Brand Name

Jublia

Generic Name
Efinaconazole
View Brand Information
FDA approval date: June 06, 2014
Classification: Azole Antifungal
Form: Solution

What is Jublia (Efinaconazole)?

Dealing with toenail fungus can be a slow, stubborn, and often embarrassing battle. The sight of a thickened, discolored or brittle nail can make you feel self-conscious, especially in situations where you might want to be barefoot. For years, treating this common condition, known medically as onychomycosis, was a challenge. Oral medications carried the risk of systemic side effects, while many over-the-counter topical treatments struggled to penetrate the hard nail plate to reach the infection. This is where Jublia (efinaconazole) has made a significant impact.

Jublia is a modern prescription medication designed specifically to treat fungal infections of the toenails. It is not a pill; instead, it is a topical solution applied directly to the affected nail. Jublia belongs to a powerful class of drugs called azole antifungals. It represents a major advancement in topical therapy because of its chemical properties, which allow it to effectively penetrate the nail and attack the fungus at its source. For many people seeking to avoid oral medications, Jublia offers a safe, targeted, and effective way to clear the infection and regrow a healthy nail.

What does Jublia do?

Jublia is approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of onychomycosis of the toenails. Its one and only job is to kill the fungi (primarily dermatophytes) that cause these stubborn infections.

Jublia treatment aims for a complete cure: a clear nail with no fungus. Since the medication enables new, healthy nail growth to replace the infected one, visible results are gradual, not immediate.

The effectiveness of Jublia has been well-established in clinical trials. In these studies, after a full course of treatment (48 weeks), a significant percentage of patients achieved a completely clear nail. For instance, in two large studies, about 15-18% of patients using Jublia reached a complete cure, which was a substantially better outcome than for those who used a placebo (Bausch Health, 2020). While this number may seem modest, it represents a significant success for a topical-only treatment against a notoriously difficult-to-treat condition.

How does Jublia work?

To understand how Jublia works, it helps to know a little about the fungus itself. Like all living cells, the fungi that cause nail infections have a protective outer layer called a cell membrane. This membrane is essential for the fungus to hold its structure, function, and survive. A critical building block needed to construct this membrane is a substance called ergosterol.

Jublia’s mechanism of action is to stop the fungus from being able to make ergosterol. It does this by potently inhibiting a specific fungal enzyme called lanosterol 14α-demethylase. Think of this enzyme as a crucial factory worker on the assembly line that produces ergosterol. Jublia comes in and completely shuts down this worker’s station.

By blocking this enzyme, Jublia halts the production of ergosterol. Without this vital component, the fungus cannot build or maintain its cell membrane. The fungal cell becomes weak, leaky, and structurally unsound, which ultimately prevents it from growing and causes it to die. Jublia’s low keratin binding allows it to effectively penetrate the nail plate and reach the fungal infection in the nail bed.

Jublia side effects

One of the major advantages of Jublia is its excellent safety profile. Because it is a topical medication that is applied directly to the toenail, it is not significantly absorbed into the bloodstream. This means that systemic (whole-body) side effects are extremely rare. The side effects that do occur are almost always localized to the application area.

The most common side effects of Jublia are generally mild and may include:

  • Application site dermatitis: Redness, itching, rash, or irritation of the skin around the treated nail.
  • Ingrown toenail: This may occur as the new, healthy nail grows in.
  • Application site vesicles: Small blisters on the skin around the nail.
  • Pain at the application site.

Serious side effects are rare. Contact your doctor for persistent skin reactions. Seek immediate medical attention for severe allergic reactions like hives, face/throat swelling, or breathing difficulty.

Jublia dosage

Jublia is a topical solution with a built-in brush applicator. Apply once daily for 48 weeks (approx. 11 months). Consistency is key for this long treatment course.

For best results, apply Jublia to the entire affected toenail surface, including skin folds and under the nail tip. Let it dry before covering. Consistent application is crucial for success; skipping doses allows fungal regrowth. Jublia doesn’t require blood tests; your doctor will monitor progress visually at follow-up appointments.

Does Jublia have a generic version?

No, there is currently no FDA-approved generic version of Jublia (efinaconazole). It is a brand-name medication protected by patents. This means that for now, it is only available under the brand name Jublia. However, international versions may exist in other markets.

Conclusion

Jublia represents a major step forward in the topical treatment of toenail fungus, offering an effective and very safe option for patients who want to avoid oral antifungal medications. By directly targeting the fungus’s ability to survive and by effectively penetrating the nail, it provides a real chance for a complete cure and the satisfaction of watching a clear, healthy nail grow back.

The key to success with Jublia is patience and unwavering consistency. Adhering to the 48-week daily application schedule is essential. By partnering with your doctor or podiatrist and committing to the full course of therapy, you can take a confident and effective step toward resolving this frustrating condition for good.

References

  1. Bausch Health. (2020). JUBLIA® (efinaconazole) topical solution, 10% Prescribing Information. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203567s007lbl.pdf
  2. Mayo Clinic. (2024). Efinaconazole (Topical Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/efinaconazole-topical-route/symptoms/drg-20150334
  3. National Institutes of Health. (2022). Efinaconazole. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a614033.html

Brand Information

JUBLIA (efinaconazole)
1INDICATIONS AND USAGE
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to
2DOSAGE AND ADMINISTRATION
Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.
JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.
3DOSAGE FORMS AND STRENGTHS
JUBLIA (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of clear, colorless to pale yellow solution.
4CONTRAINDICATIONS
None.
5DRUG INTERACTIONS
In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
6DESCRIPTION
JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution for topical use. Each gram of JUBLIA contains 100 mg of efinaconazole. Efinaconazole is an azole antifungal with a chemical name of ((2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol). The structural formula for efinaconazole is represented below:
chemical structure
JUBLIA contains the following inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
7CLINICAL STUDIES
The safety and efficacy of once daily use of JUBLIA for the treatment of onychomycosis of the toenail were assessed in two 52-week prospective, multicenter, randomized, double-blind clinical trials in subjects 18 years and older (18 to 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. The trials compared 48 weeks of treatment with JUBLIA to the vehicle solution. The Complete Cure rate was assessed at Week 52 (4 weeks after completion of therapy). Complete cure was defined as 0% involvement of the target toenail (no clinical evidence of onychomycosis of the target toenail) in addition to Mycologic Cure, defined as both negative fungal culture and negative KOH.
  • Table 2: Efficacy Endpoints
8HOW SUPPLIED/STORAGE AND HANDLING
JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution supplied in a white plastic bottle with an integrated flow-through brush applicator as follows:
  • 4 mL (NDC 0187-5400-04)
  • 8 mL (NDC 0187-5400-08)
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • JUBLIA is for external use only and is not for oral, ophthalmic, or intravaginal use. It is for use on toenails and immediately adjacent skin only.
  • Apply JUBLIA once daily to clean dry toenails. Wait for at least 10 minutes after showering, bathing, or washing before applying.
  • Use JUBLIA only on the affected toenails, as directed by your healthcare provider.
  • Inform a healthcare professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling).
  • The impact of nail polish or other cosmetic nail products on the efficacy of JUBLIA has not been evaluated.
  • Flammable, avoid use near heat or open flame.