Chemical compound
Pharmaceutical compound
Efinaconazole Clinical data Trade names Jublia, Clenafin AHFS /Drugs.com Monograph MedlinePlus a614050 License data Routes of Topical ATC code Legal status Legal status Identifiers (2R ,3R )-2-(2,4-Difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1H -1,2,4-triazol-1-yl)-2-butanol
CAS Number PubChem CID DrugBank ChemSpider UNII KEGG ChEBI ChEMBL CompTox Dashboard (EPA) ECHA InfoCard 100.245.862 Chemical and physical data Formula C 18 H 22 F 2 N 4 O Molar mass −1 3D model (JSmol ) InChI=1S/C18H22F2N4O/c1-13-5-7-23(8-6-13)14(2)18(25,10-24-12-21-11-22-24)16-4-3-15(19)9-17(16)20/h3-4,9,11-12,14,25H,1,5-8,10H2,2H3/t14-,18-/m1/s1
Key:NFEZZTICAUWDHU-RDTXWAMCSA-N
Efinaconazole , sold under the brand nameJublia among others, is atriazole antifungal medication. It is approved for use in the United States, Canada, and Japan as a 10% topical solution for the treatment ofonychomycosis (fungal infection of thenail ).[ 3] [ 4] 14α-demethylase inhibitor .[ 5] [ 2]
It is available as ageneric medication .[ 6] [ 7] [ 8] [ 9]
Efinaconazole is anazole antifungal indicated in the US for the topical treatment ofonychomycosis of thetoenails due toTrichophyton rubrum Trichophyton mentagrophytes [ 2]
In twoclinical trials 17.8% (trial 1) and 15.2% (trial 2) of participants using efinaconazole were completely cured (0% clinical involvement of the target toenail, plus negativeKOH test and negative culture), compared with 3.3% (trial 1) and 5.5% (trial 2) of participants using aplacebo .[ 2] [ 2]
In 2014, the U.S.Food and Drug Administration (FDA) approved theNew Drug Application (NDA).[ 10] [ 11] Valeant Pharmaceuticals International Inc CEOJ. Michael Pearson they acquired Jublia through their purchase of Dow Pharmaceutical Sciences in 2008.[ 11]
In 2020, the FDA approved a supplementalNew 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; it was first approved in 2014, in people aged 18 years of age and older.[ 12]
Society and culture [ edit ] In 2015, the cost of treatment with efinaconazole in the United States was said to beUS$2,307 per nail.[ 13]
In 2019, a study by theCanadian 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.[ 14]
^ "Archived copy" (PDF) .Archived (PDF) from the original on 10 June 2022. Retrieved10 June 2022 .{{cite web }}: CS1 maint: archived copy as title (link )^a b c d e "Jublia- efinaconazole solution" .DailyMed . 30 September 2016.Archived from the original on 30 November 2020. Retrieved27 April 2020 .^ Patel T, Dhillon S (November 2013). "Efinaconazole: first global approval".Drugs .73 (17):1977– 1983.doi :10.1007/s40265-013-0152-x .PMID 24249649 .S2CID 40015633 . ^ Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R (February 2013). "Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study".J Drugs Dermatol .12 (2):186– 192.PMID 23377392 . ^ Tatsumi Y, Nagashima M, Shibanushi T, et al. (May 2013)."Mechanism of action of efinaconazole, a novel triazole antifungal agent" .Antimicrob Agents Chemother .57 (5):2405– 2509.doi :10.1128/aac.02063-12 .PMC 3632939 PMID 23459486 . ^ "Efinaconazole: FDA-Approved Drugs" .U.S.Food and Drug Administration (FDA) .Archived from the original on 21 March 2021. Retrieved14 February 2021 .^ "Efinaconazole: FDA-Approved Drugs" .U.S.Food and Drug Administration (FDA) .Archived from the original on 21 March 2021. Retrieved14 February 2021 .^ "First Generic Drug Approvals" .U.S.Food and Drug Administration (FDA) .Archived from the original on 26 January 2021. Retrieved13 February 2021 .^ "Competitive Generic Therapy Approvals" .U.S.Food and Drug Administration (FDA) . 3 March 2023. Retrieved6 March 2023 .^ "Drug Approval Package: Jublia topical solution (efinaconazole) NDA #203567" .U.S.Food and Drug Administration (FDA) . 24 December 1999.Archived from the original on 29 May 2020. Retrieved27 April 2020 .^a b "Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis" .Valeant Pharmaceuticals (Press release). 9 June 2014. Archived fromthe original on 8 November 2015. Retrieved1 November 2015 .^ "FDA Approves Ortho Dermatologics' Labeling For Jublia (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old" .Bausch Health (Press release).Archived from the original on 10 June 2022. Retrieved10 June 2022 .^ Mikailov A, Cohen J, Joyce C, Mostaghimi A (2015)."Cost-effectiveness of Confirmatory Testing Before Treatment of Onychomycosis" .JAMA Dermatology .152 (3):1– 6.doi :10.1001/jamadermatol.2015.4190 PMID 26716567 . ^ "Table 5, CDR Cost Comparison Table for Onychomycosis" .www.ncbi.nlm.nih.gov . 8 June 2019.Archived from the original on 10 June 2022. Retrieved10 June 2022 ."Efinaconazole" .Drug Information Portal . U.S. National Library of Medicine.
Wall/
Intracellular
Others
