NDAORALTABLETPriority Review
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
REZDIFFRA (resmetirom) by Madrigal Pharmaceuticals is thyroid hormone receptor beta agonists [moa]. First approved in 2024.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REZDIFFRA (resmetirom) is an oral thyroid hormone receptor beta (THR-β) agonist approved by the FDA on March 14, 2024. It selectively activates THR-β to modulate metabolic and hepatic function. The exact indication(s) have not been disclosed in available data but align with THR-β agonist therapeutic potential in metabolic disease.
Growth18.6 years to LOE
Early-stage product in growth phase with minimal competitive pressure, indicating opportunity for team expansion and market development roles.
Mechanism of Action
Thyroid Hormone Receptor beta Agonists
Pharmacologic Class:
Thyroid Hormone Receptor beta Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Rezdiffra Pregnancy and Lactation Registry
Started Mar 2026
10 enrolled
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
Started Dec 2025
120 enrolled
MASH - Metabolic Dysfunction-Associated Steatohepatitis
A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants
Started Sep 2025
40 enrolled
Healthy
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
Started Mar 2024
28 enrolled
Renal Impairment
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
Started Aug 2022
845 enrolled
NASHCirrhosis, Liver
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.