A critical review of Roxadustat formulations, solid state studies, and analytical methodology.

This review aims to collate information about the analytical methodologies, bioanalytical methodologies, pharmaceutical formulations, solid-state studies, and the current and future market scenario for a relatively new class of drugs, Roxadustat. Roxadustat is a hypoxia-inducible factor propyl hydroxylase inhibitor that significantly increases blood hemoglobin via the action of transcriptional activator HIF. As the molecule has a promising role in stimulating erythropoiesis, it is considered an ideal therapeutic agent for patients with anemia. In the current review, an attempt has been made to compile the pharmacological, pharmacokinetic, and pharmacodynamic characteristics of Roxadustat and systematically present product development data. This drug has several polymorphs of cocrystal, co-former, and salt, which have been explained in detail in the current work. The comprehensive review summarizes all the chromatographic methods and is presented in table form. This review has extensively covered Liquid chromatography-tandem mass spectrometry methods used to analyze Roxadustat in the biological matrix. The literature needs more data on forced degradation study, impurity profiling, gas chromatography, analytical methods for assay, dissolution, and different formulation aspects of Roxadustat.