更新于：2024-12-26
Isavuconazonium Sulfate
硫酸艾沙康唑鎓
更新于：2024-12-26
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 (欧盟)、孤儿药 (澳大利亚)、孤儿药 (美国) |
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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Factors influencing isavuconazole concentrations in intensive care patients - a retrospective monocentric evaluation - FisaCon
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。
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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775
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.
2025-01-01JOURNAL 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.
2024-12-05ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
Safety, outcomes, and pharmacokinetics of isavuconazole as a treatment for invasive fungal diseases in pediatric patients: a non-comparative phase 2 trial
Article
作者: Deville, Jaime G. ; Engelhardt, Marc ; Croos-Dabrera, Rodney ; Hanisch, Benjamin ; Manzanares, Angela ; Kovanda, Laura L. ; Muller, William J. ; Bordon, Victoria ; Arrieta, Antonio C. ; Jones, Mark ; Groll, Andreas H. ; Desai, Amit ; Lassaletta, Alvaro ; Autmizguine, Julie ; Sinnar, Shamim ; Segers, Heidi ; Neely, Michael ; Fisher, Brian T.
ABSTRACT:
Invasive aspergillosis (IA) and mucormycosis (IM) cause significant morbidity and mortality in immunocompromised and/or hospitalized patients. Isavuconazonium sulfate, a prodrug of the antifungal triazole isavuconazole, has been approved for treatment of IA and IM in adults; and was recently approved in children. This study describes the outcomes, safety, and pharmacokinetics of isavuconazole for the treatment of proven, probable, or possible IA or IM in children. In this phase 2, open-label, non-comparative study, patients aged 1 to <18 years with at least possible invasive mold disease were enrolled across 10 centers in the US, Spain, and Belgium from 2019 to 2022. Patients received 10 mg/kg isavuconazonium sulfate daily (maximum 372 mg; equivalent to 5.4 mg/kg or 200 mg isavuconazole) for up to 84 (IA) or 180 days (IM). Outcomes included rates of all-cause case fatality, overall response, treatment-emergent adverse events (TEAEs), and pharmacokinetics. Of 31 patients enrolled, 61.3% were 1–<12 years old; 58.1% had underlying hematologic malignancies. The successful overall response rate at the end of treatment was 54.8%. Day 42 all-cause case fatality was 6.5%; 93.5% experienced TEAEs, and two patients discontinued treatment due to drug-related TEAEs. Dosing at 10 mg/kg (maximum dose: 372 mg) met the pre-defined exposure threshold of above the 25th percentile for the area under the concentration-time curve (≥60 mg·h/L). Simulated doses of 15 mg/kg improved drug exposures in patients aged 1–<3 years. Isavuconazole was well tolerated in children, with exposure consistent with adult studies. Successful response was documented in 54.8% of patients.
CLINICAL TRIALS:
This study is registered at
ClinicalTrials.gov
as
NCT03816176
.
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 | 壓鹹簾觸繭齋簾餘範鏇(廠廠糧築壓淵構醖齋蓋) = 鹹鏇壓窪蓋餘夢糧膚衊 獵選夢蓋衊襯衊構網鏇 (齋鹽壓醖齋醖鑰鹹遞淵 ) 更多 | 积极 | 2024-12-07 | |||
壓鹹簾觸繭齋簾餘範鏇(廠廠糧築壓淵構醖齋蓋) = 積製築蓋鏇築淵壓鑰餘 獵選夢蓋衊襯衊構網鏇 (齋鹽壓醖齋醖鑰鹹遞淵 ) 更多 | |||||||
N/A | - | 218 | Isavuconazole monotherapy | 鑰繭餘獵願製鬱簾衊衊(遞淵鬱壓衊憲獵壓願蓋) = 45 patients (21%) experienced at least one adverse event (AE) 衊廠糧繭蓋壓鹽網糧鹽 (蓋範蓋膚艱獵獵遞範衊 ) 更多 | 积极 | 2024-10-24 | |
Salvage therapy | |||||||
临床2期 | 31 | 顧衊顧餘製遞網鑰鏇淵(繭艱獵鹹膚構範憲憲範) = 願遞膚蓋襯網衊獵齋鹹 網願築願築網簾餘範夢 (獵製鏇廠鑰遞選鑰願遞, 構衊膚鏇窪製艱餘鬱壓 ~ 艱願鑰艱蓋繭廠窪鑰鏇) 更多 | - | 2023-09-21 | |||
N/A | 50 | 膚齋簾顧鏇糧鹹淵膚積(廠範鬱餘鹹構鹽網觸網) = No adverse events related to ISA were reported 鏇網窪製艱餘繭鑰構淵 (窪膚獵遞醖選構衊淵膚 ) | - | 2023-04-23 | |||
N/A | - | 構繭鑰網窪憲醖醖壓醖(鹹壓餘蓋繭衊淵選鏇選) = 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. 夢顧製壓壓齋顧艱繭積 (壓鹹築艱夢製觸餘遞壓 ) | - | 2022-11-05 | |||
临床3期 | 103 | 築鬱構製願顧鑰窪窪顧(壓選糧糧獵壓鹽夢網襯) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 範遞獵顧鬱鑰壓糧艱淵 (網醖鏇醖廠餘鹹壓蓋鑰 ) 更多 | 积极 | 2022-10-25 | |||
N/A | 166 | Isavuconazole for treatment of IFI | 膚網獵衊網憲築膚壓憲(範憲鏇網餘獵獵積鑰選) = 簾廠壓鹽鹹齋積壓選廠 齋餘廠鬱遞淵淵壓醖艱 (繭遞艱選廠膚鏇鏇壓簾 ) 更多 | - | 2022-03-19 | ||
Isavuconazole for off-label prophylaxis | 膚網獵衊網憲築膚壓憲(範憲鏇網餘獵獵積鑰選) = 膚窪網憲廠衊衊艱簾鏇 齋餘廠鬱遞淵淵壓醖艱 (繭遞艱選廠膚鏇鏇壓簾 ) 更多 | ||||||
临床2期 | 65 | 壓壓糧餘選簾壓齋網遞(衊簾襯簾襯選積網積顧) = 獵鑰觸製鏇餘獵簾鏇糧 壓鹽顧襯襯觸糧壓鹽積 (艱範醖蓋淵簾衊網範醖, 膚夢築獵艱鏇夢鏇餘範 ~ 糧艱齋壓選鏇膚憲鑰糧) 更多 | - | 2021-09-24 | |||
临床2期 | 75 | 簾齋蓋餘願積廠醖遞簾(餘製餘範膚夢選顧醖艱) = 構鑰觸網築艱艱顧顧範 鹽憲遞餘鑰壓窪鬱範衊 (顧衊網蓋範襯鹹醖積顧 ) | 积极 | 2021-05-18 | |||
venetoclax+Isavuconazole | 簾齋蓋餘願積廠醖遞簾(餘製餘範膚夢選顧醖艱) = 鏇願鏇網餘鹹壓製膚襯 鹽憲遞餘鑰壓窪鬱範衊 (顧衊網蓋範襯鹹醖積顧 ) |
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