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A second international phase III non-inferiority, pivotal trial to study ibezapolstat for the treatment of C. difficile Infection.

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Trial Profile

A second international phase III non-inferiority, pivotal trial to study ibezapolstat for the treatment of C. difficile Infection.

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2025

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At a glance

  • Drugs Ibezapolstat (Primary) ; Vancomycin
  • Indications Clostridium difficile infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Acurx Pharmaceuticals

Most Recent Events

  • 09 Jun 2025 According to an Acurx Pharmaceuticals media release, information package submitted to EMA by the Company to which agreement has been reached with EMA included details on two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from EMA and FDA, company is well positioned to commence international Phase 3 trials.
  • 06 Jan 2025 According to an Acurx Pharmaceuticals media release, the company announced that it has received positive regulatory guidance from the EMA during its Scientific Advice Procedure that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted supports advancement of the ibezapolstat Phase 3 program.
  • 09 Dec 2024 According to an Acurx Pharmaceuticals media release, is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada.

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