The most common side effects include diarrhea and nausea.[2]
Resmetirom was approved for medical use in the United States in March 2024.[2][3]
Medical usesedit
Resmetirom is indicated, in conjunction with diet and exercise, for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).[1][2]
Historyedit
In a phase III clinical trial, it was found to be effective for resolving noncirrhotic nonalcoholic steatohepatitis and improving liver fibrosis.[4]
The US Food and Drug Administration (FDA) evaluated the safety and efficacy of resmetirom based on an analysis of a surrogate endpoint at month twelve in a 54-month, randomized, double-blind placebo-controlled trial.[2] The surrogate endpoint measured the extent of liver inflammation and scarring.[2] The FDA requires the sponsor to conduct a postapproval study to verify and describe the clinical benefit of resmetirom, which will be done through completing the same 54-month study.[2] In the trial, 888 participants were randomly assigned to receive one of the following: placebo (294 participants); 80 milligrams of resmetirom (298 participants); or 100 milligrams of resmetirom (296 participants); once daily, in addition to standard care for noncirrhotic nonalcoholic steatohepatitis, which includes counseling for healthy diet and exercise.[2]
The FDA granted the application for resmetirom accelerated approval, along with breakthrough therapy, fast track, and priority review designations.[2] The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals.[2]
^ abcdefghi"FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease". U.S. Food and Drug Administration (FDA) (Press release). 14 March 2024. from the original on 14 March 2024. Retrieved 14 March 2024. This article incorporates text from this source, which is in the public domain.
^"Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis". Madrigal Pharmaceuticals (Press release). 14 March 2024. from the original on 14 March 2024. Retrieved 14 March 2024.
^Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, et al. (February 2024). "A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis". The New England Journal of Medicine. 390 (6): 497–509. doi:10.1056/NEJMoa2309000. PMID 38324483. S2CID 267544939.
resmetirom, sold, under, brand, name, rezdiffra, medication, used, treatment, noncirrhotic, nonalcoholic, steatohepatitis, thyroid, hormone, receptor, beta, nr1a2, agonist, clinical, datatrade, namesrezdiffraother, namesmgl, 3196license, dataus, dailymed, rout. Resmetirom sold under the brand name Rezdiffra is a medication used for the treatment of noncirrhotic nonalcoholic steatohepatitis 1 It is thyroid hormone receptor beta NR1A2 agonist 1 ResmetiromClinical dataTrade namesRezdiffraOther namesMGL 3196License dataUS DailyMed ResmetiromRoutes ofadministrationBy mouthATC codeNoneLegal statusLegal statusUS only 1 IdentifiersIUPAC name 2 3 5 dichloro 4 6 oxo 5 propan 2 yl 1H pyridazin 3 yl oxy phenyl 3 5 dioxo 1 2 4 triazine 6 carbonitrileCAS Number920509 32 6PubChem CID15981237DrugBankDB12914UNIIRE0V0T1ES0KEGGD11602ChEMBLChEMBL3261331Chemical and physical dataFormulaC 17H 12Cl 2N 6O 4Molar mass435 22 g mol 13D model JSmol Interactive imageSMILES CC C C1 CC NNC1 O OC2 C C C C C2Cl N3C O NC O C N3 C N ClInChI InChI 1S C17H12Cl2N6O4 c1 7 2 9 5 13 22 23 15 9 26 29 14 10 18 3 8 4 11 14 19 25 17 28 21 16 27 12 6 20 24 25 h3 5 7H 1 2H3 H 23 26 H 21 27 28 Key FDBYIYFVSAHJLY UHFFFAOYSA NThe most common side effects include diarrhea and nausea 2 Resmetirom was approved for medical use in the United States in March 2024 2 3 Medical uses editResmetirom is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis consistent with stages F2 to F3 fibrosis 1 2 History editIn a phase III clinical trial it was found to be effective for resolving noncirrhotic nonalcoholic steatohepatitis and improving liver fibrosis 4 The US Food and Drug Administration FDA evaluated the safety and efficacy of resmetirom based on an analysis of a surrogate endpoint at month twelve in a 54 month randomized double blind placebo controlled trial 2 The surrogate endpoint measured the extent of liver inflammation and scarring 2 The FDA requires the sponsor to conduct a postapproval study to verify and describe the clinical benefit of resmetirom which will be done through completing the same 54 month study 2 In the trial 888 participants were randomly assigned to receive one of the following placebo 294 participants 80 milligrams of resmetirom 298 participants or 100 milligrams of resmetirom 296 participants once daily in addition to standard care for noncirrhotic nonalcoholic steatohepatitis which includes counseling for healthy diet and exercise 2 The FDA granted the application for resmetirom accelerated approval along with breakthrough therapy fast track and priority review designations 2 The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals 2 References edit a b c d Rezdiffra resmetirom tablet coated Rezdiffra resmetirom tablet coated Rezdiffra resmetirom tablet coated DailyMed 14 March 2024 Retrieved 2 April 2024 a b c d e f g h i FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease U S Food and Drug Administration FDA Press release 14 March 2024 Archived from the original on 14 March 2024 Retrieved 14 March 2024 nbsp This article incorporates text from this source which is in the public domain Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra resmetirom for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis NASH with Moderate to Advanced Liver Fibrosis Madrigal Pharmaceuticals Press release 14 March 2024 Archived from the original on 14 March 2024 Retrieved 14 March 2024 Harrison SA Bedossa P Guy CD Schattenberg JM Loomba R Taub R et al February 2024 A Phase 3 Randomized Controlled Trial of Resmetirom in NASH with Liver Fibrosis The New England Journal of Medicine 390 6 497 509 doi 10 1056 NEJMoa2309000 PMID 38324483 S2CID 267544939 Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Resmetirom amp oldid 1216905464, wikipedia, wiki, book, books, library,
