Initial Clinical Pharmacology Profile of Remdesivir

Author: John A. Wagner, MD, PhD on June 30, 2020


The battle against the COVID-19 pandemic continues as infections rise in the US and the world. As of June 30, 2020, COVID-19 has plagued the world with more than 10 million confirmed infections and more than 500,000 deaths. Patients afflicted with severe COVID-19 are sorely in need of effective treatment. Remdesivir, a viral RNA polymerase inhibitor, recently received US Food and Drug Administration emergency use authorization in the US and approval in Japan for treatment of severe COVID‐19 patients. Because of the unique and rapid drug development path for remdesivir, little published knowledge regarding its clinical pharmacology has been available. 

For the first time, Humeniuk et al. provide findings in Clinical and Translational Science (CTS) from the initial first-in-human rising single and multiple dose phase 1 clinical studies with remdesivir. They found that remdesivir exhibited a linear pharmacokinetic profile consistent with once-daily administration following single-dose IV administration. Importantly, high intracellular concentrations of the active triphosphate were observed following IV infusion of 75 mg or 150 mg. Remdesivir exhibited a multiple dose pharmacokinetic profile similar to single-dose administration. Overall, this initial characterization of the clinical pharmacology profile of remdesivir will facilitate its clinical use.   

The ASCPT family of journals, including CTS, Clinical Pharmacology & Therapeutics, and CPT: Pharmacometrics & Systems Pharmacology, continue to leverage the collective translational and clinical pharmacology expertise of the Society. The research being published in all three is available in a cross-journal virtual issue on COVID-19. We will be adding to this collection as more data become available and as more treatments are considered. The editorial teams of all three journals welcome original COVID-19 contributions spanning the entire spectrum from discovery to implementation. 

Image source: Getty Images

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