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IIT

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.

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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267

项与艾氟康唑相关的文献（医药）

2024-11-01·JOURNAL OF DERMATOLOGY

Development of treatment strategies by comparing the minimum inhibitory concentrations and minimum fungicidal concentrations of azole drugs in dermatophytes

Article

作者: Harada, Kazutoshi ; Nojyo, Honoka ; Hiruma, Junichiro ; Kano, Rui

Abstract:

We compared the minimum inhibitory concentrations (MICs) and minimum fungicidal concentrations (MFCs) of azoles in antifungal drug‐susceptible, terbinafine‐resistant, and lowly itraconazole (ITCZ)‐susceptible strains of dermatophytes. To assess the MICs of ITCZ, ravuconazole (RVCZ), efinaconazole (EFCZ), and luliconazole (LUCZ) in the isolates, broth microdilution assays were performed based on the Clinical and Laboratory Standards Institute M38‐A2 guidelines with modifications. After the assays for determining the MICs, the inoculum suspensions in wells were resuspended, then 10 μL of the growth solution in each well was inoculated onto potato dextrose agar with the use of a pipette. After 7 days of incubation at 28°C, the MFCs were determined as the lowest concentration of a drug that allowed the growth of colonies on the potato dextrose agar. The MICs in the dermatophytes were <0.03 to >32 mg/L for ITCZ, <0.03 to 4 mg/L for RVCZ, <0.03 to 2 mg/L for EFCZ, and <0.03 mg/L for LUCZ. The MFCs in the dermatophytes were 1 to >32 mg/L for ITCZ, 0.06 to >32 mg/L for RVCZ, <0.03 to 4 mg/L for EFCZ, and <0.03 to 2 mg/L for LUCZ. If the drug susceptibility test shows that the fungi are resistant to the drug, the treatment can be changed to a susceptible drug in advance, or if the fungi are low‐susceptible, the treatment can be done with the recognition that it may require a longer treatment period than usual.

2024-09-01·Dermatology and Therapy

Transungual Penetration and Antifungal Activity of Prescription and Over-the-Counter Topical Antifungals: Ex Vivo Comparison

Article

作者: Kadry, Ahmed ; Elabbasi, Ali ; Ghannoum, Mahmoud ; Elewski, Boni ; Joseph, Warren

INTRODUCTION:

Topical antifungals for toenail onychomycosis must penetrate the nail to deliver an inhibitory concentration of free drug to the site of infection. In two ex vivo experiments, we tested the ability of topical antifungals to inhibit growth of Trichophyton rubrum and Trichophyton mentagrophytes, the most common causative fungi in toenail onychomycosis.

METHODS:

Seven topical antifungals were tested: three U.S. Food and Drug Administration-approved products indicated for onychomycosis (ciclopirox 8% lacquer; efinaconazole 10% solution; tavaborole 5% solution) and four over-the-counter (OTC) products for fungal infections (tolnaftate 1% and/or undecylenic acid 25% solutions). The ability to inhibit fungal growth was tested in the presence and absence of keratin. Products were applied either to human cadaverous nails or keratin-free cellulose disks prior to placement on an agar plate (radius: 85 mm) seeded with a clinical isolate of T. rubrum or T. mentagrophytes. After incubation, the zone of inhibition (ZI), defined as the radius of the area of no fungal growth, was recorded.

RESULTS:

In the nail penetration assay, average ZIs for efinaconazole (T. rubrum: 82.1 mm; T. mentagrophytes: 63.8 mm) were significantly greater than those for tavaborole (63.5 mm; 39.1 mm), ciclopirox (7.4 mm; 3.6 mm) and all OTC products (range: 10.5-34.2 mm against both species; all P < 0.001). In the cellulose disk diffusion assay, efinaconazole and tavaborole demonstrated maximal antifungal activity against both species (ZIs = 85 mm); average ZIs against T. rubrum and T. mentagrophytes were smaller for ciclopirox (59.0 and 55.7 mm, respectively) and OTC products (range: 31.2-57.8 mm and 25.7-47.7 mm, respectively).

CONCLUSIONS:

Among all antifungals tested, the ability to penetrate human toenails to inhibit growth of both T. rubrum and T. mentagrophytes was greatest for efinaconazole, followed by tavaborole. These results indicate superior transungual penetration of efinaconazole compared to the other antifungals, suggesting lower keratin binding in the nail.

2024-09-01·The Journal of clinical and aesthetic dermatology

Concealing Meets Healing in the Treatment of Toenail Onychomycosis: A Review of Concurrent Nail Polish Use with Topical Efinaconazole 10% Solution.

Review

作者: Elewski, Boni ; Vlahovic, Tracey C ; Pandit, Bela

Objective:

Patients with onychomycosis may use nail polish to camouflage affected nails, despite potential interactions between nail polish use and topical onychomycosis treatments. Our objective was to review available data on nail polish use concurrent with topical efinaconazole 10% solution for the treatment of onychomycosis.

Methods:

We conducted a PubMed search and narrative review of data on effects of nail polish on penetration of efinaconazole and clinical studies of efinaconazole in the treatment of toenail onychomycosis concurrent with nail polish use, including results of an investigator-initiated study of gel nail polish pedicures.

Results:

In vitro, penetration of efinaconazole through cadaverous nails coated with traditional nail polish was similar to penetration through uncoated nails. In a 52-week clinical study, efinaconazole treatment was associated with similar improvements in onychomycosis severity and clear toenail growth between participants who used traditional nail polish and those who did not use nail polish. In a second clinical study, participants received efinaconazole treatment concurrent with monthly gel nail polish pedicures. After 6 months, 100% of participants tested negative for fungal infection and all experienced visible improvements in treated toenails. Efinaconazole application was associated with degradation of traditional nail polish texture/appearance. In contrast, efinaconazole did not affect the duration, quality, or texture of gel polish.

Limitations:

Only four small studies have assessed nail penetration and efficacy of efinaconazole 10% solution with concurrent nail polish use.

Conclusion:

Efinaconazole 10% solution demonstrated efficacy in the treatment of toenail onychomycosis among participants concurrently using toenail polish, with no visible impact on gel-polished nails.

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2024-10-15

·Pharmaceutical Technology

Almirall completes EU regulatory procedure for antifungal Jublia

Efinaconazole’s low binding affinity to keratin enables it to penetrate nails effectively to treat onychomycosis. Credit: Prabodha D Herath/Shutterstock. Almirall has completed the decentralised European regulatory procedure for efinaconazole, a triazole antifungal substance with the trade name Jublia, to treat onychomycosis. This is a significant step in enhancing Almirall’s medical dermatology portfolio in Europe and the procedure is the last step before European countries can issue national marketing authorisations. Onychomycosis, a fungal infection impacting an estimated 5.5% of the world population, accounts for half of all nail disorder consultations. It is a notoriously tenacious condition, often resistant to treatments. Efinaconazole’s low binding affinity to keratin, key in nail composition, enables it to penetrate nails effectively. In May 2022, Almirall initiated the regulatory submission process for efinaconazole in Germany and Italy, utilising the European decentralised procedure. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC Germany’s regulatory authority acted as the reference member state. Almirall research and development, chief scientific officer and executive vice-president Dr Karl Ziegelbauer stated: “The completion of the decentralised regulatory procedure for efinaconazole in Europe enables European countries to approve this advanced treatment option to support people with onychomycosis. “Efinaconazole as a topical treatment is a valuable addition to our expanding onychomycosis portfolio and we are looking forward to being able to offer it to European dermatologists and their patients in the near future.” In July 2021, the company obtained exclusive development and marketing rights for efinaconazole in Europe from Kaken Pharmaceutical . Kaken received an upfront cash payment from Almirall, along with milestone payments and royalties based on net sales of the product, which is currently available in the US, Canada, Korea, Hong Kong and Macau. It has been available in Japan under the trade name Clenafin since 2014. Almirall is currently collaborating with national regulatory authorities, with authorisations anticipated in the first half of 2025. In February 2024, Almirall entered a strategic collaboration with Microsoft for drug development in dermatology.

