REZDIFFRA

Growth

resmetirom

NDAORALTABLETPriority Review
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
7

Mechanism of Action

Thyroid Hormone Receptor beta Agonists

Pharmacologic Class:

Thyroid Hormone Receptor beta Agonist

Clinical Trials (5)

NCT07335601Phase 2Active Not Recruiting

Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH

Started Dec 2025
120 enrolled
MASH - Metabolic Dysfunction-Associated Steatohepatitis
NCT07216313Phase 1Completed

A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants

Started Sep 2025
NCT06397872Phase 1Completed

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
NCT05500222Phase 3Active Not Recruiting

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
700 enrolled
NASHCirrhosis, Liver
NCT04951219Phase 3Active Not Recruiting

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)

Started Jul 2021
1,000 enrolled
Non-Alcoholic Fatty Liver Disease

Loss of Exclusivity

LOE Date
Feb 4, 2045
230 months away
Patent Expiry
Feb 4, 2045
Exclusivity Expiry
Mar 14, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
7452882
Sep 12, 2026
SubstanceProduct
10376517
Sep 17, 2033
U-3861
11564926
Sep 17, 2033
SubstanceProduct
U-3861
11986481
Sep 17, 2033
U-3861
9266861
Sep 17, 2033
SubstanceProduct