This section highlights FDA-related milestones and regulatory updates for drugs developed by Madrigal Pharmaceuticals (MDGL).
Over the past two years, Madrigal Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Resmetirom and Resmetirom. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Resmetirom (MAESTRO-NAFLD-1) - FDA Regulatory Timeline and Events
Resmetirom (MAESTRO-NAFLD-1) is a drug developed by Madrigal Pharmaceuticals for the following indication: Nonalcoholic steatohepatitis (NASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Resmetirom (MAESTRO-NAFLD-1)
- Announced Date:
- May 10, 2025
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Madrigal Pharmaceuticals, Inc announced positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients (n=122) in the study achieved significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension (CSPH).
AI Summary
Madrigal Pharmaceuticals, Inc. announced positive two-year outcomes from the open-label compensated MASH cirrhosis (F4c) arm of its Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. In this study involving 122 patients with metabolic dysfunction-associated steatohepatitis (MASH), participants showed significant improvements compared to baseline. These improvements included reduced liver stiffness, less liver fat, better fibrosis biomarker profiles, decreased liver volume, and lower risk scores for clinically significant portal hypertension (CSPH). Notably, patients experienced an average reduction of 6.7 kPa in liver stiffness, and 65% of those with CSPH at baseline moved to lower risk categories by the end of two years.
The outcomes underline the promise of Rezdiffra as a treatment option for patients with compensated MASH cirrhosis. However, further placebo-controlled studies are needed to confirm these encouraging findings.
Read Announcement- Drug:
- Resmetirom (MAESTRO-NAFLD-1)
- Announced Date:
- February 26, 2025
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Madrigal Pharmaceuticals, Inc reported positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra (resmetirom)..
AI Summary
Madrigal Pharmaceuticals released positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of its Phase 3 MAESTRO-NAFLD-1 trial for Rezdiffra (resmetirom). The study showed that patients experienced a mean reduction of 6.7 kPa in liver stiffness from a baseline of 25 kPa, marking the largest improvement reported so far in this patient group. Additionally, 51% of the patients achieved at least a 25% improvement in liver stiffness, a change associated with reduced risk of progressing to end-stage liver disease. Experts noted that such significant decreases may indicate patients are moving into a lower risk category for liver-related complications. These promising results support further investigation in Madrigal’s ongoing Phase 3 MAESTRO-NASH OUTCOMES trial, aiming to evaluate Rezdiffra’s safety and efficacy in patients with compensated MASH cirrhosis.
Read Announcement
Resmetirom (MAESTRO-NASH) - FDA Regulatory Timeline and Events
Resmetirom (MAESTRO-NASH) is a drug developed by Madrigal Pharmaceuticals for the following indication: Non-alcoholic steatohepatitis (NASH) and liver fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Resmetirom (MAESTRO-NASH)
- Announced Date:
- June 20, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH) and liver fibrosis
Announcement
Madrigal Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of resmetirom (Rezdiffra) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
AI Summary
Madrigal Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of resmetirom (Rezdiffra) for adults with noncirrhotic MASH and moderate to advanced liver fibrosis. This recommendation followed the successful results of the pivotal Phase 3 MAESTRO-NASH trial, which met both primary endpoints of fibrosis reduction and MASH resolution. The positive opinion suggests resmetirom could soon become the first medication available in the European Union to treat MASH in this patient population. The European Commission is expected to make a final decision by August 2025. Madrigal’s CEO highlighted the significance of this milestone, describing it as another historic first in addressing the urgent need for effective, liver-directed therapies against MASH, a growing cause of liver-related complications in Europe.
Read Announcement- Drug:
- Resmetirom (MAESTRO-NASH)
- Announced Date:
- September 30, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) and liver fibrosis
Announcement
Madrigal Pharmaceuticals, Inc announced the publication of positive patient-reported outcomes data demonstrating Rezdiffra (resmetirom) improved health-related quality of life (HRQL) in patients with NASH with moderate to advanced fibrosis.
AI Summary
Madrigal Pharmaceuticals recently announced encouraging new results from a study showing that their drug Rezdiffra (resmetirom) significantly improves health-related quality of life (HRQL) in patients with NASH and moderate to advanced fibrosis. The patient-reported outcomes data, published in Hepatology, revealed that treatment with Rezdiffra led to meaningful improvements in emotional well-being and reduced health distress. Notably, patients reported less worry, lower health distress, and decreased feelings of stigma, especially among those who showed biopsy-confirmed improvements in liver fibrosis or resolution of NASH. The data also confirmed that the positive outcomes were achieved without any worsening of HRQL due to side effects. This study highlights Rezdiffra’s benefits in easing the emotional and physical burden of NASH, adding valuable evidence to its role in enhancing patients’ overall well-being.
Read Announcement- Drug:
- Resmetirom (MAESTRO-NASH)
- Announced Date:
- June 6, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) and liver fibrosis
Announcement
Madrigal Pharmaceuticals, Inc announced results from new analyses of the Phase 3 MAESTRO-NASH trial of Rezdiffra being presented at the EASL Congress, which takes place from June 5-8, 2024 in Milan, Italy.
AI Summary
Madrigal Pharmaceuticals, Inc. announced new analyses from the Phase 3 MAESTRO-NASH trial of Rezdiffra that will be presented at the EASL Congress in Milan, Italy from June 5-8, 2024. Using an innovative AI-driven methodology called qFibrosis, the company’s research shows that Rezdiffra significantly improved key fibrotic features in liver biopsy data. These improvements are important because they may predict a lower risk of progression to decompensated cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and moderate to advanced liver fibrosis. The data also confirmed durable benefits, including marked improvements in liver stiffness and quality of life measures over a three-year period. This analysis reinforces the potential of Rezdiffra as a foundational therapy for NASH, highlighting its role in halting or reversing liver fibrosis in this challenging patient population.
Read Announcement- Drug:
- Resmetirom (MAESTRO-NASH)
- Announced Date:
- May 29, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) and liver fibrosis
Announcement
Madrigal Pharmaceuticals, Inc announced ten data presentations at the upcoming European Association for the Study of the Liver (EASL) Congress, taking place from June 5-8, 2024 in Milan, Italy.
AI Summary
Madrigal Pharmaceuticals, Inc. announced it will present ten data presentations at the upcoming European Association for the Study of the Liver (EASL) Congress. The event will take place in Milan, Italy from June 5-8, 2024. These sessions will share new insights from the MAESTRO Phase 3 study of its drug, Rezdiffra, which is used to treat nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
According to CEO Bill Sibold, the presentations will include key analyses such as quality of life assessments, noninvasive test results, and initial data on Rezdiffra in patients with metabolic dysfunction and alcohol-associated liver disease. Additional data will explore the real-world impact of uncontrolled NASH on patients and the healthcare system. This focus highlights Madrigal’s commitment to advancing the treatment of NASH and addressing its significant human and economic challenges.
Read Announcement- Drug:
- Resmetirom (MAESTRO-NASH)
- Announced Date:
- April 9, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) and liver fibrosis
Announcement
Madrigal Pharmaceuticals, Inc announced that Rezdiffra (resmetirom) is now available in the U.S. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)
AI Summary
Madrigal Pharmaceuticals, Inc. announced that Rezdiffra (resmetirom) is now available in the U.S. This once-daily, oral medication is the first FDA-approved therapy specifically indicated to treat adults with noncirrhotic nonalcoholic steatohepatitis (NASH) who have moderate to advanced liver fibrosis (stages F2 to F3). Used alongside diet and exercise, Rezdiffra offers a new treatment option for a condition that has long had limited therapies. The drug’s approval is based on results from a blinded Phase 3 trial, and its availability marks a significant milestone for patients and healthcare providers managing NASH. Patients can now receive Rezdiffra through Madrigal’s specialty pharmacy network, reflecting the company’s commitment to improving patient care and establishing new pathways for treatment in this difficult-to-treat liver disease.
Read Announcement
