ArticleInfectious diseases and therapy2026
Pharmacokinetics, Safety, and Exploratory Efficacy of Onradivir in Children with Acute Uncomplicated Influenza: A Multicenter, Dose-Ranging, Phase 2 Study.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06656026 (A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A
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Authors and funding
11 authors.
Funding
Abstract
introductionSeasonal influenza brings high morbidity and mortality in children, with current antivirals limited by low efficacy and rising resistance. Onradivir (ZSP1273), a polymerase basic protein 2 (PB2) cap-binding inhibitor effective in adults, remains unstudied in pediatric influenza A. This phase 2 study evaluated its safety, pharmacokinetics, and preliminary efficacy in affected children.
methodsThis multicenter randomized open-label phase 2 trial enrolled children under 18 years with confirmed influenza A at 31 Chinese sites. Participants were 1:1 randomized to 5-day high-dose or low-dose onradivir granules stratified by age and weight. Primary endpoints covered safety and steady-state pharmacokinetics; exploratory outcomes included symptom relief, fever resolution, viral kinetics, and exposure-response correlation.
resultsSeventy-two participants were enrolled and randomized; 70 entered the intention-to-treat infected population. The high-dose regimen achieved systemic exposures matching efficacious adult targets. Onradivir was well tolerated: most adverse events were mild or moderate, with no serious adverse events or adverse events leading to treatment discontinuations; gastrointestinal events were mild and infrequent. Median symptom alleviation was 28.6 h (95% confidence interval 17.9-59.1) high dose vs. 33.7 h (19.4-42.7) low dose. Influenza A viral ribonucleic acid declined rapidly, falling 1.5 log10 copies/ml at 24 h and 2.4 log10 copies/ml by day 5. No resistance-associated PB2 substitutions were detected. Analyses showed a flat exposure-response relationship across clinical and virological endpoints.
conclusionOnradivir was well tolerated, achieved adult-equivalent exposure, and was associated with rapid symptom resolution and viral suppression. These findings support the selected pediatric dosing strategy and warrant confirmatory comparative trials. TRIAL REGISTRATION NUMBER: NCT06656026.
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