Efinaconazole


Efinaconazole, sold under the brand name Jublia and Clenafin among others, is a triazole antifungal compound discovered by Kaken Pharmaceutical, indicated for the treatment of onychomycosis, a fungal infection of the nail. Since it has low binding affinity with keratin, the main component of nails, it has superior nail-penetrating properties. It is approved for use in the United States, Canada, Japan and certain European countries as a 10% topical solution.
Efinaconazole acts as a 14α-demethylase inhibitor.

Medical uses

Efinaconazole is an azole antifungal indicated in the US for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. Unlike nail lacquers it does not require debridement.

Efficacy

The safety and efficacy of efinaconazole were established in two multi-centre randomised clinical trials with a total of 1,655 participants. 17.8% and 15.2% of participants using efinaconazole were completely cured, compared with 3.3% and 5.5% of participants using a placebo. The "complete cure or almost complete cure" rate for efinaconazole was 26.4% and 23.4% and 7.5% ).
In 2020, the FDA approved a supplemental New Drug Application for efinaconazole topical solution, 10%, which extended the age range included in the product's label to children six years of age and older.

History

Efinaconazole was discovered by Japan dermatology company Kaken Pharmaceutical. In 2014, the U.S. Food and Drug Administration approved the New Drug Application. According to Valeant Pharmaceuticals International Inc CEO J. [Michael Pearson] they acquired Jublia through their purchase of Dow Pharmaceutical Sciences in 2008. Japan and Korean approvals followed. In 2024, Almirall announced completion of decentralized regulatory approval procedure for Jublia in Europe.

Economics

In 2015, the cost of treatment with efinaconazole in the United States was said to be per nail.
In 2019, a study by the Canadian Agency for Drugs and Technologies in Health found the cost for a 48-week course to be $178 for a big toe, and $89 for an other toe.
A 2025 review of nine online Canadian pharmacies shows that the price for a four-week treatment is about $143 USD. Therefore a 48-week course of treatment is about 12 x $143 = $1716.
It is available as a generic medication in the USA.