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

The antifungal efficacy and safety of Jublia® topical solution will be assessed through an administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due to dermatophyte.

开始日期2017-11-10

申办/合作机构

Dong-A ST Co., Ltd.

NCT03168841 / Completed临床3期

Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects.
The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects

开始日期2017-06-06

申办/合作机构

Western University of Health Sciences.

NCT02812771 / Completed临床4期

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

Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

开始日期2016-08-04

申办/合作机构

Bausch Health Americas, Inc.

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100 项与艾氟康唑相关的专利（医药）

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248

项与艾氟康唑相关的文献（医药）

2024-02-01·Journal of drugs in dermatology : JDD

Number of Affected Nails Is the Primary Determinant of Efinaconazole 10% Solution Usage for Onychomycosis

Article

作者: Joseph, Warren S ; Feldman, Steven R ; Daniel, C Ralph ; Vlahovic, Tracey C ; Elewski, Boni ; Lipner, Shari R ; Rich, Phoebe

Good adherence to treatment is necessary for the successful treatment of onychomycosis and requires that an appropriate amount of medication be prescribed. Most prescriptions for efinaconazole 10% solution, a topical azole antifungal, are for 4 mL per month but there are no data on patient factors or disease characteristics that impact how much medication is needed. Data from two phase 3 studies of efinaconazole 10% solution for the treatment of toenail onychomycosis were pooled and analyzed to determine monthly medication usage based on the number of affected toenails, percent involvement of the target toenail, body mass index (BMI), and sex. Participants with two or more affected nails required, on average, >4 mL of efinaconazole per month, with increasing amounts needed based on the number of nails with onychomycosis (mean: 4.39 mL for 2 nails; 6.36 mL for 6 nails). In contrast, usage was not greatly impacted by target toenail involvement, BMI, or sex. Together, these data indicate that the number of affected nails should be the major consideration when determining the monthly efinaconazole quantity to prescribe. J Drugs Dermatol. 2024;23(2):110-112. doi:10.36849/JDD.7676.

2024-01-01·Mycoses

Retrospective analysis of onychomycosis prescribing patterns using the medicare part D prescribers database 2016–2020

Article

作者: Roster, Katie ; Lipner, Shari R ; Wang, Yu

Abstract:

Onychomycosis, defined as a fungal nail infection, affects 5.5% of the global population. Our objectives were to analyse prescription trends of onychomycosis medications using the Medicare Part D Prescribers database from 2016 to 2020, stratified by physician specialty. There was a 4% annual increase in the total cost of onychomycosis medications, with a notable decrease of 12.8% in 2020 during the COVID‐19 pandemic. Physicians demonstrated a strong consideration for price when selecting treatments, with the least expensive medications (ciclopirox and terbinafine) accounting for nearly 99% of all prescriptions. In contrast, the more costly medications (efinaconazole and tavaborole) were rarely prescribed. In addition, physicians often opted for the less costly generic versions of ciclopirox and itraconazole, prescribing them 99% and 91% of the time, respectively. Notably, physician assistants and nurse practitioners had higher overall increases in prescription rates, at 15%, compared to 1%–6% for other specialties. There are no recent United States onychomycosis guidelines, and our study emphasizes cost considerations when prescribing onychomycosis treatments.

2024-01-01·Mycoses

Treatment of onychomycosis in an era of antifungal resistance: Role for antifungal stewardship and topical antifungal agents

Review

作者: Guenin, Eric ; Joseph, Warren S ; Elewski, Boni ; Gupta, Aditya K ; Daniel, C Ralph ; Lipner, Shari R ; Ghannoum, Mahmoud ; Tosti, Antonella

Abstract:

A growing body of literature has marked the emergence and spread of antifungal resistance among species of Trichophyton, the most prevalent cause of toenail and fingernail onychomycosis in the United States and Europe. We review published data on rates of oral antifungal resistance among Trichophyton species; causes of antifungal resistance and methods to counteract it; and in vitro data on the role of topical antifungals in the treatment of onychomycosis. Antifungal resistance among species of Trichophyton against terbinafine and itraconazole—the two most common oral treatments for onychomycosis and other superficial fungal infections caused by dermatophytes—has been detected around the globe. Fungal adaptations, patient characteristics (e.g., immunocompromised status; drug–drug interactions), and empirical diagnostic and treatment patterns may contribute to reduced antifungal efficacy and the development of antifungal resistance. Antifungal stewardship efforts aim to ensure proper antifungal use to limit antifungal resistance and improve clinical outcomes. In the treatment of onychomycosis, critical aspects of antifungal stewardship include proper identification of the fungal infection prior to initiation of treatment and improvements in physician and patient education. Topical ciclopirox, efinaconazole and tavaborole, delivered either alone or in combination with oral antifungals, have demonstrated efficacy in vitro against susceptible and/or resistant isolates of Trichophyton species, with low potential for development of antifungal resistance. Additional real‐world long‐term data are needed to monitor global rates of antifungal resistance and assess the efficacy of oral and topical antifungals, alone or in combination, in counteracting antifungal resistance in the treatment of onychomycosis.

项与艾氟康唑相关的新闻（医药）

2024-02-19

·BioSpace

Novo Licenses to Almirall Potential First-in-Class Antibody Candidate

Pictured: Novo Nordisk's corporate headquarters in Denmark/iStock, Ole Schwander Spanish pharma Almirall announced Monday that it has licensed Novo Nordisk’s anti-IL-21 monoclonal antibody NN-8828, which it plans to develop as a treatment for immune inflammatory dermatological diseases and has first-in-class potential. Almirall is looking to “accelerate the development” of NN-8828 with an eye towards eventually debuting the candidate on the global market for “key dermatological diseases,” according to Monday’s announcement. Under the licensing agreement, Novo will receive an undisclosed upfront payment and will be entitled to developmental and commercial milestones, as well as tiered royalties on future global sales. The licensing agreement will allow Almirall to “explore the innovative approach of IL-21 blockage as a possible new pathway to effectively treat a range of dermatological diseases,” CSO Karl Ziegelbauer said in a statement. The pharma, headquartered in Barcelona, Spain, is focused on medical dermatology. NN-8828 is a monoclonal antibody that targets and binds the IL-21 cytokine with high affinity. IL-21 is a key player in the inflammatory cascade and has been implicated in various immune-based skin diseases, including atopic dermatitis, psoriasis, pemphigus and Sjögren's syndrome. By blocking IL-21 signaling, NN-8828 can potentially inhibit the underlying mechanisms of these diseases providing “a promising option for the treatment of inflammatory and autoimmune skin disorders,” according to Almirall. Before punting the candidate over to Almirall, Novo had trialed NN-8828 up to Phase II in non-dermatological conditions. In January 2013, the Danish pharma announced that it was discontinuing the development of NN-8828 in rheumatoid arthritis after the candidate delivered a middling performance in a Phase IIa study. NN-8828 met its primary endpoint of significantly lowering disease activity versus placebo but “the magnitude of the treatment effect did not warrant further development,” according to Novo. The Danish drugmaker continued assessing NN-8828 in other inflammatory diseases, such as Crohn’s disease and systemic lupus erythematosus, but ultimately exited the inflammation space entirely in September 2014. Now part of Almirall’s holdings, NN-8828 joins a pipeline of promising dermatology therapies anchored by lebrikizumab, which is currently undergoing regulatory review in the European Union for the treatment of atopic dermatitis. Almirall licensed the European rights for lebrikizumab from Dermira in June 2019. Eli Lilly acquired Dermira in January 2020. Also under review in the EU is Almirall’s efinaconazole, an investigational treatment for the fungal infection onychomycosis and sarecycline, meant to treat acne. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

引进/卖出临床2期并购临床1期临床结果

2024-01-31

·PRNewswire

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis. Onychomycosis, or tinea unguium, is a fungal infection of the nail. Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the nail bed), and nail plate thickening. Onychomycosis accounts for one half of all nail disease with an estimated U.S. prevalence of up to 14%.1 In addition to cosmetic issues, onychomycosis infection may indirectly decrease peripheral circulation, thereby worsening conditions such as venous stasis and diabetic foot ulcers.2 "The initiation of clinical studies with VTR-297 in the treatment of onychomycosis is an important milestone in studying and developing potential new therapies for this common disorder," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor with activity against dermatophytes and fungi, originally isolated from the yeast species Streptomyces hygroscopicus as an antifungal antibiotic, first described in 1976.3 Current therapies for onychomycosis include topical agents JUBLIA® (efinaconzole), KERYDIN® (tavaborole), and PENLAC® (ciclopirox). There have not been any new onychomycosis treatments approved by the FDA since 2014.4 References Centers for Disease Control and Prevention. Fungal Nail Infections. Updated September 13, 2022. Accessed January 30, 2024. Available online: Scher, R. Onychomycosis: a significant medical disorder. J Am Acad Dermatol. 35, S2–5 (1996). Available online: (96)90061-4 Tsuji, N., Kobayashi, M., Nagashima, K., Wakisaka, Y., Koizumi, K. A New Antifungal Antibiotic, Trichostatin. J Antibiot (Tokyo). 1976 Jan;29(1):1-6. Available online: Markham, A. Tavaborole: First Global Approval. Drugs 74, 1555–1558 (2014). Available online: About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on Twitter @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to statements regarding the estimated prevalence of onychomycosis and the development of new antifungals, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the accuracy of the reporting and diagnosis of onychomycosis and onychomycosis cases and the ability to successfully complete the clinical development of, and obtain regulatory approval for, VTR-297 in the treatment of onychomycosis. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] SOURCE Vanda Pharmaceuticals Inc.

上市批准临床申请

2024-01-10

·药通社

高迈药业：专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）| 邀您共赴海南MAH B证企业论坛

2024.1.12 • 海南海口【2024 MAH B证企业论坛】苏州高迈药业有限公司成立于2018年，即将搬迁至生物医药产业园四期，研发场地面积11000平方米；专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）；团队由日本的技术、生产人员领衔，国内知名高校教授为顾问团队；核心管理人员均具有多年的研发管理经验；目前已有1个外用药项目获批，2个创新药的临床1期批件，已申报3个产品。公司致力于“高端仿制”“改良型新药”“自主创新药”三步走战略，打造专业外用药“第一股”。项目清单— 项目名称 — 1利丙双卡因乳膏（已获批） 2阿达帕林凝胶（已注册申报） 3夫西地酸乳膏（已注册申报） 4过氧苯甲酰凝胶（已注册申报） 5阿达帕林过氧苯甲酰凝胶 6克立硼罗软膏 7莫匹罗星软膏 8双氯芬酸二乙胺乳胶剂 9硝酸咪康唑乳膏10盐酸阿莫罗芬乳膏11盐酸特比萘芬乳膏12联苯苄唑溶液13盐酸特比萘芬喷雾剂14利多卡因喷雾剂15盐酸阿莫罗芬搽剂16糠酸莫米松乳膏17艾氟康唑外用溶液18盐酸特比萘芬涂膜剂19盐酸利多卡因凝胶20丙酸氟替卡松乳膏21雌二醇凝胶22雌二醇贴片23非那雄胺喷雾剂24利多卡因喷雾剂25尿素乳膏26卡泊三醇软膏27卢立康唑乳膏28氟比洛芬凝胶贴膏29氟维司群乳膏30复方多粘菌素B软膏31黄体酮阴道缓释凝胶32氟轻松氢醌维A酸乳膏33利多卡因丁卡因乳膏34曲安奈德益康唑乳膏35双氯芬酸钠贴剂36双氯芬酸依泊胺贴37美沙拉秦栓38利多卡因凝胶贴膏39洛索洛芬钠凝胶贴膏40洛索洛芬钠贴剂41阿昔洛韦氢化可的松乳膏42利多卡因丙胺卡因气雾剂43多磺酸粘多糖乳膏44伊维菌素乳膏45盐酸丁卡因凝胶46克霉唑阴道乳膏47布洛芬乳膏48磷酸芦可替尼乳膏49克拉司酮乳膏50氢醌乳膏51曲咪新乳膏52双唑泰乳膏53奥昔布宁透皮贴剂54妥洛特罗贴剂55硝呋太尔制霉菌素阴道软膏56硝酸益康唑喷雾剂57盐酸氨酮戊酸外用散58复方倍氯米松樟脑乳膏59地奈德乳膏60酮洛芬凝胶设备及资质流变仪01透皮仪02粘度计03联系我们联系人：陈先生 18006207168↓↓快速报名通道↓↓▼ 本次会议议程，可上下滑动查看9:00-9:20海南省医药产业政策介绍海南省工业和信息化厅专家09:20-09:50新政实施后，如何办B证？药监专家09:50-10:10茶歇10:10-10:40最新B证监管政策解读药监专家10:40-11:10MAH制度下企业仿制药立项王立峰慧药咨询创始人11:10-11:40批文&项目合作路演11:40-13:30午餐时刻13:30-14:00医改政策盘点及企业应对策略许金灿，药闻康策创始人兼总经理14:00-14:30MAH委托生产-监管政策的解读沈红梅，重庆博腾制药科技股份有限公司制剂研发副总经理、正高级工程师14:30-15:00MAH B证企业经验谈销售型企业转型B证经验谈综合型药企持证委托生产经验谈研发型药企持证经验谈15:00-15:30批文&项目合作路演15:30-15:50茶歇15:50-16:20MAH B证公司迎接检查注意点周鹏程，国家资深GMP检查员16:20-16:50MAH制度下，B证企业委托生产共线风险考量唐老师，国家资深GMP检查员

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KEGG	Wiki	ATC	Drug Bank
D10021	艾氟康唑	D01AC19	DB09040

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甲癣	美国	Bausch Health Americas, Inc.	2014-06-06

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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


NCT02812771 (CTgov)	临床4期	甲癣	62	Efinaconazole	衊築獵願廠艱糧鏇膚獵(觸淵網鬱鏇膚遞醖鏇壓) = 範鬱簾憲鹹淵蓋衊廠構窪獵鑰獵鏇網遞願顧鑰 (獵憲艱鏇窪選顧壓繭壓, 積餘齋範襯鹹願廠獵夢 ~ 廠餘壓獵網製廠窪壓願) 更多	-	2021-11-01
NCT03168841 (CTgov)	临床3期	甲癣 \| 糖尿病	40	Efinaconazole Topical	壓醖淵願衊顧簾願鑰蓋(鑰獵觸窪製糧餘窪鹹網) = 繭廠鹽範遞鑰獵鏇選餘繭壓鏇襯膚簾鹹築製窪 (蓋壓選窪鑰齋獵鹽觸廠, 積壓窪獵願鑰繭積鹹餘 ~ 範鏇憲襯築鏇憲壓繭繭) 更多	-	2019-10-23
NCT03110029 (CTgov)	临床4期	甲癣	13	Efinaconazole 10% Topical Application Solution [JUBLIA]	膚積鹽壓積淵鬱蓋築顧(構選壓淵選壓餘齋築蓋) = 鹹廠淵夢積憲夢遞網鏇膚築積鬱顧蓋壓襯憲襯 (顧窪選鬱鹹鹽製遞顧艱, 選窪餘築淵齋襯簾遞夢 ~ 選襯襯繭夢糧壓簾艱糧) 更多	-	2019-03-20
Pubmed	临床3期	甲癣	-	Efinaconazole 10% solution	範艱製構鏇鏇築觸齋網(願鹽襯膚廠獵憲艱醖鏇) = 憲觸築鹹簾齋膚窪廠製獵遞廠壓壓廠獵艱鑰齋 (顧廠艱觸獵壓艱淵繭壓 ) 更多	-	2014-07-01
Pubmed	临床3期	甲癣	-	Vehicle	範艱製構鏇鏇築觸齋網(願鹽襯膚廠獵憲艱醖鏇) = 範顧艱膚願壓夢夢範築獵遞廠壓壓廠獵艱鑰齋 (顧廠艱觸獵壓艱淵繭壓 ) 更多	-	2014-07-01