Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) Plus Isavuconazole Versus AmBisome® in the Management of Pulmonary Mucormycosis: A multicenter, Prospective, Open Label, Randomized Controlled Study

开始日期2025-01-13

申办/合作机构

中日友好医院

DRKS00035443

/ CompletedN/AIIT

Factors influencing isavuconazole concentrations in intensive care patients - a retrospective monocentric evaluation - FisaCon

开始日期2024-11-05

申办/合作机构-

CTR20243329

/ CompletedN/A

硫酸艾沙康唑胶囊在中国健康受试者中的生物等效性试验

主要研究目的：以福安药业集团庆余堂制药有限公司持有的硫酸艾沙康唑胶囊（100mg，按C22H17F2N5OS计）为受试制剂（T），按有关生物等效性试验的规定，以Pfizer Australia Pty Ltd.持证的硫酸艾沙康唑胶囊（100mg，按C22H17F2N5OS计）为参比制剂（R）进行生物等效性试验。次要研究目的：观察受试制剂和参比制剂硫酸艾沙康唑胶囊（100mg，按C22H17F2N5OS计）在健康受试者中的安全性。

开始日期2024-09-14

申办/合作机构

福安药业集团宁波天衡制药有限公司

100 项与硫酸艾沙康唑鎓相关的临床结果

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100 项与硫酸艾沙康唑鎓相关的转化医学

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100 项与硫酸艾沙康唑鎓相关的专利（医药）

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971

项与硫酸艾沙康唑鎓相关的文献（医药）

2025-12-31·Emerging Microbes & Infections

Emerging antifungal resistance in Trichophyton mentagrophytes : insights from susceptibility profiling and genetic mutation analysis

Article

作者: Richardson, Malcolm ; Bai, Lin ; Richardson, Riina ; Shao, Jin ; Shao, Yakun ; Wan, Zhe ; Yu, Jin ; Song, Yinggai ; Verweij, Paul ; Li, Ruoyu ; de Hoog, Sybren

ABSTRACTTrichophyton species, the leading cause of dermatophytosis globally, are increasingly resistant to antifungal treatments, concerns about effective management strategies. In light of the absence of established resistance criteria for terbinafine and azoles, coupled with a dearth of research on resistance mechanisms in Trichophyton, antifungal susceptibility and drug resistance gene diversity were analyzed across 64 T. mentagrophytes, 65 T. interdigitale, and 2 T. indotineae isolates collected in China between 1999 and 2024 and 101 published T. indotineae strains. Analyses of the minimum inhibitory concentrations (MICs) of terbinafine, itraconazole, voriconazole, posaconazole, and isavuconazole revealed a concerning increase in T. indotineae with terbinafine resistance, including two novel isolates from China. Compared with T. interdigitale, T. mentagrophytes presented higher terbinafine MICs but similar azole susceptibility. Notably, 27 T. interdigitale isolates were classified as non-wild-type for terbinafine. Genetic diversity was analyzed for the SQLE, CYP51A and CYP51B gene. Specifically, T. indotineae isolates presented SQLE protein changes linked to terbinafine resistance. SQLE diversity was linked to terbinafine sensitivity, whereas alterations in CYP51A were associated with itraconazole sensitivity, with notable statistical significance evident across various protein isoforms. The relationship between protein diversity and drug sensitivity is presented in detail. Together, these findings highlight a growing prevalence of antibiotic resistance among Trichophyton and identify potential target genes for new therapies, underscoring the need for ongoing monitoring and offering directions for novel therapeutics.

2025-02-01·PATHOLOGY

Evaluation of a customised Sensititre YeastOne plate containing isavuconazole for antifungal susceptibility testing in Singapore

Article

作者: Goh, Geraldine Xue Qin ; Tan, Mei Gie ; Chua, Jing Sen ; Tan, Yen Ee ; Huang, Wenjie ; Tan, Samantha Hui Wen

This study evaluated the performance of a customised Sensititre YeastOne (SYO) plate including isavuconazole (YIT) against existing practice (comprising SYO YO10 plate and isavuconazole gradient strip) in order to streamline the workflow for antifungal susceptibility testing in a tertiary hospital in Singapore. A total of 101 (51 yeasts and 50 moulds) clinical isolates were included for analysis. Isolates included in the study were recovered from a variety of body sites and reflected the case mix encountered in daily practice. Antifungal susceptibility testing was performed using three methods: YO10, YIT and gradient diffusion strip (for isavuconazole only). Reproducibility, essential agreement (EA) and categorical agreement (CA) were calculated. When YO10 and YIT plates were compared, the reproducibility was 100% for eight common antifungals. The CA was >97% for all antifungals except for amphotericin B (89.4%), but this was attributed to seven isolates with minimum inhibitory concentrations bordering the wild-type (WT) cut-off. The EA obtained when testing isavuconazole using YIT versus gradient diffusion was 77.2% overall, 90.2% for yeasts and 64% for moulds. In conclusion, the YIT plate is suitable for antifungal susceptibility testing of yeasts in our laboratory. Its use for mould isolates needs to be monitored further.

2025-02-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Aspergillus spondylodiscitis successfully treated with a long course of isavuconazole

Article

作者: Teigell Muñoz, Francisco Javier ; Mateos-González, María ; Jiménez-Fernández, Marta ; Zuñiga Gómez, Lorenzo ; Fortún Abete, Jesús ; Sánchez-de Torre, Ana ; Batiray Polat, Abdulhamit

We present a case of spondylodiscitis caused by Aspergillus fumigatus, which we successfully treated with isavuconazole after voriconazole severe intolerance. Aspergillus spondylodiscitis is a severe and relatively rare form of extra-pulmonary invasive aspergillosis. Typically, voriconazole is the first-choice antifungal drug for treating Aspergillus osteomyelitis or spondylodiscitis. However, isavuconazole, a new antifungal medication, has been demonstrated as non-inferior to voriconazole in cases of invasive aspergillosis. It has the added benefits of fewer hepatobiliary, ocular, and cutaneous side effects. It generally does not demand serum level monitoring and poses fewer risks of drug interactions. Nonetheless, there are no studies yet that support its use in spondylodiscitis, and published experiences are very limited and based on isolated cases, albeit mainly positive. The case we present here aims to provide additional evidence on the efficacy and tolerability of isavuconazole in treating this condition.

145

项与硫酸艾沙康唑鎓相关的新闻（医药）

2025-02-08

·GlobeNewswire-Health Care

Strong launch for Cresemba in Japan triggers first sales milestone payment from AKP to Basilea

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering the first sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.2 million. David Veitch, Chief Executive Officer of Basilea, said: “Japan is a key market with significant growth potential for Cresemba. The achievement of the first sales milestone already in the second year of commercialization is a testament of the commercial capability of our partner AKP in this important market. The strong sales ramp-up in the early stage of its life cycle in Japan underscores that Cresemba is meeting critical medical needs of patients with life-threatening fungal infections.” By year-end 2024, Cresemba was marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. In Japan, the oral and intravenous formulations are approved for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis.2 Isavuconazole is also approved in the United States (US),3 China, the EU4 and several additional countries in Europe and beyond.5 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. PMDA List of Approved Drugs April 2022 to March 2023: https://www.pmda.go.jp/files/000267877.pdf [Accessed: February 04, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: February 04, 2025] European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: February 04, 2025] The content above comes from the network. if any infringement, please contact us to modify.

上市批准

2025-02-01

·GlobeNewswire-Health Care

Strong sales growth for Cresemba and Zevtera trigger further milestone payments to Basilea

January 28, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales in 2024 of the antifungal Cresemba® (isavuconazole) and the antibiotic Zevtera® (ceftobiprole) exceeded thresholds triggering sales milestone payments from distribution partners to Basilea, in the total amount of approximately CHF 2.2 million. For Cresemba, this comprises a milestone payment for sales in Canada, by AVIR Pharma Inc, as well as the first sales milestone payment for the Middle East and North Africa (MENA) region, by Hikma Pharmaceuticals LLC. For Zevtera, this reflects a milestone payment in Europe, by Advanz Pharma. David Veitch, Chief Executive Officer, said: “We are very pleased with the commercial progress of our two commercialized brands in Canada, the MENA region and Europe. Their continued growth confirms that Cresemba and Zevtera are serving significant medical needs around the world.” Basilea’s commercial partnerships cover well over 100 countries worldwide. By year-end 2024, Cresemba was marketed in more than 70 countries while Zevtera was marketed in 20 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba®. In Canada, Cresemba is approved for use in adults and pediatrics from 1 year up to 18 years for the treatment of invasive aspergillosis and invasive mucormycosis.2 In countries of the MENA region, it is indicated in adults for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate. Isavuconazole is also approved in the United States (US),3 the EU4 and several additional countries in Europe and beyond, including Japan and China.5 Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.6 In several countries in Europe, the brand is approved as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).6 Zevtera is also approved in the United States7, 8, China and several other countries.5 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. Health Canada, Cresemba® (isavuconazole) Product Monograph: https://pdf.hres.ca/dpd_pm/00077745.PDF [Accessed: January 27, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: January 27, 2025] European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: January 27, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: January 27, 2025] The content above comes from the network. if any infringement, please contact us to modify.

