A phase I study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of suraxavir marboxil: a novel oral antiviral for influenza
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT Suraxavir marboxil (GP681, abbreviated as suraxavir) is a novel, orally active small-molecule polymerase acidic (PA) inhibitor for the treatment of influenza. Its active metabolite, GP1707D07, specifically inhibits PA endonuclease activity. Suraxavir has been approved for use in adolescents (≥12 years) and adults with uncomplicated influenza A and B. This non-randomized, open-label, parallel-group phase I clinical trial evaluated the effects of hepatic impairment on the pharmacokinetics (PK) and safety of suraxavir. Subjects with mild or moderate hepatic impairment and matched healthy controls ( n = 8 per group) received a single oral dose of 40 mg suraxavir. PK parameters, including maximum plasma concentration (C max ), area under the plasma concentration–time curve from time 0 to last time point of measurable concentration (AUC 0– t ), and area under the plasma concentration–time curve from time 0 to infinity (AUC 0–∞ ), were compared. Compared with subjects with normal hepatic function, the least-squares geometric mean ratios (90% CI) of GP1707D07 in subjects with mild hepatic impairment were 101.50% (72.63%–141.83%) for C max , 86.98% (69.80%–108.38%) for AUC 0– t , and 87.06% (70.57%–107.40%) for AUC 0–∞ . In subjects with moderate impairment, the corresponding ratios were 203.63% (147.50%–281.13%) for C max , 155.23% (129.11%–186.64%) for AUC 0– t , and 157.26% (131.39%–188.22%) for AUC 0–∞ . Mild impairment had minimal effect on GP1707D07 exposure, while moderate impairment increased C max and AUC by ~1-fold and 0.5-fold, respectively, without resulting in clinically significant changes. A single 40-mg dose of suraxavir was safe and well tolerated in subjects with mild or moderate hepatic impairment. No dose adjustment is required for these populations. CLINICAL TRIALS This study is registered with ClinicalTrials.gov as NCT05814926 .
DOI: 10.1128/aac.01668-25
Authors: Jing Zhou, Shousheng Yan, Yan Zhao, Hong Zhang, Nanya Wang
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7140099158