ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection

Summary

The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection. The main aim to answer: * Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study. * Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza. Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days. Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo.

Timeline

Start

2022-12-07

Primary completion

2023-10-08

Completion

2024-01-22

Outcome

Met primary endpoint

paper 50·0 h (95% CI, 44·6 to 59·3) with ADC189, as compared with 68·1 h (95% CI, 62·8 to 84·4) with placebo (p<0·0001). PMID 40089214 ↗

release “Phase III clinical trial of their anti-influenza innovative drug, Deunoxavir Marboxil Tablets (ADC189), has achieved its primary endpoint with significant efficacy and safety results.” simcere.com ↗

Publications

• Zhao J, Sheng G, Lyu Y, Sun Y, Wang S, Chen X, Ye F, Chen L, Xu X, Wang H, Wu B, Peng C, Deng M, Qu L, Jiang X, Hu J, Feng Y, Li Y, Peng J, Li W, Shao L, Gao F, Tian D, Tan J, Zheng H, Chen M, Wu H, Zhu X, Zhou M, Qu J. Oral ADC189 for adults and adolescents with uncomplicated influenza. J Infect. 2025 Apr;90(4):106472. doi: 10.1016/j.jinf.2025.106472. Epub 2025 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADC189	Unknown	15 mg	Oral
Subject	ADC189	Unknown	45 mg	Oral

Indications

No indication recorded.