Effective, but Safe? Physiologically Based Pharmacokinetic (PBPK)-Modeling-Based Dosing Study of Molnupiravir for Risk Assessment in Pediatric Subpopulations.

ABSTRACT: Despite the end of COVID-19 pandemic, only intravenous remdesivir was approved for treatment of vulnerable pediatric populations. Molnupiravir is effective against viruses beyond SARS-CoV-2 and is orally administrable without CYP-interaction liabilities but has a burden of potential bone or cartilage toxicity, observed at doses exceeding 500 mg/kg/day in rats. Especially, activity of molnupiravir against viruses, such as Ebola, with high fatality rates and no treatment option warrants the exploration of potentially effective but safe doses for pediatric populations, i.e., neonates (0-27 days), infants (1-12 months), and children in early childhood (1-12 years). The bone and cartilage toxicity risk for these populations based on the preclinical results has not been systematically investigat

SUBMITTER: Mishra S 

PROVIDER: S-EPMC11651168 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature