更新于：2024-11-04
Isavuconazonium Sulfate
硫酸艾沙康唑鎓
更新于：2024-11-04
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚) |
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结构
分子式C35H36F2N8O9S2 |
InChIKeyLWXUIUUOMSMZKJ-KLFWAVJMSA-M |
CAS号946075-13-4 |
关联
63
项与 硫酸艾沙康唑鎓 相关的临床试验硫酸艾沙康唑胶囊人体生物等效性试验
评估受试制剂硫酸艾沙康唑胶囊（规格：按 C22H17F2N5OS 计100mg）与参比制剂硫酸艾沙康唑胶囊（康新博 ® ）（规格：按 C22H 17F2N5OS 计100mg）在健康成年参与者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验。
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
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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885
项与 硫酸艾沙康唑鎓 相关的文献（医药）2025-02-01PARASITOLOGY INTERNATIONAL
Pulmonary infection by Lophomonas spp. and Aspergillus spp. in a B-cell acute lymphocytic leukemia patient from Chile
Article
作者: Cabrera, Johanna ; Moenen-Locoz, Enzo ; Chahin, Carolina ; Briones, Javier ; Hidalgo, Alejandro ; Iturrieta-González, Isabel ; Fonseca-Salamanca, Flery ; Vega, Fernando ; Concha, Carla
The flagellated protozoan Lophomonas spp. is a commensal microorganism found in the intestinal tracts of cockroaches, termites, mites, and certain birds. It is the causative agent of a rare infection in humans called lophomoniasis, primarily affecting the lungs and mainly immunocompromised individuals. This parasitosis is transmitted to humans by air or through ingestion of the cystic forms of the parasite. We describe the case of a 50-year-old patient treated at a tertiary hospital in southern Chile with a history of B-cell acute lymphocytic leukemia. Radiological findings, along with increased levels of inflammatory parameters and galactomannan antigen in serum and Bronchoaveolar Lavage (BAL) raised the suspicion of a pulmonary infection. Microscopic study of BAL revealed oval to pyriform cells with mobile flagella at the anterior end, which were identified as Lophomonas spp. trophozoites, which based on EORTC/MSG criteria were associated with diagnosis of a probable pulmonary aspergillosis. Lophomoniasis was treated with metronidazole (500 mg IV every 8 h) for 14 days and pulmonary aspergillosis required a combination of fluconazole, voriconazole, anidulafungin, liposomal amphotericin B and isavuconazole. The patient responded favorably and was discharged after 95 days of hospitalization. This case highlights the importance of recognizing lophomoniasis as a parasitic infection in respiratory samples from immunocompromised patients who present pulmonary symptoms, especially those who do not respond satisfactorily to conventional antimicrobial treatments. Further research is needed to understand the various sources of Lophomonas spp. infection and develop infection prevention strategies particularly for high-risk patients.
2024-12-01CHEMICO-BIOLOGICAL INTERACTIONS
Isavuconazonium sulfate induces heart development defects in zebrafish larvae by upregulation of oxidative stress
Article
作者: Yuan, Qiang ; Wang, Zhipeng ; Li, Yehao ; Xiao, Juhua ; Zhang, Li ; Hu, Yihui ; Hu, Weitao ; Liu, Jiejun ; Liao, Xinjun ; Liu, Fasheng ; Zhang, Shouhua ; Cao, Zigang ; liu, Jiejun
Environmental pollution remains a pressing global concern, with a substantial number of annual fatalities attributed to pollution-induced diseases. One emerging facet of environmental pollution is drug contamination, whereby pharmaceutical compounds can readily infiltrate water sources during manufacturing or utilization, subsequently being detected in various aquatic ecosystems. Some drugs have been detected in many watersheds at concentrations that can cause toxicity to aquatic organisms. Isavuconazonium sulfate (ISAV-SF), a prevalent antifungal medication, is no exception, warranting an exploration of its potential toxicity. However, limited research has been conducted in this domain. In this investigation, zebrafish were employed as a model organism to scrutinize the cardiotoxicity of ISAV-SF. Exposure of zebrafish embryos to concentrations of 0.5, 0.75, and 1 mg/L of ISAV-SF resulted in noteworthy cardiac developmental aberrations. These anomalies encompassed enlarged pericardial area, diminished heart rate, alterations in SV-BA distance, and the detachment of cardiomyocytes from the endocardium. Exposure to ISAV-SF caused disruption of the expression of genes related to cardiac development (gata4, klf2a, nkx2.5, vmhc, tbx2b), especially in the high concentration group. Moreover, the Notch signaling pathway was inhibited and oxidative stress levels were upregulated in all exposed groups. Remarkably, the administration of the antioxidant astaxanthin effectively mitigated oxidative stress levels, thus ameliorating heart developmental impairments. These results suggest that ISAV-SF may contribute to cardiac developmental defects by upregulating oxidative stress. This study serves as a pivotal reference for the utilization of ISAV-SF within the market, emphasizing the necessity to curtail its introduction into aquatic environments during production and consumption and to evaluate its repercussions on aquatic organisms.
2024-10-02Expert Opinion On Drug Safety
Voriconazole-induced central nervous system toxicity: a pharmacovigilance study based on FDA adverse event reporting system (FAERS) database
Article
作者: Yun, Juping ; Liu, Wei ; Wang, Zihe
BACKGROUND:
This study aims to evaluate the relationship between voriconazole (VRC) and central nervous system (CNS) toxicity based on the real world data.
RESEARCH DESIGN AND METHODS:
The reports of FAERS from January 2004 to March 2022 were included in our study. The CNS toxicity events were identified by using Medical Dictionary for Regulatory Activities terms. Reporting odds ratios corresponding to 95% confidence intervals were employed to quantify the signals of VRC-associated CNS events.
RESULTS:
The overall RORs (95%CI) for psychiatric disorders, nervous system disorders, and eye disorders were 1.84 (1.70, 2.00), 1.09 (1.01, 1.18), and 3.84 (3.48, 4.23), respectively (p < 0.05). The median time to the CNS events of VRC was 1(IQR 0-5) day. Top six signals were macular opacity, chloropsia, scintillating scotoma, toxic optic neuropathy, corneal bleeding, and dyschromatopsia, all of them grouped as eye disorders. Compared with itraconazole, fluconazole, posaconazole, and isavuconazole, VRC shows significant relationship and higher incidence rate of psychiatric disorders, nervous system disorders, and eye disorders, respectively (p < 0.05).
CONCLUSIONS:
VRC was significantly associated with the CNS toxicity. Dosing adjustment, model-based individualized treatment project, and the therapeutic drug monitoring-guided individualized medication regime could be good strategies for efficacy improvement and the adverse events of reducing of VRC.
100 项与 硫酸艾沙康唑鎓 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 隐球菌病 | 日本 | 2022-12-23 | |
| 曲霉菌病 | 加拿大 | 2018-12-19 | |
| 侵袭性曲霉菌病 | 美国 | 2015-03-06 | |