上市批准

2025-01-19

·药筛

两性霉素B脂质体国产第4家，河南中帅右哌甲酯缓释胶囊首家上市 | 仿制药周报（1.12-1.19）

统计每周仿制药一致性评价申报、上市申请（1.12-1.19） 1、仿制药上市申请获批药品名称企业名称分类受理号氨氯地平贝那普利胶囊河北龙海药业有限公司3CYHS2301852氨溴特罗口服溶液南京创迪生物技术有限公司;江苏贝佳制药有限公司3CYHS2302950奥拉帕利片Natco Pharma Limited5.2JYHS2300075奥拉帕利片Natco Pharma Limited5.2JYHS2300074奥美拉唑碳酸氢钠干混悬剂湖北邦泽医药有限公司;哈尔滨美君制药有限公司3CYHS2301623奥美沙坦酯氨氯地平片裕松源药业有限公司4CYHS2404050贝前列素钠片江西科睿药业有限公司4CYHS2303507苯磺酸氨氯地平片广州一品红制药有限公司4CYHS2303192苯磺酸氨氯地平片广州一品红制药有限公司4CYHS2303193吡拉西坦注射液西安达莫制药有限公司;山东华鲁制药有限公司3CYHS2400403玻璃酸钠滴眼液辅必成（上海）医药科技有限公司;浙江赛默制药有限公司4CYHS2400844达比加群酯胶囊浙江诺得药业有限公司4CYHS2303164达比加群酯胶囊浙江诺得药业有限公司4CYHS2303162达比加群酯胶囊浙江诺得药业有限公司4CYHS2303163地夸磷索钠滴眼液山东诺明康药物研究院有限公司;山东光明药业有限公司4CYHS2302729地诺孕素片南通联亚药业股份有限公司4CYHS2301847二羟丙茶碱注射液河北千康医药科技有限责任公司;青岛金峰制药有限公司3CYHS2302021非那雄胺片乐泰药业有限公司;南京海纳制药有限公司4CYHS2302057非那雄胺片乐泰药业有限公司;南京海纳制药有限公司4CYHS2302056复方氨基酸注射液(18AA-Ⅸ)四川科伦药业股份有限公司4CYHS2302546复方甘草酸苷片东阳祥昇医药科技有限公司;浙江北生药业汉生制药有限公司4CYHS2301720富马酸福莫特罗吸入溶液南京力成药业有限公司4CYHS2303034富马酸福莫特罗吸入溶液长风药业股份有限公司4CYHS2302621腹膜透析液(艾考糊精)芜湖道润药业有限责任公司4CYHS2401530钆喷酸葡胺注射液四川国瑞药业有限责任公司4CYHS2301898甲苯磺酸艾多沙班片齐鲁制药有限公司4CYHS2302691甲苯磺酸艾多沙班片齐鲁制药有限公司4CYHS2302693甲苯磺酸艾多沙班片齐鲁制药有限公司4CYHS2302692甲钴胺注射液广州一品红制药有限公司;河北凯威制药有限责任公司4CYHS2303000甲磺酸仑伐替尼胶囊吉林敖东洮南药业股份有限公司4CYHS2301718甲磺酸仑伐替尼胶囊吉林敖东洮南药业股份有限公司4CYHS2301719间苯三酚注射液江苏悦兴药业有限公司4CYHS2302047酒石酸溴莫尼定滴眼液广东众生药业股份有限公司4CYHS2303512磷酸奥司他韦胶囊福建省闽东力捷迅药业股份有限公司4CYHS2400923磷酸奥司他韦胶囊植恩生物技术股份有限公司4CYHS2400901硫酸羟氯喹片福建广生堂药业股份有限公司4CYHS2303516硫酸特布他林雾化吸入用溶液浙江金华康恩贝生物制药有限公司4CYHS2301885氯雷他定糖浆南通广承制药有限公司;江苏广承药业有限公司4CYHS2302830氯沙坦钾氢氯噻嗪片裕松源药业有限公司4CYHS2404128罗沙司他胶囊北京福元医药股份有限公司4CYHS2302941罗沙司他胶囊北京福元医药股份有限公司4CYHS2302942罗沙司他胶囊广州康臣药业有限公司;成都倍特药业股份有限公司4CYHS2302564罗沙司他胶囊哈尔滨三联药业股份有限公司;兰西哈三联制药有限公司4CYHS2302026罗沙司他胶囊哈尔滨三联药业股份有限公司;兰西哈三联制药有限公司4CYHS2302025马来酸阿伐曲泊帕片湖南明瑞制药股份有限公司4CYHS2302991马来酸阿伐曲泊帕片瑞阳制药股份有限公司4CYHS2302556马来酸咪达唑仑片宜昌人福药业有限责任公司4CYHS2302782玛巴洛沙韦片郑州泰丰制药有限公司4CYHS2302877尼可地尔片浙江赛默制药有限公司4CYHS2303503帕拉米韦注射液长春澜江医药科技有限公司;山东新时代药业有限公司3CYHS2302932普瑞巴林口服溶液常州四药制药有限公司3CYHS2301334乳果糖口服溶液安徽美来药业股份有限公司;安徽永生堂药业有限责任公司4CYHS2302196沙库巴曲缬沙坦钠片江苏德源药业股份有限公司4CYHS2303296羧甲司坦口服溶液海南斯达制药有限公司3CYHS2300946托吡酯片海南日中天制药有限公司4CYHS2301074吸入用布地奈德混悬液浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2302457西格列汀二甲双胍片(Ⅱ)江苏康缘药业股份有限公司4CYHS2302127盐酸氮卓斯汀滴眼液浙江视方极医药科技有限公司;浙江赛默制药有限公司4CYHS2303213盐酸氮卓斯汀滴眼液浙江视方极医药科技有限公司;浙江赛默制药有限公司4CYHS2302677盐酸莫西沙星片河北天成药业股份有限公司4CYHS2302521盐酸伊托必利片裕松源药业有限公司4CYHS2404103盐酸右哌甲酯缓释胶囊河南中帅药业有限公司3CYHS2303628伊布替尼胶囊江西科睿药业有限公司4CYHS2302871异丙托溴铵雾化吸入溶液浙江金华康恩贝生物制药有限公司4CYHS2302237注射用两性霉素B脂质体江西艾施特制药有限公司4CYHS2301518注射用替考拉宁重庆药友制药有限责任公司4CYHS2301539注射用紫杉醇(白蛋白结合型)河北天成药业股份有限公司;河北道恩药业有限公司4CYHS2303294 