Efficacy and Safety of the Topical Naftifine 2% Therapy versus Topical Luliconazole 1% Therapy in Patients with Localized Tinea Corporis in a Tertiary Care Centre - NIL

开始日期2024-04-15

申办/合作机构-

CTRI/2022/06/043131

/ Completed临床3期

â??A Phase III, Prospective, Randomized, Double Blind, Active Controlled, Comparative, Parallel Group and Multicentric Clinical Study to Evaluate the Efficacy and Safety of Naftifine Hydrochloride Cream 2% w/w in the Treatment of Patients with Interdigital Tinea Pedis.â??

开始日期2022-06-20

申办/合作机构

Synokem Pharmaceuticals Ltd.

CTRI/2022/03/041466

/ Active, not recruiting临床3期

A prospective, randomized, two-arm, double-blind, active-controlled, parallel, multicentre, non-inferiority, phase III clinical trial to assess the efficacy and safety of Naftifine hydrochloride cream 2% w/w as compared to Terbinafine hydrochloride cream 1% w/w in patients with superficial fungal infection of the skin

开始日期2022-03-30

申办/合作机构

Zydus Healthcare Ltd.

100 项与盐酸萘替芬相关的临床结果

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100 项与盐酸萘替芬相关的转化医学

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100 项与盐酸萘替芬相关的专利（医药）

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306

项与盐酸萘替芬相关的文献（医药）

2026-02-04·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Protective mechanism of action of the antifungal drug naftifine against Mycobacterium abscessus infection

Article

作者: Kilgore, Paul B. ; Wang, Jia ; Brown-Elliott, Barbara ; Hendrix, Emily K. ; Lee, Sunhee ; Sha, Jian ; Paroha, Ruchi ; Verma, Atul K. ; Chopra, Ashok K. ; Neil, Blake H.

ABSTRACT:

Mycobacterium abscessus, a rapidly growing nontuberculous mycobacterium, causes chronic pulmonary infections that are difficult to treat due to extensive intrinsic drug resistance. Through high-content screening of 786 FDA-approved drugs against intracellular M. abscessus in human THP-1 macrophages, we identified naftifine, an antifungal allylamine, as a novel antimycobacterial agent with dual-acting therapeutic mechanisms. Naftifine demonstrated potent activity against reference strains and multidrug-resistant clinical isolates. It showed enhanced efficacy in intracellular environments compared to axenic culture, indicating significant host-directed effects. Mechanistic investigations revealed that naftifine operates through a unique dual mechanism. It directly targets bacteria by inhibiting MmpL3 (MAB_4508), the essential mycolic acid transporter, and modulates host immunity through autophagy activation via the mTOR pathway suppression. Whole-genome sequencing of spontaneous naftifine-resistant mutants identified point mutations (S302T and V299G) in MmpL3. Complementation studies confirmed MmpL3 as the primary molecular target. Cross-resistance analysis with other MmpL3 inhibitors (BM212 and AU1235) validated this target identification. Notably, naftifine represents the first MmpL3 inhibitor demonstrated to induce autophagy, distinguishing it from other MmpL3-targeting compounds. Naftifine-induced autophagy enhanced macrophage-mediated bacterial clearance and reduced infection-associated necrosis, improving host cell survival. In vivo studies demonstrated a significant reduction of pulmonary and splenic bacterial burden with reduced lung inflammation. Furthermore, naftifine exhibited synergistic activity with β-lactam antibiotics without antagonizing other clinically used antibiotics. This is the first report demonstrating the unique combination of MmpL3 inhibition and autophagy induction by a single compound against M. abscessus , establishing naftifine as a promising dual-action therapeutic candidate for treating multidrug-resistant infections.

2025-02-01·MYCOPATHOLOGIA

Whole Genome Sequence Analysis of Terbinafine Resistant and Susceptible Trichophyton Isolates from Human and Animal Origin

Article

作者: Meijer, Eelco F J ; Dogra, Sunil ; Rudramurthy, Shivaprakash M ; Narang, Tarun ; Spruijtenburg, Bram ; Abhishek ; Shaw, Dipika ; Thakur, Sheetal ; Meis, Jacques F ; Chakrabarti, Arunaloke ; de Groot, Theun

Trichophyton indotineae, first identified in India, has increasingly been reported in Asia, the Middle East, Europe, and recently in the USA. The global spread of terbinafine-resistant T. indotineae underscores the urgency of the issue. With its ability for human-to-human transmission, it can be considered anthropophilic. However, its highly virulent nature suggests a possible link to zoophilic species, raising the potential for disease transmission from animals. In this study, we have performed whole genome sequencing (WGS) of terbinafine susceptible and resistant Trichophyton species from animal and human origin to understand transmission dynamics of this species. Thirteen isolates of Trichophyton spp. from human (n = 9) and canine (n = 4) origin, respectively from Chandigarh and Bareilly, India, were included in this study. Isolate identification based on ITS extracted from WGS data identified six T. indotineae (ITS genotype VIII) and seven T. interdigitale (ITS genotype II) isolates. WGS single nucleotide polymorhpism (SNP) analysis separated the isolates into two distinct groups, T. indotineae and T. interdigitale and showed the clonal nature of both species. For both species, low SNP differences between isolates from humans and dogs were observed as well as low differences between isolates from Chandigarh and Bareilly, cities >350 km apart from each other. These findings suggest zoonotic transmission, next to fast spread across large distances. The T. indotineae terbinafine-resistant strains exhibited the SQLE^F397L substitution while susceptible strains had the SQLE^S395P substitution or demonstrated a wild-type (WT) SQLE sequence. However, all T. interdigitale strains displayed a WT SQLE sequence despite terbinafine minimum inhibitory concentrations (MICs) ranging between 0.031 to 64 µg/mL.

2025-01-27·CLINICAL AND EXPERIMENTAL DERMATOLOGY

Naftifine: an effective therapeutic option in cases of tinea corporis and tinea cruris – observations from an open-label randomized controlled trial

Article

作者: Shahrukh Raza ; Sujata Sengupta ; Saikat Banerjee ; Sambit Chatterjee ; Anupam Das

Many clinical trials have been conducted with the purpose of finding better drugs, both in terms of effectiveness and safety in treating dermatophytoses. Luliconazole cream is a preferred treatment option. However, owing to the risk of developing resistance to azoles, allylamines are being tried as potential alternatives. We aimed to evaluate and compare the effectiveness of naftifine 2% cream vs. luliconazole 1% cream in treating dermatophytoses. We found that naftifine can be safely used in the treatment of steroid-modified dermatophytoses and the molecule offers up itself as a new, effective and promising addition to our treatment arsenal for dermatophytoses.

项与盐酸萘替芬相关的新闻（医药）

2026-03-01

·医脉通

暗红色的肿块流着淡黄色脓性液体，11岁男孩为何会得这种病？丨医起推理吧

这蹊跷的病症究竟从何而来呢？来源 | 医脉通作者 | 昼辞 01 初到诊室小君，11岁了，来到诊室的他显得有些顽皮，东瞧瞧西看看，好不容易才在奶奶的安抚下，同意让医生检查身体。 “其他地方也没什么，就是孩子脑袋后面痒得很，皮屑很多，我给上了点药后包起来了。”小君奶奶说完便让孩子转过身去，露出了用纱布包裹的右枕部。纱布已经被药液混合着分泌物浸染成了棕褐色，揭开层层叠叠的纱布，露出里面惊心动魄的创面：一个呈圆形、暗红色隆起的肿块出现在头皮上，该肿块伴有淡黄色脓性渗出物并引发疼痛，且此处的头发已经脱落，上面似乎还覆盖着一些植物纤维以及药膏类的物质。看起来这病程已经拖了有一阵子了，小君奶奶似乎还没意识到病情的复杂性，以为到医院开点药抹抹就好了。 “以前乡下人养孩子都有个三灾两病的，长点疹子、皮癣搞点土方就好了。”因为听到要住院的建议，小君奶奶回应道。好在小君妈妈及时赶到，这才顺利办理了住院。于是，一场旷日持久的诊治就此拉开帷幕。图源：作者提供 02 病情初探与清创除了了解病史之外，医生首先决定进行清创处理。由于小君奶奶自行制作了草药为他敷上，还使用了抗炎乳膏之类的药物附着于创面，导致对病灶的评估不甚准确。医生在先后使用生理盐水、碘伏、双氧水等清洗后，真正的病灶才显露出来。原来，小君右枕部的皮疹最早在三周前就已出现。起初还只是小范围的几个红点，家长以为是天气热孩子起了痱子或是洗澡没洗干净，便用了些花露水、痱子粉处理。可是，症状非但没有好转，反而皮疹面积越来越大，渐渐地还隆起于表皮。 “就是头后面很痒，晚上更厉害，我忍不住要去挠挠。”说到这儿，小君甚至还想伸手去挠痒，但被制止了。挠完后伴随着大片的皮屑和头发脱落，意识到问题的小君奶奶才给他安排了“土方子”治疗，又耽搁了好一阵子。期间也有去诊所予静脉抗感染以及药膏外用治疗，但依旧无法阻止病灶的进一步扩大。小君觉得自己很是“另类”，再加上同学的指指点点，让他身心都备受煎熬，开始拒绝上学。 03 深入排查病因在这次生病前，小君还算是个健康活泼的孩子，成长发育也都在正常范围内。家族史、个人史、过敏史等方面未见异常，近期也没有疫源、疫区等旅居史。那么，这蹊跷的皮疹究竟从何而来呢？皮疹即皮肤损害，是指可以用视诊或触诊检查出的皮肤黏膜病变。皮疹是儿科常见的体征，如何抽丝剥茧擒住真凶非常考验医师的耐心与细心。不同的皮疹往往提示完全不同的疾病，自然治疗方案也是天差地别。儿童患者常见的皮疹病因很多，如感染性因素里的真菌、细菌、寄生虫等所致，或者是非感染因素里湿疹、荨麻疹等等。初步查看患儿的皮疹形态，医生考虑还是感染性因素的可能性更大。在皮肤科专业的辅助检查下，很多秘密都无所遁形。医生给小君完善了头皮荧光检查后发现真菌呈现阳性反应，血常规提示白细胞数高达18.82*109/L；除此之外，还为小君完善了非感染因素方面的检查，如IgE、SAA等，却都是阴性结果。因此，可以诊断患儿的皮疹为真菌感染。 04 真菌感染与脓癣特征真菌性的皮疹具有一定传染性，又叫做“癣”。而不同的癣其症状形态也不尽相同，发生在头皮的癣就有：黄癣、白癣、黑点癣以及脓癣。 1.黄癣黄癣是灰黄色菌病，它会侵犯大部分头皮。皮损初起时为针尖大小的淡黄红色斑点，上面覆盖着薄片状鳞屑，随后会形成黄豆大小的淡黄色痂，痂的周边翘起，中央紧贴着头皮，形状如同碟状（即黄癣痂）。这些痂可以扩大并融合，形成大片状，严重时可覆盖整个头皮。除去痂后，可见其下为潮红糜烂面。真菌会导致病发变得干燥无光泽、变脆易折断，毛囊被破坏后会引起毛发脱落，可形成大片永久性秃发，愈后会遗留瘢痕。 2.白癣白癣多见于学龄儿童，且男性患者多于女性。皮损初起时为群集性的红色小丘疹，很快会向四周扩大成圆形或椭圆形，上面覆盖着灰白色鳞屑。随后，附近会出现数片较小的相同皮损，被形象地称为“母子斑”。病发会在高出头皮2~4mm处折断，残根部会包绕着灰白色套状鳞屑，这被称为菌鞘，是由真菌寄生于发干而形成的。 3.黑点癣黑点癣较为少见，儿童及成人均可发病。皮损初起时为散在的鳞屑性灰白色斑，以后逐渐扩大成片，其特点是病发刚出头皮即折断，残根在毛囊口处呈现黑点状，因此得名。皮损炎症轻微或无炎症，稍有痒感。病程发展缓慢，长期不愈。它属于发内型感染，愈后常留有局灶性脱发和点状萎缩性瘢痕。 4.脓癣脓癣在感染1~2周后，局部会出现肿胀、化脓现象，典型损害为化脓性毛囊炎。皮损内的毛发会松动、折断、易拔除，皮损边缘陡直。在毛干内外及痂壳内，可见真菌菌丝和孢子，而小君的症状体征与脓癣最为接近。在进一步详细询问病史后，小君奶奶这才恍然大悟。原来，大约一个月前，小君在市场上看到有仓鼠售卖，那些毛茸茸、软乎乎的小宠物显得格外可爱，小君便缠着奶奶给他买一只。富有爱心的小君自从把仓鼠带回家后，每天都与小仓鼠形影不离，精心照料着它。而差不多就是从那个时候开始，小君逐渐出现了头皮瘙痒的症状。 05 治疗过程与波折面对入院时病情严重的脓癣，治疗显得相当棘手。首要措施是进行理发，并且需要每7~10天理发一次，以便于上药和观察创面愈合情况。在生活护理方面，也需特别注意，小君所使用的物品必须单独分开进行消毒处理，并且每日都要使用2%酮康唑洗剂或硫磺皂来洗头。在治疗上，采用了口服及外用药物相结合的方法，如口服伊曲康唑，同时在服药期间还配合外用萘替芬、酮康唑乳膏、硫软膏等药物。由于患儿血象升高，医生还加用了“头孢曲松”进行静脉滴注，并配合使用莫匹罗星软膏等抗感染药物。除此之外，还使用氩氖激光治疗仪等设备来收敛创面，促进其愈合。然而，次日小君便出现发热症状，并伴有创面刺痛。在给予利多卡因凝胶进行止痛清创处理后，逐渐地，破溃的创面开始长出新的肉芽组织。病情的这一点小波折并没有产生太大影响，肿块逐渐缩小变薄。数日后复查血常规，结果显示血象已恢复正常，于是停用抗生素。图源：作者提供出院后，小君继续口服及外用药物进行巩固治疗。数周后随访患儿，发现病灶已经基本消失，露出了淡红色的头皮。数月后，小君茂盛的头发也恢复如初，一切都在朝着好的方向发展。责编｜Zelda Atai 封面图来源｜视觉中国动真格了！国家卫健委启动3年“大清洗”：8大举措严打论文造假等，发现一起查处一起，影响终身随手回微信赔了15万？医生微信指导保胎酿大祸，终审担责75%！从“热心回复”到“对簿公堂”……丨医眼看法医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。 ☟戳这里，更有料！

核酸药物引进/卖出

2025-02-10

·EndPoints

Decade after $8B deal, Roche offloads InterMune to mysterious specialty pharma

Roche’s $8 billion InterMune acquisition, disclosed a decade ago, is now being handed to a specialty pharmaceutical company. Cayman Islands-based Legacy Pharma is run by Mark Thompson , the former CEO of Concordia, another specialty pharma that had a price-hiking reputation . It put out a short press release last week saying it had completed the acquisition of InterMune and the US IP rights to its idiopathic pulmonary fibrosis medicine Esbriet (pirfenidone) from Roche’s Genentech for undisclosed terms. Legacy said it would “ensure the continued availability and distribution of Esbriet to patients across the United States.” Genentech will provide access to the drug “until the completion of the business transfer” and Roche keeps ex-US commercial rights, according to the press release. Esbriet was the “only medicine in the Roche pipeline” that derived from InterMune, and it is available in about 40 countries, a Roche spokesperson told Endpoints News via email. The divestiture of Esbriet wasn’t entirely surprising. Roche confirmed to Endpoints last February that it was looking at offloading Esbriet. “We have strict confidentially [sic] provisions with Roche and cannot say more than what is in the press release. The transaction was funded internally,” Thompson wrote in an email to Endpoints. Sales of Esbriet, which has had generic competition since 2022, sank 56% from 2023 to 2024, Roche said last week. It reeled in $54 million in 2024, according to Roche’s annual report. Boehringer Ingelheim markets the only other approved drug for IPF, which destroys lung capacity and can lead to death for many patients within five years. Multiple biotechs are attempting to create new medicines. Not much is known about Legacy. It’s led by Thompson and chief financial officer Adeel Ahmad, the former CFO of Concordia, which rebranded to Advanz Pharma in 2018. Its president and general manager, Chris Humphrey, also comes from Advanz, according to his LinkedIn profile. Thompson posted on LinkedIn about the InterMune deal late last week, calling it a “Big Day!” A few months ago, Thompson posted to the networking site to say Legacy had acquired a “basket of products” from Sebela Pharmaceuticals, including the antifungal Naftin, to bring the company’s portfolio to 22 prescription products. A year ago, it acquired Allegis Pharmaceuticals and Marnel Pharmaceuticals, Thompson also wrote on LinkedIn. Northern Private Capital helped fund the deal, he added. At the time, it had 40 employees across multiple cities, including Scottsdale, AZ and Bridgetown, Barbados, according to the CEO. In his weekly biopharma market report on Monday, Stifel healthcare managing director Tim Opler said there were a “few things of interest” regarding the deal. “First, Roche has obviously thrown in the towel on its Intermune deal– after paying $8.1 billion for it,” Opler wrote. “Second, the buyer’s CEO, Mark Thompson, has an impressive track record. He previously built Concordia Pharma up from zero to over $3bn in value by purchasing pharmaceutical ‘tail assets.’ Let’s watch what he does this time. If we were the betting type, we would put money on Legacy Pharma to do well.”

并购

2024-09-04

·药通社

25年大盘点！FDA批准局部皮肤用凝胶剂：从2000到2024

一、前言凝胶剂（Gel）是指原料药与能形成凝胶的辅料制成的具凝胶特性的稠厚液体或半固体制剂。凝胶剂可分为全身用凝胶剂（Transdermal gel）和局部用凝胶剂（Topical gel）两类。按给药途径不同，可以进一步将局部用凝胶剂分为皮肤用凝胶剂、眼用凝胶剂、阴道用凝胶剂、直肠用凝胶剂等。表12000年至2024年FDA批准的局部皮肤用凝胶剂产品（NDA）笔者研通过调取FDA网站上发布的新药申请批准情况，收集了从2000年至2024年这25年时间里FDA批准上市（已撤市的产品不纳入统计）的具有专有名称的局部皮肤用凝胶剂产品。各产品的具体信息见表1和表2。从表中可以看出，从2000年至2024年，FDA共批准上市了26款局部皮肤用凝胶剂NDA上市申请，平均每年批准1款。表22000年至2024年FDA批准的局部皮肤用凝胶剂产品处方组成二、产品分析 2.1 凝胶基质选择局部皮肤用凝胶剂的常用辅料有凝胶基质、pH调节剂、保湿剂、防腐剂、稳定剂、助溶剂、增溶剂及透皮吸收促进剂等。其中，凝胶基质的选择在凝胶制剂的处方开发中尤为重要。在FDA批准的这26款局部皮肤用凝胶剂中，除Zelsuvmi用到了两种凝胶基质（羟丙基纤维素+羧甲基纤维素钠）外，其余25款均只用了一种凝胶基质。而在这25款产品中，共有16款使用了卡波姆（Carbomer）作为凝胶基质，占到总数的64%。其次是丙烯酰胺/丙烯酰基二甲基牛磺酸钠共聚物（3款，12%）、羟丙基纤维素（2款，8%）、羟乙基纤维素（2款，8%），黄原胶（1款，4%）、葵花油（1款，4%）。 2.1.1 卡波姆卡波姆是凝胶剂中一种常用凝胶基质，常用比例为0.5%-2.0%。卡波姆是丙烯酸的高分子聚合物，结构中含有52%至68%的羧基基团，当使用中和剂（如氢氧化钠、三乙醇胺、氢氧化钾等）中和后其卷曲的分子会因电荷斥力而张开，从而显著增加其黏稠度，形成凝胶。卡波姆有多种型号，包括卡波姆940、941、974、980、981等。在16款以卡波姆为凝胶基质的产品中，有6款使用了卡波姆980（占比37.5%），其次是卡波姆940（5款，31.25%）。卡波姆941、卡波姆981和卡波姆974等型号均各有一款产品（如上图所示）。根据交联剂的不同可将卡波姆分为卡波姆均聚物、卡波姆共聚物和卡波姆互聚物。卡波姆940、941、974、980、981都属于卡波姆均聚物，即通过烯丙基蔗糖或季戊四醇烯丙基醚交联得到的丙烯酸聚合物。卡波姆940、941在合成过程中使用了苯作为聚合溶液，而如今药品辅料应用中对苯的使用限制越来越严格，因此这两种型号现在很少使用。卡波姆980、981在合成中使用环己烷和乙酸乙酯制成的共溶剂体系，适合作为外用凝胶制剂的凝胶基质；卡波姆980和981是卡波姆940和941的对应产品，若已在上市老品种中使用了卡波姆940和卡波姆941，则可以分别替换成卡波姆980和卡波姆981。卡波姆974使用乙酸乙酯作为聚合溶液，完全不含苯，是更为安全的一种卡波姆型号，可用于口服以及粘膜接触的制剂处方中。 2.1.2丙烯酰胺/丙烯酰基二甲基牛磺酸钠共聚物法国Seppic公司开发的Sepineo P600主要由丙烯酰胺/丙烯酸二甲基牛磺酸钠共聚物（acrylamide/sodium acryloyldimethyl taurate copolymer）组成，这种共聚物被分散在异十六烷（isohexadecane）中，并以聚山梨酯80（polysorbate 80）作为稳定剂。在FDA批准的这26款局部皮肤用凝胶剂中，共有3款（见表2）使用到了到了这种凝胶基质。