Prague Med. Rep. 2026, 127, 145-150
https://doi.org/10.14712/23362936.2026.21
Resmetirom: A New FDA-approved Drug as a Targeted Therapeutic Strategy in Metabolic Dysfunction Associated Steatohepatitis: Translational Evidence from Current Clinical Trials
References
1. , H., Beran, A., Suhail, S., Ayesh, S., Niswender, K. (2025) Efficacy and safety of resmetirom in MASLD and MASH: Network meta-analysis of randomized clinical trials. J. Basic Clin. Physiol. Pharmacol. 36(1), 3–11.
<https://doi.org/10.1515/jbcpp-2024-0140>
2. , C., Reeder, S. B., Sirlin, C. B., Loomba, R. (2018) Noninvasive, quantitative assessment of liver fat by MRI-PDFF as an endpoint in NASH trials. Hepatology 68(2), 763–772.
<https://doi.org/10.1002/hep.29797>
3. , B. (2022) Targeting de novo lipogenesis by different approaches shows promise in nonalcoholic steatohepatitis. Gastroenterology 163(5), 1472–1474.
<https://doi.org/10.1053/j.gastro.2022.07.085>
4. , S. M., Tice, J. A., Suh, K., Carlson, J. J., Richardson, M., Chu, J. N., Herce-Hagiwara, B., Agboola, F., Rind, D., Pearson, S. D. (2023) Resmetirom for nonalcoholic steatohepatitis. J. Manag. Care Spec. Pharm. 29(10), 1169–1172.
5. , K., Jornayvaz, F. R. (2021) Pathophysiology of NASH in endocrine diseases. Endocr. Connect. 10(2), R52–R65.
<https://doi.org/10.1530/EC-20-0490>
6. , S. A., Bashir, M. R., Guy, C. D., Zhou, R., Moylan, C. A., Frias, J. P., Alkhouri, N., Bansal, M. B., Baum, S., Neuschwander-Tetri, B. A., Taub, R. (2019) Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: A multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet 394(10213), 2012–2024.
<https://doi.org/10.1016/S0140-6736(19)32517-6>
7. , S. A., Bashir, M., Moussa, S. E., McCarty, K., Frias, J. P., Taub, R., Alkhouri, N. (2021) Effects of resmetirom on noninvasive endpoints in a 36-week phase 2 active treatment extension study in patients with NASH. Hepatol. Commun. 5(4), 573–588.
<https://doi.org/10.1002/hep4.1657>
8. , S. A., Allen, A. M., Dubourg, J., Noureddin, M., Alkhouri, N. (2023a) Challenges and opportunities in NASH drug development. Nat. Med. 29(3), 562–573.
<https://doi.org/10.1038/s41591-023-02242-6>
9. , S. A., Taub, R., Neff, G. W., Lucas, K. J., Labriola, D., Moussa, S. E., Alkhouri, N., Bashir, M. R. (2023b) Resmetirom for nonalcoholic fatty liver disease: A randomized, double-blind, placebo-controlled phase 3 trial. Nat. Med. 29(11), 2919–2928.
<https://doi.org/10.1038/s41591-023-02603-1>
10. , S. A., Bedossa, P., Guy, C. D., Schattenberg, J. M., Loomba, R., Taub, R., Labriola, D., Moussa, S. E., Neff, G. W., Rinella, M. E., Anstee, Q. M. (2024) A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis. N. Engl. J. Med. 390(6), 497–509.
<https://doi.org/10.1056/NEJMoa2309000>
11. , H. T., Alhatemi, A. Q. M., Riaz, S., Al-Ghuraibawi, M. A., Alabide, A. S., Saeed, H., Sulaiman, F. A., Alhussain, M. A. A., Shallan, M. A., Al-Obaidi, A. D., Saab, O. (2024) Unveiling Resmetirom: A systematic review and meta-analysis on its impact on liver function and safety in non-alcoholic steatohepatitis treatment. JGH Open 8(10), e70025.
<https://doi.org/10.1002/jgh3.70025>
12. , M., Boutari, C., Hill, M. A., Kotsis, V., Loomba, R., Sanyal, A. J., Mantzoros, C. S. (2024) Resmetirom, the first approved drug for the management of metabolic dysfunction-associated steatohepatitis: Trials, opportunities, and challenges. Metabolism 154, 155835.
<https://doi.org/10.1016/j.metabol.2024.155835>
13. , M. A., Ediriweera, D. S., Withanage, M. Y., Darshika, S., De Silva, S. T., de Silva, H. J. (2023) Prevalence and associated factors for non-alcoholic fatty liver disease among adults in the South Asian Region: A meta-analysis. Lancet Reg. Health Southeast Asia 15, 100220.
<https://doi.org/10.1016/j.lansea.2023.100220>
14. , M. E. (2023) Examining the nomenclature change from NAFLD and NASH to MASLD and MASH. Gastroenterol. Hepatol. (N. Y.) 19(11), 697–700.
15. , S. K., Kumar, M., Eslam, M., George, J., Al Mahtab, M., Akbar, S. M. F., Jia, J., Tian, Q., Aggarwal, R., Muljono, D. H., Omata, M. (2020) Liver diseases in the Asia-Pacific region: A Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol. Hepatol. 5(2), 167–228.
<https://doi.org/10.1016/S2468-1253(19)30342-5>
16. , A. S., Khan, S., Rahim, H., Chishti, K. A., Khan, A. G. (2018) Prevalence of nonalcoholic fatty liver and nonalcoholic steatohepatitis in Peshawar Cantonment, Khyber Pakhtunkhwa, Pakistan. Pak. J. Pharm. Sci. 31(1), 193–198.
17. , P. S., Ghosh, S., Ghosh, D. (2024) Levothyroxine and non-alcoholic fatty liver disease: A mini review. Mini Rev. Med. Chem. 24(2), 128–138.
<https://doi.org/10.2174/1389557523666230314113543>
18. , R., Shetty, S., Pappachan, J. M. (2024) Efficacy and safety of resmetirom, a selective thyroid hormone receptor-β agonist, in the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD): A systematic review and meta-analysis. Sci. Rep. 14(1), 19790.
<https://doi.org/10.1038/s41598-024-70242-8>
19. , H., Byrne, C. D., Targher, G. (2023) NASH drug treatment development: Challenges and lessons. Lancet Gastroenterol. Hepatol. 8(10), 943–954.
<https://doi.org/10.1016/S2468-1253(23)00159-0>
20. , X. F., Wang, Q. Y., Zhao, X. Y., Sun, Y. M., Wu, X. N., Yang, L. L., Lu, Z. Z., Ou, X. J., Jia, J. D., You, H. (2022) Histological assessment based on liver biopsy: The value and challenges in NASH drug development. Acta Pharmacol. Sin. 43(5), 1200–1210.
<https://doi.org/10.1038/s41401-022-00874-x>
21. US Food and Drug Administration (2024) FDA approves first treatment for patients with liver scarring due to fatty liver disease. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
22. , X., Poulsen, K. L., Wu, L., Liu, S., Miyata, T., Song, Q., Wei, Q., Zhao, C., Lin, C., Yang, J. (2022) Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH). Signal Transduct. Target. Ther. 7(1), 287.
<https://doi.org/10.1038/s41392-022-01119-3>
23. , Z., Henry, L. (2016) Contribution of alcoholic and nonalcoholic fatty liver disease to the burden of liver-related morbidity and mortality. Gastroenterology 150(8), 1778–1785.
<https://doi.org/10.1053/j.gastro.2016.03.005>
24. , Z. M., Stepanova, M., Taub, R. A., Barbone, J. M., Harrison, S. A. (2022) Hepatic fat reduction due to resmetirom in patients with nonalcoholic steatohepatitis is associated with improvement of quality of life. Clin. Gastroenterol. Hepatol. 20(6), 1354–1361.e7.
<https://doi.org/10.1016/j.cgh.2021.07.039>



