Rezdiffra

(Resmetirom)

ApprovedSmall molecule

Rezdiffra is a small molecule that works as a THR-Beta Agonist.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Rezdiffra is one of 74 small molecule programs targeting NASH/MASH. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

NASH/MASHActive, not recruiting

MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseRecruiting

MASHRecruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

EfficacyRecruiting

NASH/MASHApproved

Active, not recruiting

MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 2

Recruiting

MASHPhase 2

Recruiting

Non-Alcoholic Fatty Liver DiseasePhase 3

Active, not recruiting

EfficacyApproved

Recruiting

Competition

Competitive Landscape

145 competitors in Efficacy

#DrugCompanyPhaseTrials

Rezdiffra

Madrigal Pharmaceuticals

Approved

1 2

Tivicay

GSK

Phase 3

2 3

Rayos

RRoxane Laboratories

Phase 3

5 4

Paraplatin

AAvyxa

Phase 3

4 5

Alimta

SShawn Eagle

Phase 3

3 6

Cytoxan

BBaxter Healthcare Corporation

Phase 3

3 7

Lesinurad

EEsperion Therapeutics, Inc.

Phase 3

2 8

Insulin 320

Novo Nordisk

Phase 3

5 9

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Phase 3

1 10

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Efficacy

NCT07249788

Q1 2027

Phase 3Active, not recruiting

NASH

NCT05500222

Q4 2027

Phase 2Recruiting

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT07143968

Q1 2029

Phase 2Recruiting

MASH - Metabolic Dysfunction-Associated Steatohepatitis

NCT07335601

Clinical

Trials by Indication[1]

Non-Alcoholic Fatty Liver Disease1 trial

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)

Active, not recruiting· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 3·NCT04951219·1,000 enrolled

Renal Impairment1 trial

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

Completed· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 1·NCT06397872·28 enrolled

Efficacy1 trial

Resmiterom Efficacy & Safety in Patients With MASH

Recruiting·NNabiqasim Industries (Pvt) Ltd·Phase 4·NCT07249788·165 enrolled

Interaction1 trial

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

Completed·SSagimet Biosciences Inc.·Phase 1·NCT07216313·40 enrolled

Alcoholic Fatty Liver Disease1 trial

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients

Completed· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 3·NCT04197479·1,343 enrolled

4 more indications

MASH1 trial

A Phase 2a, Multicenter, Open-label, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Resmetirom in Pediatric Subjects Ages 6-17 Years With MASH With Fibrosis Stage F1-F3

Recruiting· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 2·NCT07763015·61 enrolled

MASH - Metabolic Dysfunction-Associated Steatohepatitis1 trial

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

Recruiting· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 2·NCT07335601·120 enrolled

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease1 trial

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)

Recruiting·NNaga P. Chalasani·Phase 2·NCT07143968·120 enrolled

NASH1 trial

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 recruiting· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 3·NCT05500222·845 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 14, 2024

REZDIFFRA

NDA NDA217785

Mar 14, 2024

REZDIFFRA

NDA NDA217785

Dec 19, 2025

REZDIFFRA

NDA NDA217785

Dec 19, 2025

REZDIFFRA

NDA NDA217785

Dec 19, 2025

REZDIFFRA

NDA NDA217785

Jul 24, 2026

REZDIFFRA

NDA NDA217785

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Resmetirom. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Resmetirom compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Resmetirom. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217785). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rezdiffra. U.S. Food & Drug Administration.
[6]
PubMed — 2 publications indexed for Resmetirom. U.S. National Library of Medicine.
[7]
SEC EDGAR — Madrigal Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: THR-Beta Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Madrigal Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Sep 17, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7452882Sep 12, 2026

11564926Sep 17, 2033

10376517Sep 17, 2033

9266861Sep 17, 2033

11986481Sep 17, 2033

3 more patents

12661359Jan 27, 2042

12667575Feb 3, 2045

12377104Feb 4, 2045

Key Publications[6]

Resmetirom for NASH with Liver Fibrosis: MAESTRO-NASH Phase 3

N Engl J MedFeb 15, 2024DOI: 10.1056/NEJMoa2309000

Thyroid Hormone Receptor Beta Agonism in NASH: Mechanism and Outcomes

Lancet Gastroenterol HepatolJan 22, 2024DOI: 10.1016/S2468-1253(24)00015-3

Rezdiffra

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q1 2029

Trials by Indication[1]

Non-Alcoholic Fatty Liver Disease1 trial

Renal Impairment1 trial

Efficacy1 trial

Interaction1 trial

Alcoholic Fatty Liver Disease1 trial

MASH1 trial

MASH - Metabolic Dysfunction-Associated Steatohepatitis1 trial

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease1 trial

NASH1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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