ArticleFrontiers in pharmacology2025
Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Anti-phage defense systems in bacteria: molecular mechanisms and their role in shaping phage therapy strategies.Molecular biology reports · 2026Review
- The application of the CRISPR-Cas system in Pseudomonas aeruginosa infections.Molecular biology reports · 2026Review
- Review
- The Therapeutic Potential of Phages in Multi-Drug Resistance Infections and Future Directions.Viruses · 2026Review
- Bacteriophage therapy for antimicrobial-resistant, biofilm‑associated diabetic foot infection: delivery routes, phage antibiotic synergy, and practical wound‑care integration.Archives of microbiology · 2026Review
- Bacteriophages as Phagobiotics: Scientific Rationale and Translational Boundaries for Gut Microbiome Modulation.Viruses · 2026Review
- Regenerative Microbiology: Harnessing Bacterial Antagonism and Spatiotemporal Signaling for Diabetic Wound Repair.Smart medicine · 2026Review
- Artificial Intelligence in Bacteriophage Science: A Comprehensive Narrative Review of Applications, Challenges, and Translational Opportunities.Antibiotics (Basel, Switzerland) · 2026Review
- Bacteriophages as Potential Sustainable Alternatives to Antibiotics for ControllingAntibiotics (Basel, Switzerland) · 2026Review
- Helicobacter pylori phages: resource landscape, translational challenges, and engineered antibacterial strategies.Archives of microbiology · 2026Review
- Phage Therapy Beyond Static Pharmaceuticals: A Framework for Controlled Evolutionary Platforms.Viruses · 2026Review
- Disease-Causing Mechanisms and Therapeutic Targets in Infectious Diseases: Implications for Clinical Management and Public Health.Biomedicines · 2026Review
- The Evolving Microbial Paradigm in Acne.Biomolecules · 2026Review
- Phage-Based Approaches to ChronicAntibiotics (Basel, Switzerland) · 2026Review
- Autoimmune disease-associated pathobionts: mechanisms and therapeutic potential of phage-based approaches.Frontiers in immunology · 2026Review
- Skin microbiome and cutaneous aging mechanisms and clinical implications.Frontiers in microbiology · 2026Review
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recently, there have been growing expectations that treatment of infections with bacteriophages (phages), viruses which specifically infect bacteria, can be used as a treatment option for antimicrobial resistant bacterial infections. In Europe and the United States, in addition to phage therapy as a form of personalized medicine, development of pre-defined phage therapy medicinal products (PTMPs) is progressing, and clinical trials are underway. From October 2024 to July 2025, the Pharmaceuticals and Medical Devices Agency exchanged opinions on trends and points to consider in drug development of PTMPs used for antimicrobial resistant bacterial infections with external experts. Development of PTMPs for regulatory approval requires quality control strategies, establishment of manufacturing methods, non-clinical evaluations, and clinical trial plans based on the characteristics of the phage. In this document, based on the regulatory and development trends in Europe and the United States, the current considerations on quality, non-clinical evaluation, and clinical trial planning including the Cartagena Act in the development of PTMPs in Japan are summarized. The basic concepts presented here are intended to be applied to antimicrobial resistant bacterial infections targeted by PTMPs but can be mostly applicable to bacterial infections in general. We hope that these findings will further accelerate more active development of PTMPs towards timely patient access to innovative products.
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