Regulatory Sources
U.S. Food and Drug Administration — REZDIFFRA
The FDA prescribing information provides the U.S. indication, dosage, warnings, interactions, adverse reactions and pharmacology.
European Medicines Agency — Rezdiffra
The EMA EPAR provides EU authorization information, clinical assessment, indication and safety information.
Clinical evidence
FDA’s Drug Trials Snapshot summarizes the principal trial population supporting the original U.S. approval.
ClinicalTrials.gov provides records for ongoing resmetirom research, including MAESTRO-NASH-OUTCOMES.
Scientific literature
The pivotal phase 3 resmetirom study was published in the New England Journal of Medicine in 2024.
Development history
Public corporate and scientific records describe the development of MGL-3196/resmetirom and Madrigal’s acquisition of the relevant rights from VIA.
Resiliva-specific documentation
Manufacturer, authorization, packaging and product-specific regulatory information for Resiliva are Everest Pharmaceuticals Ltd.