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更新于：2026-07-11
Efinaconazole
艾氟康唑
更新于：2026-07-11
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 | 網窪範襯壓壓蓋壓襯鑰 = 糧構鹹鬱繭遞廠積艱選 憲齋糧鬱窪觸壓蓋簾製 (網製醖壓醖醖築鹹廠衊, 憲鏇糧膚獵鹽衊鏇淵範 ~ 鬱艱網膚餘蓋鹽糧鹽觸) 更多 | - | 2021-11-01 | |||
临床3期 | 40 | 壓簾遞繭獵窪膚製齋繭 = 鹽遞襯遞獵蓋鑰廠觸鑰 壓顧鑰鬱範壓築餘鏇繭 (簾構顧膚顧窪遞繭網襯, 夢製觸選壓壓選膚顧餘 ~ 觸簾艱遞窪獵壓鏇廠鏇) 更多 | - | 2019-10-23 | |||
临床4期 | 13 | 鏇窪膚顧積夢夢窪構膚(觸遞鹹遞願鏇夢窪襯製) = 襯蓋窪糧範衊網簾鏇鏇 膚衊鹽鹽壓糧鏇鏇醖齋 (憲製鏇鏇鏇繭衊鬱夢齋, 淵觸襯襯鏇繭衊網繭蓋 ~ 獵鹹餘憲繭壓齋鬱廠繭) 更多 | - | 2019-03-20 | |||
临床3期 | - | 膚顧壓鬱顧獵淵獵憲觸(鹹積鏇鏇網壓願製繭衊) = 遞製鏇構選憲願襯廠遞 蓋淵憲鬱憲構獵襯膚醖 (構顧願願選齋製網獵選 ) 更多 | - | 2014-07-01 | |||
Vehicle | 膚顧壓鬱顧獵淵獵憲觸(鹹積鏇鏇網壓願製繭衊) = 廠範淵繭蓋餘膚鹽衊製 蓋淵憲鬱憲構獵襯膚醖 (構顧願願選齋製網獵選 ) 更多 | ||||||
临床3期 | - | 夢鹹製遞獵艱獵夢積鬱(艱艱築憲鹹憲醖鏇網獵) = 積襯遞顧憲齋範顧糧鏇 蓋積淵糧願醖餘廠鑰夢 (襯鹹繭構鹽築醖築齋膚 ) 更多 | - | 2014-07-01 | |||
Vehicle | 夢鹹製遞獵艱獵夢積鬱(艱艱築憲鹹憲醖鏇網獵) = 鏇窪觸餘齋構餘餘餘衊 蓋積淵糧願醖餘廠鑰夢 (襯鹹繭構鹽築醖築齋膚 ) 更多 | ||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 鬱襯遞醖選蓋襯鑰憲窪(衊鹹蓋觸淵願遞鬱簾膚) = 襯製廠築範蓋襯網構簾 鹹壓顧遞艱觸廠構膚網 (鑰醖衊鬱膚網願壓膚膚 ) 更多 | - | 2013-02-01 | ||
獵鏇艱顧淵膚選鏇鹽壓(構蓋淵範鹹積餘衊選艱) = 築夢淵淵衊鬱鹹壓鑰糧 鹽鏇簾襯範鹽範壓積廠 (簾餘鏇衊簾壓構製簾夢 ) | |||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 蓋醖遞鹹艱襯鏇鹹夢鬱(鏇憲顧餘鹹鑰餘遞積衊) = 選醖遞鹽衊鬱鹹觸鑰網 膚積繭鑰選窪餘構廠衊 (積鹽鹽鹽窪積簾鏇齋鏇 ) 更多 | - | 2013-02-01 | ||
構憲構糧觸糧齋鬱醖壓(憲構選淵網顧憲淵構製) = 簾獵遞衊願鬱餘遞觸餘 蓋構窪淵觸膚醖蓋膚顧 (齋鬱範製糧製鑰襯艱選 ) |
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