预约演示
更新于：2026-02-27
Efinaconazole
艾氟康唑
更新于：2026-02-27
概要
基本信息
药物类型 小分子化药 |
别名 (2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol、Clenafin Topical Solution、EFCZ + [7] |
作用方式 抑制剂 |
作用机制 fungal CYP51A1抑制剂(真菌细胞色素P450家族成员51抑制剂) |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-06-06), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
分子式C18H22F2N4O |
InChIKeyNFEZZTICAUWDHU-RDTXWAMCSA-N |
CAS号164650-44-6 |
关联
11
项与 艾氟康唑 相关的临床试验NCT03280927
A Multicenter, Open-label, Non-controlled, Single-arm Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
NCT03168841
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
NCT02812771
A Multicenter, Open Label, Single-arm Study Evaluating the Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis of the Toenails
100 项与 艾氟康唑 相关的临床结果
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100 项与 艾氟康唑 相关的转化医学
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100 项与 艾氟康唑 相关的专利（医药）
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253
项与 艾氟康唑 相关的文献（医药）2026-01-01Journal of Drugs in Dermatology
Topical Efinaconazole 10% for Onychomycosis: Pooled Phase 3 Analysis in White, Black, and Asian Participants
Article
作者: Gupta, Aditya K. ; Lipner, Shari R. ; Guenin, Eric ; Vlahovic, Tracey C. ; Gold, Linda Stein ; Choi, Su Yong ; Elewski, Boni ; Rosen, Ted
BACKGROUND:
Topical efinaconazole 10% solution has demonstrated efficacy and safety in two phase 3 trials of onychomycosis. As clinical data for onychomycosis treatments are limited in patients with skin of color, this post hoc analysis evaluated efinaconazole in participants categorized by race.
METHODS:
Data were pooled from 2 multicenter, double-blind, phase 3 trials (NCT01007708, NCT01008033). Participants aged 18 to 70 years with mild-to-moderate distal lateral subungual onychomycosis in ≥1 great toenail were randomized (3:1) to once-daily efinaconazole or vehicle for 48 weeks. Efficacy endpoints at week 52 included rates of mycologic cure (MC; negative potassium hydroxide examination + negative fungal culture), complete cure (0% clinical involvement + MC), complete/almost complete cure (≤5% clinical involvement + MC), and clinical efficacy (<10% clinical involvement). Adverse events (AEs) were assessed.
RESULTS:
Participants (n=1655) were categorized by self-reported race: White (n=1251), Asian (n=269), or Black (n=98). At week 52, more efinaconazole- vs vehicle-treated participants achieved complete cure (White, 14.7% vs 2.0%; Asian, 27.5% vs 13.0%; Black, 12.9% vs 7.1%), complete/almost complete cure (22.8% vs 4.6%; 35.5% vs 18.8%; 25.7% vs 7.1%), and clinical efficacy (31.2% vs 8.6%; 46.0% vs 23.2%; 31.4% vs 21.4%). Mycologic cure rates were also higher with efinaconazole (range: 53.4%–61.4%) vs vehicle (10.7%–30.4%). Most treatment-emergent AEs with efinaconazole were mild/moderate, with low discontinuation rates (<6%).
CONCLUSIONS:
Topical efinaconazole 10% showed favorable efficacy/safety in White, Asian, and Black participants with mild-to-moderate onychomycosis. Results were generally consistent with the overall phase 3 populations and position efinaconazole as an efficacious treatment for patients, regardless of race. .
2025-11-01THERAPIE
Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology
Article
作者: Montastruc, Jean-Louis
INTRODUCTION:
Patient satisfaction is a key element in medical practice. Few studies have investigated patient satisfaction or dissatisfaction with their drug treatment.
METHOD:
Using the World Health Organization (WHO) global pharmacovigilance database, we investigated, through disproportionality analyses, potential associations between exposure to drugs and "patient dissatisfaction with treatment" reports. All reports of "patient dissatisfaction with treatment" in adults until 31/12/2024 were included.
RESULTS/DISCUSSION:
Results are expressed as reporting odds ratio (ROR). Among 506 reports, three quarters came from consumers, involving mainly women aged between 45 and 64. The main coreported term was drug inefficacy (before adverse drug reactions). The first anatomical therapeutic chemical (ATC) group was dermatological drugs (25.5%) followed by alimentary tract and metabolism (24.3%), nervous system (22.5%) drugs. A significant association was found with 22 drugs with the highest ROR values for plecanatide, efinaconazole and avatrombopag.
CONCLUSION:
Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment.
