Trial reportClinical pharmacokinetics2024
Population Pharmacokinetics of Ensitrelvir in Healthy Participants and Participants with SARS-CoV-2 Infection in the SCORPIO-SR Study.
Trial report in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- A Phase 3 Study of Ensitrelvir in Japanese Participants Aged 6-11 Years with SARS-CoV-2 Infection.Journal of the Pediatric Infectious Diseases Society · 2026Trial
- Prospective Study of Treatment with Ensitrelvir for COVID-19 in Patients Undergoing Hemodialysis (PROTECT-HD).Infectious diseases and therapy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEnsitrelvir, a novel oral inhibitor of the 3C-like protease of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has shown efficacy and safety in participants with mild to moderate coronavirus disease 2019 (COVID-19) with once-daily multiple doses of 375 mg on day 1 followed by 125 mg on days 2-5. The aims of this study were to characterize the pharmacokinetics of ensitrelvir and to explore its exposure-response relationships on the dose regimen.
methodsPharmacokinetic data, including 8034 plasma concentration datasets from 2060 participants, from two phase I and one phase II/III study in healthy participants and participants infected with SARS-CoV-2 were used to develop a population pharmacokinetic model. The correlation between exposure and drug response was evaluated using observed plasma concentrations and estimated pharmacokinetic parameters as pharmacokinetic indexes and viral RNA as drug response.
resultsA two-compartment model with a first-order absorption model effectively described plasma ensitrelvir concentrations. The effects of body weight on clearance and volume of distribution and of food conditions and formulation on the absorption rate constant were selected as significant covariates. The efficacy indexes changed in the active group, but the responses were similar across the exposure range in the phase II/III study (SCORPIO-SR) regardless of the effects of the pharmacokinetic covariates.
conclusionPopulation pharmacokinetics revealed that body weight is the most important covariate in the pharmacokinetics of ensitrelvir. The antiviral effect, independent of ensitrelvir exposure, was demonstrated on the current dose regimen for treatment of SARS-CoV-2 infection.
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