Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability.
This study aims to explore the variability of isavuconazole plasma concentrations in critically ill patients and its correlation with efficacy and adverse effects. The research includes:
1. The distribution and variability of isavuconazole plasma concentrations in critically ill patients;
2. Clinical outcomes;
3. Adverse effects.

开始日期2025-08-01

申办/合作机构

上海市第十人民医院

NCT07191756

/ Active, not recruitingN/AIIT

A Retrospective, Multicenter Cohort Study Comparing the Efficacy and Safety of Amphotericin B Versus Isavuconazole for the Treatment of Mucormycosis: Analysis of Institutional Data and Literature Review

Background:
Mucormycosis is a serious but rare fungal infection that requires rapid and effective treatment. The two main antifungal medicines used are amphotericin B and isavuconazole. However, more real-world data is needed to directly compare how well they work and how safe they are for patients.
What is the purpose of this study? The main goal of this research study is to compare the effectiveness and safety of amphotericin B versus isavuconazole in treating mucormycosis. Investigators will look at which medicine leads to better survival rates and fewer serious side effects.
How will the study be done? This is a retrospective study. This means investigators will look back at information that has already been collected. Investigators will analyze data from the medical records of patients who were treated for mucormycosis at three hospitals. Investigators will also review and combine findings from relevant studies published on PubMed.
What will the researchers measure?
Investigators will measure and compare:
How long patients survived after treatment (survival rates).
Whether the infection was successfully cured or controlled (treatment response).
What kinds of side effects (like kidney problems or liver issues) patients experienced with each medicine.
What are the possible benefits of this study? This study will not directly benefit the participants whose records are reviewed. However, investigators hope that what investigators learn will help doctors make better treatment decisions for future patients with mucormycosis by providing clearer evidence on the best choice of medicine.

开始日期2025-05-15

申办/合作机构

广西医科大学

[+1]

CTR20244305

/ CompletedN/A

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

主要研究目的：按有关生物等效性试验的规定，选择Pfizer Australia Pty Ltd持证，SwissCo Services AG生产的硫酸艾沙康唑胶囊（商品名：康新博®，规格：100mg（按C22H17F2N5OS计））为参比制剂，对北京博康健基因科技有限公司生产并提供的受试制剂硫酸艾沙康唑胶囊（规格：100mg（按C22H17F2N5OS计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂硫酸艾沙康唑胶囊（规格：100mg（按C22H17F2N5OS计））和参比制剂硫酸艾沙康唑胶囊（商品名：康新博®，规格：100mg（按C22H17F2N5OS计））的安全性。

开始日期2025-03-08

申办/合作机构

北京博康健基因科技有限公司

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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829

项与硫酸艾沙康唑鎓相关的文献（医药）

2025-12-31·JOURNAL 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.

2025-12-31·Emerging 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.

2025-11-01·DIAGNOSTIC 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.

205

项与硫酸艾沙康唑鎓相关的新闻（医药）

2025-09-25

·GlobeNewswire-Health Care

Basilea awarded BARDA contract for the development of novel oral phase 3-ready antibiotic ceftibuten-ledaborbactam

- Total non-dilutive funding of up to USD 159 million upon completion of predefined milestones, including near-term committed funding of USD 6 million Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, September 25, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services, has novated a contract from Venatorx Pharmaceuticals, Inc. (Venatorx) to Basilea to support the development of the novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. Basilea recently acquired the global rights to ceftibuten-ledaborbactam etzadroxil from Venatorx. David Veitch, Chief Executive Officer of Basilea, said: “We thank BARDA for their continued collaboration and support for the development of novel anti-infectives to help patients with severe infections. The funding helps us to further advance our newly in-licensed novel antibiotic ceftibuten-ledaborbactam, which we believe holds a strong promise in addressing the critical unmet need for the oral treatment of cUTIs caused by multidrug-resistant Gram-negative bacteria.” The existing funding agreement between BARDA and Venatorx was novated, with Basilea replacing Venatorx as a contracting party. Under the terms of the contract, Basilea will be reimbursed for a portion of the development costs required to bring ceftibuten-ledaborbactam etzadroxil to market, including the planned Phase 3 clinical studies. The non-dilutive funding comprises an initial amount of approximately USD 6 million and options to provide up to USD 153 million of additional non-dilutive funding upon completion of predefined milestones. About beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections caused by multidrug-resistant bacterial pathogens. About ceftibuten-ledaborbactam etzadroxil Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales.[1] Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. About complicated urinary tract infections (cUTI) Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options.[2] Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@basilea.cominvestor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References J. A. Karlowsky, M. G. Wise, M. A. Hackel et al. Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018–2020 Global Surveillance Collection. Antimicrobial Agents and Chemotherapy 2022, Nov 15;66(11):e0093422T. P. Lodise, T. Chopra, B. H. Nathanson et al. Epidemiology of Complicated Urinary Tract Infections due to Enterobacterales Among Adult Patients Presenting in Emergency Departments Across the United States. Open Forum Infectious Diseases 2022, Jun 24;9(7):ofac315. Attachment Press release (PDF)

临床3期快速通道合格传染病产品引进/卖出

2025-09-16

·GlobeNewswire-Health Care

Basilea receives USD 25 million funding under BARDA agreement to continue to advance novel antifungals fosmanogepix and BAL2062

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, September 16, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 25 million to Basilea to continue to advance the development of Basilea’s novel antifungals fosmanogepix and BAL2062. This additional funding follows the achievement of a prespecified enrollment milestone in the fosmanogepix phase 3 study in candidemia/invasive candidiasis within the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033), which allows for potential total funding of up to approximately USD 268 million to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. These compounds, with novel mechanisms of action, promise new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening invasive fungal infections. There continues to be a high medical need for new innovative antifungal treatments.” He added: “This third tranche of funding within the BARDA OTA will support our two ongoing phase 3 studies with fosmanogepix in yeast infections and in mold infections. It also provides further funding for the phase 2 development of BAL2062 in mold infections.” The USD 25 million is in addition to the USD 68 million already committed by BARDA since the signing of the OTA in September 2024. BARDA’s financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 The FAST study, a phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis and the FORWARD study, a phase 3 study, in the treatment of adult patients with invasive mold infections, are ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). About BAL2062 BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239FAST study (candidemia/invasive candidiasis): ClinicalTrials.gov identifier NCT05421858; FORWARD study (invasive mold infections): ClinicalTrials.gov identifier NCT06925321K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: September 15, 2025)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)

临床3期孤儿药快速通道临床1期临床2期

2025-09-15

·国家药品监督管理局

2025年09月15日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CXHS2400097、CXHB2500087安瑞克芬注射液海思科医药集团股份有限公司国药准字H202500142025年09月09日2CXHS2500005枸橼酸伏维西利胶囊锦州奥鸿药业有限责任公司国药准字H202500232025年09月09日3CXHS2500006枸橼酸伏维西利胶囊锦州奥鸿药业有限责任公司国药准字H202500242025年09月09日4CXSS2400041Sabin株脊髓灰质炎灭活疫苗（Vero细胞）北京民海生物科技有限公司国药准字S202500512025年09月09日5CXZS2400036枇杷清肺饮颗粒河北万岁药业有限公司国药准字C202500112025年09月09日6CYHB2402063恩格列净片山东新时代药业有限公司国药准字H202581972025年09月12日7CYHB2450141注射用头孢他啶重庆吉斯瑞制药有限责任公司国药准字H202581962025年09月12日8CYHB2450142注射用头孢他啶重庆吉斯瑞制药有限责任公司国药准字H202581952025年09月12日9CYHB2450547头孢泊肟酯片浙江普洛巨泰药业有限公司————2025年09月12日10CYHB2501287甲苯磺酸艾多沙班片辰欣药业股份有限公司————2025年09月12日11CYHB2501324盐酸多巴酚丁胺注射液浙江沣华医药科技有限公司————2025年09月12日12CYHS2202121国、CYHB2500713水合氯醛灌肠剂海南天盛保和生物科技有限公司国药准字H202553872025年09月09日13CYHS2202122国、CYHB2501017水合氯醛灌肠剂海南天盛保和生物科技有限公司国药准字H202553882025年09月09日14CYHS2300221马来酸奈拉替尼片湖南科伦制药有限公司国药准字H202553372025年09月09日15CYHS2300737托拉塞米注射液江苏睿实生物科技有限公司国药准字H202554262025年09月09日16CYHS2300738托拉塞米注射液江苏睿实生物科技有限公司国药准字H202554272025年09月09日17CYHS2301749盐酸多巴胺注射液酒泉大得利制药股份有限公司国药准字H202554542025年09月09日18CYHS2302225西格列汀二甲双胍缓释片越洋医药开发（广州）有限公司国药准字H202554282025年09月09日19CYHS2302380波生坦片北京颐康兴医药有限公司国药准字H202553892025年09月09日20CYHS2302851盐酸甲氧氯普胺注射液四川邈济生物医药科技有限公司国药准字H202553712025年09月09日21CYHS2302985碳酸氢钠注射液江西璟瑞药业有限公司国药准字H202553902025年09月09日22CYHS2303053磷酸奥司他韦干混悬剂海南葫芦娃药业集团股份有限公司国药准字H202554552025年09月09日23CYHS2303085吡格列酮二甲双胍片（15mg/500mg）江苏安必生制药有限公司国药准字H202553572025年09月09日24CYHS2303124注射用头孢哌酮钠舒巴坦钠广东粤和泽药物研究有限公司国药准字H202553972025年09月09日25CYHS2303125注射用头孢哌酮钠舒巴坦钠广东粤和泽药物研究有限公司国药准字H202553982025年09月09日26CYHS2303156、CYHB2500607盐酸甲氧氯普胺注射液朗天药业（湖北）有限公司国药准字H202553992025年09月09日27CYHS2303337盐酸左沙丁胺醇雾化吸入溶液苏州弘森药业股份有限公司国药准字H202553912025年09月09日28CYHS2303338盐酸左沙丁胺醇雾化吸入溶液苏州弘森药业股份有限公司国药准字H202553922025年09月09日29CYHS2303339盐酸左沙丁胺醇雾化吸入溶液苏州弘森药业股份有限公司国药准字H202553932025年09月09日30CYHS2303407米诺地尔搽剂辽宁新高制药有限公司国药准字H202553382025年09月09日31CYHS2303409坎地沙坦酯氢氯噻嗪片（Ⅱ）浙江华海药业股份有限公司国药准字H202554562025年09月09日32CYHS2303497复方匹可硫酸钠颗粒北京民康百草医药科技有限公司国药准字H202554572025年09月09日33CYHS2303549乳果糖口服溶液国药控股星鲨制药（厦门）有限公司国药准字H202553722025年09月09日34CYHS2303550乳果糖口服溶液国药控股星鲨制药（厦门）有限公司国药准字H202553732025年09月09日35CYHS2303575酮咯酸氨丁三醇注射液重庆莱美药业股份有限公司国药准字H202553582025年09月09日36CYHS2303585甲磺酸伊马替尼片浙江麒正药业有限公司国药准字H202553392025年09月09日37CYHS2303589氯化钾注射液江西博泰药业有限公司国药准字H202554582025年09月09日38CYHS2303590氯化钾注射液江西博泰药业有限公司国药准字H202554592025年09月09日39CYHS2303625碘佛醇注射液重庆圣华曦药业股份有限公司国药准字H202554602025年09月09日40CYHS2400026氟比洛芬酯注射液宜昌人福药业有限责任公司国药准字H202554002025年09月09日41CYHS2400047乳果糖口服溶液广西维威制药有限公司国药准字H202554292025年09月09日42CYHS2400048乳果糖口服溶液广西维威制药有限公司国药准字H202554302025年09月09日43CYHS2400051盐酸甲氧氯普胺注射液中润药业有限公司国药准字H202554012025年09月09日44CYHS2400147法莫替丁注射液锦州奥鸿药业有限责任公司国药准字H202553402025年09月09日45CYHS2400262糠酸莫米松乳膏重庆华邦制药有限公司国药准字H202553592025年09月09日46CYHS2400263糠酸莫米松乳膏重庆华邦制药有限公司国药准字H202553602025年09月09日47CYHS2400267利多卡因凝胶贴膏陕西东科制药有限责任公司国药准字H202553412025年09月09日48CYHS2400280盐酸美金刚口服溶液沈阳天邦药业有限公司国药准字H202554022025年09月09日49CYHS2400306硫代硫酸钠注射液南京海辰药业股份有限公司国药准字H202554032025年09月09日50CYHS2400322注射用醋酸地加瑞克正大天晴药业集团股份有限公司国药准字H202553422025年09月09日51CYHS2400323注射用醋酸地加瑞克正大天晴药业集团股份有限公司国药准字H202553432025年09月09日52CYHS2400333盐酸戊乙奎醚注射液国药集团工业有限公司廊坊分公司国药准字H202553612025年09月09日53CYHS2400384熊去氧胆酸胶囊山东淄博新达制药有限公司国药准字H202553442025年09月09日54CYHS2400427他达拉非片山东汇泽生物制药有限公司国药准字H202553742025年09月09日55CYHS2400478氨氯地平贝那普利胶囊东阳祥昇医药科技有限公司国药准字H202553752025年09月09日56CYHS2400491甲氨蝶呤注射液吉斯美（武汉）制药有限公司国药准字H202554312025年09月09日57CYHS2400492甲氨蝶呤注射液吉斯美（武汉）制药有限公司国药准字H202554322025年09月09日58CYHS2400531夫西地酸乳膏湖北成田药业有限公司国药准字H202553622025年09月09日59CYHS2400552二甲双胍恩格列净片（Ⅰ）山东新时代药业有限公司国药准字H202554042025年09月09日60CYHS2400553二甲双胍恩格列净片（Ⅵ）山东新时代药业有限公司国药准字H202554052025年09月09日61CYHS2400556盐酸普罗帕酮注射液成都瑞尔医药科技有限公司国药准字H202554612025年09月09日62CYHS2400557注射用盐酸罗沙替丁醋酸酯浙江华海药业股份有限公司国药准字H202554062025年09月09日63CYHS2400625盐酸克林霉素棕榈酸酯颗粒广州一品红制药有限公司国药准字H202553762025年09月09日64CYHS2400628吡仑帕奈口服混悬液锦州奥鸿药业有限责任公司国药准字H202553942025年09月09日65CYHS2400638碘佛醇注射液重庆煜洋药业有限公司国药准字H202554332025年09月09日66CYHS2400662盐酸奥洛他定颗粒成都倍特药业股份有限公司国药准字H202554622025年09月09日67CYHS2400684马来酸氯苯那敏注射液辽宁海神联盛制药有限公司国药准字H202554452025年09月09日68CYHS2400704盐酸鲁拉西酮片山东新时代药业有限公司国药准字H202553452025年09月09日69CYHS2400712己酮可可碱缓释片普济生物科技（台州）有限公司国药准字H202553772025年09月09日70CYHS2400730、CYHB2501194托吡酯口服溶液梦阳药业（上海）有限公司国药准字H202553782025年09月09日71CYHS2400826富马酸伏诺拉生片重庆圣华曦药业股份有限公司国药准字H202554072025年09月09日72CYHS2400856吡仑帕奈片锦州奥鸿药业有限责任公司国药准字H202553632025年09月09日73CYHS2400857吡仑帕奈片锦州奥鸿药业有限责任公司国药准字H202553642025年09月09日74CYHS2400877盐酸贝尼地平片辰欣药业吉林有限公司国药准字H202554342025年09月09日75CYHS2400881替米沙坦氨氯地平片（II）成都奥邦药业有限公司国药准字H202553652025年09月09日76CYHS2400882替米沙坦氨氯地平片成都奥邦药业有限公司国药准字H202553792025年09月09日77CYHS2400893吗啉硝唑氯化钠注射液石家庄四药有限公司国药准字H202554462025年09月09日78CYHS2400906氨磺必利口服溶液仁合益康集团有限公司国药准字H202554632025年09月09日79CYHS2400914克立硼罗软膏浙江赛默制药有限公司国药准字H202553802025年09月09日80CYHS2400916法莫替丁注射液武汉福星生物药业有限公司国药准字H202553462025年09月09日81CYHS2400918琥珀酸普芦卡必利片漯河市汇创医药有限公司国药准字H202554472025年09月09日82CYHS2400934替格瑞洛片安若维他药业泰州有限公司国药准字H202554352025年09月09日83CYHS2400935替格瑞洛片安若维他药业泰州有限公司国药准字H202554362025年09月09日84CYHS2400940重酒石酸去甲肾上腺素注射液海南美康达药业有限公司国药准字H202553812025年09月09日85CYHS2400980己酮可可碱缓释片广东君康药业有限公司国药准字H202553472025年09月09日86CYHS2400995吡格列酮二甲双胍片（15mg/850mg）北京福元医药股份有限公司国药准字H202553662025年09月09日87CYHS2401007、CYHB2500786二甲双胍恩格列净片（Ⅰ）河南福森药业有限公司国药准字H202554082025年09月09日88CYHS2401048米拉贝隆缓释片南京易亨制药有限公司国药准字H202554642025年09月09日89CYHS2401087左氧氟沙星注射液陕西博森生物制药股份集团有限公司国药准字H202554092025年09月09日90CYHS2401106西咪替丁注射液石家庄迪斯凯威医药科技有限公司国药准字H202554102025年09月09日91CYHS2401133丙酸氟替卡松吸入粉雾剂润生药业有限公司国药准字H202554652025年09月09日92CYHS2401148沙库巴曲缬沙坦钠片迪沙药业集团有限公司国药准字H202553482025年09月09日93CYHS2401206盐酸替罗非班氯化钠注射液安徽双鹤药业有限责任公司国药准字H202553492025年09月09日94CYHS2401208盐酸替罗非班氯化钠注射液安徽双鹤药业有限责任公司国药准字H202553502025年09月09日95CYHS2401236卡格列净片沐邦（北京）医药科技有限公司国药准字H202553512025年09月09日96CYHS2401256盐酸布比卡因注射液山东诚创蓝海医药科技有限公司国药准字H202554112025年09月09日97CYHS2401257盐酸布比卡因注射液山东诚创蓝海医药科技有限公司国药准字H202554122025年09月09日98CYHS2401258盐酸布比卡因注射液山东诚创蓝海医药科技有限公司国药准字H202554132025年09月09日99CYHS2401265乳果糖口服溶液江西远超医药科技有限公司国药准字H202553822025年09月09日100CYHS2401266乳果糖口服溶液江西远超医药科技有限公司国药准字H202553832025年09月09日101CYHS2401270磷酸奥司他韦胶囊山东鲁抗三叶制药有限公司国药准字H202554142025年09月09日102CYHS2401277注射用头孢他啶阿维巴坦钠安徽威尔曼制药有限公司国药准字H202554482025年09月09日103CYHS2401280枸橼酸西地那非口崩片山东新华制药股份有限公司国药准字H202553522025年09月09日104CYHS2401288他达拉非片辽宁鑫善源药业有限公司国药准字H202554152025年09月09日105CYHS2401289他达拉非片辽宁鑫善源药业有限公司国药准字H202554162025年09月09日106CYHS2401290他达拉非片辽宁鑫善源药业有限公司国药准字H202554172025年09月09日107CYHS2401294马来酸氟伏沙明片石家庄龙泽制药股份有限公司国药准字H202554662025年09月09日108CYHS2401297布南色林片山东京卫制药有限公司国药准字H202554672025年09月09日109CYHS2401306枸橼酸托瑞米芬片重庆圣华曦药业股份有限公司国药准字H202554182025年09月09日110CYHS2401311普瑞巴林口服溶液海南斯达制药有限公司国药准字H202553672025年09月09日111CYHS2401312普瑞巴林口服溶液海南斯达制药有限公司国药准字H202553682025年09月09日112CYHS2401314普瑞巴林口服溶液海南斯达制药有限公司国药准字H202553692025年09月09日113CYHS2401319盐酸利多卡因注射液南京泽恒医药技术开发有限公司国药准字H202554682025年09月09日114CYHS2401323培哚普利氨氯地平片（Ⅰ）江西施美药业股份有限公司国药准字H202554192025年09月09日115CYHS2401324培哚普利氨氯地平片（Ⅲ）江西施美药业股份有限公司国药准字H202554202025年09月09日116CYHS2401325培哚普利氨氯地平片（Ⅱ）江西施美药业股份有限公司国药准字H202554212025年09月09日117CYHS2401401双醋瑞因胶囊赛灵药业科技集团股份有限公司国药准字H202553952025年09月09日118CYHS2401426盐酸贝尼地平片深圳大佛药业股份有限公司国药准字H202554372025年09月09日119CYHS2401427盐酸贝尼地平片深圳大佛药业股份有限公司国药准字H202554382025年09月09日120CYHS2401441法莫替丁注射液成都倍特药业股份有限公司国药准字H202553532025年09月09日121CYHS2401442二甲双胍恩格列净片（Ⅴ）北京双鹭药业股份有限公司国药准字H202554492025年09月09日122CYHS2401443二甲双胍恩格列净片