Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona, Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride, dipotassium glycyrrhizate, sodium fluoride, panthenol and xylitol, within its ingredients. Thus, it may be relevant to test the efficacy of this new "Lacer Oros Acción Integral" mouth rinse formulation in a RCT.
Primary Objective: The primary objective of this RCT will be to evaluate the antiplaque/antigingivitis effects of the test mouth rinse.
Population: Consecutive subjects in supportive periodontal therapy (SPT) will be screened at the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, and enrolled in the clinical trial if they are periodontitis patients, already enrolled in a SPT, for at least 6 months, systemically healthy, with moderate gingival inflammation and complains of dentin hypersensitivity.
Study design: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
Intervention: The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
Visits: Screening, baseline, 2 and 12 weeks.
Outcomes: Periodontal clinical outcomes (plaque levels, gingival condition, probing pocket depth), Stainign, Microbiological outcomes (culture and qPCR). Patient reported outcomes, compliance, adverse effects.

开始日期2021-09-04

申办/合作机构

Universidad Complutense de Madrid

[+1]

NCT04395950

/ Withdrawn临床1期IIT

A Phase 1B, Single-Blinded, Linear Two Period, Placebo-controlled Study to Evaluate the Effects of 10 mg/Day of PF-05221304, Liver Targeted Acetyl-CoA Carboxylase Inhibitor (ACCi) on Very Low Density Lipoprotein ApoB100 and TG Secretion

The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat. The planned study will identify why the fat in the blood increases at the same time this drug reduces fat in the liver. The study will have two treatment periods of 6 weeks each, separated by a 3 week rest period with no treatment. The subjects will receive the active drug in one of the 6 week treatment periods and a placebo in the other 6 week period. The investigators will know when the subjects are receiving active treatment or placebo, but the subject will not know.

开始日期2020-12-01

申办/合作机构

Columbia University

[+1]

NCT04399538

/ Terminated临床2期

A PHASE 2A, 2-PART, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PLACEBO-CONTROLLED, PARALLEL-GROUP (SPONSOR OPEN) STUDY TO ASSESS PHARMACODYNAMICS AND SAFETY OF PF-06865571 (DGAT2I) COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH PRESUMED NONALCOHOLIC STEATOHEPATITIS (NASH)

The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.

开始日期2020-08-10

申办/合作机构

Pfizer Inc.

100 项与 Clesacostat 相关的临床结果

登录后查看更多信息

100 项与 Clesacostat 相关的转化医学

登录后查看更多信息

100 项与 Clesacostat 相关的专利（医药）

登录后查看更多信息

项与 Clesacostat 相关的文献（医药）

2025-12-01·JOURNAL OF CLINICAL PHARMACOLOGY

Effect of Varying Degrees of Hepatic Impairment on the Pharmacokinetics of Ervogastat, a Diacylglycerol Acyltransferase 2 (DGAT2) Inhibitor, and Clesacostat, an Acetyl‐CoA Carboxylase (ACC) Inhibitor

Article

作者: Hughes, Jim ; Amin, Neeta B. ; Gosset, James R. ; Bergman, Arthur J. ; Vourvahis, Manoli ; Ogden, Adam G. ; Kalgutkar, Amit S.

Abstract:

Ervogastat, a diacylglycerol‐O‐acyltransferase‐2 inhibitor, and clesacostat, an acetyl‐CoA carboxylase inhibitor, are in clinical development for the treatment of metabolic dysfunction‐associated steatohepatitis (MASH). Study 1 and Study 2 were open‐label, Phase 1 trials that assessed the pharmacokinetics (PK) of a single dose of ervogastat (100 mg) and clesacostat (25 mg), respectively, in participants (n = 6/cohort) with mild, moderate, or severe hepatic impairment (HI) and compared to those without HI (reference). Plasma samples were analyzed for both total and unbound concentrations in Study 2 as clesacostat is highly protein bound. In Study 1, compared to participants without HI, ervogastat exposure (AUC inf ) was 56%, 65%, and 52% higher in participants with mild, moderate, and severe HI, respectively. However, when excluding PK data from a participant with unexplained low exposures in reference group, ervogastat exposures were similar between those with/without HI. In Study 2, total clesacostat exposure was 36%, 24%, and 19% higher for mild, moderate, and severe HI, respectively, as compared to reference group. Unbound clesacostat exposures were 70%, 83%, and 166% higher for mild, moderate, and severe HI cohorts, respectively, with clesacostat plasma protein binding shown to decrease with increasing HI severity. Ervogastat and clesacostat were well tolerated with no clinically significant laboratory abnormalities or changes in vital signs and/or electrocardiograms observed. Observed exposures in HI studies were consistent with simulated exposures in MASH population. Taking into consideration the safety margins at the highest doses evaluated in Phase 2, no dose adjustment of ervogastat or clesacostat is currently warranted for patients with hepatic impairment.

