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Jublia (EFINACONAZOLE)
Jublia works by inhibiting the fungal enzyme lanosterol 14α-demethylase, which is essential for the production of ergosterol, a critical component of fungal cell membranes.
Jublia (efinaconazole) is a small molecule azole antifungal medication developed by Dow Pharma and currently owned by Bausch. It is used to treat onychomycosis, a fungal infection of the toenails, caused by Trichophyton mentagrophytes and other dermatophytes. Jublia was FDA-approved in 2014 and is available as a generic medication. As an azole antifungal, Jublia works by inhibiting the growth of fungal cells. It is a commercially available medication with multiple generic manufacturers.
At a glance
| Generic name | EFINACONAZOLE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Azole Antifungal [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2014 |
Mechanism of action
JUBLIA topical solution is an azole antifungal [see Microbiology (12.4)].
Approved indications
- Onychomycosis due to Trichophyton mentagrophytes
- Onychomycosis due to dermatophyte
- Onychomycosis of toenails
Common side effects
- Ingrown toenail
- Application site dermatitis
- Application site vesicles
- Application site pain
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)
- Real-World Evaluation of the Effect of Jublia on Nail Polish (NA)
- 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Jublia CI brief — competitive landscape report
- Jublia updates RSS · CI watch RSS
- Bausch Health portfolio CI