（Ⅰ）北京双鹭药业股份有限公司国药准字H202554502025年09月09日123CYHS2401452盐酸去氧肾上腺素注射液云南龙海天然植物药业有限公司国药准字H202554692025年09月09日124CYHS2401493葡萄糖酸钙氯化钠注射液石家庄四药有限公司国药准字H202553962025年09月09日125CYHS2401546拉莫三嗪分散片仁合益康集团有限公司国药准字H202553542025年09月09日126CYHS2401548左炔诺孕酮片武汉九珑人福药业有限责任公司国药准字H202554222025年09月09日127CYHS2401581注射用阿糖胞苷石家庄迪斯凯威医药科技有限公司国药准字H202554392025年09月09日128CYHS2401622塞来昔布胶囊大桐制药（中国）有限责任公司国药准字H202554512025年09月09日129CYHS2401678巴瑞替尼片杭州民生药业股份有限公司国药准字H202554702025年09月09日130CYHS2401714尼可地尔片重庆莱美药业股份有限公司国药准字H202554522025年09月09日131CYHS2401734注射用硫酸艾沙康唑合肥亿帆生物制药有限公司国药准字H202554402025年09月09日132CYHS2401737甲硝唑凝胶合肥启旸生物医药科技有限公司国药准字H202554412025年09月09日133CYHS2401753盐酸丙卡特罗吸入溶液北京海步医药科技有限公司国药准字H202554232025年09月09日134CYHS2401803卡铂注射液中寰医药有限公司国药准字H202553552025年09月09日135CYHS2401839注射用亚胺培南西司他丁钠深圳华药南方制药有限公司国药准字H202553702025年09月09日136CYHS2401939硫酸艾沙康唑胶囊杭州沐源生物医药科技有限公司国药准字H202554532025年09月09日137CYHS2401960盐酸戊乙奎醚注射液广州瑞尔医药科技有限公司国药准字H202553842025年09月09日138CYHS2401961磷/碳酸氢钠血滤置换液山东齐都药业有限公司国药准字H202553852025年09月09日139CYHS2402067盐酸阿罗洛尔片成都苑东生物制药股份有限公司国药准字H202554242025年09月09日140CYHS2402128恩格列净片康臣药业（内蒙古）有限责任公司国药准字H202553562025年09月09日141CYHS2402307替格瑞洛片浙江京新药业股份有限公司国药准字H202554422025年09月09日142CYHS2402308替格瑞洛片浙江京新药业股份有限公司国药准字H202554432025年09月09日143CYHS2402345普拉洛芬滴眼液鲁南贝特制药有限公司国药准字H202554442025年09月09日144CYHS2403653地夸磷索钠滴眼液武汉先路医药科技股份有限公司国药准字H202554252025年09月09日145CYHS2403793布比卡因脂质体注射液湖南科伦制药有限公司国药准字H202446862025年09月09日146CYHS2403794布比卡因脂质体注射液湖南科伦制药有限公司国药准字H202446852025年09月09日147CYHS2403864氧江苏宝祥气体有限公司国药准字H202553862025年09月09日148CYZB2501317脉络通葵花药业集团（佳木斯）有限公司————2025年09月12日149CYZB2501818跌打活血胶囊江西远超医药科技有限公司————2025年09月12日150CYZB2501820牛黄清心丸(局方)河南乐同堂医药科技有限公司————2025年09月12日151CYZB2501821胃灵颗粒蓝耘智合生物科技有限责任公司————2025年09月12日152CYZB2501826乌鸡白凤丸广生堂药业（漳州）有限公司————2025年09月12日153CYZB2501829三七丹参颗粒海南鑫康达医药科技有限公司————2025年09月12日154JTH2500135注射用醋酸亮丙瑞林微球上海安必生制药技术有限公司————2025年09月12日155JTS2500071乙型肝炎疫苗-成品-标准品葛兰素史克（中国）投资有限公司————2025年09月12日156JTS2500072乙型肝炎疫苗-成品-内控品葛兰素史克（中国）投资有限公司————2025年09月12日157JXHS2400017、JXHB2500059雌二醇透皮喷雾剂吉瑞医药（中国）有限公司国药准字HJ202501092025年09月09日158JXHS2400053盐酸伊普可泮胶囊北京诺华制药有限公司国药准字HJ202400162025年09月09日159JXHS2400113盐酸卡马替尼片北京诺华制药有限公司国药准字HJ202400412025年09月09日160JXHS2400114盐酸卡马替尼片北京诺华制药有限公司国药准字HJ202400422025年09月09日161JYHB2400457厄多司坦胶囊辉盈（上海）医药科技有限公司————2025年09月12日162JYHB2500331恩扎卢胺软胶囊安斯泰来制药（中国）有限公司————2025年09月12日163JYHS2300113尼洛替尼胶囊瑞迪博士（北京）药业有限公司国药准字HJ202501102025年09月09日164JYHS2300114尼洛替尼胶囊瑞迪博士（北京）药业有限公司国药准字HJ202501112025年09月09日

疫苗申请上市高管变更

100 项与硫酸艾沙康唑鎓相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10643	硫酸艾沙康唑鎓	G01AG J02AC	DB06636

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
隐球菌病	日本	Asahi Kasei Pharma Corp.	2022-12-23
曲霉菌病	加拿大	Avir Pharma, Inc.	2018-12-19
侵袭性曲霉菌病	美国	Astellas Pharma US, Inc.	2015-03-06
毛霉菌病	美国	Astellas Pharma US, Inc.	2015-03-06

未上市

10 条进展最快的记录,

后查看更多信息

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	Asahi Kasei Corp.	2022-01-30
新型冠状病毒感染	临床3期	美国	Astellas Pharma Global Development, Inc.	2021-03-16
肺曲霉菌病	临床3期	美国	Astellas Pharma Global Development, Inc.	2021-03-16
深部真菌病	临床3期	日本	Asahi Kasei Pharma Corp.	2018-04-16
念珠菌血症	临床3期	美国	Basilea Pharmaceutica AG	2007-03-08
念珠菌血症	临床3期	美国	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	中国	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	中国	Basilea Pharmaceutica AG	2007-03-08
念珠菌血症	临床3期	阿根廷	Basilea Pharmaceutica AG	2007-03-08
念珠菌血症	临床3期	阿根廷	Astellas Pharma, Inc.	2007-03-08

