Drugs / Resmetirom
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed metabolic dysfunction-associated steatohepatitis 2 milestones | |||||
| Filed | EU (EMA) | Rezdiffra | metabolic dysfunction-associated steatohepatitis | 2024-03-05 | “In March 2024 , Madrigal announced that the marketing authorization application (MAA) for resmetirom for the treatment of MASH with liver fibrosis was validated” madrigalpharma.com ↗ “On March 5 , announced EMA validation of the Marketing Authorization Application (MAA) for Rezdiffra;” madrigalpharma.com ↗ |
| Filed | US (FDA) | — | metabolic dysfunction-associated steatohepatitis | 2023-06-30 | “initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of resmetirom” madrigalpharma.com ↗ “announced the completion of the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for resmetirom” madrigalpharma.com ↗ “Madrigal announced submission of the NDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis.” madrigalpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved · conditional | EU (EMA) | Rezdiffra | — | 2025-08-18 | europa.eu ↗ |
| Approved | US (FDA) | REZDIFFRA | — | 2024-03-14 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT07830758 | Sep 2026 → Nov 2027 expected | diastolic heart failure, metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07216313 | Sep → Oct 2025 | — | Sagimet Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06397872 | Mar → Sep 2024 | impaired renal function disease | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04671069 | Jul → Aug 2019 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04671056 | Nov → Dec 2018 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04643795 | Oct 2018 → Aug 2021 | cirrhosis of liver, metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03220165 | Aug → Sep 2017 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02749578 | Apr → May 2016 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02542969 | Sep → Oct 2015 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01519531 | Jan → Nov 2012 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01367873 | Jun → Oct 2011 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT07763015 | Aug 2026 → Jul 2029 expected | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07143968 | Apr 2026 → Oct 2027 expected | HIV infectious disease, metabolic dysfunction-associated steatotic liver disease | Naga P. Chalasani | Recruiting | No outcome recorded |
| Phase 2 | NCT03038022 | Feb 2017 → Jan 2018 | familial hypercholesterolemia | Madrigal Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT02912260 | Oct 2016 → Oct 2017 | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04951219 | Jul 2021 → Mar 2027 expected | NAFLD1 | Madrigal Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04197479 | Dec 2019 → Jan 2023 | NAFLD1 | Madrigal Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07680478 | Oct 2026 → Feb 2028 expected | metabolic dysfunction-associated steatohepatitis | City University of New York | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07848191 | Sep 2026 → Nov 2027 expected | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07249788 | Oct 2025 → Oct 2026 expected | metabolic dysfunction-associated steatohepatitis | Nabiqasim Industries (Pvt) Ltd | Recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT03413124 Comparator | Feb 2018 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT07335601 Comparator | Dec 2025 → Aug 2028 expected | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05500222 Comparator | Aug 2022 → Dec 2026 expected | cirrhosis of liver, metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03900429 Comparator | Mar 2019 → Jan 2028 expected | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | Synta Pharmaceuticals Corp. | Results Madrigal Announces Publication in the Journal of Hepatology Demonstrating Consistent Rezdiffra Efficacy Across Common MASH Genetic Risk Variants madrigalpharma.com ↗
The analysis demonstrated that treatment with Rezdiffra resulted in fibrosis improvement, MASH resolution and liver fat and biomarker reductions across patients with several well-established genetic variants associated with MASH progression, including PNPLA3, HSD17B13, TM6SF2, MTARC1 and MBOAT7. |
| 2026-05-27 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Two Posters at EASL 2026 on Denifanstat/Resmetirom Combination in MASH sagimet.com ↗
Combination of denifanstat and resmetirom was generally well-tolerated in Phase 1 clinical trial |
| 2026-05-27 | Synta Pharmaceuticals Corp. | Results Madrigal Presents Data Demonstrating Rezdiffra Reduced Markers of Cardiovascular and Liver-Related Risk in Patients with MASH madrigalpharma.com ↗ |
| 2025-12-18 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Positive Results from the Phase 1 PK Clinical Trial of Denifanstat and Resmetirom Combination sagimet.com ↗
