A phase Ⅱ clinical study on the early bactericidal activity, safety, and tolerability of oral sudapyridine (WX-081) tablets in patients with newly diagnosed drug-susceptible and drug-resistant pulmonary tuberculosis

doi:10.19983/j.issn.2096-8493.20260098

Abstract

Abstract:

Background: Drug-resistant tuberculosis (TB) is a significant global public health challenge, with treatment regimens often characterized by long durations and numerous adverse effects. Sudapyridine (WX-081) is China’s first Class Ⅰ novel anti-tuberculosis drug, demonstrating good anti-tuberculosis activity and better safety compared to bedaquiline. Methods: This study is a national, randomized, controlled, multicenter Phase Ⅱ clinical trial, aiming to evaluate the early bactericidal activity, safety, and tolerability of oral sudapyridine tablets in patients with newly diagnosed drug-susceptible and drug-resistant pulmonary tuberculosis, and to preliminarily assess its effectiveness in patients with drug-resistant tuberculosis. The study collects data on sputum colony-forming units and time to positivity during monotherapy and early treatment with the new drug regimen, observing trends and comparing them with classic treatment regimens to evaluate anti-tuberculosis activity. Safety and tolerability data are also collected during treatment to assess the safety of the drug. Discussion: This study aims to validate the new anti-tuberculosis drug and optimize treatment regimens for drug-resistant pulmonary tuberculosis. By ensuring anti-tuberculosis activity while improving drug safety, it provides theoretical basis and clinical data to increase the cure rate of drug-resistant pulmonary tuberculosis.

Key words: Antitubercular agents, Tuberculosis, multidrug-resistant, Randomized controlled trial, Sudapyridine

CLC Number:

R521

Zeng Chunmei, Lu Qingxia, Nie Wenjuan, Zhu Qingdong, Chu Naihui, Zhu Fengmei. A phase Ⅱ clinical study on the early bactericidal activity, safety, and tolerability of oral sudapyridine (WX-081) tablets in patients with newly diagnosed drug-susceptible and drug-resistant pulmonary tuberculosis[J]. Journal of Tuberculosis and Lung Disease, 2026, 7(5): 574-580. doi: 10.19983/j.issn.2096-8493.20260098

Figures/Tables 3

研究期	筛选期		住院期																		随访
访视	访视1	访视2 (电话)	住院药物治疗前		住院药物治疗阶段														住院药物治疗后		访视3
研究时间	-D14~ -D3	-D14~ -D3	-D2	-D1	D1	D2	D3	D4	D5	D6	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D28
知情同意书签署	√
入选/排除标准	√
人口统计学资料	√
肺结核病史及药物治疗史	√
其他疾病史及药物治疗史^a	√
告知入院或药物洗脱^b		√
随机化分组			√
体格检查	√			√															√
生命体征	√			√	√	√	√	√	√	√	√	√	√	√	√	√	√	√
身高	√
体质量	√			√															√
12导联心电图	√			√							√								√
胸部CT平扫	√
血常规	√				√						√								√
尿液分析	√				√						√								√
粪常规+隐血	√																		√
尿妊娠试验^c	√				√
HIV及乙肝五项	√
电解质(Na、K、Cl、Ca、Mg、P)	√				√														√
血肌酐、血尿素氮和估算肾小球滤过率^d	√				√						√								√
血尿酸	√				√						√								√
肝功能检查(谷草转氨酶/谷丙转氨酶/总胆红素/碱性磷酸酶/谷氨酰转肽酶)	√				√						√								√
血淀粉酶					√														√
糖化血红蛋白(HbA1c)	√
血脂(甘油三酯、总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇)、空腹血糖	√				√														√
肌钙蛋白-Ⅰ					√														√
痰液采集^e	√			√	√	√	√	√	√	√	√	√		√		√		√
药代动力学血样采集					√													√	√	√
药物治疗					√	√	√	√	√	√	√	√	√	√	√	√	√	√
研究期间合并用药	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√
不良事件	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√

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