TheraRadar
Data updated: May 26, 2026

REZDIFFRA (resmetirom)

Thyroid Hormone Receptor beta Agonists Trial Activity: Expansion 5 active trials
First-in-Class Breakthrough Therapy Priority Review Accelerated Approval Fast Track
Hepatology Approved 2024-03-14

REZDIFFRA is indicated for the treatment of Nonalcoholic Steatohepatitis; Liver Fibrosis; Cirrhosis.

Source: FDA Label • MADRIGAL
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

Madrigal Pharmaceuticals, Inc. conducting 4 trials (57%)
7 indications explored (Moderate)
→ mash - metabolic dysfunction-associated steatohepatitis (2 trials)
→ non-alcoholic fatty liver disease (2 trials)
→ masld - metabolic dysfunction-associated steatotic liver disease (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
2
Years on Market

Details

Status
Prescription
First Approved
2024-03-14
Patent Cliff
2045

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

MADRIGAL
Active Ingredient: RESMETIROM

REZDIFFRA Approval History

2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2024 to 2025
Dec 2025 SUPPL
Label · Labeling
FDA Letter Label
Mar 2024 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What REZDIFFRA Treats

3 indications

REZDIFFRA is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Nonalcoholic Steatohepatitis
  • Liver Fibrosis
  • Cirrhosis
Source: FDA Label

REZDIFFRA Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

6

Same indication, different mechanism — what else might this patient receive?

ETHACRYNATE SODIUM
Viatris
2015 9 indic.
OPTISON
GE HEALTHCARE
1997 12 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to REZDIFFRA

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DYRENIUM
TRIAMTERENE
1 shared
ADVANZ PHARMA
Shared indications:
Cirrhosis
EDECRIN
ETHACRYNATE SODIUM
1 shared
BAUSCH
Shared indications:
Cirrhosis
ETHACRYNATE SODIUM
ETHACRYNATE SODIUM
1 shared
Viatris
Shared indications:
Cirrhosis
View all 4 similar drugs Pro
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Clinical Trial Registry

7 trials
Trial Sponsor ID Phase Status Title
NCT07143968 HCRN005 Ph 2 recruiting A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
NCT07335601 MGL-3196-27 Ph 2 recruiting Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
NCT07216313 SB2640-CLIN-013 Ph 1 completed A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants
NCT07249788 REZMASH NQ/HT/REZ/CT-003 Ph 4 recruiting Resmiterom Efficacy & Safety in Patients With MASH
NCT04951219 MGL-3196-18 Ph 3 active 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)
NCT05500222 MGL-3196-19 Ph 3 active 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)
NCT04197479 MAESTRO-NAFLD1 MGL-3196-14 Ph 3 completed A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

REZDIFFRA FDA Label Details

Indications & Usage

FDA Label (PDF)

REZDIFFRA is indicated for the treatment of Nonalcoholic Steatohepatitis; Liver Fibrosis; Cirrhosis.

View full patent landscape →
6 OB patents · 3 families · 173 international docs across 38 countries

REZDIFFRA Patents & Exclusivity

Latest Patent: Feb 2045
Exclusivity: Mar 2029

Patents (6 active)

US12377104 Expires Feb 4, 2045
US11986481 Expires Sep 17, 2033
US11564926 Expires Sep 17, 2033
US10376517 Expires Sep 17, 2033
US9266861 Expires Sep 17, 2033
US7452882 Expires Sep 12, 2026

Exclusivity

NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
NCE Until Mar 2029
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for REZDIFFRA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2045
  • • 54 active patents

Trial Analysis

  • • 7 total trials
  • • Stage: Expansion

Competitive Landscape

  • • 4 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA217785 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment