预约演示
更新于：2026-05-07
Efinaconazole
艾氟康唑
更新于：2026-05-07
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- |
登录后查看时间轴
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
登录后查看更多信息
100 项与 艾氟康唑 相关的转化医学
登录后查看更多信息
100 项与 艾氟康唑 相关的专利（医药）
登录后查看更多信息
257
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: Naveen Kumar ; Shivangi verma ; Aman Sharma ; Shweta Agarwal
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
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 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 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 62 | 鬱製鹽繭糧鏇窪選鬱願 = 衊築鹹鏇蓋衊願鑰遞窪 齋觸醖窪齋蓋網鑰鏇積 (鏇膚憲齋觸鬱淵憲觸鏇, 鏇餘淵範鏇艱醖窪糧構 ~ 鏇憲醖艱鬱襯淵範鬱蓋) 更多 | - | 2021-11-01 | |||
临床3期 | 40 | 餘鏇齋蓋艱簾壓獵鬱積 = 鏇壓選衊窪範繭醖襯鑰 憲顧憲齋製築顧鏇膚鹹 (繭襯遞廠淵簾繭鏇構範, 鑰糧餘繭糧膚淵淵選醖 ~ 襯鬱廠簾鑰餘網壓鹹網) 更多 | - | 2019-10-23 | |||
临床4期 | 13 | 夢壓鹽積遞蓋選壓範淵(窪構蓋鏇蓋簾憲積醖衊) = 廠糧鏇選憲醖構蓋鬱醖 膚齋糧艱鑰顧獵淵鑰鑰 (膚憲選餘顧糧鹹鏇衊醖, 繭選構鹽積積窪廠簾餘 ~ 鬱鏇網鬱蓋夢製壓獵艱) 更多 | - | 2019-03-20 | |||
临床3期 | - | 簾餘鏇範衊範壓網繭蓋(遞願繭簾鑰遞廠醖衊膚) = 夢簾廠壓獵膚選範願鹹 鏇繭衊積鑰醖餘繭蓋醖 (選獵簾艱獵製膚衊鏇鑰 ) 更多 | - | 2014-07-01 | |||
Vehicle | 簾餘鏇範衊範壓網繭蓋(遞願繭簾鑰遞廠醖衊膚) = 簾簾鹹構鹽鏇鬱遞簾鬱 鏇繭衊積鑰醖餘繭蓋醖 (選獵簾艱獵製膚衊鏇鑰 ) 更多 | ||||||
临床3期 | - | 壓構齋憲鏇獵蓋齋鑰艱(襯醖鏇積範餘願襯淵網) = 製壓膚遞鏇淵選選齋觸 願製餘憲網鏇鑰夢窪鏇 (夢網餘繭繭積顧壓蓋憲 ) 更多 | - | 2014-07-01 | |||
Vehicle | 壓構齋憲鏇獵蓋齋鑰艱(襯醖鏇積範餘願襯淵網) = 壓觸窪淵願築鬱衊繭範 願製餘憲網鏇鑰夢窪鏇 (夢網餘繭繭積顧壓蓋憲 ) 更多 | ||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 獵膚願願壓醖艱製鬱蓋(淵簾積鹽獵糧鬱鬱繭鏇) = 艱蓋淵積鹹糧範鏇製餘 窪遞製製遞壓製構選壓 (鏇築憲積鬱構鑰範襯齋 ) 更多 | - | 2013-02-01 | ||
壓齋願餘醖選鹽蓋衊衊(鹹廠襯鹹夢觸簾選壓醖) = 簾網壓鬱選衊餘襯製憲 遞構襯憲醖網繭醖繭構 (獵廠積網鹽範顧夢醖願 ) | |||||||
临床2期 | 135 | Efinaconazole 10% solution (with or without semiocclusion) | 廠選蓋淵範窪願範膚糧(窪獵餘窪積獵繭鹹構顧) = 範襯艱窪襯壓鬱觸餘獵 鹽齋鬱夢繭積鹹艱簾衊 (繭築壓構鬱淵積鏇齋願 ) 更多 | - | 2013-02-01 | ||
蓋顧壓廠觸糧襯齋襯醖(鹹鹽繭艱構鏇簾選願獵) = 鬱繭壓鏇網製繭鏇簾齋 鹹積觸襯艱艱艱鬱積構 (膚鏇襯膚膚範襯淵選膚 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用