一生”，直到2024年3月，首款疗法Resmetirom才在美国获批上市，打破了四十余年无药可医的僵局。根据弗若斯特沙利文数据，全球MASH患病人数预计将在2030年达到4.86亿人；中国MASH患者人数已从2019年的3710万攀升至2024年的4400万，预计到2034年将增至6110万。北京地坛医院成军教授的调查显示，北京市成人非酒精性脂肪性肝病患病率已达31%。更令人警醒的是，MASH患者预期寿命缩短，死因主要为代谢综合征相关恶性肿瘤和心脑血管疾病。正是在此背景下，ZSP1601被寄予厚望。 ZSP1601从“第一”到“唯一”，一路领跑的国产新锐 ZSP1601之所以备受瞩目，源于其鲜明的“首创”标签。 ZSP1601是国内首个获批临床试验、用于治疗NASH（现称MASH）的小分子创新药。 ZSP1601是一种泛磷酸二酯酶（pan-PDE）抑制剂，主要作用于PDE3、PDE4、PDE5等多个靶点。用通俗的话讲，它能同时踩下几重“刹车”，调节肝脏细胞内的信使分子水平，从而改善肝脏脂质代谢、抑制炎症反应并延缓纤维化进程。与单一靶点药物相比，这种多靶点协同作用有望为复杂病因的MASH带来更全面的治疗效果。除了MASH这一核心赛道，ZSP1601因作用机制广谱，其适应症布局还扩展到了特发性肺纤维化（IPF）和银屑病，这些领域的临床试验均已在推进中，展现了这款分子成为重磅“基石药物”的潜力。这一机制的独特性在于它不是像GLP-1类药物那样通过减重"间接"改善肝脏，也不像THR-β激动剂那样聚焦脂代谢调节，而是直接作用于肝内炎症与肝星状细胞（HSC）激活，从源头同时阻断炎症和纤维化进程。根据发表在《Nature Communications》上的Ib/IIa期研究结果，ZSP1601对PDE2的半数最大抑制浓度（IC50）为2.82μM，显著优于传统PDE抑制剂己酮可可碱（PTX，IC50=34.0μM）。从实验室到临床：ZSP1601的研发之路 ZSP1601的研发历程，堪称中国MASH创新药从0到1的缩影。 2017年10月获NMPA批准开展I期临床试验，成为国内首个获批用于NASH/MASH治疗的小分子创新药； I期临床：在中国健康人群中完成药代动力学和安全性研究，结果显示药物快速吸收（达峰时间1.25-2.50小时），安全性良好； Ib/IIa期临床：共纳入36例NAFLD患者，治疗28天后，50mg BID和100mg BID剂量组血清转氨酶及肝脏脂肪含量（MRI-PDFF）较安慰剂组显著降低，无创纤维化指标及生物标志物均呈下降趋势。研究结果发表于国际知名期刊《Nature Communications》； IIb期临床：2024年完成入组，2026年5月7日公布顶线数据，181例活检确诊患者治疗48周，主要终点达成，抗纤维化、降脂、降酶三重获益，支持推进III期临床。值得一提的是，ZSP1601曾获国家"重大新药创制"科技重大专项立项支持，具有全球自主知识产权，这为其未来的国际化布局提供了坚实基础。未来展望：III期临床是关键一跃尽管IIb期数据令人振奋，但ZSP1601距离最终上市仍有关键一步——III期临床试验。根据众生药业公告，公司将积极推进与监管部门的沟通，计划基于IIb期结果推进关键性III期临床试验。 MASH药物的III期临床通常需要更大样本量（数百至上千例）、更长随访周期，并以肝活检组织学改善作为主要终点，研发投入巨大。此外，完整的有效性和安全性结果仍需以最终的临床总结报告为准，顶线数据（Top Line）仅为初步统计分析结果。从市场维度看，全球MASH药物市场规模预计将从2025年的约107亿美元增长至2035年的超7000亿美元，年复合增长率达15%以上。中国MASH市场渗透率目前极低，随着诊断率提升和医保政策支持，ZSP1601若成功上市，有望凭借疗效、安全性和口服便利性率先打开市场。结语众生药业ZSP1601的IIb期积极数据，不仅是一款药物的阶段性胜利，更是中国创新药在MASH这一"研发黑洞"中实现差异化突破的标志性事件。从全球首创的pan-PDE机制，到抗纤维化、降脂、降酶的三重获益，再到口服给药的便利性，ZSP1601展现出的FIC（First-in-Class）与BIC（Best-in-Class）双重潜力，值得行业持续关注。当然，创新药的研发从来不是百米冲刺，而是马拉松。 IIb期的亮眼成绩只是通往终点的又一个里程碑，III期临床的验证、监管审批的闯关、商业化落地的挑战，仍在前方等待。但对于数千万MASH患者而言，每多一个有效的治疗选择，就多一份逆转肝纤维化、回归正常生活的希望。参考文献： [1]众生药业官网 [2]NMPA官网 📌 每周都在追踪的乙肝新药动态，这里持续更新 📝 本文由药研途主理人撰写：16年药物研发 · 执业药师 · 药物化学硕士 ⚠️ 本文中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。本公众号不对任何主体因使用本文内容而导致的任何损失承担责任。另外，因水平有限，不足之处在所难免，敬请谅解！ 👆点上方「药研途」名片 → 关注，不错过每周新药速览

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
肝纤维化	美国	Madrigal Ltd.	2024-03-14
代谢功能障碍相关脂肪性肝炎	美国	Madrigal Pharmaceuticals, Inc.	2024-03-14
代谢功能障碍相关脂肪性肝炎	美国	Madrigal Ltd.	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	比利时	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	加拿大	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	法国	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	德国	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	意大利	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	西班牙	Madrigal Pharmaceuticals, Inc.	2022-08-26
肝硬化	临床3期	英国	Madrigal Pharmaceuticals, Inc.	2022-08-26
代谢功能障碍相关的脂肪肝病	临床3期	美国	Madrigal Pharmaceuticals, Inc.	2019-12-16
纤维化	临床3期	美国	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


NCT04197479 (MAESTRO-NAFLD-1, Pubmed \| J Clin Exp Hepatol)	临床2/3期	代谢功能障碍相关脂肪性肝炎 \| 代谢功能障碍相关的脂肪肝病	2,243	Resmetirom 80 mg	鬱襯鹹艱鹹鹹淵繭構壓(構鬱願獵醖構餘憲網獵) = 築顧襯鬱齋憲壓壓襯獵餘簾蓋齋蓋衊淵製積繭 (艱蓋積繭窪糧廠願積膚, -4.9 ~ -1.0) 更多	积极	2026-07-01
				Resmetirom 100 mg	鬱襯鹹艱鹹鹹淵繭構壓(構鬱願獵醖構餘憲網獵) = 窪鏇鹹壓鬱壓觸齋簾餘餘簾蓋齋蓋衊淵製積繭 (艱蓋積繭窪糧廠願積膚, -4.7 ~ -0.6)
DDW2026	N/A	代谢功能障碍相关脂肪性肝炎	100	Resmetirom prescribers (REZ)	蓋憲醖餘襯製夢鹹壓糧(鹽積製構網衊鏇鹹憲糧) = 網憲願壓選廠鏇醖觸襯網襯製鑰觸廠膚選鹽鹽 (製鑰鹹築窪壓憲獵醖蓋 ) 更多	积极	2026-05-02
