A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar/Vaginal Symptoms of Vaginitis/Infectious Vaginosis (Bacterial and/or Mycotic and/or Parasitic)

The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).

开始日期2007-12-01

申办/合作机构

Janssen-Cilag SA

100 项与特康唑相关的临床结果

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100 项与特康唑相关的转化医学

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100 项与特康唑相关的专利（医药）

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118

项与特康唑相关的文献（医药）

2024-08-01·International Journal of Food Microbiology

Nobiletin enhances the antifungal activity of eugenol nanoemulsion against Penicillium italicum in both in vitro and in vivo settings

Article

作者: Guo, Long ; Liu, Yanchi ; Ye, Zimao ; Chen, Hongyang ; Zhou, Zhiqin ; Zhao, Lintao

The study prepared and used eugenol nanoemulsion loaded with nobiletin as fungistat to study its antifungal activity and potential mechanism of Penicillium italicum (P. italicum). The results showed that the minimum inhibitory concentration (MIC) of eugenol nanoemulsion loaded with nobiletin (EGN) was lower than that of pure eugenol nanoemulsion (EG), which were 160 μg/mL and 320 μg/mL, respectively. At the same time, the mycelial growth inhibition rate of EGN nanoemulsion (54.68 %) was also higher than that of EG nanoemulsion (9.92 %). This indicates that EGN nanoemulsion is more effective than EG nanoemulsion. Compared with EG nanoemulsion, the treatment of EGN nanoemulsion caused more serious damage to the cell structure of P. italicum. At the same time, in vitro inoculation experiments found that EGN nanoemulsion has better control and delay the growth and reproduction of P. italicum in citrus fruits. And the results reflected that EGN nanoemulsion may be considered as potential resouces of natural antiseptic to inhibit blue mold disease of citrus fruits, because it has good antifungal activity.

2024-08-01·International Journal for Parasitology: Drugs and Drug Resistance

Exploring therapeutic approaches against Naegleria fowleri infections through the COVID box

Article

作者: Lorenzo-Morales, Jacob ; Piñero, José E ; Chao-Pellicer, Javier ; Arberas-Jiménez, Iñigo ; Sifaoui, Ines

Naegleria fowleri, known as the brain-eating amoeba, is the pathogen that causes the primary amoebic meningoencephalitis (PAM), a severe neurodegenerative disease with a fatality rate exceeding 95%. Moreover, PAM cases commonly involved previous activities in warm freshwater bodies that allow amoebae-containing water through the nasal passages. Hence, awareness among healthcare professionals and the general public are the key to contribute to a higher and faster number of diagnoses worldwide. Current treatment options for PAM, such as amphotericin B and miltefosine, are limited by potential cytotoxic effects. In this context, the repurposing of existing compounds has emerged as a promising strategy. In this study, the evaluation of the COVID Box which contains 160 compounds demonstrated significant in vitro amoebicidal activity against two type strains of N. fowleri. From these compounds, terconazole, clemastine, ABT-239 and PD-144418 showed a higher selectivity against the parasite compared to the remaining products. In addition, programmed cell death assays were conducted with these four compounds, unveiling compatible metabolic events in treated amoebae. These compounds exhibited chromatin condensation and alterations in cell membrane permeability, indicating their potential to induce programmed cell death. Assessment of mitochondrial membrane potential disruption and a significant reduction in ATP production emphasized the impact of these compounds on the mitochondria, with the identification of increased ROS production underscoring their potential as effective treatment options. This study emphasizes the potential of the mentioned COVID Box compounds against N. fowleri, providing a path for enhanced PAM therapies.

2023-09-26·ACS omega

Expired Antifungal Drugs as Effective Corrosion Inhibitors for Carbon Steel in 1 M HCl Solution: Practical and Theoretical Approaches.

Article

作者: Motawea, Mohamed S ; Abdallah, Metwally ; Al-Bonayan, Ameena Mohsen ; Soliman, Kamal A ; Alfakeer, Majda ; Al-Juaid, Salih S ; Hawsawi, Hanaa ; Abd El Wanees, Salah

The anticorrosion potency of two expired antifungal drugs, namely, bifonazole (BIF) and terconazole (TER), for X65 carbon steel (X65CS) in a 1.0 M HCl solution was estimated using practical and computational measurements. The results of all methods applied showed that the percentage of anticorrosive efficacy (% AE) increased for expired BIF and TER and reduced at elevated temperatures. The % AE values of expired BIF and TER (375 mg L^-1) reached 92.08 and 94.19%, respectively, using polarization methods. The anticorrosion activities of the two expired drugs were interpreted based on their adsorption on the X65CS surface. The adsorption occurred according to the Langmuir isotherm model. The polarization results indicated that the expired drugs BIF and TER were mixed inhibitors. The impedance results showed a single capacitive loop, confirming that the charge transfer process controlled the corrosion of X65CS. Expired BIF and TER served as good pitting inhibitors by shifting the pitting potential to positive values. The thermodynamic functions of activation and adsorption were defined and explained. Density functional theory and Monte Carlo simulations were used to investigate the BIF and TER inhibitors. The theoretical parameters were consistent with the experimental results. The anticorrosion efficiencies determined using the various methods were in complete agreement.

项与特康唑相关的新闻（医药）

2023-01-17

·米内网

FDA年度盘点来了，37个创新药获批！国产新药“出海”告捷，这两家国内药企亮了

精彩内容近日，FDA发布了2022新药年度报告，数据显示FDA去年共批准了37个创新药物上市，数量创近6年新低，其中近5成已在国内上市或在审评阶段。FDA通过“多管齐下”，用多种方式促进、加快新药审评。2022年多款国产创新药物“出海”闯关FDA，结果“喜忧参半”，2个国产创新药获FDA批准，4个碰壁。图1：近十年FDA获批新药数量来源：FDA2022新药年度报告（New Drug Therapy Approvals 2022）37个创新药获批，18个加速闯关中国市场近日，美国FDA药物评价和研究中心（CDER）发布了2022新药年度报告。2022年FDA共批准了37个创新药物上市，数量创近6年新低。在获批的创新药物中，有20个（54%）属于“first-in-class”首创新药，20个（54%）是罕见病用药。FDA作为全球医药监管的标杆，已获批准新药中，28个（76%）是首轮获批，25个（68%）先于其它国家在美国获批。2022年FDA通过“多管齐下”，用多种方式促进和加快新药审评。12个（32%）被认定为快速通道，13个（35%）被认定为突破性治疗药物，21个（57%）被认定为优先审评，6个（16%）获得加速审批。CDER对2022年批准的所有新药中的24个（65%）使用了一项或多项加快开发和审评方法。表1：2022年FDA获批的创新药情况来源：FDA网站、米内网数据库近几年，国内对创新药物的关注度越来越高。2022年在美国获批的创新药也在以“中国速度”加速奔跑进入中国市场，以解决更多中国患者未被满足的健康需求。据统计，目前已有18个（49%）创新药在国内处于申请临床及以上阶段。其中，阿布昔替尼、伏诺拉生、本维莫德、佩索利单抗4个创新药已获批上市，奥特康唑、氘可来昔替尼处于申请上市阶段，而处于临床III期的有9个创新药，临床I期的有1个，申请临床的有2个。表2：创新药物在国内研发情况来源：米内网数据库2个国产创新药“出海”成功，传奇生物积极扩展版图2022年多款国产创新药“出海”闯关FDA，西达基奥仑赛和本维莫德传回了可喜消息，成功获批上市。2022年2月28日，金斯瑞旗下的传奇生物研发的BCMA CAR-T药品西达基奥仑赛获得FDA的批准上市，用于治疗复发或难治性多发性骨髓瘤。西达基奥仑赛成为中国首个获FDA批准的细胞治疗产品，及全球第2款获批靶向BCMA的CAR-T细胞免疫疗法。这在FDA宣布收紧中国创新药上市政策后，打了一个漂亮的“翻身仗”，更是意味着中国在细胞疗法这个领域，正式走到了世界一线的位置。在美国成功上市之后，西达基奥仑赛在2022年还将上市版图扩展到了欧盟和日本。2022年5月，欧盟委员会（EC）已授予西达基奥仑赛附条件上市许可，用于治疗既往接受过至少三种治疗，包括免疫调节药物、蛋白酶体抑制剂和抗CD38抗体，并且末次治疗出现疾病进展的复发或难治性多发性骨髓瘤成人患者。2022年9月，日本厚生劳动省批准西达基奥仑赛用于治疗复发或难治性多发性骨髓瘤成人患者。目前，在国内西达基奥仑赛处于申请上市阶段。图2：西达基奥仑赛全球研发进度2022年5月24日，Dermavant Sciences宣布FDA已批准VTAMA（本维莫德，1％）乳膏上市，用于成人斑块型银屑病的局部治疗。本维莫德由国内企业天济医药研发、是具有自主知识产权的“first-in-class”首创新药。2012年，GSK以近2亿美元的首付款获得本维莫德境外开发权，2018年7月，GSK宣布以3.3亿美元的价格将本维莫德境外开发权出售给Dermavant公司。早在2019年5月，本维莫德以“1类新药”在国内获批上市，用于适合局部治疗的成人轻至中度稳定性寻常型银屑病。目前为止，本维莫德是我国先批准上市之后才获美国FDA批准的首款创新药。图3：本维莫德全球上市情况“出海”之路并非坦途，信达生物、君实生物……另谋出路“出海”之路并非一帆风顺，2022年信达生物、君实生物、和黄医药、百济神州的创新药物均在FDA提交上市申请，可惜接连被FDA拒之门外。表3：2022年未被FDA批准的药物2022年3月，信达生物公布，FDA拒绝批准信迪利单抗联合培美曲塞和铂类化疗用于非鳞状非小细胞肺癌患者一线治疗的新药上市申请。FDA在对信达生物的回复中指出，信达生物旗下相关产品试验仅在中国进行，而不是全球多中心临床，鉴于单一国家性质，结果不适用于美国患者。2022年5月，和黄医药宣布，美国FDA未批准索凡替尼用于治疗胰腺和非胰腺神经内分泌瘤的新药上市申请。FDA拒绝和黄医药的理由和信达生物的相似，认为和黄医药当前基于两项成功的中国III期研究以及一项美国桥接研究的数据包尚不足以支持药品现时于美国获批，需要纳入更多代表美国患者人群的国际多中心临床试验来支持美国获批。同月，君实生物的PD-1抗体特瑞普利单抗的上市申请收到FDA的完整回复函，要求进行一项质控流程变更。该项流程变更因新冠期间的旅行限制导致设施无法进行现场检查而被拒。2022年7月，百济神州发布公告称，美国FDA因新冠肺炎疫情相关的旅行限制，无法如期在中国完成所需的现场核查工作，因此将延长替雷利珠单抗针对二线食管鳞癌新药上市许可申请的目标审评完成时间，但随后其合作伙伴诺华在季报中透露已经取消了在美递交替雷利珠单抗单药治疗非小细胞肺癌的上市申请。面对FDA的“无情”拒绝，君实生物很快做出了调整措施，向美国FDA重新提交了特瑞普利单抗上市申请。FDA已将PDUFA日期定为2022年12月23日，特瑞普利单抗目前还在审批阶段，未有没明确结果。和黄医药方面则表示，正在与FDA合作，以评估下一步行动。百济神州传言要转战欧洲，预计2023年将会在欧盟首次提交上市申请。信达生物则在年底时宣布，已从合作伙伴礼来制药方面收回信迪利单抗在海外的权益。国内创新药出海失败案例不少，一方面是FDA对国内药企出海产品要求高。按照FDA此前对信达生物的要求，新PD-1要想在美国上市，就需要和现有标准疗法一较高下。而K药在美国获批了几十个适应症，同适应症的产品想要获批须得翻越K药这座大山。另一方面，目前，国内创新药如何在海外进行临床试验仍处于摸索期，这些失败的案例，本质上体现的是国外成熟市场对中国临床试验质量的质疑。结语2022年已然过去，FDA获批的创新药是全球创新药物研发动态的方向标，为创新药企引领方向。对于国内创新药企而言，如果希望自己的产品走出国门，无疑要总结以往在FDA闯关创新药物的经验，时刻注意临床格局的变化，与FDA保持沟通进行临床设计。同时，要从体现产品的创新性，满足未被满足的临床需求、提高药物可及性、改进工艺、适应症选择、提高安全性疗效性等多个维度，提高自己的产品。资料来源：米内网综合数据库本文为原创稿件，转载请注明来源和作者，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

优先审批上市批准临床3期免疫疗法细胞疗法

2006-03-22

·BioSpace

Perrigo Company Announces Approval For Terconazole Suppositories

ALLEGAN, Mich., March 21 /PRNewswire-FirstCall/ -- The Perrigo Company announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market terconazole vaginal suppositories, 80 mg. The product is the AB-rated equivalent to Ortho-McNeil Pharmaceutical's Terazol(R) 3 Vaginal Suppositories, 80 mg, an anti-fungal medication indicated for the treatment of vaginal candida (yeast) infections. Perrigo is currently the only approved generic for this product. Shipments will begin immediately. According to NDC data, annual U.S. sales are approximately $8.5 million. The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by food, drug, mass merchandise, dollar store and club store retailers under their own labels. The Company also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products, and operates manufacturing facilities in the United States, Israel, United Kingdom, Mexico and Germany. Visit Perrigo on the Internet ( ). Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. Please see the "Cautionary Note Regarding Forward-Looking Statements" on pages 33 - 41 of the Company's Form 10-K for the year ended June 25, 2005, as well as the Company's subsequent filings with the Securities and Exchange Commission, for a discussion of certain important factors that relate to forward-looking statements contained in this press release. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Perrigo Company CONTACT: Ernest J. Schenk, Manager, Investor Relations and Communicationof Perrigo Company, +1-269-673-9212, E-mail: eschenk@perrigo.com Web site:

仿制药

100 项与特康唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00888	特康唑	G01AG02	DB00251

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
外阴阴道念珠菌病	美国	Taro Pharmaceuticals U.S.A., Inc.	2004-04-06

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
阴道疾病	临床前	美国	Curatek Pharmaceuticals, LLC	2015-06-01
感染性阴道炎	临床前	墨西哥	Janssen-Cilag SA	2007-12-01
阴道炎	临床前	墨西哥	Janssen-Cilag SA	2007-12-01

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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


NCT02308007 (SMART GIVES, CTgov)	临床3期	感染性阴道炎	475	Terconazole (Terconazole Vaginal Gel)	淵艱網糧蓋膚製膚襯鏇(積餘遞積窪膚艱構廠艱) = 築齋獵鬱夢鹹蓋窪廠糧構餘網鑰襯鑰積壓淵繭 (製遞遞選網遞淵積積衊, 築鑰壓夢鑰鹹鬱鹽鹽鑰 ~ 簾艱願夢窪顧餘簾憲選) 更多	-	2020-08-04
				Metronidazole (Metronidazole Vaginal Gel)	淵艱網糧蓋膚製膚襯鏇(積餘遞積窪膚艱構廠艱) = 鬱鹽範糧醖範艱顧觸憲構餘網鑰襯鑰積壓淵繭 (製遞遞選網遞淵積積衊, 糧築鹹鹹窪觸選醖壓觸 ~ 繭襯願製築獵選蓋淵製) 更多
NCT02308046 (SMART GIVES, CTgov)	临床3期	感染性阴道炎	212	Terconazole (Terconazole Vaginal Gel)	壓構積網鏇壓鹽齋鑰獵(衊夢觸顧觸獵廠夢鏇積) = 廠簾窪艱壓顧膚獵蓋醖鏇顧醖淵膚餘築構願衊 (壓構鹹齋鹽襯膚鏇淵鹽, 鏇鹹憲選醖壓繭鑰構襯 ~ 窪鑰鏇襯糧醖蓋襯範製) 更多	-	2020-07-27
				Placebo (Gel Vehicle)	壓構積網鏇壓鹽齋鑰獵(衊夢觸顧觸獵廠夢鏇積) = 遞鹽簾構鹽獵鏇淵廠艱鏇顧醖淵膚餘築構願衊 (壓構鹹齋鹽襯膚鏇淵鹽, 壓獵繭獵構襯鬱醖鹹餘 ~ 廠遞淵壓膚夢襯鹽壓艱) 更多
NCT01867164 (CTgov)	临床3期	感染性阴道炎 \| 阴道炎	160	Terconazole+Fluocinolone Acetonide+Gynoclin V (Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide))	網積顧鬱構淵構齋淵餘(鬱顧獵糧憲顧廠繭願艱) = 鹹遞鑰醖膚窪廠鑰範膚顧獵範鹹蓋繭衊糧鹽窪 (餘繭範醖衊鏇鑰鬱願醖, 窪齋壓齋餘網鏇簾糧廠 ~ 構繭製艱蓋窪遞憲簾蓋) 更多	-	2013-12-24
				Fluocinolone Acetonide+Nystatin+Metronidazole (Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin))	網積顧鬱構淵構齋淵餘(鬱顧獵糧憲顧廠繭願艱) = 夢鏇夢淵醖構壓鹹鏇鑰顧獵範鹹蓋繭衊糧鹽窪 (餘繭範醖衊鏇鑰鬱願醖, 構憲齋範顧繭鏇廠衊選 ~ 網範範觸壓艱壓築廠製) 更多
NCT00803738 (CTgov)	N/A	外阴阴道念珠菌病	572	Terconazole (Terconazole Vaginal Suppositories, 80 mg - Perrigo)	齋鹹糧襯膚蓋選鏇網鏇(膚鏇艱顧蓋觸範築糧壓) = 夢觸選獵顧衊遞簾淵選積齋鹹蓋夢繭選選膚淵 (夢蓋糧膚憲糧範餘醖積, 膚艱積築範觸蓋膚壓鑰 ~ 鏇齋鬱衊網願齋顧醖鏇) 更多	-	2013-02-20
				Terazol 3 - Terconazole (Terazol 3 - Terconazole Vaginal Suppositories 80 mg)	齋鹹糧襯膚蓋選鏇網鏇(膚鏇艱顧蓋觸範築糧壓) = 鹽醖構觸鑰膚構簾壓構積齋鹹蓋夢繭選選膚淵 (夢蓋糧膚憲糧範餘醖積, 膚築艱醖網範獵衊鏇窪 ~ 壓糧鹹遞夢網鏇願構壓) 更多