上市批准引进/卖出

2024-08-08

·药通社

高迈药业——专注于外用药的药学研发 | CMC-China博览会展商速递

公司介绍苏州高迈药业有限公司成立于2018年，位于苏州工业园区纳米园；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；4个已经申报受理项目；2024年计划申报12个项目。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”。项目清单乳膏/软膏/凝胶类1、利丙双卡因乳膏(已获批)11、维氟醌乳膏(氟轻松氢醌维A酸乳膏)21、磷酸芦可替尼乳膏31、复方多粘菌素B软膏2、阿达帕林凝胶(已注册申报)12、尿素乳膏22、复方倍他米松樟脑乳膏32、盐酸丁卡因凝胶3、夫西地酸乳膏(已注册申报)13、盐酸特比萘芬乳膏23、曲咪新乳膏33、壬二酸凝胶4、过氧苯甲酰凝胶(已注册申报)14、卢立康唑乳膏24、多磺酸粘多糖乳膏34、酮洛芬凝胶5、阿达帕林过氧苯甲凝胶(已注册申报)15、曲安奈德益康唑乳膏25、氟维司群乳膏35、雌二醇凝胶6、盐酸阿莫罗芬乳膏16、布洛芬乳膏26、克霉唑阴道乳膏36、黄体酮阴道缓释凝胶7、硝酸咪康唑乳膏17、阿昔洛韦氢化可的松乳膏27、莫匹罗星软膏37、盐酸利多卡因凝胶8、利多卡因丁卡因乳膏18、氢醌乳膏28、克立硼罗软膏38、硝呋太尔制霉菌素阴道软膏9、克拉司酮乳膏19、糠酸莫米松乳膏29、双唑泰乳膏10、伊维菌素乳膏20、丙酸氟替卡松乳膏30、卡泊三醇软膏贴剂1、利多卡因凝胶贴膏4、双氯芬酸依泊胺贴7、双氯芬酸二乙胺乳胶剂10、美沙拉嗪栓2、双氯芬酸钠贴剂5、洛索洛芬钠凝胶贴膏8、妥洛特罗贴剂11、奥昔布宁透皮贴剂3、氟比洛芬凝胶贴膏6、洛索洛芬钠贴剂9、雌二醇贴片 // 其他 1、非那雄胺喷雾剂 2、盐酸阿莫罗芬搽剂 3、联苯苄唑溶液 4、盐酸特比萘芬喷雾剂 5、盐酸特比萘芬涂膜剂 6、硝酸益康唑气雾剂 7、西甲硅油乳剂 8、利多卡因丙胺卡因气雾剂 9、艾氟康唑外用溶液 10、利多卡因喷雾剂 11、盐酸氨酮戊酸外用散 *绿色标色已经获批 *浅绿色表示已经申报设备及资质联系我们联系人：曹总13861331380 ↓↓扫描下方二维码免费报名

临床申请

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

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外链

KEGG	Wiki	ATC	Drug Bank
D10021	艾氟康唑	D01AC19	DB09040

研发状态

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适应症	国家/地区	公司	日期
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	餘蓋獵衊齋鹹選鑰選選(積鏇鹽衊範鏇齋憲獵鹽) = 積願糧選憲襯範醖壓夢衊醖構築廠蓋積鹽鹹網 (願顧選廠鏇鬱艱憲繭積, 襯艱範製蓋壓製鹽蓋夢 ~ 襯鏇構餘鹽繭範窪襯範) 更多	-	2021-11-01
NCT03168841 (CTgov)	临床3期	糖尿病 \| 甲癣	40	Efinaconazole Topical	衊襯衊願鑰獵鬱築膚糧(膚夢廠衊製積鬱窪夢觸) = 遞獵襯艱艱構願壓壓範觸獵網繭醖壓鹽簾鏇糧 (鹽遞夢選構膚築遞顧夢, 糧膚鬱製醖醖遞艱齋窪 ~ 鹹廠範蓋鑰齋構鏇獵製) 更多	-	2019-10-23
NCT03110029 (CTgov)	临床4期	甲癣	13	Efinaconazole 10% Topical Application Solution [JUBLIA]	簾製願選蓋鬱遞積網鹹(蓋構積鹽願觸淵鑰窪顧) = 衊窪夢襯簾艱築糧鹹醖膚壓廠蓋憲齋選壓壓構 (積鬱範積願鹹繭鏇糧蓋, 簾選衊淵窪廠壓蓋淵餘 ~ 積鏇顧製鏇糧艱範鏇鬱) 更多	-	2019-03-20
Pubmed	临床3期	甲癣	-	Efinaconazole 10% solution	壓衊網構簾繭窪壓鹹鬱(膚鏇鑰憲襯窪艱餘顧繭) = 襯醖壓廠構顧夢積淵衊願積齋憲鹽選壓糧選淵 (醖鬱膚醖觸願選廠襯簾 ) 更多	-	2014-07-01
Pubmed	临床3期	甲癣	-	Vehicle	壓衊網構簾繭窪壓鹹鬱(膚鏇鑰憲襯窪艱餘顧繭) = 鹽衊範遞選廠窪淵醖廠願積齋憲鹽選壓糧選淵 (醖鬱膚醖觸願選廠襯簾 ) 更多	-	2014-07-01