Reproductive and developmental safety of nirmatrelvir (PF-07321332), an oral SARS-CoV-2 M^pro inhibitor in animal models.

ABSTRACT: Nirmatrelvir (PF-07321332; NMV) the antiviral component of PAXLOVID™ is a potent and selective inhibitor of the SARS-CoV-2 main protease (M^pro), which plays a critical role in viral replication. PAXLOVID, comprised of nirmatrelvir and ritonavir (used as a pharmacokinetic enhancer), is an oral therapy currently in development as a therapeutic option for those infected with SARS-CoV-2 to prevent progression to severe disease, hospitalization, and death. PAXLOVID has been shown to be efficacious against hospitalization and death in two Phase 2/3 clinical studies that evaluated non hospitalized patients both with and without high risk factors for progression to severe illness. Given that males and females of reproductive age are included in the intended patient population, we assess

SUBMITTER: Catlin NR 

PROVIDER: S-EPMC8801796 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature