Unveiling Vadadustat: Comprehensive Review of its Chemistry, Pharmacology, Bioanalysis, and Patent Landscape as a Novel HIF-PH Inhibitor.

Abstract

Introduction: The goal of this study is to provide a comprehensive review of physicochemical and pharmacological properties, including pharmacokinetics and pharmacodynamics parameters, with an overview of preclinical and clinical trial data, chemistry, and multiple routes of synthesis, bioanalytical methods, and patents of the API: Vadadustat Methods: A review was conducted by compiling data from Science Direct, PubMed, Drug Bank, WIPO patent, Clinicaltrialgov, Wolters Kluwer, and many others to enhance understanding of the topic Results: The FDA approved Vadadustat on March 27, 2024, for treating anemia in adults with CKD on dialysis. Vadadustat effectively increased hemoglobin levels in both non-dialysis and dialysis- dependent CKD patients. It showed comparable efficacy to traditional erythropoiesisstimulating agents (ESAs) like darbepoetin alfa. Multiple clinical trials, including Phase 2 and Phase 3 studies, demonstrated Vadadustat's potential as an effective treatment for anemia in CKD patients.

Discussion: Vadadustat, as an oral HIF-PH inhibitor, offers significant advantages in the treatment of anemia in CKD. Its oral route of administration improves patient compliance, and its efficacy is comparable to ESAs. Clinical and preclinical data support its safety and therapeutic potential, although long-term cardiovascular effects remain under observation.

Conclusion: This review examines therapeutic, pharmacological, analytical, and regulatory aspects related to Vadadustat.