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Bacteriophage
Bacteriophage is a Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development. Also known as: ShigActive, Sextaphag, WPP-201- Bacteriophage.
Bacteriophages are viruses that infect and replicate within bacteria, composed of proteins that encapsulate a DNA or RNA genome. Bacteriophages have been studied in clinical trials for various conditions, including trauma injury, brain injuries, abdominal sepsis, pancreatitis, and meningitis, as a potential treatment or decontamination method.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Bacteriophage |
|---|---|
| Also known as | ShigActive, Sextaphag, WPP-201- Bacteriophage |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia (PHASE1)
- Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia (PHASE1, PHASE2)
- A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) (PHASE2)
- Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus (PHASE1, PHASE2)
- Bacteriophages in Addition to Antibiotics for the Treatment of Patients With Infective Endocarditis (PHASE3)
- Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection (PHASE1, PHASE2)
- Natural Product System and Lifestyle Modification (NA)
- Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bacteriophage CI brief — competitive landscape report
- Bacteriophage updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about Bacteriophage
What is Bacteriophage?
Who makes Bacteriophage?
Is Bacteriophage also known as anything else?
What development phase is Bacteriophage in?
Related
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Also known as: ShigActive, Sextaphag, WPP-201- Bacteriophage
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing