Last reviewed · How we verify
mycobacteriophage
mycobacteriophage is a Biologic drug developed by National Jewish Health. It is currently in Phase 2 development.
Mycobacteriophages are viruses that specifically infect mycobacteria, a group of bacteria that includes the causative agent of tuberculosis. Mycobacteriophages have been studied as a potential treatment for various mycobacterial infections, including Cystic Fibrosis and Nontuberculous Mycobacterial Lung Disease, in clinical trials.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | mycobacteriophage |
|---|---|
| Sponsor | National Jewish Health |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection (PHASE1)
- Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection (PHASE1)
- Biomarkers of Phage Treatment Response in NTM and Other Infections
- Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
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:
- mycobacteriophage CI brief — competitive landscape report
- mycobacteriophage updates RSS · CI watch RSS
- National Jewish Health portfolio CI
Frequently asked questions about mycobacteriophage
What is mycobacteriophage?
Who makes mycobacteriophage?
What development phase is mycobacteriophage in?
Related
- Manufacturer: National Jewish Health — full pipeline
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing