预约演示
更新于：2025-02-06
Terbinafine Hydrochloride
盐酸特比萘芬
更新于：2025-02-06
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C21H26ClN |
InChIKeyBWMISRWJRUSYEX-SZKNIZGXSA-N |
CAS号78628-80-5 |
关联
40
项与 盐酸特比萘芬 相关的临床试验EUCTR2022-001797-59-DK
A multi-center, single-arm, open-label study to evaluate tolerability, safety, and efficacy of topical MOB015B solution in the treatment of mild to moderate distal subungual onychomycosis (DSO) in subjects aged 6-17 years
NCT05279846
A Multi-center, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
NCT05135910
An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
100 项与 盐酸特比萘芬 相关的临床结果
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100 项与 盐酸特比萘芬 相关的转化医学
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100 项与 盐酸特比萘芬 相关的专利（医药）
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2,784
项与 盐酸特比萘芬 相关的文献（医药）2025-04-01INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
Octyl succinic anhydride-modified chitosan/oxidized sodium alginate Schiff base hydrogel loaded with terbinafine hydrochloride: pH-responsive, self-repairing, antifungal properties
Article
作者: Cheng, Qiuqi ; Ning, Junkai ; Wu, Chunxuan ; Liang, Zhengmin ; He, Jiakang ; Yi, Dandan ; He, Weiwei ; Zhong, Yawen ; Xiang, Yifei ; Huang, Luyuan ; Li, Jiada ; Xu, Chuang ; Liu, Chengzhi ; Qin, Lanqian ; Liu, Niu
The application of hydrogels to drug delivery limited by the difficulty of encapsulating hydrophobic drugs; therefore, the development of novel composite hydrogels for the delivery of hydrophobic drugs is urgently needed. In this study, terbinafine hydrochloride/hydroxypropyl-β-cyclodextrin inclusion complexes (TFH/HP-β-CD ICs) were added to a Schiff base hydrogel matrix containing octenyl succinic anhydride-modified chitosan (OSA-CS) and sodium alginate (OIA) to prepare a TFH composite hydrogel (TFH GEL). The results revealed that the solubility of TFH in water within TFH/HP-β-CD IC reached 32.13 mg/mL. The TFH GEL successfully encapsulated the IC without any drug leakage and exhibited excellent acid pH responsiveness. Moreover, the hydrogels were mechanically stable, self-healing, and injectable. Haemocompatibility and cytotoxicity tests confirmed the excellent biocompatibility of the TFH GEL. Importantly, TFH GEL effectively inhibited Microsporum canis growth in vitro and in vivo. In summary, a novel composite hydrogel was developed by combining a modified natural polymer hydrogel with a complexing agent to deliver the hydrophobic antifungal drug TFH, this study provides a new strategy for treating fungal skin infections.
2025-02-01JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Precision diagnostics in paediatric dermatology: Advancing management of tinea capitis through dermatophyte PCR
Article
作者: Schwieger‐Briel, A. ; Weibel, L. ; Luchsinger, I. ; Rast, A. C. ; Bosshard, P. P. ; Theiler, M.
Abstract:
Background:
Tinea capitis (TC) is the most frequent dermatophyte infection in children requiring systemic and topical treatment for several weeks. Traditionally, diagnosis and treatment monitoring were based on microscopic examination and fungal culture of scales and plucked hairs, which both have significant limitations.
Objectives:
To investigate the role of dermatophyte polymerase chain reaction (PCR) in the treatment of TC.
Methods:
Scales and plucked hairs of children with TC were investigated by dermatophyte PCR, microscopic examination and fungal culture at baseline and during antifungal treatment.
Results:
Seventeen children with TC were included. At baseline, sensitivity of PCR was 100% as compared to 60% and 87% for direct microscopy and fungal culture, respectively. Species identification by PCR and fungal culture was consistent in all cases. During follow‐up, analysis of 38 samples under treatment showed a sensitivity of PCR, direct microscopy and fungal culture of 68%, 26% and 89% while specificity was 84%, 100% and 100%, respectively. PCR during therapy proved to be false‐negative in six and false‐positive in three instances. The latter turned negative after 4 weeks without further systemic treatment.
Conclusions:
Dermatophyte PCR is an excellent tool for baseline diagnostics of TC providing rapid and accurate results. Our findings suggest that due to the fast and reliable results, it may replace direct microscopy and fungal culture to confirm or exclude TC in children. In the treatment course, diagnostic accuracy and performance of PCR seem reduced as compared to fungal culture, limiting its value for treatment monitoring. Mycological cure ascertained by fungal culture should currently remain the therapeutic goal.
2025-02-01JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
A systematic review on the emergence of terbinafine‐resistant Trichophyton indotineae in Europe: Time to act?
Review
作者: Lisboa, Carmen ; Ferreira, Carolina B.
Abstract:
Background:
There is a recent growing global concern regarding the rise in antifungal resistance of dermatophytosis. The emergence of terbinafine‐resistant Trichophyton indotineae (T. indotineae), previously known as Trichophyton mentagrophytes genotype VIII, is particularly alarming given that terbinafine is considered the treatment of choice for dermatophyte infections and the limited number of available antimycotics. This strain surfaced in the Indian subcontinent in the mid‐2010s and more recently there have been reports of its arrival in Europe.
Objective:
The objective of this review is to document the presence of terbinafine‐resistant T. indotineae in Europe with the aim to guide antifungal stewardship and ultimately prevent the spread of resistance.
Methods:
This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines. A systematic literature search was performed using PubMed, Scopus and Web of Science databases.
Results:
We extracted information from 16 studies published between 2019 and 2023 that described a total of 63 cases of antifungal‐resistant dermatophytosis caused by T. indotineae in Europe. Antifungal susceptibility testing (AFST) revealed a wide range of terbinafine minimum inhibitory concentrations (MICs), varying from 0.014 to ≥16 μg/mL. However, these values are hard to interpret due to variations among used methodologies as well as the lack of clinical breakpoints. In all cases included in this study, elevated terbinafine MICs were associated with mutations in the squalene epoxidase (SQLE) gene. Itraconazole was the most frequently used alternative to terbinafine in this study and complete remission of tinea lesions after treatment switch was shown. Nevertheless, relapse rates are concerningly high.
Conclusions:
We propose the implementation of surveillance programmes for a fast identification through sequencing of T. indotineae (and SQLE mutations) and standardization of procedures for AFST to facilitate the establishment of clinical breakpoints and enable guidance on the appropriate use of antifungals.
100 项与 盐酸特比萘芬 相关的药物交易
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研发状态
批准上市
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 |
|---|---|---|---|
| 体癣 | 澳大利亚 | 2003-12-22 | |
| 股癣 | 澳大利亚 | 2003-12-22 | |
| 足癣 | 美国 | 1999-03-09 | |
| 皮肤真菌病 | 中国 | 1997-01-01 | |
| 皮肤念珠菌病 | 日本 | 1993-07-02 | |
| 花斑癣 | 日本 | 1993-07-02 | |
| 头癣 | 美国 | 1992-12-30 | |
| 真菌病 | 英国 | 1990-10-03 | |
| 甲癣 | 英国 | 1990-10-03 | |
| 癣 | 英国 | 1990-10-03 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 红斑 | 临床1期 | 美国 | 2017-10-15 |
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临床结果
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Company_Website 人工标引  | 临床3期 | 384 | 獵範網鬱壓簾齋觸蓋遞(鹹遞鹹鏇齋蓋餘襯願糧) = 獵襯遞蓋簾顧顧顧廠遞 繭網壓選願鹹積艱壓範 (鏇餘顧膚餘醖構網鏇觸 ) 更多 | 不佳 | 2025-01-10 | ||
临床1期 | 20 | 餘鏇壓構構鹽窪窪壓製(獵繭餘遞願製衊鬱鹹壓) = Adverse events (five patients), such as headache (n = 3), seasonal allergy (n = 1), and neck pain (n = 1), were considered unrelated to MOB015B; no application site reactions or study discontinuations due to an adverse event were observed. 糧顧鬱顧齋壓構遞齋衊 (選築艱築廠夢顧繭鑰齋 ) | 积极 | 2024-08-19 | |||
临床3期 | - | 衊醖簾餘顧鬱鬱膚觸齋(鹽醖願蓋顧廠壓範網顧) = 窪鬱淵鹽壓鹹構壓窪鑰 獵觸膚齋簾蓋廠憲餘壓 (糧糧鏇製構願簾廠膚糧 ) 更多 | 非优 | 2021-07-01 | |||
vehicle | 衊醖簾餘顧鬱鬱膚觸齋(鹽醖願蓋顧廠壓範網顧) = 夢築鹹餘構範衊積繭製 獵觸膚齋簾蓋廠憲餘壓 (糧糧鏇製構願簾廠膚糧 ) 更多 | ||||||
临床3期 | 452 | 觸鬱醖餘網夢築鹽積遞(鑰齋夢網齋衊淵願構鑰) = 襯齋鹹窪糧膚觸窪範窪 製壓鹽糧艱壓憲範醖鹽 (構蓋積鹽蓋醖繭範鹽願 ) 更多 | 非劣 | 2020-06-25 | |||
觸鬱醖餘網夢築鹽積遞(鑰齋夢網齋衊淵願構鑰) = 鹽簾範淵構網醖膚壓遞 製壓鹽糧艱壓憲範醖鹽 (構蓋積鹽蓋醖繭範鹽願 ) 更多 |
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