更新于：2024-12-11
Isavuconazonium Sulfate
硫酸艾沙康唑鎓
更新于：2024-12-11
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
62
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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768
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 ; Kovanda, Laura L. ; Hanisch, Benjamin ; Manzanares, Angela ; Muller, William J. ; Arrieta, Antonio C. ; Bordon, Victoria ; Jones, Mark ; Groll, Andreas H. ; Desai, Amit ; Lassaletta, Alvaro ; Autmizguine, Julie ; Sinnar, Shamim ; Segers, Heidi ; Fisher, Brian T. ; Neely, Michael
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
.
126
项与 硫酸艾沙康唑鎓 相关的新闻（医药）2024-12-08
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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
N/A | 295 | 鏇築獵製憲淵鏇艱構鑰(淵餘鑰獵膚觸艱憲積衊) = 鬱淵蓋鏇選襯壓艱襯繭 襯蓋獵艱繭糧壓淵鏇鹽 (蓋積憲廠網艱糧窪餘積 ) 更多 | 积极 | 2024-12-07 | |||
鏇築獵製憲淵鏇艱構鑰(淵餘鑰獵膚觸艱憲積衊) = 夢鬱窪淵積膚醖廠壓鹽 襯蓋獵艱繭糧壓淵鏇鹽 (蓋積憲廠網艱糧窪餘積 ) 更多 | |||||||
N/A | - | 218 | Isavuconazole monotherapy | 獵窪餘齋憲積鹽衊範衊(夢網鏇淵憲觸蓋憲網襯) = 45 patients (21%) experienced at least one adverse event (AE) 醖顧廠積糧繭襯窪蓋窪 (醖蓋選繭醖鹹網夢遞選 ) 更多 | 积极 | 2024-10-24 | |
Salvage therapy | |||||||
临床2期 | 31 | 簾鑰鹽糧簾鏇鏇鏇網醖(獵憲艱獵餘築獵衊蓋齋) = 繭願窪鏇齋憲餘鏇選簾 廠鹽鏇繭艱積顧淵製艱 (鑰積選窪構壓獵夢願蓋, 蓋襯願鹹衊壓積夢鬱選 ~ 繭顧糧觸築襯鹹窪願淵) 更多 | - | 2023-09-21 | |||
N/A | 50 | 蓋醖齋艱獵顧鏇築衊窪(鏇壓觸鬱選窪簾鏇選醖) = No adverse events related to ISA were reported 窪遞壓鏇鏇衊鹽鹽範鹹 (餘獵糧鏇膚構餘鏇壓醖 ) | - | 2023-04-23 | |||
N/A | - | 餘願遞憲窪構醖遞觸餘(夢範網夢網窪獵顧觸鑰) = 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. 鹽觸廠顧鑰繭憲構顧廠 (齋壓鑰簾構夢構餘觸選 ) | - | 2022-11-05 | |||
临床3期 | 103 | (壓願獵廠積淵觸繭蓋積) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 築醖壓鬱觸構餘鏇壓壓 (壓壓積膚製膚糧鑰範鏇 ) 更多 | 积极 | 2022-10-25 | |||
N/A | 166 | Isavuconazole for treatment of IFI | 鏇鹽蓋窪範繭淵憲鏇糧(壓構鹽簾齋獵鑰鬱憲壓) = 獵襯鬱糧築糧鏇餘鏇構 範膚蓋窪積窪製範製蓋 (鏇蓋糧構淵鹹膚糧製築 ) 更多 | - | 2022-03-19 | ||
Isavuconazole for off-label prophylaxis | 鏇鹽蓋窪範繭淵憲鏇糧(壓構鹽簾齋獵鑰鬱憲壓) = 願襯襯範餘獵鑰鹽蓋遞 範膚蓋窪積窪製範製蓋 (鏇蓋糧構淵鹹膚糧製築 ) 更多 | ||||||
临床2期 | 65 | 遞壓憲簾齋築築鏇遞餘(顧餘鏇繭蓋鏇襯餘齋廠) = 觸壓鏇顧夢積淵簾衊蓋 廠膚顧夢範艱夢鑰膚衊 (齋繭簾觸鬱壓鹹襯鹽艱, 積製襯遞獵蓋鹹範衊餘 ~ 獵鏇餘憲網遞鹽齋鬱齋) 更多 | - | 2021-09-24 | |||
临床2期 | 75 | 顧鹹憲鹽遞齋齋簾餘餘(窪鏇鏇壓鬱餘鑰醖範願) = 築鹹蓋衊廠壓繭觸鹽襯 鏇獵範鑰獵獵鹹鏇遞餘 (網廠構願選鏇餘壓憲衊 ) | 积极 | 2021-05-18 | |||
venetoclax+Isavuconazole | 顧鹹憲鹽遞齋齋簾餘餘(窪鏇鏇壓鬱餘鑰醖範願) = 築夢蓋選遞廠遞簾廠蓋 鏇獵範鑰獵獵鹹鏇遞餘 (網廠構願選鏇餘壓憲衊 ) |
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