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A Phase 3 trial of oral MRX-1 to treat complicated skin and skin structure infections (cSSSI) in China

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Trial Profile

A Phase 3 trial of oral MRX-1 to treat complicated skin and skin structure infections (cSSSI) in China

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Contezolid (Primary) ; Linezolid
  • Indications Bacterial infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Sponsors MicuRx Pharmaceuticals

    • Most Recent Events

    • 03 Jun 2021 According to a MicuRx Pharmaceuticals media release, the China National Medical Products Administration (NMPA) has approved new drug application for contezolid as the treatment of complicated skin and soft tissue infection, based on data from this trial.
    • 19 Sep 2019 Primary endpoint (Noninferiority compared to linezolid for the Clinical cure rate at the test-of-cure visit (TOC visit, 7-14 days after the last dose of study drug)) has been met, according to the MicuRx Pharmaceuticals media release.
    • 19 Sep 2019 According to a MicuRx media release, the company plan to file a New Drug Application with the National Medical Products Administration (NMPA) of China in the 4th quarter of 2019.
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