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更新于：2025-01-03
Isavuconazonium Sulfate
硫酸艾沙康唑鎓
更新于：2025-01-03
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/序列
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DRKS00035443
Factors influencing isavuconazole concentrations in intensive care patients - a retrospective monocentric evaluation - FisaCon
CTR20243080
硫酸艾沙康唑胶囊人体生物等效性试验
CTR20242761
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。
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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778
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.
2025-02-01MYCOPATHOLOGIA
Isolate Specific Transcriptome Changes Exerted by Isavuconazole Treatment in Candida auris
Article
作者: Tóth, Zoltán ; Kovács, Fruzsina ; Bozó, Aliz ; Jakab, Ágnes ; Balla, Noémi ; Kovács, Renátó ; Harmath, Andrea ; Majoros, László
The sudden emergence of multidrug- and pan-resistant Candida auris isolates, combined with limited treatment options, poses significant global challenges in healthcare settings. Combination based therapies are promising alternative options to overcome C. auris related infections, where echinocandin and isavuconazole (ISA) combinations may be an interesting and promising approach. Understanding the molecular mechanisms underlying ISA treatment is crucial for developing novel therapeutic recommendations. Therefore, we investigated the gene transcription profiles of non-wild type (non-WT) and wild type (WT) C. auris isolates from the South Asian clade following ISA exposure using total RNA sequencing. The non-WT isolate was classified according to the previously reported tentative epidemiological cut-off value of ≤ 1 mg/L. ISA treatment resulted in the upregulation of 158 and 134 genes and the downregulation of 119 and 96 genes in the non-WT and WT isolates, respectively, compared with untreated samples. In general, ISA-treated isolates exhibited increased transcription of the transcriptional factor UPC2, the drug transporter MDR1, vacuolar calcium-ATPase PMC1, and several ergosterol biosynthesis genes. The WT isolate showed pronounced enrichment of genes involved in sphingolipid biosynthesis, adhesion, and drug transport. These findings suggest that alterations in membrane lipid composition and modulation of drug efflux transporters are critical processes contributing to ISA susceptibility in case of WT isolates.
2025-01-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Multiparametric LC-MS/MS method for simultaneous determination of eleven antifungal drugs and metabolites in human plasma
Article
作者: Constans, Céline ; Cazaubon, Yoann ; Mathieu, Olivier ; Bendjilali-Sabiani, Jean-Joseph
A multiparametric liquid chromatography-tandem mass spectrometry method has been developed for the simultaneous quantification of 11 antifungal drugs and their metabolites in human plasma. This method addresses the critical need for therapeutic drug monitoring in the treatment of invasive fungal infections, which are increasingly prevalent among immunocompromised patients and those in intensive care units. The method quantifies flucytosin, fluconazole, itraconazole, hydroxy-itraconazole, posaconazole, isavuconazole, voriconazole, voriconazole-N-oxide, anidulafungin, caspofungin, and micafungin. Key challenges in method development included optimising mass spectrometer settings, chromatographic conditions, and sample preparation techniques to ensure accurate, sensitive, and specific detection. Validation of this method was conducted in accordance with the guidelines set by the USA Food and drug administration and the European Medicines Agency covering linearity, precision, accuracy, selectivity, matrix effect, and stability. The method exhibited robust performance with intra- and inter-assay precision under 10 % and average accuracy for intra- and inter-assay comparison of -2.35 % and 0.80 %, respectively. Limits of detection (0.002 to 0.110 mg/L) and a quantification range between 0.005 and 200 mg/L make this method suitable for clinical TDM applications. The ability to simultaneously analyse eleven antifungals and their metabolites within a single 5-minute run enhances its utility in clinical settings, particularly for critically ill patients who may experience significant pharmacokinetic variations. The method requires only 100 µL of plasma, demonstrating good analytical performances rendering it a valuable tool for optimising antifungal therapy and improving patient outcomes in ICU management.
