ReviewFrontiers in microbiology2016
Adapting Drug Approval Pathways for Bacteriophage-Based Therapeutics.
Review in Frontiers in microbiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 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
84 citing papers in PubMed, 166 citations in OpenAlex.
- Strain-level molecular and infection traits are associated with differences in phage efficacy against Pseudomonas aeruginosa.Scientific reports · 2026Article
- Single Treatment of Mature 3D Single-, Dual- and Poly-Species Biofilms Using a Combination Therapy of Phage or Phage-Hetero-Cocktails and Ciprofloxacin.Antibiotics (Basel, Switzerland) · 2026Article
- Engineered Bacteriophages: A Next-Generation Platform for Precision Antimicrobials and Therapeutics.Viruses · 2026Review
- Phages as antimicrobials against multi-drug resistant bacteria.Frontiers in microbiology · 2026Review
- Environmental isolation and in vitro characterisation of bacteriophages active against multidrug-resistantLe infezioni in medicina · 2026Article
- [Bacteriophages for the treatment of musculoskeletal infections-An overview of clinical use, open questions, and legal framework].Orthopadie (Heidelberg, Germany) · 2025Article
- Reconstructing the Antibiotic Pipeline: Natural Alternatives to Antibacterial Agents.Biomolecules · 2025Review
- Marine Bacteriophages as Next-Generation Therapeutics: Insights into Antimicrobial Potential and Application.Viruses · 2025Review
- Article
- Advances in Gene Therapy with Oncolytic Viruses and CAR-T Cells and Therapy-Related Groups.Current issues in molecular biology · 2025Review
- Delivering living medicines with biomaterials.Nature reviews. Materials · 2025Article
- Antibiotic Resistance ofPharmaceuticals (Basel, Switzerland) · 2025Review
- Isolation and genomic analysis of phage BUCT551 against drug-resistantFrontiers in veterinary science · 2025Article
- Phage-Derived Endolysins Against Resistant Staphylococcus spp.: A Review of Features, Antibacterial Activities, and Recent Applications.Infectious diseases and therapy · 2025Review
- Bacteriophage as a potential biotherapeutics to combat present-day crisis of multi-drug resistant pathogens.Heliyon · 2024Review
- A Comprehensive Review on Phage Therapy and Phage-Based Drug Development.Antibiotics (Basel, Switzerland) · 2024Review
- Article
- Phage K exposure generates phage-neutralizing activity in a rabbit model-humoral receptiveness may impact efficacy of phage therapy.Antimicrobial agents and chemotherapy · 2024Article
- Bacteriophage therapy for drug-resistantFrontiers in cellular and infection microbiology · 2024Review
- Activity of Bacteriophage D29 Loaded on Nanoliposomes against Macrophages Infected withDiseases (Basel, Switzerland) · 2023Article
24 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The global rise of multi-drug resistant bacteria has resulted in the notion that an "antibiotic apocalypse" is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long clinical history of phage therapy in Eastern Europe, combined with more recent in vitro and in vivo success, demonstrates the potential for whole phage or phage based antibacterial agents. To date, no whole phage or phage derived products are approved for human therapeutic use in the EU or USA. There are at least three reasons for this: (i) phages possess different biological, physical, and pharmacological properties compared to conventional antibiotics. Phages need to replicate in order to achieve a viable antibacterial effect, resulting in complex pharmacodynamics/pharmacokinetics. (ii) The specificity of individual phages requires multiple phages to treat single species infections, often as part of complex cocktails. (iii) The current approval process for antibacterial agents has evolved with the development of chemically based drugs at its core, and is not suitable for phages. Due to similarities with conventional antibiotics, phage derived products such as endolysins are suitable for approval under current processes as biological therapeutic proteins. These criteria render the approval of phages for clinical use theoretically possible but not economically viable. In this review, pitfalls of the current approval process will be discussed for whole phage and phage derived products, in addition to the utilization of alternative approval pathways including adaptive licensing and "Right to try" legislation.
Indexed as
Identifiers
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.