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Efinaconazole Topical
Efinaconazole Topical is a Triazole antifungal Small molecule drug developed by Western University of Health Sciences. It is currently in Phase 3 development for Onychomycosis (fungal nail infection).
Efinaconazole is a triazole antifungal that inhibits fungal lanosterol 14α-demethylase, disrupting ergosterol synthesis in fungal cell membranes.
Efinaconazole Topical is a small molecule inhibitor of lanosterol 14-alpha demethylase, classified as an INHIBITOR. It is used to treat conditions such as onychomycosis of the toenail, onychomycosis, and dermatophytosis.
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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 | Efinaconazole Topical |
|---|---|
| Sponsor | Western University of Health Sciences |
| Drug class | Triazole antifungal |
| Target | Lanosterol 14α-demethylase (CYP51) |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
By blocking the cytochrome P450-dependent enzyme lanosterol 14α-demethylase, efinaconazole prevents the conversion of lanosterol to ergosterol, a critical component of fungal cell membranes. This leads to accumulation of toxic sterol precursors and membrane destabilization, ultimately causing fungal cell death. The topical formulation allows high local concentrations at the site of infection while minimizing systemic exposure.
Approved indications
- Onychomycosis (fungal nail infection)
Common side effects
- Application site erythema
- Application site pruritus
- Nail discoloration
- Contact dermatitis
Key clinical trials
- A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails (PHASE2)
- Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis (PHASE4)
- Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis (PHASE4)
- Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients (PHASE3)
- Study Evaluating the Effect of Jublia on Dermatophytomas (PHASE4)
- Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish (PHASE4)
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:
- Efinaconazole Topical CI brief — competitive landscape report
- Efinaconazole Topical updates RSS · CI watch RSS
- Western University of Health Sciences portfolio CI
Frequently asked questions about Efinaconazole Topical
What is Efinaconazole Topical?
How does Efinaconazole Topical work?
What is Efinaconazole Topical used for?
Who makes Efinaconazole Topical?
What drug class is Efinaconazole Topical in?
What development phase is Efinaconazole Topical in?
What are the side effects of Efinaconazole Topical?
What does Efinaconazole Topical target?
Related
- Drug class: All Triazole antifungal drugs
- Target: All drugs targeting Lanosterol 14α-demethylase (CYP51)
- Manufacturer: Western University of Health Sciences — full pipeline
- Therapeutic area: All drugs in Dermatology / Infectious Disease
- Indication: Drugs for Onychomycosis (fungal nail infection)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing