A multi-center, single-arm, open-label study to evaluate tolerability, safety, and efficacy of topical MOB015B solution in the treatment of mild to moderate distal subungual onychomycosis (DSO) in subjects aged 6-17 years

开始日期2023-05-01

申办/合作机构

Moberg Pharma AB

NCT05279846

/ Active, not recruiting临床3期

A Multi-center, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

This is a Phase 3 multicenter, double-blind study to evaluate the safety and efficacy of vehicle-controlled topical MOB015B in the treatment of Distal Subungual Onychomycosis (DSO)

开始日期2022-05-09

申办/合作机构

Moberg Pharma AB

NCT06295328

/ Recruiting临床1/2期IIT

From Fungus to Virus, a Phase 1b Clinical Trial Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients

Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB).
Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group.
Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial.
Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir > 6 months (group B, n=16).
Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B).
Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg >0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA >0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage.

开始日期2022-04-13

申办/合作机构-

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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2,796

项与盐酸特比萘芬相关的文献（医药）

2025-04-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Octyl succinic anhydride-modified chitosan/oxidized sodium alginate Schiff base hydrogel loaded with terbinafine hydrochloride: pH-responsive, self-repairing, antifungal properties

Article

作者: Cheng, Qiuqi ; Ning, Junkai ; Wu, Chunxuan ; Liang, Zhengmin ; He, Jiakang ; Yi, Dandan ; He, Weiwei ; Zhong, Yawen ; Xiang, Yifei ; Huang, Luyuan ; Li, Jiada ; Xu, Chuang ; Liu, Chengzhi ; Qin, Lanqian ; Liu, Niu

The application of hydrogels to drug delivery limited by the difficulty of encapsulating hydrophobic drugs; therefore, the development of novel composite hydrogels for the delivery of hydrophobic drugs is urgently needed. In this study, terbinafine hydrochloride/hydroxypropyl-β-cyclodextrin inclusion complexes (TFH/HP-β-CD ICs) were added to a Schiff base hydrogel matrix containing octenyl succinic anhydride-modified chitosan (OSA-CS) and sodium alginate (OIA) to prepare a TFH composite hydrogel (TFH GEL). The results revealed that the solubility of TFH in water within TFH/HP-β-CD IC reached 32.13 mg/mL. The TFH GEL successfully encapsulated the IC without any drug leakage and exhibited excellent acid pH responsiveness. Moreover, the hydrogels were mechanically stable, self-healing, and injectable. Haemocompatibility and cytotoxicity tests confirmed the excellent biocompatibility of the TFH GEL. Importantly, TFH GEL effectively inhibited Microsporum canis growth in vitro and in vivo. In summary, a novel composite hydrogel was developed by combining a modified natural polymer hydrogel with a complexing agent to deliver the hydrophobic antifungal drug TFH, this study provides a new strategy for treating fungal skin infections.

2025-03-01·JOURNAL OF DERMATOLOGY

Onychomycosis caused by Aspergillus species belonging to section Circumdati

Article

作者: Fukushima, Satoshi ; Hayashi, Daiki ; Kashiwada‐Nakamura, Kayo ; Makino, Katsunari ; Yaguchi, Takashi ; Matsumoto, Tadahiko ; Ohara, Sayaka ; Kubo, Masahide ; Noguchi, Hiromitsu

Abstract:

We encountered two cases of onychomycosis caused by Aspergillus (A.) subramanianii and A. sclerotiorum. These species belong to the Aspergillus section Circumdati, which is reportedly common in a wide range of habitats. The members of section Circumdati rarely cause onychomycosis. We report the second and fifth cases of A. subramanianii and A. sclerotiorum in the world. Positive findings in dermatophyte antigen kits helped us to diagnose these infections. These isolates were sensitive to ravuconazole, with a minimum inhibitory concentration of 0.5 μg/mL. They were successfully treated with oral fosravuconazole. We discuss 14 cases of onychomycosis caused by Aspergillus section Circumdati.

2025-03-01·BRAZILIAN JOURNAL OF MICROBIOLOGY

Evaluation of biofilm formation and antimicrobial susceptibility (drug resistance) of Candida albicans isolates

Article

作者: Kumaran, K Senthil ; Sivasubramani, K ; Alvarez, Loretta ; Nitha, B

Candida albicans comprises over 80% of isolates from all forms of human candidiasis. Biofilm formation enhances their capacity to withstand therapeutic treatments. In addition to providing protection, biofilm formation by C. albicans enhances its pathogenicity. Understanding the fundamental mechanisms underlying biofilm formation is crucial to advance our understanding and treatment of invasive Candida infections. An initial screening of 57 Candida spp. isolates using CHROMagar Candida (CHROMagar) media revealed that 46 were C. albicans. Of these, 12 isolates (33.3%) had the capacity to form biofilms. These 12 isolates were subjected to multiple biochemical and physiological tests, as well as 18 S rRNA sequencing, to confirm the presence of C. albicans. Upon analysis of their sensitivity to conventional antifungal agents, the isolates showed varying resistance to terbinafine (91.6%), voriconazole (50%), and fluconazole (42%). Among these, only CD50 showed resistance to all antifungal agents. Isolate CD50 also showed the presence of major biofilm-specific genes such as ALS3, EFG1, and BCR1, as confirmed by PCR. Exposure of CD50 to gentamicin-miconazole, a commonly prescribed drug combination to treat skin infections, resulted in elevated levels of gene expression, with ALS3 showing the highest fold increase. These observations highlight the necessity of understanding the proteins involved in biofilm formation and designing ligands with potential antifungal efficacy.

项与盐酸特比萘芬相关的新闻（医药）

2025-02-20

·国家药品监督管理局

国家药监局公布药品说明书适老化及无障碍改革试点名单（第四批）

根据《国家药监局关于发布药品说明书适老化及无障碍改革试点工作方案的公告》（2023年第142号），省级药品监管部门和国家药监局药品审评中心报送了参与试点的药品上市许可持有人和药品名单（第四批），现予公布。序号药品名称药品上市许可持有人1替格瑞洛片华润双鹤药业股份有限公司2非布司他片华润双鹤药业股份有限公司3盐酸贝那普利片北京诺华制药有限公司4甲钴胺片辽宁亿帆药业有限公司5布洛伪麻片辽宁亿帆药业有限公司6盐酸奈福泮片辽宁亿帆药业有限公司7红霉素肠溶片辽宁亿帆药业有限公司8乙酰螺旋霉素片辽宁亿帆药业有限公司9双氯芬酸钠肠溶片辽宁亿帆药业有限公司10益肝灵片辽宁亿帆药业有限公司11复方磺胺甲噁唑片辽宁亿帆药业有限公司12盐酸莫雷西嗪片辽宁亿帆药业有限公司13复方茶碱甲麻黄碱片辽宁亿帆药业有限公司14复方妥英麻黄茶碱片辽宁亿帆药业有限公司15伤科跌打片辽宁亿帆药业有限公司16清脑降压片辽宁亿帆药业有限公司17格列本脲片辽宁亿帆药业有限公司18复方阿司匹林片辽宁亿帆药业有限公司19磷酸苯丙哌林胶囊辽宁亿帆药业有限公司20盐酸环丙沙星胶嚢辽宁亿帆药业有限公司21通便灵胶囊辽宁亿帆药业有限公司22氨咖黄敏胶囊朝阳龙城制药有限公司23对乙酰氨基酚片朝阳龙城制药有限公司24复方龙胆碳酸氢钠片朝阳龙城制药有限公司25维D2磷酸氢钙片朝阳龙城制药有限公司26独一味颗粒朝阳龙城制药有限公司27酒石酸美托洛尔片翎耀生物科技（上海）有限公司28利培酮口服溶液翎耀生物科技（上海）有限公司29阿托伐他汀钙片翎耀生物科技（上海）有限公司30利伐沙班片翎耀生物科技（上海）有限公司31氨己烯酸口服溶液用散翎耀生物科技（上海）有限公司32美洛昔康片上海勃林格殷格翰药业有限公司33利奈唑胺片上海迪赛诺医药集团股份有限公司34富马酸丙酚替诺福韦片上海迪赛诺医药集团股份有限公司35齐多拉米双夫定片上海迪赛诺医药集团股份有限公司36扶正化瘀胶囊上海黄海制药有限责任公司37扶正化瘀片上海黄海制药有限责任公司38替米沙坦片上海现代制药股份有限公司39硝苯地平片上海信谊天平药业有限公司40盐酸氨溴索胶囊上海信谊天平药业有限公司41卡托普利片上海信谊天平药业有限公司42辛伐他汀片上海信谊万象药业股份有限公司43甲氨蝶呤片上海上药信谊药厂有限公司44盐酸二甲双胍片上海上药信谊药厂有限公司45雷贝拉唑钠肠溶片上海上药信谊药厂有限公司46瑞舒伐他汀钙片上海上药信谊药厂有限公司47卡培他滨片上海上药信谊药厂有限公司48双氯芬酸钠缓释片上海上药信谊药厂有限公司49盐酸二甲双胍缓释片上海上药信谊药厂有限公司50盐酸胺碘酮片上海上药信谊药厂有限公司51酚氨咖敏片上海上药信谊药厂有限公司52复方甲氧那明胶囊上海上药信谊药厂有限公司53洛索洛芬钠片上海旭东海普药业有限公司54复方卡托普利片上海旭东海普药业有限公司55盐酸氟桂利嗪胶囊上海旭东海普药业有限公司56盐酸安非他酮缓释片（Ⅱ）上海宣泰医药科技股份有限公司57盐酸帕罗西汀肠溶缓释片上海宣泰医药科技股份有限公司58头孢丙烯胶囊上海新亚药业闵行有限公司59头孢拉定胶囊上海新亚药业闵行有限公司60盐酸克林霉素胶囊上海新亚药业闵行有限公司61阿莫西林克拉维酸钾分散片上海新亚药业闵行有限公司62复方磺胺甲噁唑片上海新亚药业闵行有限公司63头孢克肟分散片上海新亚药业闵行有限公司64甲钴胺片上海新亚药业闵行有限公司65单硝酸异山梨酯缓释片上海新亚药业闵行有限公司66丙酸氯倍他索乳膏上海新亚药业闵行有限公司67林可霉素利多卡因凝胶上海新亚药业闵行有限公司68六神丸上海雷允上药业有限公司69关节镇痛巴布膏上海雷允上药业有限公司70通塞脉胶囊江苏康缘阳光药业有限公司71淫羊藿总黄酮胶囊江苏康缘阳光药业有限公司72夜宁胶囊江苏康缘阳光药业有限公司73通塞脉片江苏康缘阳光药业有限公司74参乌益肾片江苏康缘阳光药业有限公司75六味地黄软胶囊江苏康缘阳光药业有限公司76银翘解毒软胶囊江苏康缘阳光药业有限公司77元胡止痛软胶囊江苏康缘阳光药业有限公司78七味通痹口服液江苏康缘阳光药业有限公司79小儿氨酚黄那敏颗粒江苏康缘阳光药业有限公司80非那雄胺片南京海鲸药业股份有限公司81维生素D2软胶囊南京海鲸药业股份有限公