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RESMETIROM
Resmetirom is a marketed drug primarily indicated for Noncirrhotic Nonalcoholic Steatohepatitis (NASH), positioning it in a growing therapeutic area with significant unmet need. A key strength of Resmetirom is its unique mechanism of action, which differentiates it from other treatments in the NASH market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | RESMETIROM |
|---|---|
| Drug class | Thyroid Hormone Receptor beta Agonist [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2024 |
Approved indications
- Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Common side effects
- Diarrhea
- Nausea
- Pruritus
- Vomiting
- Constipation
- Abdominal pain
- Dizziness
Drug interactions
- Strong CYP2C8 Inhibitors (e.g., gemfibrozil)
- Moderate CYP2C8 Inhibitors (e.g., clopidogrel)
- Atorvastatin
- Pravastatin
- Rosuvastatin
- Simvastatin
- CYP2C8 Substrates
Key clinical trials
- A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV (PHASE2)
- A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants (PHASE1)
- Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH (PHASE2)
- Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) (PHASE2)
- Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) (PHASE2)
- Resmiterom Efficacy & Safety in Patients With MASH (PHASE4)
- A 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 (PHASE1)
- 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 (MAESTRO-NAFLD-OLE) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |