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Ibezapolstat - Acurx Pharmaceuticals

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Drug Profile

Ibezapolstat - Acurx Pharmaceuticals

Alternative Names: 362E; ACX-362E; GLS-362E; MorE-DCBG

Latest Information Update: 29 Feb 2024

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At a glance

  • Originator GLSynthesis
  • Developer Acurx Pharmaceuticals
  • Class Antibacterials; Chlorobenzenes; Morpholines; Purines; Pyrimidines; Small molecules
  • Mechanism of Action DNA polymerase III inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Clostridium difficile infections

Most Recent Events

  • 27 Feb 2024 Acurx Pharmaceuticals plans an End of phase II meeting with the US FDA to finalise the phase III development plan for Clostridium difficile infections in late April 2024
  • 26 Feb 2024 Acurx Pharmaceuticals submits its pre-meeting information Meeting Package (or Briefing Document) to the US FDA for its phase III trial for Clostridium difficile infections
  • 14 Feb 2024 The US FDA grants an End of phase II meeting to discuss the overall phase III development plan to support an NDA filing for ibezapolstat for Clostridium difficile infections
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