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号硫酸阿托品注射液湖北美林药业有限公司;天津金耀药业有限公司CYHB2350793马来酸曲美布汀片信合援生制药股份有限公司CYHB2350919碳酸氢钠注射液河北天成药业股份有限公司CYHB2350816碳酸氢钠注射液河北天成药业股份有限公司CYHB2350815碳酸氢钠注射液湖南科伦制药有限公司CYHB2350800碳酸氢钠注射液湖南科伦制药有限公司CYHB2350799依达拉奉注射液北京四环制药有限公司;吉林四环制药有限公司CYHB2350087依达拉奉注射液华润双鹤药业股份有限公司CYHB2250464吲达帕胺片上海迪冉郸城制药有限公司CYHB2450115注射用奥美拉唑钠常州四药制药有限公司CYHB2350953注射用头孢唑肟钠汕头金石粉针剂有限公司CYHB2350958注射用维库溴铵海南斯达制药有限公司CYHB2350684 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号阿司匹林肠溶片华中药业股份有限公司4CYHS2500315阿昔莫司胶囊天津掌心医药科技有限公司;淄博万杰制药有限公司4CYHS2500359艾拉莫德片宁夏康亚药业股份有限公司4CYHS2500290艾普拉唑肠溶片北京福元医药股份有限公司4CYHS2500267氨酚羟考酮片河北奥星集团药业有限公司3CYHS2500297氨溴特罗口服溶液江苏神华药业有限公司;安徽永生堂药业有限责任公司3CYHS2500307苯溴马隆片沐源（安徽）药业有限公司;华益药业科技（安徽）有限公司3CYHS2500325苯溴马隆片广州一品红制药有限公司3CYHS2500326比拉斯汀片江苏联环药业股份有限公司4CYHS2500324比索洛尔氨氯地平片海南广升誉制药有限公司;华益泰康药业股份有限公司4CYHS2500343吡拉西坦注射液石药银湖制药有限公司3CYHS2500336别嘌醇片安徽圣鹰药业有限公司3CYHS2500282玻璃酸钠滴眼液修正药业集团长春高新制药有限公司4CYHS2500306布美他尼注射液浙江赛默制药有限公司3CYHS2500331布美他尼注射液浙江赛默制药有限公司3CYHS2500330布瑞哌唑片浙江华义制药有限公司4CYHS2500280布瑞哌唑片浙江华义制药有限公司4CYHS2500281草酸艾司西酞普兰片山东普瑞曼药业有限公司4CYHS2500272蛋白琥珀酸铁口服溶液国药控股星鲨制药（厦门）有限公司4CYHS2500266地屈孕酮片M/s MANKIND PHARMA LIMITED5.2JYHS2500004碘佛醇注射液山东齐都药业有限公司;博瑞制药（苏州）有限公司4CYHS2500275二十碳五烯酸乙酯软胶囊北京诚济制药股份有限公司;人福普克药业（武汉）有限公司4CYHS2500358二十碳五烯酸乙酯软胶囊浙江创新生物有限公司4CYHS2500312氟脲嘧啶注射液海南倍特药业有限公司3CYHS2500316氟脲嘧啶注射液海南倍特药业有限公司3CYHS2500317复方氨基酸(15)双肽(2)注射液成都诺和晟鸿生物制药有限公司;四川美大康佳乐药业有限公司4CYHS2500268复方氨基酸(15)双肽(2)注射液成都诺和晟鸿生物制药有限公司;四川美大康佳乐药业有限公司4CYHS2500269富马酸伏诺拉生片浙江华海药业股份有限公司4CYHS2500278富马酸伏诺拉生片浙江华海药业股份有限公司4CYHS2500277富马酸酮替芬滴眼液石家庄格瑞药业有限公司3CYHS2500328富马酸酮替芬滴眼液石家庄格瑞药业有限公司3CYHS2500329富马酸依美斯汀滴眼液广州大光制药有限公司4CYHS2500349枸橼酸西地那非口崩片东莞松山湖美健生物技术有限公司;东莞市金美济药业有限公司4CYHS2500293枸橼酸西地那非口崩片南京康川济医药科技有限公司;浙江四维医药科技有限公司4CYHS2500283己酮可可碱缓释片浙江普洛康裕制药有限公司3CYHS2500327己酮可可碱缓释片福建海西新药创制股份有限公司;广东安诺药业股份有限公司3CYHS2500310甲硝唑阴道凝胶杭州上禾健康科技有限公司;浙江鼎泰药业股份有限公司3CYHS2500352精氨酸布洛芬片海南赛立克药业有限公司4CYHS2500294酒石酸阿福特罗雾化吸入溶液江苏长泰药业股份有限公司3CYHS2500279聚多卡醇注射液海南合瑞制药股份有限公司4CYHS2500318聚多卡醇注射液海南合瑞制药股份有限公司4CYHS2500319聚乙二醇钠钾散湖北唯森制药有限公司4CYHS2500334聚乙二醇钠钾散郑州泰丰制药有限公司4CYHS2500338聚乙烯醇滴眼液南京恒道医药科技股份有限公司;江苏大红鹰恒顺药业有限公司4CYHS2500321糠酸莫米松乳膏江苏知原药业股份有限公司4CYHS2500288利丙双卡因乳膏江苏吴中医药集团有限公司苏州制药厂;浙江赛默制药有限公司4CYHS2500322硫酸氢氯吡格雷片华泰民康（沈阳）科技有限公司;苏州特瑞药业股份有限公司4CYHS2500311硫酸沙丁胺醇口服溶液辽宁海一制药有限公司3CYHS2500292硫酸特布他林雾化吸入用溶液复星医药（徐州）有限公司4CYHS2500351硫糖铝片新乡市常乐制药有限责任公司3CYHS2500284柳氮磺吡啶口服混悬液上海信谊金朱药业有限公司3CYHS2500341罗沙司他胶囊华北制药金坦生物技术股份有限公司;华北制药股份有限公司4CYHS2500303罗沙司他胶囊华北制药金坦生物技术股份有限公司;华北制药股份有限公司4CYHS2500302洛索洛芬钠贴剂前沿生物药业（南京）股份有限公司;湖南派格兰药业有限公司4CYHS2500354洛索洛芬钠贴剂前沿生物药业（南京）股份有限公司;湖南派格兰药业有限公司4CYHS2500355吗替麦考酚酯干混悬剂昆明贝克诺顿制药有限公司3CYHS2500271美索巴莫片石家庄四药有限公司3CYHS2500273蒙脱石混悬液合肥远志医药科技开发有限公司;安徽永生堂药业有限责任公司4CYHS2500320米库氯铵注射液四川美大康佳乐药业有限公司4CYHS2500332米库氯铵注射液江西远超医药科技有限公司;朗天药业（湖北）有限公司4CYHS2500340米库氯铵注射液四川美大康佳乐药业有限公司4CYHS2500333米库氯铵注射液江西远超医药科技有限公司;朗天药业（湖北）有限公司4CYHS2500339帕拉米韦氯化钠注射液湖南九维生物医药有限公司;湖南金健药业有限责任公司4CYHS2500309帕拉米韦氯化钠注射液湖南九维生物医药有限公司;湖南金健药业有限责任公司4CYHS2500308培哚普利氨氯地平片(Ⅰ)杭州和泽坤元药业有限公司;山西同达药业有限公司4CYHS2500289双醋瑞因胶囊江苏永安制药有限公司4CYHS2500345双氯芬酸二乙胺乳胶剂福建品腾药业有限公司;江苏知原药业股份有限公司4CYHS2500270碳酸氢钠注射液江西泰吉立生物医药科技有限公司;浙江赛默制药有限公司3CYHS2500295碳酸氢钠注射液江西泰吉立生物医药科技有限公司;浙江赛默制药有限公司3CYHS2500296维生素B12注射液南京赛瑞谱顿制药有限公司;山东新时代药业有限公司3CYHS2500265吸入用乙酰半胱氨酸溶液重庆莱美药业股份有限公司4CYHS2500291西格列汀二甲双胍缓释片南京易亨制药有限公司3CYHS2500350西格列汀二甲双胍缓释片华中药业股份有限公司3CYHS2500276腺苷钴胺胶囊合肥康惠医药技术有限公司;上海海虹实业（集团）巢湖今辰药业有限公司3CYHS2500313盐酸二甲双胍片石家庄四药有限公司4CYHS2500286盐酸二甲双胍片石家庄四药有限公司4CYHS2500287盐酸非索非那定干混悬剂桂林华信制药有限公司3CYHS2500300盐酸非索非那定干混悬剂桂林华信制药有限公司3CYHS2500298盐酸美金刚口服溶液常州四药制药有限公司3CYHS2500337盐酸纳美芬注射液浙江赛默制药有限公司3CYHS2500353盐酸异丙肾上腺素注射液海南倍特药业有限公司3CYHS2500305盐酸异丙肾上腺素注射液海南倍特药业有限公司3CYHS2500304叶酸片江苏贝佳制药有限公司3CYHS2500342脂肪乳氨基酸(17)葡萄糖(19%)注射液四川太平洋药业有限责任公司4CYHS2500274注射用磷丙泊酚二钠河北科源药业有限公司;仁合益康汇泽药业河北有限公司4CYHS2500285注射用磷酸特地唑胺浙江尖峰药业有限公司4CYHS2500344注射用磷酸特地唑胺珠海优润医药科技有限公司;珠海同源药业有限公司4CYHS2500314注射用硫酸艾沙康唑桂林南药股份有限公司;苏州二叶制药有限公司4CYHS2500348注射用硫酸艾沙康唑湖南赛隆药业（长沙）有限公司;湖南赛隆药业有限公司4CYHS2500335注射用培美曲塞二钠湖南赛隆药业（长沙）有限公司;山西普德药业有限公司4CYHS2500347注射用培美曲塞二钠湖南赛隆药业（长沙）有限公司;山西普德药业有限公司4CYHS2500346注射用亚胺培南西司他丁钠珠海优润医药科技有限公司;珠海联邦制药股份有限公司4CYHS2500301注射用亚胺培南西司他丁钠珠海优润医药科技有限公司;珠海联邦制药股份有限公司4CYHS2500299唑来膦酸注射液四川太平洋药业有限责任公司3CYHS2500323ω-3鱼油中/长链脂肪乳注射液贝朗医疗（苏州）有限公司4CYHS2500356ω-3鱼油中/长链脂肪乳注射液贝朗医疗（苏州）有限公司4CYHS2500357 4、新增一致性评价补充申报药品名称企业名称受理号醋酸甲羟孕酮片浙江仙琚制药股份有限公司CYHB2550051醋酸甲羟孕酮片浙江仙琚制药股份有限公司CYHB2550050丁溴东莨菪碱注射液中孚药业股份有限公司CYHB2550053瑞巴派特片浙江大冢制药有限公司CYHB2550052盐酸甲氧氯普胺注射液成都倍特药业股份有限公司CYHB2550049注射用头孢他啶深圳信立泰药业股份有限公司CYHB2550048注射用头孢他啶深圳信立泰药业股份有限公司CYHB2550047 数据来源：摩熵医药

