Product Name: Resmetirom API
Chemical Name: 2-[3,5-Dichloro-4-[(4-hydroxy-3-isopropylphenoxy)phenyl]methyl]thiazole-4-carboxylic acid
Molecular Formula: C₂₁H₁₈Cl₂NO₄S
Molecular Weight: 451.34 g/mol
CAS Number: 913390-85-1
Therapeutic Category: Thyroid Hormone Receptor (THR)-β Selective Agonist
Indication: Resmetirom is an investigational drug primarily developed for the treatment of non-alcoholic steatohepatitis (NASH/MASH) and other metabolic disorders. It selectively activates the thyroid hormone receptor beta (THR-β), which plays a key role in regulating lipid metabolism, reducing liver fat, and improving liver function.
Mechanism of Action: Resmetirom is a liver-directed, selective thyroid hormone receptor beta (THR-β) agonist. By selectively activating THR-β, it enhances lipid metabolism, reduces hepatic fat accumulation, and improves markers of liver inflammation and fibrosis. Unlike non-selective thyroid hormone agonists, Resmetirom minimizes off-target effects on the heart and bones by sparing the THR-α receptor.
Dosage Form: Resmetirom is available as an active pharmaceutical ingredient (API) for formulation into oral dosage forms, such as tablets or capsules.
Pharmacokinetics:
Absorption: Resmetirom is well-absorbed following oral administration, with peak plasma concentrations achieved within a few hours.
Distribution: It exhibits a high degree of liver targeting, with minimal distribution to extrahepatic tissues.
Metabolism: Resmetirom is primarily metabolized in the liver via glucuronidation and oxidation pathways.
Excretion: The drug and its metabolites are predominantly excreted in the feces.
Storage Conditions: Resmetirom API should be stored in a cool, dry place, protected from light and moisture.
Stability: Resmetirom is stable under recommended storage conditions. It should be protected from extreme temperatures and humidity to maintain its stability and efficacy.
Regulatory Status: Resmetirom is currently under clinical development and has not yet received approval for commercial use. It is being evaluated in various clinical trials to assess its safety and efficacy in treating non-alcoholic steatohepatitis (NASH) and related metabolic conditions.
Packaging: Resmetirom API is supplied in sealed, light-resistant containers to ensure product integrity. The packaging is designed to protect the API from environmental factors that could compromise its quality.
Quality Standards: Resmetirom API is manufactured in compliance with current Good Manufacturing Practices (cGMP) and meets stringent quality control standards to ensure its purity, potency, and consistency.
Applications: Resmetirom API is intended for use in the development and production of pharmaceutical formulations aimed at treating non-alcoholic steatohepatitis (NASH) and other metabolic disorders. It is suitable for use in both clinical trials and commercial pharmaceutical manufacturing.
Note: This product is intended for research and development purposes only. It is not for human or veterinary use unless specified by regulatory authorities.