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Cited by 56Bacteriophages and microbial interactionsVirus-based gene therapy researchPhotodynamic Therapy Research Studies

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Bacteriophage Therapy: Discovery, Development, and FDA Approval Pathways

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Niazi, Sarfaraz K.·2025·Pharmaceuticals
DOI 10.3390/ph18081115PMC PMC12389134
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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.

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  • Development and implementation of comprehensive regulatory standards for phage-based therapies remain an evolving challenge in the field.

    “Development and implementation of comprehensive regulatory standards for phage-based therapies remain an evolving challenge in the field [159,160]”

    From Phage therapy in oncology: opportunities for cancer prevention and treatment (2026) · cites this paper as [160]

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Cited by

Sorted by citations

Metadata

Authors
Niazi, S. K.
Affiliations
University of Illinois Chicago (US)
Corresponding author
Niazi, Sarfaraz K.
ORCID
Niazi, Sarfaraz K.
Venue
Pharmaceuticals
Publisher
MDPI AG
Published
2025-07-26
Volume
18
Issue
8
Pages
1115
ISSN
1424-8247 (ISSN-L)
DOI
10.3390/ph18081115
PMC
PMC12389134
OpenAlex
W4412689472
Cited by
56
References
4
Citations by year
2026: 51 · 2025: 5
FWCI
5.99
Type
journal article
Language
en
Open access
Licence
Locations
  • Pharmaceuticals (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Life Sciences › Immunology and Microbiology › Virology › Bacteriophages and microbial interactions
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Photodynamic Therapy Research Studies
Keywords
phage therapy, antimicrobial resistance, regulatory framework, drug-resistant bacteria

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