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BX 004

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Drug Profile

BX 004

Alternative Names: BX-004; BX004-A

Latest Information Update: 09 Nov 2025

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At a glance

  • Originator BiomX
  • Class Antibacterials; Bacteriophages
  • Mechanism of Action Cell death stimulants
  • Orphan Drug Status

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

    Yes - Pseudomonal infections
  • New Molecular Entity No

Highest Development Phases

  • Phase II Pseudomonal infections
  • Preclinical Bronchiectasis

Most Recent Events

  • 17 Oct 2025 BiomX addresses the FDA’s queries related to the third-party nebulizer used to deliver BX004. An additional FDA request for limited technical clarifications on the nebulizer has been addressed
  • 17 Oct 2025 BiomX plans a phase III trial for cystic fibrosis
  • 19 Aug 2025 The US FDA issues a clinical hold on a phase IIb trial for BX 004 in Cystic fibrosis (CF), with no mention of safety or efficacy concerns related to the BX 004

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