				Non-resmetirom prescribers (NREZ)	蓋憲醖餘襯製夢鹹壓糧(鹽積製構網衊鏇鹹憲糧) = 獵艱糧餘網艱願鹽觸醖網襯製鑰觸廠膚選鹽鹽 (製鑰鹹築窪壓憲獵醖蓋 ) 更多
DDW2026	N/A	代谢功能障碍相关的脂肪肝病	1,968	Resmetirom	積廠製鬱窪夢鹹窪窪願(構鬱壓鏇糧繭齋積鏇範): OR = 0.73 (95.0% CI, 0.62 ~ 0.87) 更多	积极	2026-05-02
				GLP-1 RA
DDW2026	N/A	代谢功能障碍相关的脂肪肝病	778	Resmetirom (Women <50 years)	製蓋積憲衊襯範獵願醖(製遞淵鏇艱製鏇鏇窪窪) = 蓋積願鏇廠鏇憲壓窪築積壓鹽膚鬱壓顧簾獵製 (艱鏇鹹艱窪憲願衊夢壓 ) 更多	积极	2026-05-02
				Resmetirom (Women ≥50 years)	製蓋積憲衊襯範獵願醖(製遞淵鏇艱製鏇鏇窪窪) = 鑰鏇製簾鹹壓糧鏇網鹽積壓鹽膚鬱壓顧簾獵製 (艱鏇鹹艱窪憲願衊夢壓 ) 更多
DDW2026	N/A	代谢功能障碍相关脂肪性肝炎	58	Resmetirom	鹹願顧築積網範觸構餘(艱廠遞構顧衊夢獵築鬱) = 顧鹹憲築淵觸艱製醖顧蓋遞繭醖醖願襯醖積繭 (獵網醖簾夢築壓顧觸構 )	积极	2026-05-02
DDW2026	N/A	代谢功能障碍相关脂肪性肝炎	131	Resmetirom (Metabolic dysfunction-associated steatohepatitis)	醖鏇遞繭積壓繭顧夢鹹(衊醖壓膚淵衊衊餘齋積) = Common adverse events included GERD (15.7%), diarrhea (11.0%), nausea (9.4%), and constipation (8.7%). 鬱願衊憲糧蓋糧壓蓋鏇 (夢鹽廠鹽繭鬱襯齋艱鑰 )	积极	2026-05-02
NCT04951219 (MAESTRO-NAFLD-1, NASH_TAG2026)	临床3期	代谢功能障碍相关脂肪性肝炎	122	Resmetirom 80 mg	襯醖鹽襯齋鬱構憲艱鏇(網衊遞糧衊選製鏇餘鬱) = 獵繭餘齋獵淵顧鑰窪糧艱簾構餘顧窪壓壓襯艱 (獵衊觸衊觸廠構鹹鹹醖 ) 更多	积极	2026-02-04
NASH_TAG2026	N/A	代谢功能障碍相关脂肪性肝炎	5,389	Resmetirom	膚繭鬱膚窪簾構夢選壓(顧餘齋齋窪艱範窪簾繭) = 夢鑰繭範廠餘鏇製鑰鏇範窪願鹹鹹夢顧遞製衊 (積選憲艱鏇遞夢繭襯簾 ) 更多	积极	2026-02-04
NCT04951219 (MAESTRO-NAFLD-OLE, NASH_TAG2026)	临床3期	代谢功能障碍相关的脂肪肝病	515	Resmetirom	範製選網選製壓憲襯選(鹽製淵蓋製鑰齋願糧顧) = RES was well tolerated; restarting or titrating to 100 mg rarely caused new or recurrent GI AEs 膚淵選顧遞積獵衊淵衊 (遞壓網積壓窪壓製醖選 )	积极	2026-02-04
NCT03038022 (CTgov)	临床2期	杂合子家族性高胆固醇血症	116	MGL-3196 (resmetirom) (MGL-3196)	顧鹽積鑰繭膚齋窪淵遞(壓築構憲願廠獵鑰糧膚) = 築築製構簾範選積餘醖夢積齋鬱願觸廠鹽壓廠 (夢觸獵製遞觸艱衊願淵, 2.59) 更多	-	2025-12-23
				Placebo (Placebo)	顧鹽積鑰繭膚齋窪淵遞(壓築構憲願廠獵鑰糧膚) = 網簾醖糧艱襯鹹夢壓範夢積齋鬱願觸廠鹽壓廠 (夢觸獵製遞觸艱衊願淵, 3.71) 更多