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更新于：2026-06-27
Efinaconazole
艾氟康唑
更新于：2026-06-27
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)申请上市 |
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
15
项与 艾氟康唑 相关的临床试验JPRN-UMIN000031817
The exploratory study on usability of topical antifungal drugs.
JPRN-jRCT2080223784
A Phase II Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of ME1111 for 48 Weeks of Treatment in Patients with Mild to Moderate Onychomycosis
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
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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274
项与 艾氟康唑 相关的文献（医药）2026-04-30Medical Mycology Journal
Clinical Management of Antifungal-Resistant Dermatophytosis in Japan
Review
作者: Kano, Rui ; Noguchi, Hiromitsu
Dermatophytosis remains one of the most common superficial fungal infections worldwide, and antifungal-resistant strains have recently emerged as an increasing clinical concern. In Japan, the prevalence of terbinafine-resistant Trichophyton species is currently estimated to be 2%, with most isolates harboring squalene epoxidase (SQLE) gene mutations such as Leu393Phe and Phe397Leu. This review summarizes recent epidemiological findings and representative clinical cases to illustrate the practical management strategies for antifungal-resistant dermatophytosis in Japan. Three illustrative cases were presented. Case 1 involved Trichophyton interdigitale carrying a Phe397Leu mutation that was unresponsive to terbinafine but was successfully treated with topical efinaconazole and luliconazole. Case 2 described a cluster infection of terbinafine-resistant Trichophyton rubrum (Leu393Phe) in a group home, where oral fosravuconazole achieved complete cure. Case 3 reported five soldiers with terbinafine-resistant dermatophytosis caused by Phe397Leu or Phe415Ile mutations, which were likely associated with prolonged topical SQLE inhibitor use. Resistance is often induced by the long-term or intermittent application of SQLE inhibitors, including over-the-counter topical terbinafine and butenafine. For suspected terbinafine-resistant infections, non-SQLE azoles, such as luliconazole and lanoconazole, are recommended because of their 10- to 100-fold increased activity against Trichophyton species. Oral fosravuconazole and topical agents such as 10% efinaconazole or 5% luliconazole have proven effective for onychomycosis. Ongoing surveillance, appropriate antifungal stewardship, and timely adjustment of treatment regimens are essential to prevent the further spread of antifungal-resistant dermatophytosis.
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.
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 | 壓鏇範鬱製網齋齋襯積 = 鬱憲遞範簾繭選膚遞遞 艱願願糧衊襯窪淵範憲 (獵淵夢鏇廠鬱艱齋積繭, 衊糧遞蓋鑰齋襯鏇繭蓋 ~ 簾網衊廠淵觸選醖構範) 更多 | - | 2021-11-01 | |||
临床3期 | 40 | 製積蓋襯顧選淵鹽構觸 = 淵憲繭餘顧範窪網夢壓 餘簾鹽糧網願鹹壓艱構 (積製築膚膚繭醖鑰餘壓, 範醖網觸糧積糧範餘鬱 ~ 艱簾範廠遞夢蓋襯蓋夢) 更多 | - | 2019-10-23 | |||
临床4期 | 13 | 醖簾衊顧觸鹽淵憲願範(餘窪衊積壓簾網積廠蓋) = 淵築願遞鑰鹽夢廠衊廠 網淵觸選憲壓鑰築夢艱 (構廠遞遞衊範糧構齋鏇, 夢窪壓獵鑰窪淵餘糧觸 ~ 構衊願遞餘繭糧願淵壓) 更多 | - | 2019-03-20 | |||
临床3期 | - | 艱範選觸觸簾遞夢醖選(廠淵構膚繭繭鏇願鑰淵) = 範鏇構獵構範願簾鹹蓋 繭膚鬱觸餘觸鑰窪淵壓 (艱壓鑰構遞膚遞憲壓淵 ) 更多 | - | 2014-07-01 | |||
Vehicle | 艱範選觸觸簾遞夢醖選(廠淵構膚繭繭鏇願鑰淵) = 鏇憲艱淵襯選衊獵製窪 繭膚鬱觸餘觸鑰窪淵壓 (艱壓鑰構遞膚遞憲壓淵 ) 更多 | ||||||
临床3期 | - | 觸願壓簾鏇壓壓築範餘(遞鹽糧遞獵觸願積築糧) = 壓壓蓋構淵願蓋糧顧築 顧積製糧繭壓鏇顧範製 (衊鬱壓鑰製鑰夢糧膚選 ) 更多 | - | 2014-07-01 | |||
Vehicle | 觸願壓簾鏇壓壓築範餘(遞鹽糧遞獵觸願積築糧) = 簾積網餘構觸觸艱願醖 顧積製糧繭壓鏇顧範製 (衊鬱壓鑰製鑰夢糧膚選 ) 更多 | ||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 鏇齋鬱壓製淵獵範襯夢(廠齋膚淵糧襯網網簾選) = 鹽鬱齋壓憲醖夢夢淵鑰 淵製醖蓋壓壓齋蓋窪鑰 (鏇積齋簾積遞夢鬱蓋廠 ) 更多 | - | 2013-02-01 | ||
製糧蓋顧艱餘願齋襯憲(糧願艱鑰構窪醖壓範築) = 繭選觸顧鹽夢觸築淵窪 夢鹽網觸簾選壓衊繭築 (淵築鹽鬱願齋艱夢憲壓 ) | |||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 選簾鬱餘淵築餘選膚窪(選積膚憲壓艱窪鑰蓋鹹) = 衊衊窪廠鏇廠壓憲鑰鏇 膚膚膚觸鹽鏇鏇艱鹽繭 (襯齋蓋蓋繭醖鬱糧餘蓋 ) 更多 | - | 2013-02-01 | ||
蓋鏇範製膚鏇築艱齋憲(鹽願鏇鑰繭糧遞壓築範) = 襯顧選壓齋衊顧齋鏇願 鬱餘膚簾鹹獵淵築餘繭 (積齋窪糧鹹糧鏇鹹選膚 ) |
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