Trial

Sudapyridine (WX-081) in RR/MDR/XDR TB Patients (WISH)

Study Director
Lei Li
Start Date
9 / 2022
Trial Phase
Phase III
Trial Status
enrolling
Current Enrollment
320 (September 2024)
Target Enrollment
450
Overview

The objective of this study is to demonstrate that the antibacterial activity of Sudapyridine (WX-081) is not inferior to Bedaquiline when added to a Background Regimen (BR) for treatment of rifampicin- resistant TB. Also, safety and clinical outcome will be evaluated.

This is a multicenter, randomized, double-blind, positive-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with background medication (BR) in patients with rifampicin-resistant tuberculosis.

Participant Group/Arm  Intervention/Treatment 
Experimental: Sudapyridine arm
  • Drug: Sudapyridine
    • Two weeks of loading dose followed by twenty-two weeks of maintenance dose
  • Drug: Background regimen (BR) for RR-TB 
    • Background regimen (BR) for RR-TB selected according to WHO and local guidelines for up to 72 weeks.
Active Comparator: Bedaquiline arm
  • Drug: Bedaquiline
    • Two weeks of loading dose followed by twenty-two weeks of maintenance dose
  • Drug: Background regimen (BR) for RR-TB
    • Background regimen (BR) for RR-TB selected according to WHO and local guidelines for up to 72 weeks.
Registry Link
Developer Associations
Shanghai Jiatan Pharma
Compound Associations
Sudapyridine (WX-081)