一致性评价上市批准专利到期

100 项与硫酸艾沙康唑鎓相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10643	硫酸艾沙康唑鎓	G01AG J02AC	DB06636

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
隐球菌病	日本	Asahi Kasei Pharma Corp.	2022-12-23
曲霉菌病	加拿大	Avir Pharma, Inc.初创企业	2018-12-19
侵袭性曲霉菌病	美国	Astellas Pharma US, Inc.	2015-03-06
毛霉菌病	美国	Astellas Pharma US, Inc.	2015-03-06

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
侵袭性真菌感染	申请上市	日本	Asahi Kasei Corp.	2022-01-30
新型冠状病毒感染	临床3期	美国	Astellas Pharma Global Development, Inc.	2021-03-16
肺曲霉菌病	临床3期	美国	Astellas Pharma Global Development, Inc.	2021-03-16
深部真菌病	临床3期	日本	Asahi Kasei Pharma Corp.	2018-04-16
念珠菌血症	临床3期	美国	Basilea Pharmaceutica AG	2007-03-08
念珠菌血症	临床3期	美国	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	中国	Basilea Pharmaceutica AG	2007-03-08
念珠菌血症	临床3期	中国	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	阿根廷	Basilea Pharmaceutica AG	2007-03-08
念珠菌血症	临床3期	阿根廷	Astellas Pharma, Inc.	2007-03-08

