盐酸特比萘芬(Terbinafine Hydrochloride) - 药物靶点：SQLE_在研适应症：甲癣，体癣，股癣_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Tebinafine Hydrochloride、Terbinafine Hydrochioride Liniment、Terbinafine hydrochloride (JP17/USP)

+ [33]

靶点

SQLE

作用方式

抑制剂、调节剂

作用机制

SQLE抑制剂(角鲨烯单加氧酶抑制剂)、细胞膜调节剂

治疗领域

感染皮肤和肌肉骨骼疾病

在研适应症

甲癣体癣股癣+ [7]

非在研适应症

粘膜念珠菌病口腔念珠菌病红斑+ [1]

原研机构

Novartis Pharma AG

在研机构

Novartis Pharmaceuticals Australia Pty Ltd.

Novartis Pharmaceuticals Canada, Inc.

Sun Pharmaceutical Industries Ltd.

+ [6]

非在研机构

Polichem SA (Switzerland)

Novartis AG

Novartis Pharmaceuticals Corp.

权益机构

深圳市康哲药业有限公司

Moberg Pharma AB

Cipher Pharmaceuticals, Inc.

+ [9]

最高研发阶段批准上市

首次获批日期

美国 (1992-12-30),

头癣

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

81

项与盐酸特比萘芬相关的临床试验

TCTR20250319015

/ Not yet recruiting临床2期IIT

Efficacy and Safety of 1% Terbinafine Film-Forming Solution Single Application versus 1% Clotrimazole Cream Standard Dose in the Treatment of Tinea Pedis in Correctional Setting

开始日期2025-06-01

申办/合作机构-

NCT06400056

/ Not yet recruiting临床1期IIT

Clinical and Laboratory Evaluation of Antifungal Resistance in Tinea Capitis

AIM OF WORK :
1. Detect the most common fungal strains that cause tinea capitis
2. Detect Different effectiveness of terbinafine in different cases
3. Detect the resistant strains.
4. Detect the mycological and the clinical cure rates upon using systemic terbinafine in treatment of tinea capitis

开始日期2024-05-01

申办/合作机构

Assiut University

IRCT20240225061105N1

/ Recruiting临床2期IIT

Comparison of the Effect of Terbinafine alone with the Combination of Terbinafine and Prednisolone in the Treatment of Inflammatory Tina Capitis

开始日期2023-11-15

申办/合作机构

Kermanshah University of Medical Sciences

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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2,803

项与盐酸特比萘芬相关的文献（医药）

2025-07-03·Expert Opinion On Drug Safety

Analysis of clinical characteristics of terbinafine-induced subacute cutaneous lupus erythematosus

Review

作者: Wang, Chunjiang ; Guo, Yuge ; He, Yang ; Ouyang, Linqi ; He, Yiran ; Fan, Zhiqiang

INTRODUCTION:

Terbinafine may cause subacute cutaneous lupus erythematosus (SCLE), and we aimed to analyze its clinical characteristics.

METHODS:

We collected literature on terbinafine-induced SCLE from 1997 to 2023 for retrospective analysis. Thirty-seven patients (33 females and 4 males) were included.

RESULTS:

The patients have a median age of 49.5 years (range 18-79) and onset time of 5 weeks (range 1-12). SCLE is mainly manifested as annular erythematous (83.3%), scaly erythematous (44.4%), and maculopapular erythematous (13.9%). Mainly, histopathological manifestations are lymphocytic infiltrate (55.6%), hyperkeratosis (38.9%) and keratinocyte necrosis (38.9%). Positive immunological parameters mainly include antinuclear antibody (100.0%), anti-Ro/SSA antibody (94.1%), and anti-La/SSB antibody (72.2%). Past medical history usually includes photosensitivity (33.3%), inflammatory disease (33.33%), and lupus erythematosus (12.1%). Symptoms are completely resolved within a median time of 35 days (range 7-84) after discontinuation of terbinafine and treatment with topical corticosteroids, systemic corticosteroids, hydroxychloroquine, and immunosuppressant. No recurrence was observed within 12 months (range 1.5-48) of follow-up.

CONCLUSION:

These results suggest that terbinafine-induced SCLE should be comprehensively diagnosed based on clinical symptoms, histopathological manifestations, immunological parameters, and past medical history. Terbinafine should be immediately discontinued when SCLE occurs, while systemic and topical corticosteroids combined with hydroxychloroquine may be an effective treatment.

2025-06-01·CURRENT MICROBIOLOGY

Fungal Infections Resulting From Prolonged Use of Personal Protective Equipment

Article

作者: Berikten, Derya ; Aydin, Elif ; Renders, Duygu Percin ; Utku, Selve Arslan

This study is the first to investigate fungal infections resulting from prolonged use of personal protective equipment (PPE) among healthcare workers at Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital, during the COVID-19 pandemic. The research aimed to isolate, molecularly type, and assess the antifungal susceptibility of superficial fungal infection agents associated with PPE use. Additionally, the relationship between these fungi and PPE use was evaluated through a questionnaire. Samples were collected from 100 healthcare workers experiencing skin issues. Among them, all N95/FFP2 mask users, 44.3% of glove users, 36.1% of surgical mask users, and 22.9% of hair cap users reported skin reactions, with acne (n = 34) being the most common. Identified fungal isolates included Trametes hirsuta, Penicillium chrysogenum, Aspergillus fumigatus, Rhodotorula sp., Candida sp., Pichia fermentans, and the dermatophyte Microsporum ferrugineum. Antifungal susceptibility tests revealed 47.6% resistance to fluconazole and 76.2% resistance to voriconazole (n = 16). This study provides the first institutional data on PPE-associated fungal infections and antifungal resistance in healthcare settings. These findings highlight the dermatological risks of prolonged PPE use. To mitigate these effects, healthcare institutions should prioritize high-quality materials, establish optimal usage guidelines, and provide continuous training on self-protection.

2025-05-04·Expert Opinion On Drug Safety

Compartment syndrome associations with drugs: a pharmacovigilance study of the FDA adverse event reporting system (FAERS)

Article

作者: Yang, Xueting ; Shu, Yunfeng ; Tang, Juan ; Wan, Jie ; Kong, Wenqiang

BACKGROUND:

Compartment syndrome is an uncommon but life-threatening condition. No study has comprehensively compared compartment syndrome (CS) association with available drugs. The objective of this study was to estimate the association between CS and drugs using the FDA Adverse Event Report System (FAERS).

RESEARCH DESIGN AND METHODS:

FAERS reports from the first quarter of 2004 to the third quarter of 2023 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CS cases. Reporting odds ratio (ROR), corresponding to 95% confidence intervals (95% CI) were calculated to detect a positive signal.

RESULTS:

A total of 2197 reports were considered in the study after the inclusion criteria were applied. Totally 100 drugs were found to be associated with CS. The median time for drug-associated CS was 45 days.

CONCLUSIONS:

By analyzing the FAERS database, the study revealed that certain drugs are significantly associated with compartment syndrome. Further studies are needed to verify whether these drugs are associated with such a risk.

105

项与盐酸特比萘芬相关的新闻（医药）

2025-07-09

·米内网

【聚焦】福元医药2个新品同日获批，撬开200亿市场大门

精彩内容近日，北京福元医药一口气拿下了利丙双卡因乳膏和盐酸阿莫罗芬搽剂的新批文，公司的产品矩阵越来越丰富。早前，公司未有麻醉剂获批，利丙双卡因乳膏助力公司开拓新市场。今年以来，北京福元医药已累计拿下了15个新产品，成绩可喜。图1：北京福元医药最新获批的产品来源：米内网中国申报进度（MED）数据库图2：利丙双卡因乳膏的销售情况（单位：万元）来源：米内网格局数据库在中国三大终端六大市场（统计范围见文末），利丙双卡因乳膏是麻醉剂TOP22产品，近三年保持高速增长态势。2024年在中国三大终端六大市场，麻醉剂的市场规模保持在200亿元水平，利丙双卡因乳膏是北京福元医药首个获批的麻醉剂，具有积极意义。图3：利盐酸阿莫罗芬搽剂的销售情况（单位：万元）来源：米内网格局数据库盐酸阿莫罗芬搽剂是皮肤病用抗真菌药TOP3产品，2024年在中国三大终端六大市场的销售额超过4.5亿元。截至目前，北京福元医药已获批的皮肤病用抗真菌药已达10款，包括了曲咪新乳膏、联苯苄唑乳膏、克霉唑乳膏、克霉唑溶液、甲紫溶液、复方酮康唑乳膏、盐酸特比萘芬喷雾剂、盐酸阿莫罗芬搽剂、盐酸特比萘芬乳膏、硝酸咪康唑乳膏。表1：今年以来北京福元医药获批的新产品来源：米内网中国上市药品（MID）数据库今年以来，北京福元医药收获满满，已累计获批了15个新产品，均为高端仿制药。除了利丙双卡因乳膏为公司新开拓了麻醉剂市场外，双氯芬酸二乙胺乳胶剂也是公司首款关节和肌肉痛的局部用药。资料来源：米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月8日，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准

2025-07-04

·国家药品监督管理局

2025年07月04日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2450207注射用头孢米诺钠安徽省先锋制药有限公司————2025年07月02日2CYHB2450208注射用头孢米诺钠安徽省先锋制药有限公司————2025年07月02日3CYHB2450209注射用头孢米诺钠安徽省先锋制药有限公司国药准字H202581202025年07月02日4CYHB2450258克林霉素磷酸酯注射液天方药业有限公司————2025年07月02日5CYHB2450259克林霉素磷酸酯注射液天方药业有限公司————2025年07月02日6CYHB2450344盐酸布比卡因注射液山东辉成药业有限公司————2025年07月02日7CYHB2450345盐酸布比卡因注射液山东辉成药业有限公司国药准字H202581192025年07月02日8CYHB2450350维生素B₆注射液信合援生制药股份有限公司国药准字H202581212025年07月02日9CYHB2500789盐酸舍曲林片晖致制药（大连）有限公司————2025年07月02日10CYHB2500790盐酸舍曲林片晖致制药（大连）有限公司————2025年07月02日11CYHB2500910注射用头孢哌酮钠辉瑞制药科技有限公司————2025年07月03日12CYHB2500951地氯雷他定口服溶液广东大鹏医药科技有限公司————2025年07月03日13CYHB2501176吲哚美辛呋喃唑酮栓湖北龙辅药业有限公司————2025年07月02日14CYHB2501179玻璃酸钠滴眼液苏州欧康维视生物科技有限公司————2025年07月02日15CYHB2501186复方乙酰水杨酸片吉林省祈克药业有限公司————2025年07月02日16CYHB2501187复方妥英麻黄茶碱片吉林省祈克药业有限公司————2025年07月02日17CYHB2501199阿奇霉素干混悬剂亚宝药业集团股份有限公司————2025年07月02日18CYHB2501224盐酸特比萘芬乳膏唐山王清任制药有限公司————2025年07月03日19CYSB2400114静注人免疫球蛋白（pH4)成都蓉生药业有限责任公司国药准字S202580092025年07月02日20CYSB2500093斯鲁利单抗注射液上海复宏汉霖生物制药有限公司————2025年07月02日21JTH2500097醋酸兰瑞肽缓释注射液上海研诺医药科技有限公司————2025年07月02日22JTS2500043TrenibotulinumtoxinE艾尔建信息咨询（上海）有限公司————2025年07月02日23JTS2500044Netakimab原液上药帛康生物医药（上海）有限公司————2025年07月02日24JTS2500046Netakimab注射液上药帛康生物医药（上海）有限公司————2025年07月02日25JYHB2500234塞来昔布胶囊晖致医药有限公司————2025年07月02日26JYHB2500235塞来昔布胶囊晖致医药有限公司————2025年07月02日27JYHB2500327枸橼酸西地那非片美享生物科技（海南）有限公司————2025年07月03日28JYHB2500328枸橼酸西地那非片美享生物科技（海南）有限公司————2025年07月03日29JYHB2500329枸橼酸西地那非片美享生物科技（海南）有限公司————2025年07月03日30JYSB2500091阿替利珠单抗注射液罗氏（中国）投资有限公司————2025年07月02日

申请上市临床申请高管变更

2025-06-16

·mobergpharma.com

Terclara market leader also in Norway

Terclara® was launched in Norway in collaboration with our partner Allderma. “We are proud to announce that the Norwegian success follows the highly successful Swedish launch and is built on the same proven model: a combination of broad distribution via all pharmacy chains, targeted marketing and close collaboration with heath care professionals and the pharmacy sector.” says Mimmi Frölén, CEO of Allderma. As consumer sell-out data is not reported in Norway, the market leadership is based on sell-in data to pharmacies. Terclara® recorded the highest sell-in within its segment both in May (market share: 48% by value, 45% by units) and April (38% by value, 35% by units). As in Sweden last year, the launch in Norway was timed ahead of peak season, with pharmacy deliveries beginning in February and consumer marketing starting at the end of March 2025. Despite the short time since launch, Terclara® has already achieved market leadership for the full period January–May 2025, with a market share of 32% by value and 29% by units.[1] "We are very pleased to have already achieved our goal of becoming the market leader also in Norway," says Anna Ljung, CEO of Moberg Pharma. "This is clear evidence that our launch strategy is working and that demand for effective topical treatments is strong across multiple markets." For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se About this information The information was submitted for publication, through the agency of the contact person set out above, on June 16th, 2025, at 8.00 am CEST. About Moberg Pharma, www.mobergpharma.com Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's drug MOB-015 is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in Sweden and Norway under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB). About Allderma Pharmaceuticals, www.allderma.se Allderma Pharmaceuticals is a Swedish pharmaceutical company that since 2001 develops, sells and markets over the counter and self-care products. The range spans a number of different treatment areas, with a focus and expertise in dermatology. Founder Hans Svartholm started Allderma after working in the pharmaceutical industry for many years. The idea was simple and still applies it should be easy to find an effective and safe product for the most common skin problems. Allderma emphasis and invests in information for healthcare providers, pharmacists, doctors and consumers. Product specialists work continuously to be a spear head in research and innovation within dermatology. Allderma has been part of 3iM Invest AB's investment area Consumer Healthcare since 2020. [1] Source: IQVIA MIDAS, Pharmacy Sell-In data, Jan-May 2025

临床3期上市批准

100 项与盐酸特比萘芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02219	盐酸特比萘芬	D01AE15 D01BA02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
甲癣	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2003-12-22
体癣	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2003-12-22
股癣	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2003-12-22
足癣	美国	GlaxoSmithKline Consumer Healthcare Ltd.	1999-03-09
皮肤真菌病	中国	山东安弘制药有限公司	1997-01-01
皮肤念珠菌病	日本	Sun Pharmaceutical Industries Ltd.	1993-07-02
真菌病	日本	Sun Pharmaceutical Industries Ltd.	1993-07-02
癣	日本	Sun Pharmaceutical Industries Ltd.	1993-07-02
花斑癣	日本	Sun Pharmaceutical Industries Ltd.	1993-07-02
头癣	美国	Novartis Pharmaceuticals Corp.	1992-12-30

未上市

10 条进展最快的记录,

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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	Moberg Pharma AB	2017-10-15
粘膜念珠菌病	临床阶段不明	美国	Novartis AG	2001-08-31
口腔念珠菌病	临床阶段不明	美国	Novartis AG	2001-08-31
HIV感染	临床阶段不明	美国	Novartis AG	2001-08-31

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05279846 (Company_Website) 人工标引	临床3期	甲癣	384	MOB-015	顧襯廠顧網鏇鏇夢鏇衊(願廠簾選鑰觸顧齋膚糧) = 衊廠衊選鏇艱憲餘醖餘願醖憲製糧夢築築構鏇 (簾鏇醖襯網衊淵鑰憲鏇 ) 更多	不佳	2025-01-10
NCT03244280 (phase 1 maximal usage trial, Pubmed \| Antimicrob Agents Chemother)	临床1期	甲癣	20	MOB015B	網廠網簾網淵築遞觸膚(鑰襯襯範網醖餘製顧構) = 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. 鏇網襯艱顧構構願鏇鏇 (膚蓋願構選餘醖觸鹹構 )	积极	2024-08-19
NCT02859519 (Pubmed \| J Am Acad Dermatol) 人工标引	临床3期	甲癣	-	MOB-015	鏇醖餘鏇獵壓窪簾鏇淵(醖衊壓製鏇簾鬱糧窪獵) = 築顧簾築壓鏇鹽廠艱願艱願淵醖鑰鬱簾鹽膚醖 (衊壓願膚觸艱網繭蓋夢 ) 更多	非优	2021-07-01
NCT02859519 (Pubmed \| J Am Acad Dermatol) 人工标引	临床3期	甲癣	-	vehicle	鏇醖餘鏇獵壓窪簾鏇淵(醖衊壓製鏇簾鬱糧窪獵) = 遞簾淵範鏇夢願網壓鹽艱願淵醖鑰鬱簾鹽膚醖 (衊壓願膚觸艱網繭蓋夢 ) 更多	非优	2021-07-01
Corporate Publications 人工标引	临床3期	甲癣	452	Terbinafine Hydrochloride	製選鑰糧膚餘繭憲築廠(遞糧鏇築夢選壓齋餘餘) = 糧壓範糧憲顧衊齋積壓鏇鹹網構壓顧夢膚鑰網 (簾憲膚鏇構顧餘築衊鏇 ) 更多	非劣	2020-06-25
Corporate Publications 人工标引	临床3期	甲癣	452	ciclopirox	製選鑰糧膚餘繭憲築廠(遞糧鏇築夢選壓齋餘餘) = 窪觸壓鑰遞夢網齋顧範鏇鹹網構壓顧夢膚鑰網 (簾憲膚鏇構顧餘築衊鏇 ) 更多	非劣	2020-06-25