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8-Fluoroerythromycin (FLURITHROMYCIN)
8-Fluoroerythromycin (generic name: FLURITHROMYCIN) is a flurithromycin drug. It is currently in Phase 2 development.
Flurithromycin works by binding to the bacterial ribosome and inhibiting the action of the 50S subunit, thereby preventing the synthesis of essential bacterial proteins.
8-Fluoroerythromycin, also known as Flurithromycin, is a small molecule antibiotic belonging to the drug class of flurithromycin. Its exact target is unknown, but it is believed to work by inhibiting bacterial protein synthesis. Flurithromycin is not FDA-approved for any indications, and its commercial status is unclear. As a result, there is limited information available on its safety profile and pharmacokinetic properties. Further research is needed to fully understand the potential benefits and risks of this antibiotic.
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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 | FLURITHROMYCIN |
|---|---|
| Drug class | flurithromycin |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells are like factories that make proteins to keep you healthy. Bacteria are like tiny factories that make proteins to harm you. Flurithromycin is a special tool that blocks the bacterial factories from making proteins, ultimately killing the bacteria and helping to fight off infections.
Approved indications
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- 8-Fluoroerythromycin CI brief — competitive landscape report
- 8-Fluoroerythromycin updates RSS · CI watch RSS
Frequently asked questions about 8-Fluoroerythromycin
What is 8-Fluoroerythromycin?
How does 8-Fluoroerythromycin work?
What is the generic name of 8-Fluoroerythromycin?
What drug class is 8-Fluoroerythromycin in?
What development phase is 8-Fluoroerythromycin in?
Related
- Drug class: All flurithromycin drugs
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing