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Bifazol (BIFONAZOLE)
Bifazol (generic name: BIFONAZOLE) is a bifonazole drug. It is currently in Phase 3 development.
Bifazol works by inhibiting the enzyme steroid 17-alpha-hydroxylase/17,20 lyase, which is involved in the production of steroids in the body.
Bifazol is a small molecule inhibitor of the enzyme lanosterol 14-alpha demethylase. It is classified as a drug in the inhibitor class and has synonyms such as BAY H 4502, BAY-H-4502, BIFONAZOL, BIFONAZOLE, and BIFONAZOLE.
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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 | BIFONAZOLE |
|---|---|
| Drug class | bifonazole |
| Target | Indoleamine 2,3-dioxygenase 1, Lanosterol 14-alpha demethylase, Cytochrome P450 3A4 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Think of it like a traffic cop: bifazol blocks the enzyme that helps make certain steroids, which can contribute to fungal infections. By blocking this enzyme, bifazol reduces the amount of steroids available to the fungus, making it harder for the infection to grow and spread.
Approved indications
Common side effects
Key clinical trials
- Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1% (PHASE4)
- Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo (PHASE2)
- Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste (PHASE3)
- Efficacy and Safety of RV4104A Ointment in Onychomycosis (NA)
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:
- Bifazol CI brief — competitive landscape report
- Bifazol updates RSS · CI watch RSS
Frequently asked questions about Bifazol
What is Bifazol?
How does Bifazol work?
What is the generic name of Bifazol?
What drug class is Bifazol in?
What development phase is Bifazol in?
What does Bifazol target?
Related
- Drug class: All bifonazole drugs
- Target: All drugs targeting Indoleamine 2,3-dioxygenase 1, Lanosterol 14-alpha demethylase, Cytochrome P450 3A4
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing