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.

Start Date05 Mar 2024

Sponsor / Collaborator

Madrigal Pharmaceuticals, Inc.

NCT05500222

/ RecruitingPhase 3

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.

Start Date26 Aug 2022

Sponsor / Collaborator

Madrigal Pharmaceuticals, Inc.

NCT04951219

/ RecruitingPhase 3

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)

Start Date09 Jul 2021

Sponsor / Collaborator

Madrigal Pharmaceuticals, Inc.

100 Clinical Results associated with Resmetirom

100 Translational Medicine associated with Resmetirom

100 Patents (Medical) associated with Resmetirom

179

Literatures (Medical) associated with Resmetirom

01 Apr 2025·Diabetes, Obesity and Metabolism

Hepatic thyroid hormone receptor‐β signalling: Mechanisms and recent advancements in the treatment of metabolic dysfunction‐associated steatohepatitis

Review

Author: Targher, Giovanni ; Polyzos, Stergios A.

AbstractThe pharmacotherapy of metabolic dysfunction‐associated steatotic liver disease (MASLD) and its progressive form, the metabolic dysfunction‐associated steatohepatitis (MASH), remains a hot topic in research and a largely unmet need in clinical practice. As the first approval of a disease‐specific drug, resmetirom, was regarded as a milestone for the management of this common liver disease, this comprehensive and updated review aimed to highlight the importance of the hepatic thyroid hormone (TH) receptor (THR)‐β signalling for the treatment of MASH, with a special focus on resmetirom. First, the genomic and non‐genomic actions of the liver‐directed THR‐β mediated mechanisms are summarized. THR‐β has a key role in hepatic lipid and carbohydrate metabolism; disruption of THR‐β signalling leads to dysmetabolism, thus promoting MASLD and possibly its progression to MASH and cirrhosis. In the clinical setting, this is translated into a significant association between primary hypothyroidism and MASLD, as confirmed by recent meta‐analyses. An association between MASLD and subclinical intrahepatic hypothyroidism (i.e. a state of relatively low hepatic triiodothyronine concentrations, with circulating TH concentrations within the normal range) is also emerging and under investigation. In line with this, the favourable results of the phase 3 placebo‐controlled MAESTRO trials led to the recent conditional approval of resmetirom by the US FDA for treating adults with MASH and moderate‐to‐advanced fibrosis. This conditional approval of resmetirom opened a new window to the management of this common and burdensome liver disease, thus bringing the global scientific community in front of new perspectives and challenges.

01 Apr 2025·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

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

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.

01 Apr 2025·Liver International

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

Article

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

ABSTRACTBackground and AimsSeveral scientific associations recommend a sequential combination of non‐invasive tests (NITs) to identify high‐risk MASLD patients but their cost‐effectiveness is unknown.MethodsA 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.ResultsAll 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.ConclusionsScreening for high‐risk MASLD is cost‐effective according to recent guidelines. Implementing these screening strategies in primary care should be considered.

253

News (Medical) associated with Resmetirom

18 Mar 2025

·www.prnewswire.com

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

13 Mar 2025

·www.prnewswire.com

Unveiling Pharma Market Potential: DelveInsight's Strategic Insights into the Rapidly Expanding MASH Landscape in Asia

A case study on how DelveInsight helped a pharma client navigate the evolving metabolic dysfunction-associated steatohepatitis (MASH) landscape with actionable market intelligence LAS VEGAS, March 13, 2025 /PRNewswire/ -- DelveInsight recently conducted an in-depth MASH Market Size and Share Assessment to help a pharmaceutical client understand the evolving Metabolic Dysfunction-Associated Steatohepatitis (MASH) market in key Asian countries. Formerly known as Non-Alcoholic Steatohepatitis (NASH), MASH was officially renamed in 2023 by leading liver disease authorities, including the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), to reflect its metabolic origins better. The client sought to evaluate MASH prevalence, MASH patient burden, existing and emerging therapies for MASH, and market entry feasibility in China, India, Japan, South Korea, and Southeast Asian nations. Understanding MASH grade- and severity-specific patient pools, treatment adoption, and competitive dynamics was crucial to shaping their market entry and product positioning strategy. With decades of expertise in Pharma Market Assessments, DelveInsight employed rigorous epidemiological research, competitive intelligence, and strategic forecasting to equip the client with actionable insights. Our comprehensive analysis provided a clear picture of MASH treatment trends, market gaps, and the potential opportunities for innovative therapies. MASH is a rising global health concern, particularly in Asia, where factors such as ethnicity, obesity, and metabolic syndrome contribute to high prevalence rates. According to DelveInsight, there were approximately 42 million prevalent cases of MASH in the 7MM (US, EU5, and Japan) in 2023, with 15 million diagnosed cases, a figure projected to increase significantly by 2034. In Asia, MASH prevalence varies significantly between rural and urban populations. Japan accounted for 2.5 million diagnosed cases in 2023, while India exhibited a higher prevalence in urban areas (17–25%) compared to rural regions (10%). Other Southeast Asian countries, such as Sri Lanka, Malaysia, and Singapore, show prevalence rates ranging from 5% to 35%. Additionally, in South Korea, obesity and abdominal obesity rates reached 36% and 24%, respectively, highlighting a growing risk factor for MASH. Currently, only one drug is approved for MASH treatment . On March 14, 2024, the FDA approved REZDIFFRA for NASH patients with moderate to severe fibrosis (F2-F3), setting a new benchmark for efficacy and safety. Its acceptance is expected to accelerate future NASH treatments, with clinical trials likely expanding to Southeast Asia. Beyond Rezdiffra, several companies are advancing therapies in the pipeline, including I nventiva Pharma, Novo Nordisk, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim/Zealand Pharma, Galectin Therapeutics, Viking Therapeutics, Eli Lilly, Pfizer, Merck & Co./Hanmi Pharmaceutical, Gilead Sciences, and others. For the latest insights, explore DelveInsight's updated MASH Market Report . A data-driven Market Size and Share Assessment is vital for strategic decision-making in today's competitive pharmaceutical landscape. DelveInsight's market analysis helps companies identify target patient populations, assess treatment landscapes, and analyze emerging therapies to uncover growth opportunities. DelveInsight enables pharmaceutical firms to make informed decisions, optimize strategies, and secure a strong market presence by providing market forecasting, adoption trends, and competitive positioning insights. With MASH gaining attention as a high-burden disease with significant unmet needs, understanding market dynamics is critical for companies looking to make a meaningful impact. DelveInsight's Data-Driven Market Assessment Methodology for Unlocking MASH Opportunities To help our client navigate the MASH market, DelveInsight employed a multifaceted research and strategic analysis approach, combining epidemiological insights, competitive intelligence, and market forecasting. Our methodology included the following key steps: Market Dynamics Evaluation – The current MASH treatment landscape was analyzed across each target country, assessing market share data for existing therapies and forecasting the adoption of treatments in development. Competitor Analysis & Market Entry Assessment – An in-depth competitor landscape study was conducted, identifying key companies developing MASH drugs and evaluating the feasibility of market entry in each region. Strategic Product Positioning – To differentiate the client's product in a symptom-management-dominated market, a treatment-based approach was emphasized, ensuring better alignment with healthcare providers and patient needs. Grade-Specific Patient Focus – Based on the client's request, research was prioritized on grade-specific patient populations, offering targeted recommendations by understanding disease progression and unmet needs at different stages. Strategic Outcomes of DelveInsight's Market Size and Share Assessment for MASH By integrating rigorous data analysis with strategic insights, DelveInsight provided the client with a clear, actionable roadmap for market entry, competitive positioning, and long-term success in the evolving MASH market. DelveInsight's rigorous epidemiological research provided the client with a detailed assessment of the MASH (formerly NASH) burden across key Asian markets. By analyzing prevalence data across different disease grades and severity levels, we equipped the client with actionable insights into the target patient population, enabling informed strategic planning. Our market dynamics evaluation gave the client a comprehensive view of the existing treatment landscape, including market share insights and future adoption forecasts for emerging therapies. This allowed the client to identify growth opportunities, optimize product positioning, and make data-driven market entry decisions. Through competitive intelligence and feasibility assessments, we pinpointed key players and potential market entry barriers in each target country. These insights helped the client anticipate challenges, refine market penetration strategies, and gain a competitive edge. By prioritizing grade-specific patient segmentation, we provided tailored recommendations, helping the client better understand patient needs at various disease stages. This enabled them to align their strategy with real-world clinical and commercial dynamics, ultimately strengthening their position in the evolving MASH market. Curious about how the MASH landscape is evolving? Let DelveInsight be your guide . Get in touch today for expert insights and strategic solutions! Market Size and Share Assessment Services: DelveInsight provides a 360-degree market landscape analysis, delivering 10-year epidemiology-driven market forecasts. Our expertise offers precise insights into emerging therapies' current and projected market share, helping stakeholders navigate evolving treatment landscapes. By integrating epidemiology-based models, emerging trends, competitive dynamics, and unmet needs, we empower businesses to craft data-driven strategies and identify lucrative opportunities. Whether it's pipeline analysis, pricing strategies, epidemiology-driven forecasting, or competitive benchmarking, DelveInsight delivers actionable intelligence tailored to your strategic goals. Competitive Intelligence Services Tailored to Gastroenterology Domain: DelveInsight's competitive intelligence services deliver real-time, precise insights across therapeutic domains, with gastroenterology being one of our key areas of expertise. We provide in-depth analysis of advancements across both prevalent and rare conditions, including MASH, Primary Sclerosing Cholangitis, Ulcerative Colitis, and Barrett's Esophagus. Our services track competitor pipelines, clinical trial progress, regulatory shifts, and patent landscapes, offering a comprehensive view of the evolving gastroenterology market. By leveraging these insights, stakeholders can identify emerging threats, seize growth opportunities, and craft strategic moves to stay ahead in this dynamic space. Conference Coverage Services: DelveInsight's Conference Coverage Services offer a thorough analysis of outcomes from major gastroenterology events like WCOG, Euro-Global Gastroenterology Conference, ICGH, ICGDD, and ICCGVG. This detailed examination provides businesses with essential insights for competitive intelligence and market trend forecasting, supporting the formulation of future strategies. R&D Analysis: DelveInsight's skilled research and development analyst specializes in the complexities of different indications, offering essential insights and advice to clients aiming to advance in research and development. They utilize a methodical assessment approach, aligned with industry norms, to track the progress of each drug in both pre-clinical and clinical stages. DelveInsight's comprehensive reports are crafted to reduce uncertainties and highlight overlooked areas, providing organizations with timely and strategic intelligence. Why Choose DelveInsight? DelveInsight's Market Assessment Services provide data-driven insights and competitive intelligence to help pharmaceutical companies navigate evolving market landscapes. With 10-year forecasts, drug uptake analysis, competitive benchmarking, and customized market evaluations, we deliver precise projections for both emerging and established markets. Our expertise in epidemiology modeling, primary intelligence, and data analytics ensures clients gain a clear, strategic understanding of their therapy's potential and competitive positioning. Covering the 7MM region and beyond, DelveInsight equips stakeholders with actionable intelligence to drive informed decision-making and commercial success. Get in touch today to leverage our expertise and stay ahead in the competitive market! Contact us for a personalized consultation. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

