ArticleEuropean journal of drug metabolism and pharmacokinetics2026
Pharmacokinetics, Safety, and Tolerability of Obeldesivir in Healthy Japanese and White Participants.
Article in European journal of drug metabolism and pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
objectiveObeldesivir is an orally administered prodrug of the nucleoside GS-441524. In vitro and preclinical studies have shown that obeldesivir can inhibit severe acute respiratory syndrome coronavirus 2, respiratory syncytial virus, and filoviruses with a high barrier to resistance. Prior population pharmacokinetic modeling has shown that certain factors, such as coronavirus disease 2019 (COVID-19), body weight, and renal function, can impact GS-441524 exposure. This study aimed to evaluate the pharmacokinetics and safety of obeldesivir in Japanese and white participants.
methodsIn this phase 1 study, healthy Japanese and white participants in the USA who were aged 18-65 years, were nonsmokers, had a body mass index of 18.0-30.0 kg/m
conclusionsPlasma pharmacokinetic exposures of GS-441524 were higher in Japanese participants compared with white participants but were within the ranges observed in previous phase 1 studies. Differences in body weight between the populations in the study likely contributed to the increases in exposure. Obeldesivir was generally safe and well tolerated in both Japanese and white participants. These findings indicate that obeldesivir is likely to have favorable pharmacokinetic exposures and safety across different racial populations, supporting its potential use in treating multiple viral infections.
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