2025-02-01·CPT-Pharmacometrics & Systems Pharmacology

Exposure–response modeling of liver fat imaging endpoints in non‐alcoholic fatty liver disease populations administered ervogastat alone and co‐administered with clesacostat

Article

作者: Wojciechowski, Jessica ; Hughes, Jim H. ; Vourvahis, Manoli ; Amin, Neeta B.

Abstract:

Non‐alcoholic fatty liver disease and non‐alcoholic steatohepatitis describe a collection of liver conditions characterized by the accumulation of liver fat. Despite biopsy being the reference standard for determining the severity of disease, non‐invasive measures such as magnetic resonance imaging proton density fat fraction (MRI‐PDFF) and FibroScan® controlled attenuation parameter (CAP™) can be used to understand longitudinal changes in steatosis. The aim of this work was to describe the exposure–response relationship of ervogastat with or without clesacostat on steatosis, through population pharmacokinetic/pharmacodynamic (PK/PD) modeling of both liver fat measurements simultaneously. Population pharmacokinetic and exposure–response models using individual predictions of average concentrations were used to describe ervogastat/clesacostat PKPD. Due to both liver fat endpoints being continuous‐bounded outcomes on different scales, a dynamic transform‐both‐sides approach was used to link a common latent factor representing liver fat to each endpoint. Simultaneous modeling of both MRI‐PDFF and CAP™ was successful with both measurements being adequately described by the model. The clinical trial simulation was able to adequately predict the results of a recent Phase 2 study, where subjects given ervogastat/clesacostat 300/10 mg BID for 6 weeks had a LS means and model‐predicted median (95% confidence intervals) percent change from baseline MRI‐PDFF of −45.8% and −45.6% (−61.6% to −31.8%), respectively. Simultaneous modeling of both MRI‐PDFF and CAP™ was successful with both measurements being adequately described. By describing the underlying changes of steatosis with a latent variable, this model may be extended to describe biopsy results from future studies.

2025-01-01·Gastro hep advances

Modeling Reductions in Liver Fat: Comparing Noninvasive Tests to Magnetic Resonance Imaging–Proton Density Fat Fraction

Article

作者: Wai-Sun Wong, Vincent ; Fournier-Poizat, Céline ; Tuthill, Theresa ; Kayali, Zeid ; Ashworth, Amy Lauren ; Amin, Neeta B ; Carvajal-Gonzalez, Santos

Background and Aims:

Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) is an accurate, noninvasive tool for diagnosing metabolic dysfunction-associated steatotic liver disease, but its feasibility is limited in routine clinical practice. We aimed to assess the clinical utility of alternative, cost-efficient approaches for assessing liver fat changes and their relationship with MRI-PDFF changes.

Methods:

This is a secondary analysis of a phase 2a study that included adults with metabolic dysfunction-associated steatotic liver disease who received clesacostat, a selective, reversible inhibitor of acetyl-CoA carboxylase. In this secondary analysis, responders were defined as those in whom a ≥30% decrease in liver fat by MRI-PDFF was observed with clesacostat or placebo. Other endpoints were evaluated for their ability to predict MRI-PDFF responder status, including controlled attenuation parameter (CAP), liver enzymes (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase), metabolic dysfunction-associated steatohepatitis-related biomarkers (liver stiffness measurement by vibration-controlled transient elastography, cytokeratin 18-M30, and cytokeratin 18-M65), and markers of hepatic steatosis (hepatic steatosis index and fatty liver index). These relationships were investigated through correlation, univariate, and multivariable regression analyses.

Results:

Of 260 participants with a baseline and on-treatment measure at week 12 or week 16, 143 were responders. Based on correlation analyses, a significant but weak positive correlation between MRI-PDFF and CAP measurements of relative percentage change from baseline in liver fat was observed. By combining the selected 6 parameters (CAP, hepatic steatosis index, fatty liver index, alanine aminotransferase, gamma-glutamyl transferase, and cytokeratin 18-M65) through multivariable regression modeling, responders can be predicted with a high level of sensitivity and specificity (mean area under the receiver operating characteristic curve = 0.831 from 10-fold cross-validation).

Conclusion:

Modeling multiple noninvasive assessments of liver fat closely aligned with MRI-PDFF measurements. These data support further assessment of its suitability in real-world clinical practice.

项与 Clesacostat 相关的新闻（医药）

2026-02-03

·FierceBiotech

Pfizer CEO says pipeline pruning is mostly finished after 6 more early-stage culls, $4.4B in impairment charges

After announcing six newly dropped early-stage assets, Pfizer CEO Albert Bourla, Ph.D., told investors that he expects the pharma\'s pipeline pruning to be mostly finished.\n Pfizer has pumped the brakes on six early-stage assets, including three being tested for ulcerative colitis.The Big Pharma has also ceased development of disitamab vedotin, an antibody-drug conjugate (ADC), in bladder cancer, with the company instead set to focus on approved ADC Padcev (enfortumab vedotin) in that setting, Chief Financial Officer David Denton said during Pfizer’s Feb. 3 earnings call (PDF).Overall, the company\'s pipeline adjustments during the fourth quarter resulted in $4.4 billion in impairment charges, Denton added. Disitamab vedotin is still being explored in other HER2-positive cancers, according to Pfizer’s website.Pfizer picked up both Padcev and disitamab vedotin through its $43 billion buyout of Seagen in 2023. The pharma dropped two other Seagen ADCs last November, part of a group of 11 discontinuations at that time.Despite this winnowing of its Seagen haul, Denton said that overall, “the Seagen portfolio is progressing ahead of our expectations.” The three newly dropped phase 1 colitis candidates are CCR6 antagonist PF-07054894, SIK inhibitor PF-07899895 and PF-06414300. Two other assets headed to the scrap heap are PF-07853578, a PNPLA3 modulator that was being studied in metabolic dysfunction-associated steatohepatitis, and anemia candidate PF-07940369. Pfizer has not yet disclosed the modalities of PF-06414300 and PF-07940369, a company spokesperson told Fierce.At the time of publication, Pfizer had not responded to questions from Fierce about the reasons behind the culls or whether they represent a shift away from ulcerative colitis. Pfizer is currently less than a year in to an autoimmune disease collaboration with Flagship Pioneering, part of the duo’s broader multibillion-dollar partnership.Pfizer also shelved a MASH program last quarter, a combo therapy of DGAT2i inhibitor ervogastat and acetyl-CoA carboxylase inhibitor clesacostat.The final of the six newly dropped programs is a phase 1 combo of prifetrastat and atirmociclib in metastatic breast cancer. Both small molecules are still being developed as cancer monotherapies. Asked during Pfizer’s earnings call if more pipeline pruning is expected going forward, CEO Albert Bourla, Ph.D., said the company has “done most of our pruning of our pipeline right now.”“The things that we are continuing right now, at large, are things that we believe they are the ones to invest,” Bourla said.2025 was a year of prioritizing and focusing Pfizer’s portfolio, Chief Scientific Officer Chris Boshoff, M.D., Ph.D., added, which led to “up to $500 million savings in R&D, which is now reinvested in phase three programs.”But that doesn’t mean Pfizer plans on setting its pipeline in stone, Bourla said.“When you speak about realigning, creating synergies, or creating cost savings in R&D that we reinvest, we don\'t mean going forward with this configuration of programs,” the chief exec said. Instead, Pfizer plans to increase its number of programs “by deploying AI, which already happened in 2025 with excellent results.”

临床1期并购抗体药物偶联物临床2期

2026-01-26

·网易号

降脂还护肝？“双效合一”新药登《柳叶刀》，3.5亿患者迎曙光

权威医学期刊《柳叶刀》显示，全球近三分之一成年人深受脂肪肝（MASLD）困扰，而作为脂肪肝的严重阶段，代谢功能障碍相关脂肪性肝炎（MASH）患者更面临从肝纤维化、肝硬化到肝病变的多重健康威胁。多年来，MASH始终缺乏真正有效的药物手段。患者只能依靠严格饮食控制与长期运动维持。即便如此，许多人哪怕竭尽全力，依旧难以阻止病情的持续恶化。值得振奋的是，这一困境在近期迎来了“重大突破”——一种“双点”创新组合疗法，在《柳叶刀》子刊公布了令人瞩目的疗效：可使约三分之二的MASH患者显著改善！要知道，长期以来，MASH陷入瓶颈，传统思路往往只针对单一靶点。但脂肪肝的发生涉及脂肪合成、堆积、炎症反应和代谢通路紊乱，犹如一个堵塞的交通枢纽，仅疏通一条道路根本无法解决全局问题。而此次新发布的“双靶点疗法”之所以备受关注，就在于它同时锁定了“减产”和“清库存”这两个关键环节：ACC抑制剂（clesacostat）可关闭肝脏脂肪合成的“总开关”，从源头上阻断新脂肪的生成；DGAT2抑制剂（ervogastat）则能有效抑制脂肪在细胞内的“储存行为”，加速已合成脂肪的代谢与清除。与此同时，该联合疗法Ⅱ期临床试验结果还显示，在255例伴有2-3期肝纤维化的MASH患者中，联合治疗组高达66%和63%的患者实现MASH消退且纤维化改善，效果远优于单药组及安慰剂组。不过，尽管这一试验成果被视作MASH治疗领域的“突破性进展”，但研究人员也客观指出：该疗法对已形成的纤维化组织改善有限，且目前仍处于临床试验阶段。当前，随着超重和糖代谢异常问题高发，全球范围内MASH患病数还在持续增长。弗若斯特沙利文预测，至2030年，全球患者数量将从3.5亿增长至4.9亿，中国患者人数也将突破5550万。庞大的治疗需求与尚未充分满足的临床方案之间，存在着巨大的市场空白。更令人担忧的是，肝脏损伤具有隐匿性，等到出现不适症状时，往往已错失最佳干预时机。这种“沉默的威胁”让早期干预与日常养护的重要性愈发凸显！此前，国际护肝方案大多着重于降低转氨酶指标，对于因外卖饮食、久坐办公、熬夜应酬所引发的肝脂超标问题，干预成效有限。在此背景下，国内肝脏健康领域的科研与应用正不断取得进展。其中，由香港生科企业TS研发的“倍清肝”，凭借“融脂-抗炎-修复-代谢”四维干预网络，有效解决肝脏负担及肝脂堆积问题，受到业内外的广泛关注。据人民网等报道，该方案采用二氢杨梅素、担子菌提取物等前沿护肝成分，打造出“内源强肝+外源减负”的双重修复体系。韩/仁济大学试验显示，200名慢性肝患在接受相关核心成分干预后，代表肝损程度的指标（ALT、AST）分别下降了12.8%、16.2%。京J东商智数据显示，自问世以来，“倍清肝”的搜索量就持续攀升，复购率达到行业领先的67%。其中35-65岁的金融、IT等行业高收入人群为消费主力。难怪深圳某互联网高管说：“现在都离不开它，已将其作为日常养护的常备”随着全球MASLD（普通脂肪肝）患病率逐年上升，越来越多的中青年人因熬夜、应酬、代谢异常而被确诊。“找到有效的治疗药物”早已不只是单纯的问题，更是关乎大家的议题。总的来说，新药研发的突破不仅带来了治疗的希望，更促使整个社会对MASH的认知发生转变。越来越多的人开始主动关注肝脏健康，并更早地进行筛查，从而构建起完整的“预防-干预-治疗”健康管理链条。未来，MASH治疗的“可及性”将持续提升。针对脂肪合成的靶向药，或许不久后患者便能在医院开到，将不必再因“无药可医”而忧虑。

2026-01-13

·药时代

5000万美元首付款！Madrigal 买下辉瑞“弃药”

出海机会来了！多款MASH 产品（小分子、siRNA）正寻找有实力的合作伙伴，PCC~preclinical阶段，合作模式灵活可谈！请感兴趣的公司立即联系：药时代BD团队 BD@drugtimes.cn 正文共：2376字预计阅读时间：7分钟 2026年1月9日， Madrigal宣布与辉瑞达成全球独家协议，获得其口服二酰基甘油酰基转移酶2（DGAT2）抑制剂Ervogastat及两项早期代谢相关脂肪性肝炎（MASH）资产。根据协议，Madrigal将支付5000万美元首付款，并承诺未来基于研发与销售进展的里程碑付款及特许权使用费。颇具戏剧性的是，此次交易的重要标的Ervogastat曾被辉瑞搁置。2025年11月4日，辉瑞在研发管线更新中宣布终止一项MASH联合疗法的开发，该方案的核心正是Ervogastat与另一款药物Clesacostat的组合。谁知两个月过去，Ervogastat摇身一变成为“香饽饽”，Madrigal的高价接盘，也改变了该药的命运。 Ervogastat的发现过程是对辉瑞NASH候选分子PF-06427878（已终止）的优化。同为DGAT2抑制剂，前者主要解决了代谢稳定问题，以达到高渗透、低清除、药效高的。在被终止的联合疗法中，Ervogastat与乙酰辅酶A羧化酶（ACC）抑制剂Clesacostat在Ⅱ期研究中确实展现了不俗疗效，两者协同阻断肝脏甘油三酯合成，让肝脏脂肪降低40%。然而，或许是抑制ACC引发的血清甘油三酯升高问题，辉瑞最终决定终止该联合方案。联合疗法虽然折戟，但Ervogastat依就获得市场认可。新东家Madrigal此次出手，大致还是看中了期联合疗法潜力，只是联合对象是自家的Rezdiffra。 Rezdiffra是全球首款MASH新药，也是Madrigal的核心管线。作为一种甲状腺激素受体β（THR-β）激动剂，它通过增加线粒体生物合成来增强肝细胞处理脂肪的能力，从而减少肝脏脂肪堆积。其关键3期临床试验MAESTRO-NASH结果显示，治疗52周时，100毫克剂量组有29.9%的患者实现MASH症状消除且肝纤维化未恶化（安慰剂组仅为9.7%）。凭借出色的疗效与每日一次口服的便捷性，Rezdiffra上市仅五个完整季度，年销售额就已突破10亿美元。目前Madrigal正围绕着Rezdiffra构建联合治疗方案，逻辑可以参考默沙东对K药的策略。将Ervogastat与Rezdiffra联用，旨在从脂质合成与代谢清除两个不同源头协同干预，共同解决肝脏脂肪堆积及其引发的炎症与纤维化问题。二者在作用机制上具有显著的互补性，理论上具备实现“1+1>2”疗效的潜力，不仅有望为患者提供更优的治疗结果，也为控制这一复杂慢性病设定了新的潜在治疗标准。鉴于Rezdiffra的专利保护期已延长至2045年，Madrigal拥有了进行长期战略布局与创新的充足窗口，以巩固其市场领导地位。这也预示了未来MASH领域的竞争核心：不再是单一药物的对决，而是不同作用机制的药物如何被巧妙组合，以达成更佳疗效的策略较量。全球首款MASH新药的标签，并未让Madrigal得到满意的商业回报。2025年8月，诺和诺德宣布司美格鲁肽（Wegovy）获得FDA加速批准用于治疗MASH患者，Rezdiffra一家独大的市场局面被打破。此外，面对GLP-1类药物在减重和代谢改善方面的显著优势，Madrigal的应对策略是“联合”。事实上，在引入Ervogastat之前，公司已于2025年以21亿美元获得了石药集团的口服小分子GLP-1受体激动剂，旨在打造“Rezdiffra + 口服GLP-1”的全口服方案。该策略旨在平衡GLP-1的减重益处与Rezdiffra的抗纤维化及肝脏靶向降脂作用，从而提供更具吸引力的MASH综合治疗选择。与此同时，其他GLP-1相关多靶点药物也在MASH领域取得突破。礼来公布的替尔泊肽（GLP-1/GIP双受体激动剂）II期SYNERGY-NASH研究结果显示，最高剂量组有73.3%的患者实现MASH消退且肝纤维化未恶化，且超过半数患者肝纤维化改善≥1级。勃林格殷格翰旗下的Survodutide（GCGR/GLP-1R双激动剂）也通过双重机制，将GLP-1R激动作用（减少能量摄入）与GCGR激动作用（增加能量消耗）相结合，为改善代谢健康提供了新策略。