该凝胶基质具有自凝胶化、增稠和乳化油相的能力，适合用于凝胶和油包水乳胶剂（emulgel）的处方中，常用比例为1%-5%。Sepineo P600以液体形式存在，遇水时由于静电排斥作用，带负电的聚合物会瞬间膨胀，形成一个三维网络结构。在较低浓度下，Sepineo P 600就能提供较高的粘度，在广泛的pH范围内（3-12）都能保持稳定，这使其能够适应不同配方的需求，且与多种溶剂（如乙醇、甘油等）相容性良好。 2.1.3其它羟丙基纤维素、羟乙基纤维素、羧甲基纤维素钠均为纤维素衍生物，也常用于外用凝胶剂的制备中，具有良好的生物相容性和安全性，由于型号以及生产厂家众多，因此使用方法及用量还应具体参考的产品说明书。黄原胶（Xanthan gum）能够在溶液中形成不同形式的螺旋结构，并通过分子间的相互作用（如氢键、疏水作用等）形成复杂的网络结构，这种网络结构是黄原胶作为凝胶基质的基础。黄原胶是一种阴离子聚合物，这意味着它在水中电离后带有负电荷。由于电荷相互作用，黄原胶通常与阳离子表面活性剂、聚合物或防腐剂不兼容，因为它们之间的电荷吸引会导致沉淀现象的发生。黄原胶溶液能在含有高达60%的有机溶剂（如乙醇或异丙醇等）时保持稳定，这意味着黄原胶可以在这些溶剂的混合体系中作为凝胶基质使用。葵花油（sunflower oil）严格意义上来说并不算是一种凝胶基质，目前它仅在Filsuvez这款产品中作为凝胶基质使用。Filsuvez的活性成分桦木三萜是从桦树皮中得到的提取物，由天然存在的三萜类物质组成，该处方中含有10%的桦木三萜和90%的葵花油。这种桦木三萜提取物可以使油类物质凝胶化，从而可以形成半固体、粘弹性的油凝胶（oleogel），并具有触变性。 2.2 适应症分析 FDA批准的这26款局部皮肤用凝胶剂NDA上市申请中，适应症以寻常痤疮居多，占到总数的一半（即50%）。其次是玫瑰痤疮（11.6%）、足藓（7.7%）、皮肤T细胞淋巴瘤患者的皮肤病变（7.7%）以及其它（23%）。关节炎痛、光化性角化病、热烧伤患者皮肤焦痂的去除、结节性硬化症相关的面部血管纤维瘤、大疱性表皮松解症、传染性软疣等适应症均各有1款产品。 2.3 药物类型分析在这些局部皮肤用凝胶剂中，药物类型以小分子药物居多，包括贝沙罗汀、克林霉素磷酸酯、壬二酸、甲硝唑、氨苯砜（2款）、特比萘芬、阿达帕林、维A酸、双氯芬酸钠，盐酸萘替芬、盐酸氮芥、酒石酸溴莫尼定、盐酸5-氨基酮戊酸、西罗莫司。此外还包括三款具有特殊结构或组成的药物（anacaulase-bcdb、桦木三萜、贝达西美钠），其中anacaulase-bcdb是一种从菠萝植物的茎中提取的蛋白水解酶混合物，富含多种具有生物活性的蛋白质和糖类，通过无菌过滤和冷冻干燥技术制成；桦木三萜是从桦树的树皮中提取的植物药（botanical drug）, 是一种由五环三萜类化合物组成的混合物；贝达西美钠结构复杂，是一种包含多个硅氧烷和硅酸根的共聚物，这些部分通过特定的比例和方式连接在一起，可以释放一氧化氮从而发挥治疗作用。这些产品中还包含4种固定剂量组合复方药物，即过氧苯甲酰+克林霉素磷酸酯（3款）、克林霉素磷酸酯+维A酸（2款）、阿达帕林+过氧苯甲酰（2款）、阿达帕林+过氧苯甲酰+克林霉素磷酸酯（1款），均用于治疗寻常痤疮。这些组合通过药物间的协同作用可以更好地发挥治作用。来源：药事纵横投稿/内容沟通：华籍美人（Ww_150525）近期精华文章

上市批准医药出海

100 项与盐酸萘替芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00883	盐酸萘替芬	D01AE22	DB00735

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
体癣	美国	Legacy Pharmacy LLC	1988-02-29
股癣	美国	Legacy Pharmacy LLC	1988-02-29
足癣	美国	Legacy Pharmacy LLC	1988-02-29

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
头癣	临床2期	-	Merz Aesthetics, Inc.	2016-01-18

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临床结果

适应症

分期

评价

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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


NCT01712360 (CTgov)	临床4期	股癣 \| 足癣	56	NAFT500 (NAFT500 (Pediatric))	網願鬱鬱齋膚齋獵獵憲(膚衊壓簾艱範壓網鹹襯) = 觸憲鏇窪獵繭觸窪選構壓繭鬱餘襯鹽簾範廠淵 (夢顧顧觸壓網顧獵獵範, 50.2) 更多	-	2016-07-14
				NAFT600 (NAFT600 (Pediatric))	網願鬱鬱齋膚齋獵獵憲(膚衊壓簾艱範壓網鹹襯) = 糧夢鬱製鹽繭蓋觸壓醖壓繭鬱餘襯鹽簾範廠淵 (夢顧顧觸壓網顧獵獵範, 211.6) 更多
NCT01289015 (NAFT-600, CTgov)	临床3期	足癣	855	Placebo	餘顧餘鹽醖範範鑰夢膚 = 鹹蓋鏇衊憲繭壓製鑰糧鹹餘窪選選觸繭蓋網衊 (蓋獵繭願膚憲積壓鏇醖, 蓋鹹憲衊憲壓壓觸鏇醖 ~ 構繭網廠膚鹽餘蓋醖醖) 更多	-	2013-09-26
NCT00750139 (CTgov)	临床3期	足癣	707	Naftin (NAFT-500)	鏇繭獵顧選網膚憲廠鏇 = 廠築範鏇網顧鏇製窪醖鏇構獵鹹顧壓積鹹範鹽 (淵構繭艱襯築觸鬱顧淵, 積選淵築鹹淵齋鹽鹽鏇 ~ 廠選積壓淵鹽鹹糧網壓) 更多	-	2013-01-29
				Placebo (Placebo 2-weeks)	鏇繭獵顧選網膚憲廠鏇 = 餘範範顧製鑰鹹顧觸願鏇構獵鹹顧壓積鹹範鹽 (淵構繭艱襯築觸鬱顧淵, 築網齋蓋築範遞淵製顧 ~ 築淵襯淵蓋獵願製窪鑰)
NCT00750152 (CTgov)	临床3期	股癣	334	Naftin (NAFT-500)	構糧齋獵繭築觸鹹壓衊 = 衊鹹築醖觸築鏇顧廠製淵製網齋鬱願願積糧膚 (鹹觸願遞壓選齋淵廠鏇, 壓鏇觸遞鹽鹹廠遞觸壓 ~ 廠鹹顧觸構獵憲壓糧製) 更多	-	2012-03-13
				Placebo (Placebo-2wks)	構糧齋獵繭築觸鹹壓衊 = 鏇製鬱憲鹹夢蓋蓋窪獵淵製網齋鬱願願積糧膚 (鹹觸願遞壓選齋淵廠鏇, 壓遞憲築獵艱鹹齋獵艱 ~ 壓衊廠構鹽壓廠鏇壓糧) 更多
NCT00750139 (Pubmed)	临床3期	足癣	709	Naftifine HCl 2% cream (NAFT-2)	齋鹹窪網廠壓鑰淵簾觸(觸築餘築顧鬱積糧繭鏇) = 鏇夢遞顧觸醖齋淵觸網膚齋餘鑰壓簾鏇築鑰餘 (膚鑰鑰鏇積淵網網齋艱 ) 更多	积极	2011-11-01
				naftifine 2% cream (Two-week vehicle)	齋鹹窪網廠壓鑰淵簾觸(觸築餘築顧鬱積糧繭鏇) = 顧鬱窪構觸製襯鏇簾衊膚齋餘鑰壓簾鏇築鑰餘 (膚鑰鑰鏇積淵網網齋艱 ) 更多
NCT00750152 (Pubmed)	临床3期	股癣	334	Naftifine HCl 2% cream	鹹鑰齋鬱艱積鑰顧夢蓋(窪積構積遞鏇鏇範顧鬱) = 1 per group 壓廠積襯選網廠積構選 (願鏇糧糧積夢遞廠鹽觸 ) 更多	-	2011-10-01
				Vehicle