IP Library Granted Patent US 12,661,361
Granted Patent B2
US 12,661,361 · App. 19/386,839 · Granted Jun 23, 2026

Resmetirom for reducing liver volume

Inventor: Rebecca Taub (Villanova, PA)
Assignee: Madrigal Pharmaceuticals, Inc.
A61K31/53A61P1/16
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,661,361
App. No.
19/386,839
Filed
Nov 12, 2025
Granted
Jun 23, 2026
Kind
B2
Art Unit
1611
USPC
514/242
Abstract

The present disclosure describes a method of reducing liver volume in a cirrhotic or non-cirrhotic subject, the method comprising administering resmetirom, a prodrug thereof, or a pharmaceutically acceptable salt of the resmetirom or the resmetirom prodrug. The present disclosure also describes a method of treating NASH in a cirrhotic subject in need thereof, the method comprising administering to the subject resmetirom, a prodrug thereof, or a pharmaceutically acceptable salt of the resmetirom or the resmetirom prodrug.

Claims (10)

1 . A method of treating well-compensated cirrhotic nonalcoholic steatohepatitis (NASH) comprising administering to a human subject in need thereof a therapeutically effective amount of resmetirom or a pharmaceutically acceptable salt thereof.

2 . The method of claim 1 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 60 mg to 80 mg.

3 . The method of claim 1 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 60 mg.

4 . The method of claim 1 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 80 mg.

5 . The method of claim 1 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 100 mg.

6 . A method of reducing liver volume comprising administering to a human subject in need thereof a therapeutically effective amount of resmetirom or a pharmaceutically acceptable salt thereof, wherein the human subject in need thereof has well-compensated cirrhotic nonalcoholic steatohepatitis (NASH).

7 . The method of claim 6 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 60 mg to 80 mg.

8 . The method of claim 6 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 60 mg.

9 . The method of claim 6 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 80 mg.

10 . The method of claim 6 , wherein the therapeutically effective amount of resmetirom or the pharmaceutically acceptable salt thereof is 100 mg.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 12, 2025
From: TAUB, REBECCA
To: MADRIGAL PHARMACEUTICALS, INC.
Reel/Frame 072882/0146 →
Continuity (3)
Continuation 18695572
Provisional Application 63248634 · Sep 27, 2021
Related Publication 20260069598A1 · Mar 12, 2026
References Cited (33)
US 7452882B2 · Haynes et al. · 2008 [cited by applicant]
US 8076334B2 · Haynes et al. · 2011 [cited by applicant]
US 11090308B2 · Taub · 2021 [cited by applicant]
US 11986481B2 · Kelly et al. · 2024 [cited by applicant]
US 12102646B2 · Lian et al. · 2024 [cited by applicant]
US 20210122740A1 · Mirmehrabi et al. · 2021 [cited by applicant]
US 20240051925A1 · Confalone et al. · 2024 [cited by applicant]
WO WO2020049556 · 2020 [cited by examiner]
Harrison et al (Treatment of cirrhotics with resmetirom in Phase 3 Maestro-NAFLD-1 NASH study open label arm effects on biomarkers and imagine, EASL Congress® 2021: Jun. 23-26, 2021) (Year: 2021). [cited by examiner]
Harrison et al (Hepatology Comm 5:573-588, Apr. 2021) (Year: 2021). [cited by examiner]
Madrigal Pharmaceuticals, Inc. “Press Release: Madrigal Pharmaceuticals Exceeds Target Enrollment in Phase 3 Maestro NAFLD-1 Trial” (Sep. 3, 2020) (Year: 2020). [cited by examiner]
Tanaka et al (Pharmacol Ther 179:142-157, 2017) (Year: 2017). [cited by examiner]
Kling (“NASH drug passes phase 2 trial”, available online at https://www.mdedge.com/endocrinology/article/184420/hepatology/nash-drug-passes-phase-2-trial, Nov. 13, 2018) (Year: 2018). [cited by examiner]
Bashir et al (Liver volume reduction in resmetirom-treated non-cirrhotic and cirrhotic NASH patients, AASLD Nov. 2021) (Year: 2021). [cited by examiner]
International Search Report and Written Opinion mailed Dec. 22, 2022, directed to International Application No. PCT/US2022/044826; 13 pages. [cited by applicant]
Aimo Kannt et al., “Activation of thyroid hormone receptor-[beta] improved disease activity and metabolism independent of body weight in a mouse model of non-alcoholic steatohepatitis and fibrosis”, British Journal of P… [cited by applicant]
Harrison Stephen A et al.,“Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial”, Lancet, Nov. 30, 2019, 394(10213):2012-20… [cited by applicant]
Feigh Michael et al., “NHS Core Content (Athens): Metabolic, biochemical, histopathological, and transcriptomic effects of resmetirom (MGL-3196) in the GAN diet-induced obese and biopsy confirmed mouse model of NASH”, (… [cited by applicant]
Anonymous, “NCT05500222: A Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis”, (Sep. 1, 2022), Internet, URL: https://clinicaltrials.gov/ct2/history/NCT0550… [cited by applicant]
Bashir Mustafa et al., “Liver Volume Reduction in Resmetirom Treated Non-Cirrhotic and Cirrhotic NASH Patients”, (Nov. 1, 2021), URL: https://www.natap.org/2022/HCV/060322_05.htm, (Dec. 12, 2022), XP093007394 [XP]. [cited by applicant]
Madrigal Pharmaceuticals, Inc., “Press Release: Madrigal Pharmaceuticals Exceeds Target Enrollment in Phase 3 Maestro NAFLD-1 Trial,” Retrieved from: https://ir.madrigalpharma.com/node/13456/pdf, Sep. 3, 2020; 3 pages. [cited by applicant]
Madrigal Pharmaceuticals, Inc., “Press Release: Madrigal Pharmaceuticals Highlights Presentations at the Liver Meeting Digital ExperienceTM, The American Association for the Study of Liver Diseases Meeting Nov. 13, 2020… [cited by applicant]
Madrigal Pharmaceuticals, Inc., “Press Release: Madrigal Pharmaceuticals Announces Presentation of Positive Clinical Data of Resmetirom from Open-Label Portion of Ongoing Phase 3 Clinical Trial Maestro-NAFLD-1 at the In… [cited by applicant]
Madrigal Pharmaceuticals, Inc., “Press Release: Madrigal Pharmaceuticals Reports 2021 Second Quarter Financial Results and Provides Corporate Update,” Retrieved from: https://ir.madrigalpharma.com/node/13756/pdf, Aug. 5… [cited by applicant]
Prescribing information: Rezdiffra (resmetirom) tablets, for oral use, revised Mar. 2024. [cited by applicant]
Harrison et al, “Treatment of cirrhotics with resmetirom in Phase 3 Maestro-NAFLD-1 Nash study open label arm: effects on biomarkers and imaging,” Presented at EASL Congress™ 2021; Jun. 23-26, 2021; held online. [cited by applicant]
ClinicalTrials.gov Identifier NCT02912260, “Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH),” Last Update Posted Dec. 19, 2017, 9 pages. [cited by applicant]
Kelly M. J., et al., “Discovery of 2-[3,5-Dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl]-3,5 dioxo-2,3,4,5-tetrahydro[1,2,4]triazine-6-carbonitrile (MGL-3196), a Highly Selective Thyroid Hormone Rece… [cited by applicant]
Harrison et al., “MGL-3196, a selective thyroid hormone receptor-beta agonist significantly decreases hepatic fat in NASH patients at 12 weeks, the primary endpoint in a 36 week serial liver biopsy study,” Journal of He… [cited by applicant]
Harrison et al., “MGL-3196, a selective thyroid hormone receptor-beta agonist significantly decreases hepatic fat in NASH patients at 12 weeks, the primary endpoint in a 36 week serial liver biopsy study,” The Internati… [cited by applicant]
Harrison et al., “Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH,” Hepatology Communications, vol. 5, pp. 573-588 (2021). [cited by applicant]
Harrison et al., “Reduction in Fibrosis and Steatohepatitis Imaging and Biomarkers in 52-Week Resmetirom Non-Alcoholic Steatohepatitis Trial,” NAFLD Summit Poster, Sep. 16-17, 2021. [cited by applicant]
Ratziu et al., “Phase 3 development of resmetirom, a liver-directed thyroid hormone receptor (THR)-β agonist for the treatment of patients with NASH and significant liver fibrosis,” Presented at ILC 2021 Madrigal Hosted… [cited by applicant]