其II期临床试验显示，高达83.0%的成人患者实现具有统计学意义的MASH显著改善（安慰剂组为18.2%）。除了GLP-1赛道白热化的竞争外，全球MASH研发管线已呈现出多元化态势。甲状腺激素受体β（THR-β）激动剂和成纤维细胞生长因子21（FGF21）类似物等靶点也在快速推进。 Resmetirom的上市已验证了THR-β激动剂路径的可行性。Viking Therapeutics的同靶点口服小分子VK2809进展紧随其后。在IIb期VOYAGE试验中显示，经VK2809治疗52周后，患者肝脏脂肪含量与基线相比平均降低37-55%，且64-88%的患者肝脏脂肪减少≥30%。 FGF21赛道则在2025年因一系列重磅并购成为焦点：葛兰素史克于7月以20亿美元收购波士顿制药，囊获其efimosfermin alfa；罗氏于9月以最高35亿美元收购89bio，获得其II期阶段药物pegozafermin；诺和诺德于10月以52亿美元将Akero Therapeutics及其III期核心产品Efruxifermin（EFX）收入囊中。这些FGF21靶点的临床三期资产均瞄准医疗需求最为迫切的中重度肝纤维化及肝硬化患者群体。视线转回国内，中国药企在MASH领域同样展现出活跃且多元的布局，正大天晴、歌礼制药、民为生物及众生药业等公司均有重点管线的积极进展。其中备受关注的是正大天晴以超3亿美元引进的Inventiva公司口服PPAR激动剂Lanifibranor。该药物不仅是全球首款进入III期研究的口服PPAR激动剂，也是中国首个进入临床III期的MASH口服药物。其研发过程曾遇波折：2024年因一名受试者出现转氨酶严重升高，III期NATiV3研究暂停招募，后于2025年4月重启。此前II期数据显示，经24周治疗，患者肝内甘油三酯（IHTG）含量较基线平均降低44%，显著优于安慰剂组的12%。在THR-β激动剂赛道，国内进度最快的自研药物为歌礼制药的ASC41。其II期临床数据显示，治疗12周后，受试者肝脏脂肪含量相对基线平均降幅高达68.2%，93.3%的患者实现肝脏脂肪含量降低≥30%。此外，患者的ALT与AST水平较基线也分别相对降低32.6%和24.2%。与此同时，国内企业也在探索更前沿的多靶点疗法。民为生物自主研发的MWN105是全球首款进入临床阶段的GLP-1/GIP/FGF21三重激动剂。 2025年12月4日，众生药业自主研发的GLP-1/GIP双受体激动剂RAY1225注射液，新增治疗MASH的适应症临床试验申请也获得国家药监局批准，为国内患者再添一种潜在新选择。总体来看，国内药企通过“引进”与“自研”双轮驱动，已在MASH领域构建了覆盖PPAR激动剂、THR-β激动剂及GLP-1等多靶点创新药物等多个方向的研发格局。小结：辉瑞的“弃药”Ervogastat，在Madrigal的战略版图中找到了新位置，成为其应对GLP-1冲击、加固Rezdiffra市场壁垒的关键拼图。这笔交易不仅折射出一款药物的命运起伏，更预示着MASH治疗领域已全面进入“组合疗法”驱动的新阶段。Madrigal能否凭借其前瞻性的组合策略继续引领市场，值得持续关注。参考资料： 1.https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-expands-its-mash-pipeline-exclusive-global-license 2.辉瑞大砍11条管线！Seagen与GBT收购资产被弃，涉及肿瘤、代谢病......（公众号：药时空） 3.中国Biotech能否借差异化GLP-1管线，撬动MNC的并购胃口？（公众号：研发客） 4.抢滩MASH药物下一站（公众号：氨基观察） 5其他公开资料国内首创！辉诺医药解旋酶-引物酶抑制剂HN0037完成生殖器疱疹II期临床入组 2026-01-12 5000万美元首付款！中晟全肽与诺华达成核药出海合作 2026-01-12 头对头获胜！Ollin/信达新药vs罗氏重磅双抗 2026-01-10 超10亿美元！海思科Newco出海 2026-01-10 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

