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Bacteriophage Therapy: Discovery, Development, and FDA Approval Pathways.

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Bibliographic Details
Title: Bacteriophage Therapy: Discovery, Development, and FDA Approval Pathways.
Authors: Niazi, Sarfaraz K.
Source: Pharmaceuticals (14248247); Aug2025, Vol. 18 Issue 8, p1115, 43p
Subject Terms: BACTERIOPHAGES, DRUG resistance in microorganisms, BIOLOGY, DRUG approval, CLINICAL trials, THERAPEUTICS, SCIENTIFIC method, MULTIDRUG resistance in bacteria
Geographic Terms: UNITED States
Company/Entity: UNITED States. Food & Drug Administration
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. [ABSTRACT FROM AUTHOR]
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Database: Biomedical Index
Description
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. [ABSTRACT FROM AUTHOR]
ISSN:14248247
DOI:10.3390/ph18081115