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fusidic acid [Verutex]
fusidic acid [Verutex] is a Bacterial protein synthesis inhibitor Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Bacterial infections, including osteomyelitis and septic arthritis.
Fusidic acid inhibits bacterial protein synthesis by binding to the elongation factor G.
Fusidic acid inhibits bacterial protein synthesis by binding to the elongation factor G. Used for Bacterial infections, including osteomyelitis and septic arthritis.
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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. -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | fusidic acid [Verutex] |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Bacterial protein synthesis inhibitor |
| Target | Elongation factor G |
| Modality | Small molecule |
| Therapeutic area | Infectious diseases |
| Phase | Phase 3 |
Mechanism of action
This action prevents the translocation of peptidyl-tRNA from the A site to the P site on the ribosome, thereby inhibiting the elongation of the polypeptide chain. As a result, bacterial protein synthesis is halted, leading to cell death.
Approved indications
- Bacterial infections, including osteomyelitis and septic arthritis
Common side effects
- Gastrointestinal disturbances
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- fusidic acid [Verutex] CI brief — competitive landscape report
- fusidic acid [Verutex] updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about fusidic acid [Verutex]
What is fusidic acid [Verutex]?
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Related
- Drug class: All Bacterial protein synthesis inhibitor drugs
- Target: All drugs targeting Elongation factor G
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Infectious diseases
- Indication: Drugs for Bacterial infections, including osteomyelitis and septic arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing