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BX 004

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Drug Profile

BX 004

Alternative Names: BX-004; BX004-A

Latest Information Update: 28 Aug 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

  • 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
  • 18 Aug 2025 Phase-II clinical trials in Pseudomonal infections in Spain (Inhalation) (EUCT2024-519856-94-00)
  • 14 Jul 2025 BiomX anticipates feedback from the US FDA regarding the plans on the analyses of real-world evidence to link bacterial reduction to clinical outcomes of BX 004, in the second half of 2025

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