Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial.
Summary
In a 591-participant, double-blind phase 3 trial, a single 40 mg oral dose of suraxavir marboxil significantly reduced time to alleviation of influenza symptoms (median 42 vs 63 h) and accelerated viral load decline compared with placebo. Safety and secondary outcomes, including systemic and respiratory symptoms, supported clinical benefit across uncomplicated influenza A/B.
Key Findings
- Single 40 mg dose reduced time to alleviation of influenza symptoms (median 42.0 h vs 63.0 h; P=0.002).
- More rapid viral load decline by day 1 post-dose (mean −2.2±1.3 vs −1.3±1.7 log units vs placebo).
- Efficacy observed across uncomplicated influenza A and B in otherwise healthy outpatients.
Clinical Implications
A single oral dose could streamline treatment, improve adherence, and reduce transmission windows; comparative studies vs active antivirals and high-risk populations will inform guidelines.
Why It Matters
Demonstrates efficacy of a single-dose, novel PA endonuclease inhibitor against influenza, potentially changing outpatient management with simplified dosing and rapid virologic effects.
Limitations
- Trial conducted in China; generalizability to diverse global populations and high-risk groups requires study
- No active comparator against oseltamivir/baloxavir; limited data on hospitalization or complications
Future Directions
Head-to-head trials versus standard antivirals, evaluation in high-risk and elderly populations, resistance surveillance (PA variants), and health-economic analyses of single-dose strategies.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized, double-blind, placebo-controlled phase 3 clinical trial
- Study Design
- OTHER