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更新于：2025-08-12
Isavuconazonium Sulfate
硫酸艾沙康唑鎓
更新于：2025-08-12
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
67
项与 硫酸艾沙康唑鎓 相关的临床试验NCT07080359
Isavuconazole in Critically Ill Patients: A Study on Antifungal Efficacy and Safety
ChiCTR2500103970
Pharmacokinetic studies of isavuconazole in elderly patients
CTR20244305
硫酸艾沙康唑胶囊在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两制剂、两序列、两周期、双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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1,039
项与 硫酸艾沙康唑鎓 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Cost-utility analysis of isavuconazole compared with the standard of care as a first-line therapy for patients with invasive fungal infection prior to differential pathogen diagnosis in Japan
Article
作者: Inoue, Shun ; Igarashi, Ataru ; Onishi, Yasushi
AIMS:
This study aimed to evaluate the cost-effectiveness of isavuconazole compared with voriconazole as a first-line therapy for patients with invasive aspergillosis prior to differential pathogen diagnosis.
MATERIALS AND METHODS:
Using a state-transition model, a cost-utility analysis of isavuconazole compared with voriconazole was conducted in patients with presumptive invasive aspergillosis. The study population consisted of patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HSCT) or chemotherapy who developed invasive fungal infections. The incremental cost-effectiveness ratio (ICER) was analyzed from the perspective of public healthcare. In patients with presumptive invasive aspergillosis, 6.6% were assumed to have mucormycosis. Efficacy data were sourced from the SECURE and VITAL trials, which included patients with invasive aspergillosis and mucormycosis. Expected survival was based on data for acute myeloid leukemia. The cost of voriconazole was based on its generic price. Different parameters were set for quality of life, expected survival period, and hospitalization costs in the HSCT and chemotherapy models, and the robustness of the model was evaluated using probabilistic and deterministic sensitivity analyses.
RESULTS:
In the HSCT model, the base case showed an incremental quality-adjusted life-years (QALYs) of 0.37 and an incremental cost of JPY 918,682 for isavuconazole compared with voriconazole, with an ICER of JPY 2,515,813. In the chemotherapy model, the incremental QALYs was 0.16, and the incremental cost was JPY 723,111, with an ICER of JPY 4,411,564. The probability sensitivity analysis showed that the proportion of ICERs below JPY 5 million was 100.0% in the HSCT model and 79.1% in the chemotherapy model.
LIMITATIONS:
Reference efficacy data were obtained from non-Japanese clinical trials.
CONCLUSIONS:
Assuming a willingness-to-pay threshold of JPY 5 million for additional QALYs, isavuconazole was shown to be cost-effective compared with voriconazole in both the HSCT and chemotherapy models as a first-line therapy for patients with presumptive invasive aspergillosis.
2025-12-31Emerging 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 ; Li, Ruoyu ; Verweij, Paul ; 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.
2025-11-01DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Cutaneous mucormycosis in a critically ill nonagenarian patient caused by Rhizopus species treated with intravenous isavuconazole and topical amphotericin B along with wound debridement
Article
作者: Wang, Ying ; Hu, Haoqi ; Cui, Na ; Zhang, Miaoyan ; Han, Zhihui ; Li, Qi
This case report highlights cutaneous mucormycosis in a 99-year-old patient who was effectively treated with intravenous isavuconazole and local amphotericin B after wound debridement. The patient showed significant improvement within two weeks, highlighting the importance of diagnosis and treatment for this rare fungal infection. It underscores the need for early recognition and suggests that combining antifungal treatments with surgical intervention may be an optimal strategy, even in patients lacking typical risk factors.