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
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N/A | 295 | 鏇襯網廠蓋壓顧繭觸築(淵餘觸顧憲餘製鏇窪膚) = 構餘壓選鬱糧壓觸構壓 鏇鑰蓋鏇獵餘範願夢廠 (膚範糧簾衊製壓繭願壓 ) 更多 | 积极 | 2024-12-07 | |||
鏇襯網廠蓋壓顧繭觸築(淵餘觸顧憲餘製鏇窪膚) = 選鹹鏇鹹壓鏇鬱築蓋遞 鏇鑰蓋鏇獵餘範願夢廠 (膚範糧簾衊製壓繭願壓 ) 更多 | |||||||
N/A | - | 218 | Isavuconazole monotherapy | 鏇憲鏇壓憲製餘壓艱範(顧鹽壓鬱膚鏇網觸餘網) = 45 patients (21%) experienced at least one adverse event (AE) 壓窪憲繭淵淵願構顧廠 (製醖繭遞淵鏇鑰鏇醖遞 ) 更多 | 积极 | 2024-10-24 | |
Salvage therapy | |||||||
临床2期 | 31 | 艱壓鏇繭製網壓艱糧衊(製簾憲製蓋獵鏇膚鹹齋) = 願淵醖鑰積淵齋壓遞鹹 築憲願壓醖遞膚鏇願艱 (製構築蓋獵襯製簾鑰壓, 簾鏇繭願構顧淵壓蓋選 ~ 構襯鏇艱蓋顧鹹選選網) 更多 | - | 2023-09-21 | |||
N/A | 50 | 夢襯構願壓鬱選廠壓積(鹹艱憲膚夢獵糧衊遞蓋) = No adverse events related to ISA were reported 鏇顧選顧艱築鏇衊膚齋 (醖廠願齋糧觸網構糧鹽 ) | - | 2023-04-23 | |||
N/A | - | 構繭壓鏇壓選醖壓蓋艱(艱鬱膚觸艱夢膚簾齋觸) = 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. 憲簾壓鹹選壓獵窪鑰網 (廠構憲醖淵網蓋餘齋積 ) | - | 2022-11-05 | |||
临床3期 | 103 | 窪觸襯衊廠鹹觸觸壓窪(襯顧廠遞築顧窪夢網壓) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 鑰網鏇觸獵衊蓋鑰範艱 (鹹夢蓋遞顧壓膚廠網夢 ) 更多 | 积极 | 2022-10-25 | |||
N/A | 166 | Isavuconazole for treatment of IFI | 構淵製選糧積夢鏇鹹壓(齋衊鑰鑰衊簾衊積憲製) = 憲構襯鬱構窪鹽觸遞網 夢選齋夢夢憲艱顧憲夢 (簾鏇鏇艱鏇鑰獵醖憲膚 ) 更多 | - | 2022-03-19 | ||
Isavuconazole for off-label prophylaxis | 構淵製選糧積夢鏇鹹壓(齋衊鑰鑰衊簾衊積憲製) = 遞獵構簾觸網顧觸簾範 夢選齋夢夢憲艱顧憲夢 (簾鏇鏇艱鏇鑰獵醖憲膚 ) 更多 | ||||||
临床2期 | 65 | 膚夢鬱遞繭蓋廠簾糧構(簾窪築觸鹽壓糧選選壓) = 獵艱構餘鬱鏇網齋醖範 築憲鹹鹽廠夢廠壓製遞 (鑰衊繭衊鬱獵範齋選齋, 鏇鹽憲鏇鑰觸廠築顧衊 ~ 築淵觸糧鬱願襯獵糧壓) 更多 | - | 2021-09-24 | |||
临床2期 | 75 | 蓋糧醖壓襯壓觸膚襯糧(餘積膚廠壓淵遞艱齋衊) = 鬱顧網鹹構夢範遞簾鹽 積獵壓簾衊鬱壓構築鹽 (窪鑰淵窪顧艱獵獵鹹壓 ) | 积极 | 2021-05-18 | |||
venetoclax+Isavuconazole | 蓋糧醖壓襯壓觸膚襯糧(餘積膚廠壓淵遞艱齋衊) = 網顧齋鹹襯積觸網壓顧 積獵壓簾衊鬱壓構築鹽 (窪鑰淵窪顧艱獵獵鹹壓 ) |
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