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


1480 (ASH2024)	N/A	急性髓性白血病	295	Isavuconazole	遞鬱範襯築鹹糧獵鑰鑰(衊壓齋鹹艱繭鹹願壓網) = 願鹽鏇製糧鏇獵醖艱糧鬱願鬱鏇醖構鏇鹽鑰鏇 (蓋壓蓋製鹽鑰遞廠廠製 ) 更多	积极	2024-12-07
				Voriconazole	遞鬱範襯築鹹糧獵鑰鑰(衊壓齋鹹艱繭鹹願壓網) = 襯觸壓膚憲築築遞膚繭鬱願鬱鏇醖構鏇鹽鑰鏇 (蓋壓蓋製鹽鑰遞廠廠製 ) 更多
NCT04550936 (Pubmed \| Infect Dis Ther)	N/A	-	218	Isavuconazole monotherapy	鏇齋廠選襯鑰繭鹽艱簾(餘淵築築餘鬱鹽糧顧衊) = 45 patients (21%) experienced at least one adverse event (AE) 觸醖鏇願齋鹹範衊齋壓 (淵蓋壓築鹽廠築壓簾艱 ) 更多	积极	2024-10-24
				Salvage therapy
NCT03816176 (CTgov)	临床2期	侵袭性曲霉菌病 \| 毛霉菌病	31	Isavuconazonium sulfate	鹹觸範襯壓鹽膚遞願廠(觸壓襯廠餘鑰廠鹹簾顧) = 鬱範觸淵獵夢糧淵糧構衊觸淵積積糧餘衊鏇鹽 (襯廠簾夢衊製製鹹選鏇, 衊鹹鑰餘蓋築糧醖壓襯 ~ 壓憲壓製夢製鏇範鑰窪) 更多	-	2023-09-21
EBMT2023	N/A	造血干细胞移植	50	Isavuconazole	蓋鬱鬱夢窪範積憲蓋簾(艱襯淵範顧築範衊壓壓) = No adverse events related to ISA were reported 鏇艱選鏇齋壓製範蓋構 (壓鬱鹽願築願積構蓋範 )	-	2023-04-23
ASN2022	N/A	低钠血症	-	Isavuconazonium sulfate	築襯願鏇衊範遞範繭艱(窪觸獵膚顧鹹構蓋鬱艱) = Isavuconazonium sulfate was discontinued for severe hyponatremia and patient was initiated on intravenous voriconazole. SNa progressively improved to 134 mmol/L, 10 days after discontinuation of isavuconazonium sulfate. 醖鏇糧製襯憲鬱鏇膚鑰 (壓鬱願襯齋網簾鹽鏇憲 )	-	2022-11-05
				Voriconazole
NCT03471988 (Pubmed)	临床3期	真菌病	103	Isavuconazole	憲選憲觸遞糧艱簾鹽鬱(顧膚鬱顧築鹽衊鏇襯觸) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 簾艱觸簾膚鏇膚網鏇獵 (壓鏇齋襯繭簾壓蓋廠簾 ) 更多	积极	2022-10-25
				Voriconazole
EBMT2022	N/A	造血干细胞移植	166	Isavuconazole for treatment of IFI	範襯夢築糧醖齋餘範壓(廠壓鹹鬱顧鑰膚網憲遞) = 網齋築憲壓醖膚積夢餘壓壓齋壓繭廠憲窪構醖 (壓製觸餘蓋鬱鑰衊鬱獵 ) 更多	-	2022-03-19
				Isavuconazole for off-label prophylaxis	範襯夢築糧醖齋餘範壓(廠壓鹹鬱顧鑰膚網憲遞) = 簾夢築醖鏇蓋觸夢壓夢壓壓齋壓繭廠憲窪構醖 (壓製觸餘蓋鬱鑰衊鬱獵 ) 更多
NCT03019939 (CTgov)	临床2期	急性髓性白血病 \| 中性粒细胞减少 \| 侵袭性真菌感染 ... 更多	65	Isavuconazole	鏇壓淵醖淵獵製醖選艱(構壓齋願壓襯鹽夢簾艱) = 鹹鬱獵夢夢鹹衊獵範鬱製窪製繭襯醖窪夢構願 (選範夢遞鹹餘製願夢淵, 艱齋憲構鹹艱鑰憲憲構 ~ 網膚鹹簾鏇遞膚鬱艱繭) 更多	-	2021-09-24
NCT03019939 (Pubmed \| Clin Infect Dis) 人工标引	临床2期	急性髓性白血病 \| 骨髓增生异常综合征	75	Isavuconazole	網鑰襯獵夢鹽淵觸糧簾(築憲簾鹽製構選醖構鬱) = 鏇襯遞夢壓遞鑰餘淵鏇製鑰鏇膚選蓋憲觸簾衊 (糧構窪繭廠遞觸夢網鏇 )	积极	2021-05-18
				venetoclax+Isavuconazole	網鑰襯獵夢鹽淵觸糧簾(築憲簾鹽製構選醖構鬱) = 築餘積鹹製願築顧網範製鑰鏇膚選蓋憲觸簾衊 (糧構窪繭廠遞觸夢網鏇 )