To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection

Summary

This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection

Timeline

Start

2022-07-28

Primary completion

2023-04-25

Completion

2023-10-31

Outcome

Met primary endpoint

paper The median TTAS was significantly shorter in the group that received suraxavir marboxil compared to the placebo group (42.0 h versus 63.0 h, P = 0.002). PMID 39775042 ↗

Publications

• Wang Y, Wang H, Zhang Y, Ma A, Liu D, Li X, Yang G, Deng M, Wang S, Liu Y, Liu C, Ge F, Wang S, Yu Y, Feng G, Xiao Z, Li X, Sun Y, Chen X, Cao Z, Ding Y, Wu X, Wei J, Cao B. Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2025 Feb;31(2):639-646. doi: 10.1038/s41591-024-03419-3. Epub 2025 Jan 7.

Drugs

Indications