临床3期引进/卖出siRNA

100 项与 Clesacostat 相关的药物交易

登录后查看更多信息

研发状态

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
纤维化	临床2期	美国	Pfizer Inc.	2020-06-15
纤维化	临床2期	中国	Pfizer Inc.	2020-06-15
纤维化	临床2期	日本	Pfizer Inc.	2020-06-15
纤维化	临床2期	保加利亚	Pfizer Inc.	2020-06-15
纤维化	临床2期	加拿大	Pfizer Inc.	2020-06-15
纤维化	临床2期	中国香港	Pfizer Inc.	2020-06-15
纤维化	临床2期	印度	Pfizer Inc.	2020-06-15
纤维化	临床2期	波兰	Pfizer Inc.	2020-06-15
纤维化	临床2期	斯洛伐克	Pfizer Inc.	2020-06-15
纤维化	临床2期	韩国	Pfizer Inc.	2020-06-15

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


NCT04321031 (MIRNA, CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎 \| 纤维化	256	Placebo	製鬱艱淵鑰衊製淵憲餘(鏇鹹製夢壓鏇憲顧襯餘) = 蓋蓋繭鏇簾糧糧鏇願廠膚選壓蓋範積淵淵鑰夢 (憲憲鹹醖願糧鬱製選鏇, 鏇膚觸獵願壓願鏇夢鹹 ~ 築鑰網範獵淵醖築選顧) 更多	-	2025-03-21
NCT04399538 (CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎	75	Placebo	糧獵鏇餘觸餘鹽構構鏇(淵鬱繭製壓鹽壓膚遞觸) = 鹹顧願夢衊蓋鹽醖夢廠繭繭衊獵齋願觸襯願廠 (願衊鹹積觸積膚鑰構糧, 網觸鏇餘製鹹糧繭鏇鏇 ~ 餘築壓憲遞顧憲築憲憲) 更多	-	2023-04-13
NCT03776175 (CTgov)	临床2期	代谢功能障碍相关的脂肪肝病	99	Placebo	鑰獵衊簾獵壓獵鬱鬱廠(憲選網構衊顧構襯窪壓) = 積鏇鹹鑰觸觸範遞積網鏇選積壓淵廠網廠願艱 (壓鬱鑰繭醖糧淵齋淵繭, 壓鏇餘艱選範齋艱構獵 ~ 鹽蓋鹹窪繭鬱窪壓願壓) 更多	-	2020-09-23
NCT03248882 (CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎	305	Placebo	醖鏇窪顧餘範願壓簾鏇(壓選淵鬱鏇壓網衊蓋憲) = 衊廠鹽網鹽網廠遞網獵觸鹽齋淵憲願願顧鹹願 (繭醖範艱選範糧顧淵艱, 積糧糧壓窪襯繭憲鑰範 ~ 餘鑰鹹網壓窪簾鬱願衊) 更多	-	2020-03-10
NCT03309202 (CTgov)	临床1期	肝功能不全	24	PF-05221304 (Cohort 1 (Without Hepatic Impairment))	選積窪齋憲願簾衊獵繭(鬱繭構繭糧鏇繭構鬱範) = 憲壓蓋遞艱淵蓋衊範範鏇鹹觸齋範鏇艱積構範 (範糧鏇夢廠製製製齋廠, 20) 更多	-	2019-08-08
NCT03309202 (CTgov)	临床1期	肝功能不全	24	PF-05221304 (Cohort 2 (Mild Hepatic Impairment))	選積窪齋憲願簾衊獵繭(鬱繭構繭糧鏇繭構鬱範) = 夢壓壓構選選築願蓋衊鏇鹹觸齋範鏇艱積構範 (範糧鏇夢廠製製製齋廠, 33) 更多	-	2019-08-08