BX 004
Alternative Names: BX-004; BX004-ALatest Information Update: 11 Dec 2025
At a glance
- Originator BiomX
- Class Antibacterials; Bacteriophages
- Mechanism of Action Cell death stimulants
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Orphan Drug Status
Yes - Pseudomonal infections
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase II Pseudomonal infections
- Preclinical Bronchiectasis
Most Recent Events
- 08 Dec 2025 BiomX terminates a phase IIb trial in Pseudomonal infections in USA (Inhalation), following internal analysis and DMC feedback (NCT06998043)
- 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