11 Mar 2025

·ir.madrigalpharma.com

Madrigal Appoints Jacqualyn A. Fouse, Ph.D. to Its Board of Directors

Fred Craves, Ph.D. to retire from Madrigal’s Board of Directors in July 2025 CONSHOHOCKEN, Pa., March 11, 2025 (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 Jacqualyn (“Jackie”) Fouse, Ph.D. to its Board of Directors. Fred Craves, Ph.D. is retiring from the Board in July 2025. Julian Baker, Chairman of the Board of Directors, stated, “I am delighted to welcome Jackie Fouse to Madrigal. Jackie is an accomplished biotech executive who brings more than 30 years of healthcare industry and finance experience to the Madrigal Board. She will be a tremendous asset for Madrigal as the Company continues to grow and evolve.” Mr. Baker continued, “On behalf of the Board, I would like to thank Fred Craves for his many years of service to Madrigal. From the outset of the Company through today, Fred’s leadership has been an invaluable part of Madrigal’s success.” Bill Sibold, Chief Executive Officer of Madrigal, added, “Jackie Fouse’s appointment to our Board of Directors reflects Madrigal’s commitment to long-term leadership in MASH. I look forward to working with her to drive the launch of Rezdiffra, expand geographically, advance our clinical program in compensated MASH cirrhosis, and build our pipeline. I’d also like to thank Fred Craves for the instrumental role he has played at Madrigal for more than 15 years.” Dr. Fouse was previously Chief Executive Officer of Agios Pharmaceuticals from 2019 to 2022 and currently serves as the Chair of the Board of Agios. Prior to joining Agios, she served in executive leadership roles at Celgene Corporation including President and Chief Operating Officer, President, Global Hematology & Oncology, and Chief Financial Officer. Before joining Celgene, Dr. Fouse served as chief financial officer of Bunge Limited, a leading global agribusiness and food company. Prior to Bunge, she served as Senior Vice President, Chief Financial Officer, and Head of Corporate Strategy at Alcon Laboratories, a leading ophthalmic pharmaceutical and medical device company. Prior to her tenure with Alcon, she held a variety of senior leadership roles with international companies. Dr. Fouse earned her B.A. and M.A. in economics and a Ph.D. in finance from the University of Texas at Arlington. She also holds an M.S. in environmental management from Yale and an M.S. in wildlife forensics and conservation from the University of Florida. Dr. Fouse stated, “I am thrilled to be joining the Board of Directors of Madrigal, a company that has transformed care for patients with MASH. After years of challenges and setbacks in MASH drug development, Madrigal broke through with the first approved treatment, and the early launch of Rezdiffra has demonstrated the compelling benefit that this innovative medicine represents for patients. I look forward to working with this team that has successfully developed and launched Rezdiffra to deliver on Madrigal’s growth objectives in the years ahead.” 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 is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c). For more information, visit www.madrigalpharma.com. 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 the launch of Rezdiffra and its expected use for treating MASH with moderate to advanced fibrosis, Madrigal’s aspirations to be the leading company in the MASH sector, and Madrigal’s plans to expand to Europe. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; our history of operating losses and the possibility that we 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 Madrigal’s 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; enrollment and trial conclusion uncertainties; market demand for and acceptance of Rezdiffra; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive trials; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the timing and outcomes of clinical trials of Rezdiffra (resmetirom); 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 our business and our 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. 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 submissions 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, 2024, filed with the SEC on February 26, 2025, and as updated from time to time by Madrigal’s other filings with the SEC. Investor Contact Tina Ventura, IR@madrigalpharma.com Media Contact Christopher Frates, media@madrigalpharma.com Source: Madrigal Pharmaceuticals, Inc.

