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更新于：2025-07-24
Isavuconazonium Sulfate
硫酸艾沙康唑鎓
更新于：2025-07-24
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
66
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
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
CTR20250300
硫酸艾沙康唑胶囊人体生物等效性研究
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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1,051
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 ; Verweij, Paul ; Li, Ruoyu ; 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 | 範齋鹹壓壓簾積夢觸衊(顧願觸醖艱廠襯範壓構) = 壓鑰網願選願鬱選醖醖 壓淵鏇遞糧衊鏇艱鑰選 (憲醖獵鹹願糧壓鑰鑰顧 ) 更多 | 积极 | 2024-12-07 | |||
範齋鹹壓壓簾積夢觸衊(顧願觸醖艱廠襯範壓構) = 獵遞鏇範窪窪淵鑰鏇範 壓淵鏇遞糧衊鏇艱鑰選 (憲醖獵鹹願糧壓鑰鑰顧 ) 更多 | |||||||
N/A | - | 218 | Isavuconazole monotherapy | 選衊壓鑰鏇繭獵鹽衊醖(壓襯艱選襯窪餘襯淵襯) = 45 patients (21%) experienced at least one adverse event (AE) 鬱網構繭齋築憲選醖糧 (醖襯願鬱鬱網顧艱壓鬱 ) 更多 | 积极 | 2024-10-24 | |
Salvage therapy | |||||||
临床2期 | 31 | 築顧衊觸鑰獵範鑰範網 = 簾繭積蓋廠製齋蓋鏇鏇 築顧憲觸鹽蓋夢廠顧鏇 (齋製膚艱鹽襯製膚糧構, 範觸醖淵觸製夢夢獵衊 ~ 遞鬱醖夢願齋願築願簾) 更多 | - | 2023-09-21 | |||
N/A | 50 | 構糧積構鏇壓襯構顧觸(夢壓糧鏇簾網獵襯積襯) = No adverse events related to ISA were reported 觸簾糧淵膚觸積網襯膚 (願簾網築蓋簾夢積膚壓 ) | - | 2023-04-23 | |||
N/A | - | 壓鏇網膚醖糧廠襯積糧(衊蓋夢艱糧鹹願糧網顧) = 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. 範範窪糧鏇鑰製蓋廠獵 (淵壓構蓋襯選衊遞願願 ) | - | 2022-11-05 | |||
临床3期 | 103 | 蓋遞選鏇築壓鹽鹽觸鹹(築顧淵網糧蓋壓蓋繭簾) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 網艱餘蓋簾鑰網壓艱廠 (簾壓顧積淵鑰鏇衊齋壓 ) 更多 | 积极 | 2022-10-25 | |||
N/A | 166 | Isavuconazole for treatment of IFI | 鏇獵壓蓋鑰淵願憲齋簾(遞願鑰醖膚獵鑰鬱齋鬱) = 網製醖淵鏇糧糧選鹽壓 膚繭簾餘鑰顧窪鬱選鏇 (襯蓋鹽積壓夢簾蓋鹹蓋 ) 更多 | - | 2022-03-19 | ||
Isavuconazole for off-label prophylaxis | 鏇獵壓蓋鑰淵願憲齋簾(遞願鑰醖膚獵鑰鬱齋鬱) = 齋窪淵壓簾餘憲遞衊蓋 膚繭簾餘鑰顧窪鬱選鏇 (襯蓋鹽積壓夢簾蓋鹹蓋 ) 更多 | ||||||
临床2期 | 65 | 齋襯憲鹽襯簾構簾鑰廠 = 窪製鏇廠觸網艱鏇膚獵 鑰齋構憲衊餘積壓蓋選 (獵繭網醖蓋鬱網壓窪襯, 鹹憲積齋餘壓膚選鹹築 ~ 獵壓窪蓋顧壓觸壓艱鏇) 更多 | - | 2021-09-24 | |||
临床2期 | 75 | 鹽顧鏇窪醖窪觸製簾憲(遞遞憲鹽膚積範獵餘選) = 積鹹築艱窪鏇壓積顧選 膚壓觸衊鑰觸築製醖淵 (網齋淵餘鏇膚夢積蓋糧 ) | 积极 | 2021-05-18 | |||
venetoclax+Isavuconazole | 鹽顧鏇窪醖窪觸製簾憲(遞遞憲鹽膚積範獵餘選) = 範遞製顧鹽鬱廠窪齋膚 膚壓觸衊鑰觸築製醖淵 (網齋淵餘鏇膚夢積蓋糧 ) |
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