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


1480 (ASH2024)	N/A	急性髓性白血病	295	Isavuconazole	艱觸齋鹽醖製願遞鬱廠(簾範獵繭願鑰遞鹹簾鑰) = 簾積獵鏇網艱鹹壓艱鬱鏇齋餘範夢鹹鑰襯顧鹹 (窪遞夢糧積製獵鹽製鏇 ) 更多	积极	2024-12-07
				Voriconazole	艱觸齋鹽醖製願遞鬱廠(簾範獵繭願鑰遞鹹簾鑰) = 鬱構餘鬱鹽艱艱製齋積鏇齋餘範夢鹹鑰襯顧鹹 (窪遞夢糧積製獵鹽製鏇 ) 更多
NCT04550936 (Pubmed \| Infect Dis Ther)	N/A	-	218	Isavuconazole monotherapy	網憲獵選顧鏇憲壓窪網(鏇齋衊獵廠蓋構鏇鹹簾) = 45 patients (21%) experienced at least one adverse event (AE) 構願壓遞獵鏇膚願膚觸 (淵襯醖窪醖築壓網觸蓋 ) 更多	积极	2024-10-24
				Salvage therapy
NCT03816176 (CTgov)	临床2期	侵袭性曲霉菌病 \| 毛霉菌病	31	Isavuconazonium sulfate	製齋製網選餘淵廠遞齋 = 鏇鬱醖蓋艱膚糧構鬱遞顧壓窪襯繭積鏇願鑰觸 (製鹹遞廠廠憲範衊襯壓, 積壓範範蓋壓憲鏇鹽蓋 ~ 網顧觸網簾憲壓製簾蓋) 更多	-	2023-09-21
EBMT2023	N/A	造血干细胞移植	50	Isavuconazole	鏇鑰鹽觸憲醖壓膚齋醖(築鬱窪網壓齋膚夢積選) = No adverse events related to ISA were reported 製蓋簾願觸積襯鹹積糧 (壓製淵艱淵壓鏇願衊觸 )	-	2023-04-23
NCT03471988 (Pubmed)	临床3期	真菌病	103	Isavuconazole	繭膚簾膚積築壓糧夢艱(衊顧鏇壓積觸衊鑰範網) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 鏇衊鬱壓壓壓窪衊簾簾 (壓艱鹹壓衊蓋鬱餘醖築 ) 更多	积极	2022-10-25
				Voriconazole
EBMT2022	N/A	造血干细胞移植	166	Isavuconazole for treatment of IFI	艱網構憲獵獵鬱廠醖醖(積顧壓鹹鏇積簾構選積) = 遞製糧積繭願餘壓鹽願鬱網蓋艱憲鏇簾觸顧顧 (襯餘製顧簾構網鑰鑰窪 ) 更多	-	2022-03-19
				Isavuconazole for off-label prophylaxis	艱網構憲獵獵鬱廠醖醖(積顧壓鹹鏇積簾構選積) = 蓋淵構憲鬱醖鹹膚淵廠鬱網蓋艱憲鏇簾觸顧顧 (襯餘製顧簾構網鑰鑰窪 ) 更多
NCT03019939 (CTgov)	临床2期	急性髓性白血病 \| 中性粒细胞减少 \| 侵袭性真菌感染 ... 更多	65	Isavuconazole	夢製構鑰製衊鬱鹽餘壓 = 簾築築醖蓋襯憲築壓膚網遞鬱範遞艱選觸遞獵 (襯蓋淵簾網顧網窪醖製, 鹹壓醖遞鏇襯遞繭積衊 ~ 鹹積願糧壓夢簾壓鏇鬱) 更多	-	2021-09-24
NCT03019939 (Pubmed \| Clin Infect Dis) 人工标引	临床2期	急性髓性白血病 \| 骨髓增生异常综合征	75	Isavuconazole	觸獵選網選製選淵襯襯(窪醖夢製鬱繭艱艱膚襯) = 積淵襯繭鑰願鹹獵製鑰繭鑰廠顧顧鹹廠鬱積鑰 (鏇衊觸願範選醖艱膚積 )	积极	2021-05-18
				venetoclax+Isavuconazole	觸獵選網選製選淵襯襯(窪醖夢製鬱繭艱艱膚襯) = 糧顧鹹選繭淵願鏇衊廠繭鑰廠顧顧鹹廠鬱積鑰 (鏇衊觸願範選醖艱膚積 )
Tandem Meetings ASTCT and CIBMTR2021	N/A	肿瘤	17	Isavuconazonium sulfate	鏇窪壓窪糧觸廠選膚顧(鏇選醖糧鬱鏇繭艱鏇齋) = 網壓遞選憲壓範獵製窪艱繭觸積鏇築獵艱鹹積 (繭鏇廠簾淵簾襯鑰廠鏇 ) 更多	积极	2021-03-01