Drugs / Resmetirom
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Rezdiffra | — | 2025-08-18 | europa.eu ↗ |
| Approved | US (FDA) | REZDIFFRA | — | 2024-03-14 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| 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 23 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT02912260 | Oct 2016 → Oct 2017 | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| 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 | No outcome recorded |
| Phase 42 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 | NCT07249788 | Oct 2025 → Oct 2026 expected | metabolic dysfunction-associated steatohepatitis | Nabiqasim Industries (Pvt) Ltd | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03413124 Comparator | Feb 2018 | — | Madrigal Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07335601 Comparator | Dec 2025 → Aug 2028 expected | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| 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 |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 24 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 201910“Resmetirom (MGL-3196) in Patients With Heterozygous Familial Hypercholesterolemia.” PMID 35331419 ↗ Mar 2022 |
| 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 201911“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 ↗ |
| Known as | Rezdiffra | ChEMBL registry synonym — accepted as the source's own label CHEMBL3261331 ↗ |
| Known as | VIA-3196 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01367873 ↗ |
| 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 |