The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. |
| 2025-11-10 | Synta Pharmaceuticals Corp. | Results Madrigal Presents New Data Demonstrating Rezdiffra® (resmetirom) Significantly Improved Multiple Noninvasive Imaging Tests and Biomarkers in Patients with Compensated MASH Cirrhosis madrigalpharma.com ↗
In this open-label analysis, Rezdiffra treatment for two years showed statistically significant improvements from baseline in multiple imaging and biomarker parameters in patients with compensated MASH cirrhosis (n=122; 113 completed two years of treatment). |
| 2025-08-19 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. |
| 2025-06-20 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra™) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today 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. |
| 2025-05-10 | Synta Pharmaceuticals Corp. | Results Madrigal Announces New Clinical Data Demonstrating Rezdiffra™ (resmetirom) Significantly Improved Multiple Noninvasive Tests and Portal Hypertension Risk in Patients with Compensated MASH Cirrhosis madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. |
| 2025-04-29 | Synta Pharmaceuticals Corp. | Results Madrigal to Present Late-Breaking Resmetirom Data in Patients with Compensated MASH Cirrhosis at the EASL Congress madrigalpharma.com ↗
Treatment with resmetirom for up to two years led to improvement in liver stiffness, fibrosis biomarkers, fibrosis scores and portal hypertension risk in 122 patients with compensated MASH cirrhosis. |
| 2025-02-26 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Reports Fourth-Quarter and Full-Year 2024 Financial Results and Announces New Two-Year Data Demonstrating Potential Benefit of Rezdiffra™ (resmetirom) in Patients with Compensated MASH Cirrhosis madrigalpharma.com ↗
Today, we’re sharing new two-year analyses from an active-treatment open-label extension arm of our Phase 3 MAESTRO-NAFLD-1 trial that demonstrate Rezdiffra continues to improve key markers of MASH fibrosis out to two years in patients with compensated MASH cirrhosis (F4c). |
| 2025-02-26 | Synta Pharmaceuticals Corp. | Results Madrigal Announces New Two-Year Data from the Compensated MASH Cirrhosis Arm of the MAESTRO-NAFLD-1 Trial Demonstrating Potential Benefit of Rezdiffra™ (resmetirom) in Patients with Compensated MASH Cirrhosis madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today 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). |
| 2024-09-30 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Announces Publication of Positive Health-Related Quality of Life Results from the Phase 3 MAESTRO-NASH Trial of Rezdiffra™ (resmetirom) madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today 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. |
| 2024-06-06 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Announces New Data from the Phase 3 MAESTRO-NASH Study of Rezdiffra™ (resmetirom) Presented at the EASL Congress madrigalpharma.com ↗ |
| 2024-03-20 | Sinew Pharma Inc. | Regulatory 欣耀生醫針對美國FDA核准 第一個治療代謝功能障礙相關脂肪性肝炎 MASH 藥物之報告及因應措施 sinewpharma.com ↗
近日，美國食品和藥物管理局(FDA)於3月14日批准第一個治療代謝功能障礙相關脂肪性肝炎(Metabolic dysfunction-associated steatohepatitis; MASH)伴有中度至重度肝纖維化(F2/F3)的藥物Rezdiffra (Resmetirom)。 |
| 2024-03-14 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis madrigalpharma.com ↗
Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”) |
| 2024-03-05 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Pharmaceuticals Announces EMA Validation of its Marketing Authorization Application for Resmetirom for the Treatment of NASH/MASH with Liver Fibrosis madrigalpharma.com ↗ |
| 2024-02-08 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Announces Publication of the Phase 3 MAESTRO-NASH Trial of Resmetirom in the New England Journal of Medicine madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis ( NASH ), today announced the publication of the pivotal Phase 3 MAESTRO- NASH trial of resmetirom in the New England Journal of Medicine . |
| 2023-11-10 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Presents New Data from the Phase 3 MAESTRO-NASH Trial Demonstrating Broad Treatment Effects of Resmetirom on Noninvasive Measures of Liver Health madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced new data from the Phase 3 MAESTRO-NASH trial demonstrating broad treatment effects of resmetirom on noninvasive tests that may be used to monitor NASH with liver fibrosis. |
| 2023-09-13 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis madrigalpharma.com ↗ |
| 2023-07-17 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis madrigalpharma.com ↗ |
| 2023-06-30 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis madrigalpharma.com ↗
Madrigal has submitted the majority of the NDA to the FDA and plans to submit the remaining components in July 2023 . |
| 2023-06-22 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Presents Phase 3 MAESTRO-NASH Data During the Opening General Session of the EASL Congress™ madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis ( NASH ), today presents resmetirom Phase 3 MAESTRO- NASH data at the opening general session of the European Association for the Study of the Liver Congress (EASL 2023). |
| 2023-04-18 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Receives Breakthrough Therapy Designation from FDA for Resmetirom and Completes Enrollment of the Phase 3 MAESTRO-NASH Biopsy Trial madrigalpharma.com ↗
The Breakthrough Therapy designation for resmetirom reflects the FDA’s recognition of resmetirom's potential in the treatment of NASH as a serious, life-threatening condition and an important area of investigational drug development. |
| 2023-01-06 | Synta Pharmaceuticals Corp. | Results Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis madrigalpharma.com ↗
New data to be presented at NASH -TAG using a supportive analysis, a "consensus read" by the central pathologists of digitized biopsy images, supplement the positive topline findings and reinforce the strength of results observed in the primary analysis. |
| 2022-12-19 | Synta Pharmaceuticals Corp. | Results Madrigal Announces Positive Topline Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH and Liver Fibrosis madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis ( NASH ), today announced positive topline results from the pivotal Phase 3 MAESTRO- NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. |
| 2022-06-25 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Presents Late-Breaking Phase 3 NASH Data and Multiple Oral Abstracts at EASL’s International Liver Congress™ madrigalpharma.com ↗
Today’s late-breaking presentation at EASL is our first opportunity to share the double-blind results from the MAESTRO-NAFLD-1 safety study in a major scientific meeting. |
| 2022-01-31 | Synta Pharmaceuticals Corp. | Results Positive Topline Phase 3 MAESTRO-NAFLD-1 Data Demonstrate Resmetirom was Safe, Well-Tolerated and Provided Statistically Significant Improvements in Key Measures of Liver and Cardiovascular Health madrigalpharma.com ↗
The 52-week study demonstrated that resmetirom was safe and well-tolerated at 80 and 100 mg once a day dosing. |
| 2021-11-12 | Synta Pharmaceuticals Corp. | Results Positive Resmetirom Data from Completed Open-Label Portion of Phase 3 MAESTRO-NAFLD-1 Clinical Study Presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® Digital Experience 2021 madrigalpharma.com ↗
The positive safety and efficacy findings from the open-label portion of MAESTRO-NAFLD-1 are particularly encouraging as we prepare to report initial topline data from the placebo-controlled double-blind portion of the study by year-end, |
| 2021-06-25 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Announces Presentation of Positive Clinical Data of Resmetirom from Open-Label Portion of Ongoing Phase 3 Clinical Trial MAESTRO-NAFLD-1 at The International Liver Congress™ 2021 madrigalpharma.com ↗
was safe and well-tolerated at 100 mg per day in non-cirrhotic NASH patients treated for 52 weeks; |
| 2020-11-13 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Highlights Presentations at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting November 13, 2020, Including NASH Expert Insights on the Ongoing Open Label Arm of Resmetirom 52-W madrigalpharma.com ↗
At week 16 , MRI-PDFF (magnetic resonance imaging-proton density fat fraction) reduction compared to baseline was 53% overall (p<0.0001) and up to 62% in key subgroups |
| 2020-10-01 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Announces Three Abstracts Accepted by The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting in November 2020, including Positive Data from Ongoing Open Label Arm of Resmetirom 52 W madrigalpharma.com ↗
Data from ongoing MAESTRO-NAFLD-1 open label arm confirm robust liver fat reduction on MRI- PDFF and reduction in liver fibrosis measure d on magnetic resonance elastography ( MRE ) at Week 16 of resmetirom treatment |
| 2020-08-26 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals to Present Secondary Analyses of Data from Phase 2 NASH Study of Resmetirom and Symposium at the Digital International Liver Congress™ 2020 madrigalpharma.com ↗
These findings support the pathogenicity of liver steatosis in NASH and fibrosis progression. |
| 2020-05-07 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Reports 2020 First Quarter Financial Results and Highlights madrigalpharma.com ↗
reductions in liver fat achieved by resmetirom predict NASH resolution and fibrosis improvement. |
| 2020-04-14 | Synta Pharmaceuticals Corp. | Results Madrigal MAESTRO Phase 3 NASH Trials Continue without Protocol Modifications; New Data Demonstrate that Reductions in Liver Fat Achieved by Resmetirom Predict NASH Resolution and Fibrosis Reduction madrigalpharma.com ↗ |
| 2019-11-11 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Announces Publication in The Lancet of Positive Phase 2 Results for Resmetirom (MGL-3196) for the Treatment of Non-alcoholic Steatohepatitis (NASH) madrigalpharma.com ↗
achieved secondary endpoints include statistically significant reduction and resolution of NASH on liver biopsy and statistically significant improvement in multiple noninvasive parameters of NASH and liver fibrosis including fibrosis biomarkers and liver enzymes |
| 2019-11-06 | Synta Pharmaceuticals Corp. | Regulatory Madrigal Pharmaceuticals Reports 2019 Third Quarter Financial Results and Highlights madrigalpharma.com ↗
We are also pleased to announce that FDA has granted Madrigal’s request for Fast Track designation of resmetirom for NASH. |
| 2019-04-08 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals to Present Additional Analyses of Data from The Phase 2 NASH Study with MGL-3196 (resmetirom) at The International Liver Congress™ 2019 madrigalpharma.com ↗
MRI-PDFF response (≥30% reduction in hepatic fat) at 12 weeks correlated with reduction in the ballooning and inflammation components of NAS and was predictive of NASH resolution on liver biopsy at 36 weeks |
| 2018-11-12 | Synta Pharmaceuticals Corp. | Results Phase 2 Results for Madrigal’s MGL-3196 in Non-Alcoholic Steatohepatitis (NASH) Presented during Presidential Plenary Clinical Session of The Liver Meeting® 2018 madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced the oral presentation of statistically significant results from a double-blind, placebo-controlled 36-week Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis ( NASH ). |
| 2018-05-31 | Synta Pharmaceuticals Corp. | Results Madrigal’s MGL-3196 Achieves Liver Biopsy Endpoints in Patients with Non-alcoholic Steatohepatitis (NASH) at 36 Weeks in Phase 2 Clinical Trial madrigalpharma.com ↗
Madrigal Pharmaceuticals, Inc. (Nasdaq:MDGL) today announced positive top-line, 36-week results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis ( NASH ). |
| 2018-02-08 | Synta Pharmaceuticals Corp. | Results Madrigal’s MGL-3196 Achieves Primary Endpoint in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) madrigalpharma.com ↗
Madrigal Pharmaceuticals , Inc. (NASDAQ:MDGL) today announced positive results from a double-blind, placebo-controlled, multi-center, 12-week Phase 2 clinical trial in patients with heterozygous familial hypercholesterolemia (HeFH), a severe genetic dyslipidemia that causes early onset cardiovascular disease. |
| 2017-12-06 | Synta Pharmaceuticals Corp. | Results Madrigal’s MGL-3196 Achieves Primary Endpoint in Patients with Biopsy-proven Non-alcoholic Steatohepatitis (NASH) in Phase 2 Clinical Trial madrigalpharma.com ↗
In this trial, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) β -selective agonist, demonstrated statistically significant results for the primary endpoint, the percent change in hepatic fat versus placebo as measured by MRI-PDFF, a non-invasive imaging test. |
| 2017-10-23 | Synta Pharmaceuticals Corp. | Results Madrigal Pharmaceuticals Presents Preclinical Results Supporting the Therapeutic Potential of its Lead β-Selective Thyroid Hormone Receptor Agonist, MGL-3196, at AASLD Liver Meeting madrigalpharma.com ↗
Results Demonstrate that MGL-3196 Provides Metabolic, Anti-inflammatory and Anti-fibrotic Benefits in a Long-term, High Fat Diet, Mouse NASH Model |
All press releases naming this drug 70 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | resmetirom | “Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and...” PMID 31727409 ↗ Nov 201913“Resmetirom (MGL-3196) in Patients With Heterozygous Familial Hypercholesterolemia.” PMID 35331419 ↗ Mar 2022 “Resmetirom - weight-based dosing:” NCT07848191 ↗ |
| Known as | MGL-3196 | “Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and...” PMID 31727409 ↗ Nov 201912“Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or...” NCT07335601 ↗ “A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension...” NCT04951219 ↗ “Resmetirom (MGL-3196) : Oral resmetirom administered once daily.” NCT07763015 ↗ |
| Known as | Rezdiffra | “To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)” NCT07848191 ↗ |
| Known as | VIA-3196 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01519531 ↗ |
| Action | Activate | “Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and...” PMID 31727409 ↗ Nov 2019 |
| Modality | Small molecule | — CHEMBL3261331 ↗ |
| Route | Oral | “Oral, capsule(s)” NCT01367873 ↗ |
| Target | THRB | “thyroid hormone receptor-β selective agonist” PMID 37786277 ↗ Oct 2023 |