司82瑞舒伐他汀钙片南京正大天晴制药有限公司83替格瑞洛片南京正大天晴制药有限公司84枸橼酸托法替布片南京正大天晴制药有限公司85利伐沙班片南京正大天晴制药有限公司86氟唑帕利胶囊江苏恒瑞医药股份有限公司87脯氨酸恒格列净片江苏恒瑞医药股份有限公司88爱普列特片江苏联环药业股份有限公司89苯磺酸左氨氯地平片苏州东瑞制药有限公司90甲磺酸氟马替尼片江苏豪森药业集团有限公司91替米沙坦氢氯噻嗪片常州制药厂有限公司92达格列净片昆山龙灯瑞迪制药有限公司93马来酸氟伏沙明片昆山龙灯瑞迪制药有限公司94二甲双胍恩格列净片（Ⅰ）杭州中美华东制药有限公司95吡格列酮二甲双胍片杭州中美华东制药有限公司96环孢素软胶囊杭州中美华东制药有限公司97克拉霉素片杭州中美华东制药有限公司98他克莫司胶囊杭州中美华东制药有限公司99吗替麦考酚酯分散片杭州中美华东制药有限公司100吗替麦考酚酯片杭州中美华东制药有限公司101吗替麦考酚酯胶囊杭州中美华东制药有限公司102盐酸吡格列酮片杭州中美华东制药有限公司103阿那曲唑片杭州中美华东制药有限公司104吲哚布芬片杭州中美华东制药有限公司105左氧氟沙星片浙江普洛康裕制药有限公司106非布司他片杭州朱养心药业有限公司107利伐沙班片杭州朱养心药业有限公司108硫酸氨基葡萄糖胶囊浙江施强制药有限公司109盐酸伐地那非片浙江施强制药有限公司110替格瑞洛片浙江海正药业股份有限公司111吗替麦考酚酯片浙江海正药业股份有限公司112瑞舒伐他汀钙片瀚晖制药有限公司113左氧氟沙星滴眼液浙江莎普爱思药业股份有限公司114头孢克肟分散片浙江莎普爱思药业股份有限公司115左氧氟沙星片浙江京新药业股份有限公司116瑞舒伐他汀钙片浙江京新药业股份有限公司117苯磺酸氨氯地平片浙江京新药业股份有限公司118阿司匹林肠溶片浙江京新药业股份有限公司119匹伐他汀钙分散片浙江京新药业股份有限公司120阿托伐他汀钙片浙江京新药业股份有限公司121左乙拉西坦片浙江京新药业股份有限公司122盐酸普拉克索片浙江京新药业股份有限公司123盐酸舍曲林片浙江京新药业股份有限公司124复方鱼腥草合剂浙江康恩贝中药有限公司125普瑞巴林胶囊浙江昂利康制药股份有限公司126碳酸镧咀嚼片浙江昂利康制药股份有限公司127利丙双卡因乳膏浙江昂利康制药股份有限公司128磷酸奥司他韦胶囊浙江华海药业股份有限公司129艾司奥美拉唑镁肠溶胶囊浙江华海药业股份有限公司130盐酸度洛西汀肠溶胶囊浙江华海药业股份有限公司131左乙拉西坦缓释片浙江华海药业股份有限公司132培哚普利叔丁胺片浙江华海药业股份有限公司133阿哌沙班片浙江华海药业股份有限公司134非布司他片浙江华海药业股份有限公司135利培酮分散片浙江华海药业股份有限公司136复方鲜竹沥液江西药都樟树制药有限公司137跌打损伤丸江西药都樟树制药有限公司138强力枇杷露江西药都樟树制药有限公司139荷丹片江西沃华济顺医药有限公司140荷丹胶囊江西沃华济顺医药有限公司141硝苯地平控释片江西山香药业有限公司142米拉贝隆缓释片江西山香药业有限公司143奥拉帕利片江西山香药业有限公司144罗沙司他胶囊江西山香药业有限公司145肠炎宁片江西康恩贝中药有限公司146牛黄上清胶囊江西康恩贝中药有限公司147清肝利胆胶囊江西康恩贝中药有限公司148盐酸达泊西汀片江西制药有限责任公司149米诺地尔搽剂山东京卫制药有限公司150乳果糖口服溶液山东京卫制药有限公司151利多卡因氯己定气雾剂山东京卫制药有限公司152丙酸倍氯米松鼻气雾剂山东京卫制药有限公司153水杨酸甲酯气雾剂山东京卫制药有限公司154富马酸酮替芬鼻喷雾剂山东京卫制药有限公司155盐酸索他洛尔片鲁南贝特制药有限公司156阿昔莫司胶囊鲁南贝特制药有限公司157单硝酸异山梨酯分散片鲁南贝特制药有限公司158单硝酸异山梨酯缓释片鲁南贝特制药有限公司159瑞舒伐他汀钙胶囊鲁南贝特制药有限公司160奥美拉唑碳酸氢钠胶囊鲁南贝特制药有限公司161奥美拉唑碳酸氢钠胶囊（Ⅱ）鲁南贝特制药有限公司162非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司163恩格列净片山东新时代药业有限公司164枸橼酸托法替布片山东鲁抗医药股份有限公司165盐酸莫西沙星片山东鲁抗医药股份有限公司166替格瑞洛片山东鲁抗医药股份有限公司167头孢氨苄片山东鲁抗医药股份有限公司168阿莫西林胶囊山东鲁抗医药股份有限公司169头孢氨苄胶囊山东鲁抗医药股份有限公司170他达拉非片山东明仁福瑞达制药股份有限公司171盐酸二甲双胍缓释片山东明仁福瑞达制药股份有限公司172氯化钾缓释片宜昌人福药业有限责任公司173磷酸奥司他韦胶囊宜昌人福药业有限责任公司174麦考酚钠肠溶片宜昌人福药业有限责任公司175阿奇霉素干混悬剂宜昌人福药业有限责任公司176阿奇霉素胶囊宜昌人福药业有限责任公司177恩替卡韦片宜昌人福药业有限责任公司178利伐沙班片宜昌人福药业有限责任公司179维生素C片宜昌人福药业有限责任公司180维生素B1片宜昌人福药业有限责任公司181烟酸缓释片宜昌人福药业有限责任公司182塞来昔布胶囊宜昌人福药业有限责任公司183非那雄胺片武汉人福药业有限责任公司184福多司坦片宜昌东阳光长江药业股份有限公司185苯磺酸氨氯地平片宜昌东阳光长江药业股份有限公司186阿奇霉素胶囊宜昌东阳光长江药业股份有限公司187阿奇霉素干混悬剂宜昌东阳光长江药业股份有限公司188磷酸奥司他韦胶囊宜昌东阳光长江药业股份有限公司189磷酸依米他韦胶囊宜昌东阳光长江药业股份有限公司190索磷布韦片宜昌东阳光长江药业股份有限公司191碳酸氢钠片远大医药（中国）有限公司192盐酸曲美他嗪片远大医药（中国）有限公司193替米沙坦氢氯噻嗪片远大医药（中国）有限公司194硫酸羟氯喹片远大医药（中国）有限公司195格列吡嗪片远大医药（中国）有限公司196玻璃酸钠滴眼液湖北远大天天明制药有限公司197妥布霉素滴眼液湖北远大天天明制药有限公司198复方甘草片湖南尔康制药股份有限公司199盐酸特比萘芬喷雾剂湖南及正医药科技有限公司200硝苯地平缓释片（Ⅰ）国药集团广东环球制药有限公司201硝苯地平缓释片（Ⅲ）国药集团广东环球制药有限公司202感冒灵颗粒华润三九医药股份有限公司203硫酸氢氯吡格雷片东莞市阳之康医药有限责任公司204阿奇霉素片东莞市阳之康医药有限责任公司205琥珀酸美托洛尔缓释片东莞市阳之康医药有限责任公司206枸橼酸西地那非片东莞市阳之康医药有限责任公司207阿托伐他汀钙片东莞市阳之康医药有限责任公司208利伐沙班片东莞市阳之康医药有限责任公司209恩他卡朋片东莞市阳之康医药有限责任公司210左氧氟沙星片东莞市阳之康医药有限责任公司211克拉霉素片东莞市阳之康医药有限责任公司212克拉霉素缓释片东莞市阳之康医药有限责任公司213磷酸奥司他韦干混悬剂广东东阳光药业股份有限公司214磷酸奥司他韦胶囊广东东阳光药业股份有限公司215盐酸二甲双胍片广东东阳光药业股份有限公司216瑞舒伐他汀钙片广东东阳光药业股份有限公司217他达拉非片广东东阳光药业股份有限公司218奥氮平片广东东阳光药业股份有限公司219利格列汀二甲双胍片（Ⅰ）广东东阳光药业股份有限公司220利格列汀二甲双胍片（Ⅱ）广东东阳光药业股份有限公司221利格列汀二甲双胍片（Ⅲ）广东东阳光药业股份有限公司222恩替卡韦片广东东阳光药业股份有限公司223利托那韦片广东东阳光药业股份有限公司224氢溴酸加兰他敏口腔崩解片广东东阳光药业股份有限公司225脑心清片广州白云山和记黄埔中药有限公司226绞股蓝总甙片广州白云山和记黄埔中药有限公司227消炎利胆片广州白云山和记黄埔中药有限公司228护肝片广州白云山和记黄埔中药有限公司229痰咳净散广州王老吉药业股份有限公司230痰咳净片广州王老吉药业股份有限公司231跌打榜药酒广东恒诚制药股份有限公司232风油精广东恒诚制药股份有限公司233复方醋酸曲安奈德溶液广东恒诚制药股份有限公司234复方苦参水杨酸散广东恒诚制药股份有限公司235复方鱼腥草片广东恒诚制药股份有限公司236腹可安片广东恒诚制药股份有限公司237感冒伤风咳茶广东恒诚制药股份有限公司238结石通片广东恒诚制药股份有限公司239橘红枇杷片广东恒诚制药股份有限公司240七星茶广东恒诚制药股份有限公司241清热除湿止泻合剂广东恒诚制药股份有限公司242清热除湿止泻颗粒广东恒诚制药股份有限公司243锁仙补肾口服液广东恒诚制药股份有限公司244板蓝根颗粒广东恒诚制药股份有限公司245风寒感冒颗粒广东恒诚制药股份有限公司246风热感冒颗粒广东恒诚制药股份有限公司247复方春砂颗粒广东恒诚制药股份有限公司248感冒清热颗粒广东恒诚制药股份有限公司