Phase 3Executive ChangeDrug Approval

100 Deals associated with Resmetirom

External Link

KEGG	Wiki	ATC	Drug Bank
D11602	-	-	DB12914

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Fibrosis, Liver	United States	Madrigal Pharmaceuticals, Inc.	14 Mar 2024
Nonalcoholic Steatohepatitis	United States	Madrigal Pharmaceuticals, Inc.	14 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	NDA/BLA	European Union	Madrigal Pharmaceuticals, Inc.	05 Mar 2024
liver function failure	Phase 3	Spain	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Hungary	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Australia	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Switzerland	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Mexico	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Canada	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Germany	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Italy	Madrigal Pharmaceuticals, Inc.	28 Mar 2019
liver function failure	Phase 3	Poland	Madrigal Pharmaceuticals, Inc.	28 Mar 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03900429 (MAESTRO-NASH, UEGW2024)	Phase 3	Nonalcoholic Steatohepatitis Carbohydrate Deficient Transferrin (CDT) \| PEth test	966	Resmetirom 80 mg	xkshkdtqyr(zdcliunxgu) = pjqjctvhrg uqwhyshhis (lyogdyleym ) View more	Positive	13 Oct 2024
				Resmetirom 100 mg	xkshkdtqyr(zdcliunxgu) = gsepbzncjn uqwhyshhis (lyogdyleym ) View more
UEGW2024	Not Applicable	Nonalcoholic Steatohepatitis	-	Resmetirom 80 mg	(rybbndnstl) = aebhfxydbk lpjcpvysrq (plbkhcrpvi, 4.61)	-	13 Oct 2024
				Resmetirom 100 mg	(rybbndnstl) = nwgaxtaxri lpjcpvysrq (plbkhcrpvi, 4.76)
NCT03900429 (MAESTRO-NASH, UEGW2024)	Phase 3	Nonalcoholic Steatohepatitis	966	Resmetirom 80 mg	fbdwjqimvh(afldevasfp) = mpwxrtmvwu vifgzznuew (aedsqzhzxw ) View more	Positive	13 Oct 2024
				Resmetirom 100 mg	fbdwjqimvh(afldevasfp) = arkkhkpfkd vifgzznuew (aedsqzhzxw ) View more
NCT03900429 (MAESTRO-NASH, UEGW2024)	Phase 3	FibroScan CAP \| Fibroscan VCTE \| alanine aminotransferase (ALT)	966	Resmetirom 80 mg	diezipoeyz(ldqgjxivnt) = zilwufcwmm pydgdjstvi (pwbokakxys, 6.8)	Positive	13 Oct 2024
				Resmetirom 100 mg	diezipoeyz(ldqgjxivnt) = chkcddejej pydgdjstvi (pwbokakxys, 7.1)
ADA2024	Not Applicable	Obesity	-	Semaglutide	(citlrhbuun) = fsqlacrfit qtdeqhmgsy (iyrjnelefw )	-	14 Jun 2024
				Resmetirom	(citlrhbuun) = ygcdtmoteq qtdeqhmgsy (iyrjnelefw )
NCT03900429 (MAESTRO-NASH, Pubmed) Manual	Phase 3	Nonalcoholic Steatohepatitis	966	Resmetirom 80 mg	(hwmkuodxay) = gwgtjvprdq ynbcasedge (ogujqdwyuj ) View more	Positive	08 Feb 2024
				Resmetirom 100 mg	(hwmkuodxay) = nkpmbtewwa ynbcasedge (ogujqdwyuj ) View more
NCT03900429 (MAESTRO-NASH, GlobeNewswire) Manual	Phase 3	Nonalcoholic Steatohepatitis	-	Resmetirom 100 mg	(srlznbyjsw) = tkyauqiqzr ordwfvppep (hjapbquwho ) View more	Positive	10 Nov 2023
NCT03900429 (MAESTRO-NASH, UEGW2023)	Phase 3	Nonalcoholic Steatohepatitis liver stiffness \| hepatic fat \| nonalcoholic fatty liver disease activity score (NAS)	966	Resmetirom 80 mg	(asagihxsmx) = mbczmnndtb jjzidthqst (hdxznbabhl ) View more	Positive	15 Oct 2023
				Resmetirom 100 mg	(asagihxsmx) = tigletzkei jjzidthqst (hdxznbabhl ) View more
NCT04197479 (MAESTRO-NAFLD-1, EASL2022)	Phase 3	Metabolic dysfunction-associated steatotic liver disease	-	Resmetirom	(inamjkuxyt) = edsyssmtpg byvijnxysh (wvhhscispp ) View more	Positive	25 Jun 2022
				Placebo	(inamjkuxyt) = hgtyqctqvm byvijnxysh (wvhhscispp ) View more
NCT04197479 (MAESTRO-NAFLD-1, EASL2022)	Phase 3	Metabolic dysfunction-associated steatotic liver disease	-	Resmetirom 80 mg	dbeeavdubv(jqwrgrhemg) = pvbiqretwh jtxyktwpxx (fdxovmdqxe ) View more	-	25 Jun 2022
				Resmetirom 100 mg	dbeeavdubv(jqwrgrhemg) = denttuxjpj jtxyktwpxx (fdxovmdqxe ) View more

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