ReviewFrontiers in cellular and infection microbiology2025
Regulation of phage therapy medicinal products: developments, challenges, and opportunities.
Review in Frontiers in cellular and infection microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed.
- Anti-phage defense systems in bacteria: molecular mechanisms and their role in shaping phage therapy strategies.Molecular biology reports · 2026Review
- Phage Genomics and Bioinformatics in Therapeutic Development: Evidence Limits, Validation Gates, and Translational Decision-Making.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Prophage-Derived Molecules as Anti-Antibiotics (Basel, Switzerland) · 2026Review
- Bacteriophages as Phagobiotics: Scientific Rationale and Translational Boundaries for Gut Microbiome Modulation.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
- Artificial Intelligence in Bacteriophage Science: A Comprehensive Narrative Review of Applications, Challenges, and Translational Opportunities.Antibiotics (Basel, Switzerland) · 2026Review
- Bacteriophages as Therapeutic Agents for Pulmonary Infections: From Biological Principles to Clinical Applications.Pharmaceutics · 2026Review
- Review
- Precision Microbial Therapeutics for Infertility: Next-Generation Probiotics, Engineered Biologics and Translational Pathways.Microbial biotechnology · 2026Review
- Lipopolysaccharide-targeting treatments for multidrug-resistantExpert opinion on therapeutic targets · 2026Review
- Phage-quinolone synergy: mechanisms, clinical strategies, and translational prospects.Frontiers in microbiology · 2026Review
- Microbiotherapy: an emerging adjunct for burn wound healing.Frontiers in cellular and infection microbiology · 2026Review
- Phage therapy againstFrontiers in microbiology · 2026Review
- Gut microbiota dysbiosis: Pathogenic drivers and emerging phage-based therapeutics.AIMS microbiology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Due to their biological properties, bacteriophages represent a regulatory specialty and, at the same time, a challenge with regard to medicinal product approval. Established European guidelines on pharmaceutical quality, preclinical development, and clinical development are only partially applicable. The growing threat posed by infections with multidrug-resistant bacteria has not only boosted the development of bacteriophages for the treatment of bacterial infections in recent years but has also led to substantial progress in adapting regulatory requirements. In 2024, harmonized quality criteria for phage therapy medicinal products and active substances were implemented for the first time in the European Pharmacopoeia. Future European pharmaceutical legislation and recent national acts such as the German Medical Research Act are intended to enable exemptions that address the specific characteristics of phage therapeutics and open new regulatory pathways. Increasing amounts of data on clinical use of phage therapeutics are being published; however, the anticipated breakthrough in the form of a demonstration of efficacy in randomized controlled clinical trials has not yet been achieved. Growing experience with innovative phage preparations has been utilized to adjust regulatory requirements. On the path to approval of a defined phage therapy medicinal product, the evidence-based demonstration of efficacy and safety in randomized controlled clinical trials is the next and decisive step.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.