Year: 2025
Type: review
Abstract: The escalating global crisis of antimicrobial resistance, responsible for approximately 1.27 million deaths in 2019, has catalyzed renewed interest in bacteriophage therapy as a viable therapeutic alternative. With projections indicating that drug-resistant bacteria could cause over 39 million deaths worldwide by 2050, developing alternative antimicrobial strategies has become critically urgent. This comprehensive review examines the scientific foundation of bacteriophage therapy, traces its historical development from early Soviet applications through contemporary regulatory frameworks, and provides strategic guidance for developers seeking FDA approval for bacteriophage-based therapeutics. We analyze the current regulatory landscape across major jurisdictions, including manufacturing requirements and clinical development pathways essential for successful market authorization. Approximately 90 clinical trials involving bacteriophages are ongoing worldwide, with 41 studies in the United States demonstrating significant momentum in this field.
Source: Pharmaceuticals
DOI: 10.3390/ph18081115
Author: Sarfaraz K. Niazi
Institution: University of Illinois Chicago
Language: English
Subfield: Virology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,499
OpenAlex ID: W4412689472