Rezdiffra

(Resmetirom)

ApprovedSmall molecule

Rezdiffra is a small molecule that works as a THR-Beta Agonist.[2] It is being used across 6 indications, with its most advanced program in Approved.[1]

Rezdiffra is one of 148 small molecule programs targeting Liver Transplant. It is currently in Approved.

Indications

Total Trials

Active Trials

147

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Liver TransplantActive, not recruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

NASH/MASHActive, not recruiting

NASHActive, not recruiting

CirrhosisActive, not recruiting

Liver TransplantPhase 2

Active, not recruiting

Non-Alcoholic Fatty Liver DiseasePhase 3

Active, not recruiting

Alcoholic Fatty Liver DiseasePhase 3

Active, not recruiting

NASH/MASHApproved

Active, not recruiting

NASHPhase 3

Active, not recruiting

CirrhosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

353 competitors in Liver Transplant

#DrugCompanyPhaseTrials

Rezdiffra

Madrigal Pharmaceuticals

Approved

1 2

Cysteine Hydrochloride

Novartis

Preclinical

3 3

Vemlidy

Gilead

Preclinical

3 4

Lenvima

Eisai

Preclinical

2 5

Prostigmin

Merck & Co.

Preclinical

1 6

Myfortic

Novartis

Preclinical

1 7

Beyfortus

BeiGene

Preclinical

1 8

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

4 9

Myfortic

Novartis

Preclinical

6 10

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

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 2Not yet recruiting

MASLD

NCT07143968

Phase 2Active, not recruiting

Liver Transplant

NCT07335601

Clinical

Trials by Indication[1]

MASLD1 trial

A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV

Not yet recruiting·NNaga P. Chalasani·Phase 2·NCT07143968·120 enrolled

Liver Transplant1 trial

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

Active, not recruiting· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 2·NCT07335601·120 enrolled

Efficacy1 trial

Resmiterom Efficacy & Safety in Patients With MASH

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

Interaction1 trial

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

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

3 more indications

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

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

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

Sources

References

[1]
ClinicalTrials.gov — 8 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 12, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7452882Sep 12, 2026

11986481Sep 17, 2033

11564926Sep 17, 2033

10376517Sep 17, 2033

9266861Sep 17, 2033

1 more patents

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

Trials by Indication[1]

MASLD1 trial

Liver Transplant1 trial

Efficacy1 trial

Alcoholic Fatty Liver Disease1 trial

Interaction1 trial

Renal Impairment1 trial

Non-Alcoholic Fatty Liver Disease1 trial

NASH1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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