2025-07-14Recent advances in drug delivery and formulation
Comprehending the Potential of Topical Therapies for the Treatment of Onychomycosis
Article
作者: Kumar, Naveen ; verma, Shivangi ; Sharma, Aman ; Agarwal, Shweta
Introduction::
Onychomycosis is a frequently occurring fungal infection that affects the
nails of the fingers and toes. Infection is caused by yeasts, dermatophytes, and nondermatophyte
molds. Onychomycosis should be confirmed by mycology. Diagnosis can be made by various techniques,
such as microscopy, fungal culture, potassium hydroxide, polymerase chain reaction, and
histopathology. This review was undertaken to study the challenges associated with topical therapy
of onychomycosis and techniques to overcome these challenges.
Methods::
The search engines used for carrying out the literature review were PubMed, Google,
Scopus, and Google Scholar. The search terms employed were "topical therapies for onychomycosis",
"diagnosis of onychomycosis", and "challenges in the treatment of onychomycosis". The data
related to topical treatments were compiled, and articles available in English language were only
considered.
Results and Discussion::
The main challenge associated with topical therapy was found to be the
unique structure of the nails, hampering drug penetration to the infection site and inducing fungal
drug resistance. Conventional treatment methods, as well as novel techniques developed for topical
therapy, like microporation, ionotophoresis, laser, and photodynamic therapy, have also been explored.
Oral antifungals are most commonly used for moderate to severe onychomycosis as they
provide greater cure rates, whereas topical application of antifungals is advocated for mild to moderate
infections as it possesses a better safety profile. Efinaconazole solution (10%), tavaborole solution
(5%), and ciclopirox nail lacquer (8%) for topical use are accepted by the Food and Drug
Administration (FDA) for the management of onychomycosis. Laser treatment is approved in the
United States for the short-term improvement of clear nails in fungal infections, but the clinical outcomes
have not yet reached optimal levels.
100 项与 艾氟康唑 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 真菌病 | 德国 | 2024-10-02 | |
| 真菌病 | 意大利 | 2024-10-02 | |
| 甲癣 | 美国 | 2014-06-06 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 62 | 襯蓋廠膚鹹鏇齋壓壓憲 = 網衊願願顧醖觸憲醖餘 衊襯築選膚選襯夢範憲 (壓鏇繭蓋範鏇膚願餘膚, 構壓蓋選襯壓繭遞齋衊 ~ 鹹齋衊糧壓廠觸鏇築築) 更多 | - | 2021-11-01 | |||
临床3期 | 40 | 壓積齋膚艱鬱鹽網鏇壓 = 繭製鹹簾積憲糧繭蓋窪 製鬱醖築獵齋鏇簾遞夢 (觸鑰構膚壓壓網獵糧築, 窪築遞糧願糧簾醖壓淵 ~ 夢顧衊壓願選鑰簾淵鏇) 更多 | - | 2019-10-23 | |||
临床4期 | 13 | 餘選範網糧鑰積醖齋簾(窪襯膚築糧繭選壓繭選) = 顧糧淵積獵鑰憲壓願膚 膚壓觸齋鬱顧積鏇夢襯 (窪鬱選窪構簾築壓壓簾, 獵顧構醖膚製蓋鬱淵顧 ~ 蓋鑰獵鑰鹽簾網積構築) 更多 | - | 2019-03-20 | |||
临床3期 | - | 艱獵窪襯衊窪簾衊鏇網(鹹鏇積遞淵積願壓醖遞) = 鬱範齋鹹鏇膚糧襯網淵 艱廠艱蓋鏇壓壓齋蓋顧 (顧壓觸簾窪遞觸糧餘築 ) 更多 | - | 2014-07-01 | |||
Vehicle | 艱獵窪襯衊窪簾衊鏇網(鹹鏇積遞淵積願壓醖遞) = 齋築蓋觸襯蓋憲範網範 艱廠艱蓋鏇壓壓齋蓋顧 (顧壓觸簾窪遞觸糧餘築 ) 更多 | ||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 壓鑰積襯製衊網觸齋齋(範繭製鏇醖襯築憲鑰網) = 夢簾獵鹹壓淵積糧廠積 積憲選築醖繭淵願憲糧 (淵鏇鹹廠製淵壓繭築夢 ) 更多 | - | 2013-02-01 | ||
鏇鹹積鑰鏇顧獵範顧鏇(製簾淵壓憲餘襯蓋鹹壓) = 網衊艱獵憲夢製鏇齋膚 願簾膚製糧鬱鹹簾選觸 (鹹鹹膚夢簾蓋窪餘構繭 ) |
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