Efinaconazole
Chemical compound
From Wikipedia, the free encyclopedia
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.[3][4]
| |
| Clinical data | |
|---|---|
| Trade names | Jublia, Clenafin |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a614050 |
| License data |
|
| Routes of administration | Topical |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number | |
| PubChem CID | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEBI | |
| ChEMBL | |
| CompTox Dashboard (EPA) | |
| ECHA InfoCard | 100.245.862 |
| Chemical and physical data | |
| Formula | C18H22F2N4O |
| Molar mass | 348.398 g·mol−1 |
| 3D model (JSmol) | |
| |
| |
Efinaconazole acts as a 14α-demethylase inhibitor[5][2].
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.[2] 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% (trial 1) and 15.2% (trial 2) of participants using efinaconazole were completely cured (0% clinical involvement of the target toenail, plus negative KOH test and negative culture), compared with 3.3% (trial 1) and 5.5% (trial 2) of participants using a placebo.[2] The "complete cure or almost complete cure" rate (≤5% affected target toenail area involved, and negative KOH and culture) for efinaconazole was 26.4% (trial 1) and 23.4% (trial 2) (compared with 7.0% (trial 1) and 7.5% (trial 2)).[2]
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.[6]
History
Efinaconazole was discovered by Japan dermatology company Kaken Pharmaceutical. In 2014, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA).[7][8] According to Valeant Pharmaceuticals International Inc CEO J. Michael Pearson they acquired Jublia through their purchase of Dow Pharmaceutical Sciences in 2008.[8] Japan and Korean approvals followed. In 2024, Almirall announced completion of decentralized regulatory approval procedure for Jublia in Europe[9].
Economics
In 2015, the cost of treatment with efinaconazole in the United States was said to be US$2,307 per nail.[10]
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.[11]
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.[citation needed]
A generic version has been approved in the USA[12][13][14][15] but will not be available until 2035 due to patent protection.[16]