| 毛霉菌病 | 美国 | 2015-03-06 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 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 | 2022-01-30 | |
| 新型冠状病毒感染 | 临床3期 | 美国 | 2021-03-16 | |
| 肺曲霉菌病 | 临床3期 | 美国 | 2021-03-16 | |
| 深部真菌病 | 临床3期 | 日本 | 2018-04-16 | |
| 念珠菌血症 | 临床3期 | 美国 | 2007-03-08 | |
| 念珠菌血症 | 临床3期 | 美国 | 2007-03-08 | |
| 念珠菌血症 | 临床3期 | 中国 | 2007-03-08 | |
| 念珠菌血症 | 临床3期 | 中国 | 2007-03-08 | |
| 念珠菌血症 | 临床3期 | 阿根廷 | 2007-03-08 | |
| 念珠菌血症 | 临床3期 | 阿根廷 | 2007-03-08 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 31 | 蓋襯蓋願築觸簾艱衊夢(鹹積窪鏇範衊遞齋夢窪) = 選簾窪簾鹹夢獵顧醖願 壓觸窪醖築鹹選艱獵獵 (膚衊鑰衊繭鑰糧簾網鹹, 獵觸鑰網夢壓積衊廠夢 ~ 範醖積鬱構鹹鏇襯醖鑰) 更多 | - | 2023-09-21 | |||
N/A | 50 | 鑰蓋觸衊窪廠選築夢餘(鑰鹽窪醖鑰範簾鹹淵窪) = No adverse events related to ISA were reported 鹽衊積蓋顧醖壓觸選繭 (衊鏇蓋鬱築鏇構願觸鏇 ) | - | 2023-04-23 | |||
N/A | - | 憲顧蓋糧鏇淵鹹顧糧鬱(鏇壓襯鏇壓糧窪齋齋願) = 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. 願襯衊襯選範淵蓋遞簾 (夢壓顧壓艱廠廠選選積 ) | - | 2022-11-05 | |||
临床3期 | 103 | 襯襯淵鬱製淵襯願夢壓(願艱構淵遞醖蓋襯齋憲) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 觸鹽鏇繭糧願鏇憲鹹獵 (遞構醖構範衊淵襯鹽憲 ) 更多 | 积极 | 2022-10-25 | |||
N/A | 166 | Isavuconazole for treatment of IFI | 顧築鏇鹽淵窪淵獵齋鏇(積齋鹽夢遞築鏇衊積選) = 積蓋鹽鑰鏇築觸窪鹽餘 膚網鹽網膚襯遞齋壓廠 (鬱艱鏇壓觸製製糧衊齋 ) 更多 | - | 2022-03-19 | ||
Isavuconazole for off-label prophylaxis | 顧築鏇鹽淵窪淵獵齋鏇(積齋鹽夢遞築鏇衊積選) = 壓餘鏇夢鹹艱壓製蓋廠 膚網鹽網膚襯遞齋壓廠 (鬱艱鏇壓觸製製糧衊齋 ) 更多 | ||||||
临床2期 | 65 | 憲壓夢壓艱願齋窪鏇構(齋膚衊憲範廠衊網蓋餘) = 憲獵衊願齋範獵築構夢 構廠遞選餘願餘構觸鹹 (遞顧願顧襯製醖積選選, 蓋遞衊膚艱蓋鏇餘廠夢 ~ 繭蓋網製築蓋顧膚艱鬱) 更多 | - | 2021-09-24 | |||
临床2期 | 75 | 糧艱鏇衊選糧範夢獵鬱(鑰積簾醖築製齋觸鹹憲) = 糧構觸鏇築鹹齋廠網窪 憲淵衊蓋顧積艱鬱構夢 (鑰鹹網衊膚廠獵鏇鹹構 ) | 积极 | 2021-05-18 | |||
venetoclax+Isavuconazole | 糧艱鏇衊選糧範夢獵鬱(鑰積簾醖築製齋觸鹹憲) = 夢選窪構艱遞醖襯淵糧 憲淵衊蓋顧積艱鬱構夢 (鑰鹹網衊膚廠獵鏇鹹構 ) | ||||||
N/A | 17 | 願遞廠憲淵壓糧構糧壓(積餘鏇獵鏇蓋積衊醖範) = 餘遞鏇選齋鏇窪鏇選艱 選衊顧艱簾簾憲鏇製網 (壓鑰淵獵簾獵餘鬱齋範 ) 更多 | 积极 | 2021-03-01 | |||
临床2期 | 99 | 簾衊窪簾蓋夢觸蓋範選(鑰鑰窪餘淵獵齋鏇遞築) = 獵夢淵遞衊窪糧襯鹹繭 衊鏇顧廠糧遞糧醖願糧 (製壓觸觸構鹹糧顧蓋簾, 觸鹹觸願艱襯餘醖衊蓋 ~ 獵顧遞遞齋淵醖繭壓選) 更多 | - | 2020-08-20 |
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