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Drug

Resmetirom

Approved · FDA / EMA
ClassThyroid hormone receptor beta-1 agonistEmerging researchLate-stage development

Also known as Rezdiffra.

RxNorm2677894ChEMBLCHEMBL3261331UNIIRE0V0T1ES0
5
Research papers
5
Active clinical trials
Thyroid hormone receptor beta
Primary target
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: RESMETIROM (NDA217785)

Regulatory2026-07-24FDA

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients With Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH-OUTCOMES)

Clinical trial2026-07-08Results expected Q4 2026 · ClinicalTrials.gov

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 Other Etiologies

Clinical trial2026-06-16Results expected Q3 2028 · ClinicalTrials.gov

A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, 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)

Clinical trial2026-05-27Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Resmetirom for the Treatment of Metabolic Dysfunction- Associated Steatotic Liver Disease (MASLD) in People Living With Human Immunodeficiency Virus (HIV)

Clinical trial2026-05-06Results expected Q4 2027 · ClinicalTrials.gov

Label change: RESMETIROM (NDA217785)

Regulatory2025-12-19FDA

Label change: RESMETIROM (NDA217785)

Regulatory2025-12-19FDA

Label change: RESMETIROM (NDA217785)

Regulatory2025-12-19FDA

Thyroid hormone and the Liver.

Research2024-12-20Hepatology communications

Hepatic thyroid hormone receptor-β signalling: Mechanisms and recent advancements in the treatment of metabolic dysfunction-associated steatohepatitis.

Research2024-12-10Diabetes, obesity & metabolism

Thyroid hormone receptor-β analogues for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Research2024-10-19Journal of hepatology

The first MASH drug therapy on the horizon: Current perspectives of resmetirom.

Research2024-04-05Liver international : official journal of the International Association for the Study of the Liver

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Resmetirom
Aliases & brands
Rezdiffra
RxNorm CUI
2677894
ChEMBL ID
CHEMBL3261331
UNII
RE0V0T1ES0
Primary mechanism
Thyroid hormone receptor beta-1 agonist
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Thyroid hormone receptor beta
THRB · P10828
AGONISTThyroid hormone receptor beta-1 agonist

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2024-03-14 → 2025-08-18)
Earliest approval
2024-03-14
Latest approval
2025-08-18
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 5 events
2026-07-24Label change
Label change: RESMETIROM (NDA217785)
Evidence ↗
2025-12-19Label change
Label change: RESMETIROM (NDA217785)
Evidence ↗
2025-12-19Label change
Label change: RESMETIROM (NDA217785)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2025-08-18ApprovalMulti-authority
Approval: Rezdiffra (EMA)
Indication: Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to… Show full indication

Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
8
registered trials across all phases
LATEST COMPLETION 2025
5
Active studies
3
Recruiting
4
Late-stage (III+)
3
Completed
PHASE DISTRIBUTIONn = 8
Phase 12Phase 22Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study

RecruitingPH IVNabiqasim Industries (Pvt) Ltdn=1652026

A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, 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)

Active, not recruitingPH IIIMadrigal Pharmaceuticals, Inc.n=8102027

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients With Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH-OUTCOMES)

Active, not recruitingPH IIIMadrigal Pharmaceuticals, Inc.n=8452027

A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)

CompletedPH IIIKey trialMadrigal Pharmaceuticals, Inc.n=1,3432023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open-Label Study to Evaluate the Mutual Drug-Drug Interaction Potential Between Denifanstat and Resmetirom in Healthy Adult Participants

CompletedPH ISagimet Biosciences Inc.n=402025

A Phase 1, Multi-center, Open-label 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

CompletedPH IMadrigal Pharmaceuticals, Inc.n=282024

A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)

CompletedPH IIIKey trialMadrigal Pharmaceuticals, Inc.n=1,3432023

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20242025
Most influential

The first MASH drug therapy on the horizon: Current perspectives of resmetirom.

Liver international : official journal of the International Association for the Study of the Liver · 2024 · 117 cites

Resmetirom, the first approved drug for the management of metabolic dysfunction-associated steatohepatitis: Trials, opportunities, and challenges.

Metabolism: clinical and experimental · 2024 · 114 cites

Thyroid hormone receptor-β analogues for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Journal of hepatology · 2025 · 38 cites

Hepatic thyroid hormone receptor-β signalling: Mechanisms and recent advancements in the treatment of metabolic dysfunction-associated steatohepatitis.

Diabetes, obesity & metabolism · 2025 · 14 cites

Thyroid hormone and the Liver.

Hepatology communications · 2025 · 13 cites
Recent papers

Thyroid hormone receptor-β analogues for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Journal of hepatology · 2025 · 38 cites

Hepatic thyroid hormone receptor-β signalling: Mechanisms and recent advancements in the treatment of metabolic dysfunction-associated steatohepatitis.

Diabetes, obesity & metabolism · 2025 · 14 cites

Thyroid hormone and the Liver.

Hepatology communications · 2025 · 13 cites

The first MASH drug therapy on the horizon: Current perspectives of resmetirom.

Liver international : official journal of the International Association for the Study of the Liver · 2024 · 117 cites

Resmetirom, the first approved drug for the management of metabolic dysfunction-associated steatohepatitis: Trials, opportunities, and challenges.

Metabolism: clinical and experimental · 2024 · 114 cites
Major research themes6
Fatty Liver3Liver2Non-alcoholic Fatty Liver Disease2Thyroid Hormone Receptors beta2Pyridazines1Thyroid Hormones1
Journals, researchers & institutions
Top journals
  • Diabetes, obesity & metabolism1
  • Hepatology communications1
  • Journal of hepatology1
  • Liver international : official journal of the International Association for the Study of the Liver1
  • Metabolism: clinical and experimental1
Leading researchers
  • Targher G2
  • Aghemo A1
  • Boutari C1
  • Bruinstroop E1
  • Hill MA1
  • Kokkorakis M1
  • Kotsis V1
  • Loomba R1
Leading institutions
free-text, unnormalised
  • University of Verona2
  • Beth Israel Deaconess Medical Center1
  • Biological Resource Center Unit1
  • Boston University Chobanian & Avedisian School of Medicine1
  • Clinical Nutrition Unit1
  • Dalton Cardiovascular Research Center1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Uracil

Studied across 5 of the same disease areas as Resmetirom in the shared literature.

5 shared diseases5 shared papers
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.