249感冒止咳颗粒广东恒诚制药股份有限公司250金菊五花茶颗粒广东恒诚制药股份有限公司251小儿七星茶颗粒广东恒诚制药股份有限公司252野菊花颗粒广东恒诚制药股份有限公司253银翘解毒颗粒广东恒诚制药股份有限公司254止咳枇杷颗粒广东恒诚制药股份有限公司255山楂麦曲颗粒广东恒诚制药股份有限公司256生脉颗粒(党参方)广东恒诚制药股份有限公司257寒喘丸广东恒诚制药股份有限公司258藿胆丸广东恒诚制药股份有限公司259大黄䗪虫丸广东恒诚制药股份有限公司260强力枇杷露广东恒诚制药股份有限公司261首乌补肾酒广东恒诚制药股份有限公司262维C银翘片广东恒诚制药股份有限公司263香砂六君丸广东恒诚制药股份有限公司264香砂养胃丸广东恒诚制药股份有限公司265壮腰健肾丸广东恒诚制药股份有限公司266感冒清片广东恒诚制药股份有限公司267巴戟补酒广东恒诚制药股份有限公司268川贝枇杷糖浆广东恒诚制药股份有限公司269胆香鼻炎片广东恒诚制药股份有限公司270复方海蛇酊广东恒诚制药股份有限公司271咳特灵胶囊广东恒诚制药股份有限公司272止咳枇杷糖浆广东恒诚制药股份有限公司273健儿素颗粒广东恒诚制药股份有限公司274健脾颗粒广东恒诚制药股份有限公司275复方南板蓝根颗粒广东恒诚制药股份有限公司276壮腰健肾丸广州白云山陈李济药厂有限公司277昆仙胶囊广州白云山陈李济药厂有限公司278咳喘顺丸广州白云山陈李济药厂有限公司279上清丸广州白云山陈李济药厂有限公司280乌鸡白凤丸广州白云山陈李济药厂有限公司281补脾益肠丸广州白云山陈李济药厂有限公司282舒筋健腰丸广州白云山陈李济药厂有限公司283胃疡宁丸广州白云山陈李济药厂有限公司284妇科养坤丸广州白云山陈李济药厂有限公司285新血宝胶囊广州白云山陈李济药厂有限公司286喉疾灵胶囊广州白云山陈李济药厂有限公司287雷贝拉唑钠肠溶胶囊珠海润都制药股份有限公司288盐酸伐昔洛韦片珠海润都制药股份有限公司289单硝酸异山梨酯缓释胶囊珠海润都制药股份有限公司290双氯芬酸钠缓释胶囊珠海润都制药股份有限公司291雷贝拉唑钠肠溶片珠海润都制药股份有限公司292奥美沙坦酯片珠海润都制药股份有限公司293缬沙坦片珠海润都制药股份有限公司294奥美沙坦酯氢氯噻嗪片珠海润都制药股份有限公司295盐酸伊托必利胶囊珠海润都制药股份有限公司296奥美拉唑肠溶胶囊珠海润都制药股份有限公司297厄贝沙坦胶囊珠海润都制药股份有限公司298吲达帕胺胶囊珠海润都制药股份有限公司299盐酸二甲双胍肠溶胶囊珠海润都制药股份有限公司300阿奇霉素肠溶胶囊珠海润都制药股份有限公司301布洛芬缓释胶囊珠海润都制药股份有限公司302盐酸伊托必利片珠海润都制药股份有限公司303厄贝沙坦片珠海润都制药股份有限公司304缬沙坦氢氯噻嗪片珠海润都制药股份有限公司305茶碱缓释片珠海润都制药股份有限公司306利培酮口服溶液万特制药（海南）有限公司307泊沙康唑肠溶片四川科伦药业股份有限公司308盐酸奥洛他定片四川子仁制药有限公司309磷酸奥司他韦干混悬剂四川子仁制药有限公司310复方酮康唑发用洗剂滇虹药业集团股份有限公司311消食健脾丸红云制药（玉溪）有限公司312七味糖脉舒胶囊昆明龙津药业股份有限公司313生脉饮云南白药集团股份有限公司314银黄口服液云南白药集团股份有限公司315舒列安胶囊云南白药集团股份有限公司316阿奇霉素胶囊云南白药集团股份有限公司317紫楼胃康胶囊云南白药集团股份有限公司318复方牛黄消炎胶囊云南白药集团股份有限公司319诺氟沙星胶囊云南白药集团股份有限公司320田七痛经胶囊云南白药集团股份有限公司321炎可宁胶囊云南白药集团股份有限公司322香砂平胃颗粒云南白药集团股份有限公司323新生化颗粒云南白药集团股份有限公司324田七花叶颗粒云南白药集团股份有限公司325小柴胡颗粒云南白药集团股份有限公司326千紫红颗粒云南白药集团股份有限公司327酚氨咖敏颗粒云南白药集团股份有限公司328小儿解表颗粒云南白药集团股份有限公司329小儿清咽颗粒云南白药集团股份有限公司330小儿感冒颗粒云南白药集团股份有限公司331感冒止咳颗粒云南白药集团股份有限公司332阿司匹林肠溶片云南白药集团股份有限公司333土霉素片云南白药集团股份有限公司334复方南板蓝根片云南白药集团股份有限公司335香砂养胃片云南白药集团股份有限公司336复方岩白菜素片云南白药集团股份有限公司337健胃消食片云南白药集团股份有限公司338克林霉素磷酸酯片云南白药集团股份有限公司339利胆止痛片云南白药集团股份有限公司340消渴灵片云南白药集团股份有限公司341养肝明目片云南白药集团股份有限公司342银杏叶片云南白药集团股份有限公司343云南花粉片云南白药集团股份有限公司344葡萄糖粉剂云南白药集团股份有限公司345生三七散云南白药集团股份有限公司346肿痛凝胶云南白药集团股份有限公司347肿痛搽剂云南白药集团股份有限公司348益脉康片云南白药集团大理药业有限责任公司349益脉康分散片云南白药集团大理药业有限责任公司350清肺抑火片云南白药集团大理药业有限责任公司351通宣理肺片云南白药集团大理药业有限责任公司352泻痢消片云南白药集团大理药业有限责任公司353开胸消食片云南白药集团大理药业有限责任公司354小儿导赤片云南白药集团大理药业有限责任公司355复方黄连素片云南白药集团大理药业有限责任公司356三黄片云南白药集团大理药业有限责任公司357牛黄解毒片云南白药集团大理药业有限责任公司358竹红菌素软膏云南白药集团大理药业有限责任公司359宁心宝胶囊云南白药集团大理药业有限责任公司360六味地黄丸云南白药集团大理药业有限责任公司361妇舒丸云南白药集团大理药业有限责任公司362乳酸菌素片云南白药集团大理药业有限责任公司363氨咖黄敏片云南白药集团大理药业有限责任公司364豆腐果苷片云南白药集团大理药业有限责任公司365硫酸亚铁片云南白药集团大理药业有限责任公司366盐酸小檗碱胶囊云南白药集团大理药业有限责任公司367阿咖酚散云南白药集团大理药业有限责任公司368陈香露白露片云南白药集团大理药业有限责任公司369灯盏花素片云南白药集团大理药业有限责任公司370千金藤素片云南白药集团大理药业有限责任公司371盐酸小檗碱片云南白药集团大理药业有限责任公司372维生素C片云南白药集团大理药业有限责任公司373元胡止痛片云南白药集团大理药业有限责任公司374知柏地黄丸云南白药集团大理药业有限责任公司375气血康胶囊云南白药集团文山七花有限责任公司376气血康片云南白药集团文山七花有限责任公司377盐酸氟桂利嗪胶囊西安杨森制药有限公司378和血明目片西安碑林药业股份有限公司379金嗓开音丸西安碑林药业股份有限公司380金嗓利咽丸西安碑林药业股份有限公司381金嗓散结丸西安碑林药业股份有限公司382金嗓开音胶囊西安碑林药业股份有限公司383金嗓利咽胶囊西安碑林药业股份有限公司384金嗓散结胶囊西安碑林药业股份有限公司385金嗓开音片西安碑林药业股份有限公司386金嗓散结颗粒西安碑林药业股份有限公司387金嗓开音颗粒西安碑林药业股份有限公司388甲磺酸普雷福韦片西安葛蓝新通制药有限公司389西黄丸陕西季诺康禾药业有限公司390盐酸多奈哌齐片药云（西安）医药技术有限公司391盐酸托莫西汀口服溶液西安远大科创医药科技有限公司392固肠止泻丸陕西中医药大学制药厂393天麻眩晕宁合剂陕西中医药大学制药厂394消炎退热合剂陕西中医药大学制药厂395四季抗病毒合剂陕西海天制药有限公司396阿娜尔妇洁液陕西海天制药有限公司397枣仁安神颗粒西安万隆制药股份有限公司398固精麦斯哈片西安万隆制药股份有限公司399乌龙散西安万隆制药股份有限公司400保和丸陕西紫光辰济药业有限公司401大山楂丸陕西紫光辰济药业有限公司402济生肾气丸陕西紫光辰济药业有限公司403消积丸陕西紫光辰济药业有限公司404致康胶囊西安千禾药业股份有限公司405痫愈胶囊西安千禾药业股份有限公司406缬沙坦氢氯噻嗪片Novartis Pharma Schweiz AG407奥卡西平片Novartis Pharma Schweiz AG408依伏卡塞片Kyowa Kirin Co., Ltd.409阿帕他胺片Janssen-Cilag International NV410沙格列汀片AstraZeneca AB411沙格列汀二甲双胍缓释片（Ⅰ）AstraZeneca AB412沙格列汀二甲双胍缓释片（Ⅱ）AstraZeneca AB413沙格列汀二甲双胍缓释片（Ⅲ）AstraZeneca AB414拉西地平片GLAXOSMITHKLINE, S.A.415吲哚美辛巴布膏Nipro Pharma Corporation

医药出海

2025-02-11

·mobergpharma.com

Moberg Pharma Year-end report 2024

THE YEAR (JAN-DEC 2024) Net revenue SEK 9.8 million (0) EBITDA SEK -23.5 million (-25.4) Operating profit (EBIT) SEK -324.8 million (-27.5) Total profit SEK -255.1 million (-21.1) Diluted earnings per share SEK -6.74 (-1.33) Cash and cash equivalents amounted to SEK 293.3 million (60.6) FOURTH QUARTER (OCT-DEC 2024) Net revenue SEK 1.0 million (0) EBITDA SEK -7.8 million (-8.0) Operating profit (EBIT) SEK -308.1 million (-8.2) Total profit SEK -243.3 million (-6.4) Diluted earnings per share SEK -5.21 (-23) Cash and cash equivalents amounted to SEK 293.3 million (60.6) SIGNIFICANT EVENTS DURING THE FOURTH QUARTER Terclara® continues to be the market leader in Sweden. A new terbinafine supplier has been secured for Terclara®/MOB-015. As a result, terbinafine availability is no longer a limiting factor for the company’s launch plans. Topline data from the Phase 3 study has been reported. MOB-015 did not meet the primary endpoint using 8 weeks of daily dosing followed by weekly maintenance dosing. The company’s focus going forward will be on the effective daily dosing regimen approved in 13 EU countries. Moberg Pharma and Bayer have mutually terminated the license agreement, where Moberg Pharma has regained full rights to MOB-015 in the EU and maintains previous milestone payments. SIGNIFICANT EVENTS AFTER THE QUARTER The launch of Terclara® (MOB-015) is beginning in Norway. The experience from Sweden inspires confidence in the Norwegian market, and the launch of Terclara® in Norway follows the same approach as in Sweden. In February, the first deliveries were made to Norwegian pharmacies, followed by targeted information campaigns for pharmacy staff and healthcare professionals. In parallel, consumer marketing will intensify ahead of the peak season, when the demand for nail fungus treatment traditionally increases. VD COMMENTS Terclara® continues to lead the Swedish market, solidifying its position as the market leader. Building on this momentum, we are now taking the next step by expanding to Norway. A new terbinafine supplier has been secured, eliminating a key bottleneck for future market launches. After publishing the North American phase 3 topline data, we reevaluated our U.S. plans and made a strategic decision to focus on the European markets, where strong momentum and the approval of our effective daily dosing regimen in 13 EU countries present the best opportunities for growth. For the full-year 2024, Terclara® achieved a market share in Sweden of 31% in value and 25% in units in pharmacy sales to end consumers, despite consumer marketing only beginning in April.[1] Notably, Q4 figures reached 33% in value and 26% in units – remarkable growth within a limited time period. Refined Strategy Following Phase 3 Study Results In December, the topline data from the North American Phase 3 study for MOB-015 were published. In line with previous announcements, it was confirmed that the primary endpoint was not met with 8 weeks of daily dosing followed by weekly maintenance dosing. Mycological cure (fungus-free) was lower than observed in previous studies. The North American study reduced the dosage compared to the company’s commercial product with daily dosage throughout the treatment period. EU approval is based on previous studies and is not impacted by the new study results. As predicted, the lower dosage reduced discoloration of the nails[2], but it also resulted in a lower mycological cure rate. Our analysis is that 8 weeks of daily dosing did not deliver sufficient terbinafine into the nail to kill the fungus before switching to weekly maintenance treatment. Our hypothesis has not changed, that there is a trade-off between delivering enough terbinafine and avoiding overhydration/white discoloring of the nails. While overhydration is temporary, it makes it difficult to assess the clinical cure in a clinical study. One possible solution to the problem is an additional study with a longer follow-up and/or a different combination of daily treatment and maintenance treatment, with the potential to generate stronger efficacy data. Our view is that additional clinical data needs to be generated before we can apply for approval in the U.S. This means a delay of the expected U.S. launch, and the company’s board of directors has decided therefore to recognize an intangible asset impairment. Moberg Pharma has a long-term ambition to implement an additional clinical study in the U.S. to secure FDA approval, strengthen global marketing claims, and support our ongoing patent application. In the near term, the company’s priority is firmly on the European markets, where MOB-015 is already approved. By showcasing the product’s market-leading potential through successful EU launches, we are building a strong foundation for growth before considering a new study in the U.S. or investing in marketing outside of Europe. Strategic Realignment and Partnership Changes We mutually agreed with Bayer to terminate our partnership, due to strategic considerations and the study results. This means that we regained full rights to MOB-015 in Europe while maintaining previous milestone payments from Bayer. Our partnership in the Republic of Korea has concluded as well. Due to the highly competitive and structurally unique nature of the Korean market—where Jublia (efinaconazole) has gone generic, OTC and Rx channels are blurred, and pricing and reimbursement dynamics are unfavorable—we have decided not to pursue further collaboration in Korea at this time as it does not set us up for success. These changes gives us an opportunity to manage our activities and investments in Europe and Asia according to our priorities and the company’s long-term strategy for value creation. As a first step, we have decided to take a more active role in commercialization, establishing a stronger direct presence in the EU, including ownership of the trademark, to enhance margins. Discussions with potential partners in Europe are underway to support this strategy, and I look forward to sharing updates as plans take shape. We intend to use a commercialization model similar to the one we previously successfully implemented in the U.S. by positioning Terclara as a premium brand complemented by additional products through acquisitions. Historically, we have been successful in identifying, acquiring, and developing smaller brands from larger companies, which has created economies of scale and valuable brand equity. Expanding Momentum Across Europe A new terbinafine supplier was secured during the quarter, which means that terbinafine availability is no longer a limiting factor for our launch plans, enabling us to plan further expansion with confidence. In February 2025, we proudly announced the launch of Terclara® in Norway – a significant step in our European expansion strategy. Initial deliveries have been made to Norwegian pharmacies with pharmacy and healthcare staff education and targeted consumer marketing planned in the lead-up to high season. We see great potential for Terclara® to become established as the market leader in Norway as well, building on our remarkable success in Sweden. With approval in 13 EU markets, we are on track for additional rollouts in 2026, fueled by the success of the Swedish launch. Terclara® not only emerged as the market leader in Sweden but also expanded the total market, demonstrating the strength of our marketing message. In two large phase 3 studies, 76% of patients became fungus-free - world-leading outcomes that far surpass any other topical treatment. The success validates our strategy and provides a strong foundation as we expand into new markets and continue driving growth in Europe. We remain energized and optimistic about the future, as Moberg Pharma continues to set new benchmarks for innovation, performance and market leadership. Anna Ljung, CEO Moberg Pharma [1] Source: IQVIA MIDAS, Pharmacy Sell-Out data, January - December 2024 [2] In previous phase 3 studies, whitish nails were noted after 12 weeks daily treatment in ~70% of patients, with the new dosing less than 50% of patients seemed affected by whitish nails at 12 weeks CONFERENCE CALL CEO Anna Ljung will present the report at a telephone conference today, February 11th, 2025, at 3:00 p.m. CET. Telephone: SE 010 884 80 16, US +1 646 664 1960 Access code: 223155 ABOUT THIS INFORMATION This information is information that Moberg Pharma is Obliged to make public persuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 8.00 a.m. CET on February 11th, 2025. FOR ADDITIONAL INFORMATION Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se Mark Beveridge, VP Finance, Phone: +46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se

临床3期引进/卖出临床结果财报

2025-02-03

·mobergpharma.com

Terclara (MOB-015) is now being launched in Norway

As announced on December 18, 2024, Moberg Pharma has qualified a new terbinafine supplier, which was a prerequisite for the launch in Norway to take place in 2025. Moberg Pharma has already secured enough terbinafine for initial launch, and with the new terbinafine manufacturer, the company is now confidently moving forward with the rollout of Terclara in Norway. The experience from Sweden gives us strong confidence in the Norwegian market, and the launch of Terclara® in Norway follows the same approach as in Sweden. The first deliveries to pharmacies are expected in February, followed by targeted information campaigns for pharmacy staff and healthcare professionals. In parallel, consumer marketing will intensify ahead of the peak season, when the demand for nail fungus treatment traditionally increases. "The launch of Terclara® in Norway is a milestone for our expansion in the European market. Allderma has proven to be a highly capable partner that has delivered strong results in Sweden. We have great confidence in their ability to replicate this success in the Norwegian market," says Anna Ljung, CEO of Moberg Pharma AB. "We are proud to now be able to start the launch in Norway. The experience from Sweden has been invaluable in ensuring a successful launch and we are confident that the product will secure a strong position in the Norwegian market", says Mimmi Frölén, CEO of Allderma AB. 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 February 3, 2025, at 8.00 am CET. 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 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.

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
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
花斑癣	日本	Sun Pharmaceutical Industries Ltd.	1993-07-02
头癣	美国	Novartis Pharmaceuticals Corp.	1992-12-30
真菌病	英国	Novartis Pharmaceuticals UK Ltd.	1990-10-03
甲癣	英国	Novartis Pharmaceuticals UK Ltd.	1990-10-03
癣	英国	Novartis Pharmaceuticals UK Ltd.	1990-10-03

未上市

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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

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临床结果

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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	蓋範遞鑰夢衊衊構糧衊(衊獵窪蓋顧獵膚窪鏇選) = 繭鹹壓衊襯範衊網築遞餘齋簾憲醖鑰餘選遞構 (窪觸齋鹽鬱願繭廠襯顧 ) 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	鑰構壓廠遞鹽艱築簾窪(淵鑰憲鏇艱顧淵積膚製) = 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. 構齋糧遞膚遞簾鑰壓蓋 (製顧觸願鹹蓋窪鹽壓淵 )	积极	2024-08-19
NCT02859519 (Pubmed \| J Am Acad Dermatol) 人工标引	临床3期	甲癣	-	MOB-015	鬱顧糧鏇鹽糧遞繭積願(憲膚積鬱鹹窪鹽衊膚積) = 廠鏇鑰蓋衊艱廠蓋網窪艱網鬱艱廠糧蓋簾網蓋 (窪鹹鏇積繭衊選顧選蓋 ) 更多	非优	2021-07-01
NCT02859519 (Pubmed \| J Am Acad Dermatol) 人工标引	临床3期	甲癣	-	vehicle	鬱顧糧鏇鹽糧遞繭積願(憲膚積鬱鹹窪鹽衊膚積) = 構襯廠製範鹹顧廠顧遞艱網鬱艱廠糧蓋簾網蓋 (窪鹹鏇積繭衊選顧選蓋 ) 更多	非优	2021-07-01
Corporate Publications 人工标引	临床3期	甲癣	452	Terbinafine Hydrochloride	膚鬱獵鹽齋製範醖鹹餘(鬱膚糧鏇積選蓋鹽觸襯) = 餘壓窪蓋夢獵鬱遞觸齋顧遞壓繭艱醖顧鹽淵築 (鹹鬱鬱壓鑰艱齋觸積積 ) 更多	非劣	2020-06-25
Corporate Publications 人工标引	临床3期	甲癣	452	ciclopirox	膚鬱獵鹽齋製範醖鹹餘(鬱膚糧鏇積選蓋鹽觸襯) = 淵醖鏇壓壓醖膚遞鏇蓋顧遞壓繭艱醖顧鹽淵築 (鹹鬱鬱壓鑰艱齋觸積積 ) 更多	非劣	2020-06-25