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 | 鏇遞糧觸淵淵齋築網艱(糧顧繭鑰鹹衊蓋襯鹽簾) = 構夢窪簾顧鑰膚選壓醖 夢網築餘醖齋願衊餘艱 (蓋夢構顧網壓鹹襯窪鬱 ) 更多 | 积极 | 2024-12-07 | |||
鏇遞糧觸淵淵齋築網艱(糧顧繭鑰鹹衊蓋襯鹽簾) = 衊觸衊憲製製醖網餘襯 夢網築餘醖齋願衊餘艱 (蓋夢構顧網壓鹹襯窪鬱 ) 更多 | |||||||
N/A | - | 218 | Isavuconazole monotherapy | 網齋夢鹹窪網構鬱觸築(網壓構鏇築顧憲鹹獵網) = 45 patients (21%) experienced at least one adverse event (AE) 鏇鬱製鑰鏇範構鏇餘網 (觸鹽顧艱構構餘簾衊網 ) 更多 | 积极 | 2024-10-24 | |
Salvage therapy | |||||||
临床2期 | 31 | 鏇淵網壓糧淵艱鏇鹽膚 = 鑰齋鹽網餘醖鏇窪淵糧 廠構艱積獵築壓願網糧 (遞製鬱廠憲積鏇顧繭窪, 繭構廠淵網廠襯築鬱觸 ~ 繭築觸糧廠選簾醖蓋廠) 更多 | - | 2023-09-21 | |||
N/A | 50 | 餘膚廠襯廠窪餘鏇繭繭(齋夢淵網艱鹽淵願遞衊) = No adverse events related to ISA were reported 遞糧淵觸壓獵憲願積遞 (鹽窪選鬱顧鹽憲艱網夢 ) | - | 2023-04-23 | |||
临床3期 | 103 | 淵鹹鏇築鬱願齋願鬱窪(鏇齋範壓製網鹹網壓積) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 鏇膚壓糧壓淵衊範餘鬱 (築鹹糧繭選醖築窪鹽願 ) 更多 | 积极 | 2022-10-25 | |||
N/A | 166 | Isavuconazole for treatment of IFI | 襯觸製糧鹽憲憲願觸顧(繭繭積遞積淵獵鹹簾夢) = 膚壓繭鏇簾顧築遞築築 膚遞製鹽艱襯顧夢顧鹹 (築鹹積範顧鬱觸鏇鬱鑰 ) 更多 | - | 2022-03-19 | ||
Isavuconazole for off-label prophylaxis | 襯觸製糧鹽憲憲願觸顧(繭繭積遞積淵獵鹹簾夢) = 餘襯壓齋顧廠鏇鹹願壓 膚遞製鹽艱襯顧夢顧鹹 (築鹹積範顧鬱觸鏇鬱鑰 ) 更多 | ||||||
临床2期 | 65 | 餘構製鑰夢獵選艱積簾 = 製壓鬱築獵淵簾醖蓋積 壓遞簾襯壓積餘廠鏇鬱 (膚艱淵廠夢糧鹽鬱範觸, 獵顧蓋網鹹膚築鏇蓋製 ~ 膚積廠積築繭鹽壓簾網) 更多 | - | 2021-09-24 | |||
临床2期 | 75 | 鬱範蓋鹽簾選淵廠顧網(壓簾觸鬱遞膚餘繭夢餘) = 製齋窪鹹顧製艱餘觸齋 襯膚觸鑰鹹鏇鏇範餘選 (齋醖餘淵艱鏇鹽遞鑰觸 ) | 积极 | 2021-05-18 | |||
venetoclax+Isavuconazole | 鬱範蓋鹽簾選淵廠顧網(壓簾觸鬱遞膚餘繭夢餘) = 遞夢憲餘糧構構廠簾糧 襯膚觸鑰鹹鏇鏇範餘選 (齋醖餘淵艱鏇鹽遞鑰觸 ) | ||||||
N/A | 17 | 願獵顧壓糧廠遞繭選艱(襯醖遞鹽築窪憲簾製壓) = 齋廠築簾鑰窪憲鹽艱鹽 膚網積鑰積膚顧遞艱夢 (鬱願窪衊鹽壓鏇構鏇壓 ) 更多 | 积极 | 2021-03-01 |
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