Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) Plus Isavuconazole Versus AmBisome® in the Management of Pulmonary Mucormycosis: A multicenter, Prospective, Open Label, Randomized Controlled Study

开始日期2025-01-13

申办/合作机构

中日友好医院

DRKS00035443

/ CompletedN/AIIT

Factors influencing isavuconazole concentrations in intensive care patients - a retrospective monocentric evaluation - FisaCon

开始日期2024-11-05

申办/合作机构-

CTR20243329

/ CompletedN/A

硫酸艾沙康唑胶囊在中国健康受试者中的生物等效性试验

主要研究目的：以福安药业集团庆余堂制药有限公司持有的硫酸艾沙康唑胶囊（100mg，按C22H17F2N5OS计）为受试制剂（T），按有关生物等效性试验的规定，以Pfizer Australia Pty Ltd.持证的硫酸艾沙康唑胶囊（100mg，按C22H17F2N5OS计）为参比制剂（R）进行生物等效性试验。次要研究目的：观察受试制剂和参比制剂硫酸艾沙康唑胶囊（100mg，按C22H17F2N5OS计）在健康受试者中的安全性。

开始日期2024-09-14

申办/合作机构

福安药业集团宁波天衡制药有限公司

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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1,009

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.

2025-06-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Isavuconazole in chronic pulmonary aspergillosis: What is the evidence?

Review

作者: Magri, Marcello Mihailenko Chaves ; Gonçalves Kono Magri, Adriana Satie ; Abdala, Edson ; Katayose, Jéssica Toshie ; de Oliveira, Vitor Falcão ; Dos Santos Prates, Bruno Victor ; de Souza Ritter, Isadora Cristina ; Taborda, Mariane

BACKGROUND:

Newer drugs like isavuconazole have been more widely used for invasive aspergillosis, where they are included as first-line treatments in major guidelines, whereas their use in chronic pulmonary aspergillosis (CPA) remains limited. Therefore, the aim of this study is to conduct a systematic review of the literature on the use of isavuconazole in CPA.

METHODS:

We searched PubMed/MEDLINE and Embase on August 9th, 2024. Our inclusion criteria included patients with CPA who were treated with isavuconazole. We summarized binary variables with counts and percentages, and continuous variables with mean and SD.

RESULTS:

We found 15 articles on CPA using isavuconazole. These studies were published after 2017, with a high predominance in high-income countries, especially US (40 %, n = 6) and UK (33.3 %, n = 5). There were 10 case reports, the majority of which used isavuconazole as salvage therapy. Two articles compared isavuconazole with voriconazole. The overall response rates at the end of treatment for CPA patients were similar, and the incidence of adverse drug reactions was numerically lower in the isavuconazole group compared to voriconazole. We found five articles on blood levels of isavuconazole. The mean isavuconazole serum level was >1 mg/L in all studies, even at a 100-mg daily dose. In the retrospective studies, the rate of isavuconazole discontinuation ranged from 17 % to 36 %.

CONCLUSION:

There is limited experience with isavuconazole in treating CPA. This study consolidates existing evidence on its use in CPA, highlighting its potential as a therapeutic option beyond invasive aspergillosis, though further research is needed.

161

项与硫酸艾沙康唑鎓相关的新闻（医药）

2025-04-24

·GlobeNewswire-Health Care

Strong sales for Cresemba® (isavuconazole) in Japan trigger second milestone payment from Asahi Kasei Pharma to Basilea

Allschwil, Switzerland, April 24, 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, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering a sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.7 million. This is the second milestone payment from AKP to Basilea in consecutive quarters. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued strong Cresemba sales performance by our partner AKP. Japan is a key commercial market with significant growth potential in the long-term and the strong sales uptake in the country shows that Cresemba is meeting critical medical needs of patients with life-threatening fungal infections.” Cresemba is marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between January and December 2024 amounted to USD 562 million, a 19 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 About Cresemba® (isavuconazole) Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. Basilea has entered into several license and distribution agreements for Cresemba covering approximately 115 countries. In Japan, the oral and intravenous formulations are approved for the treatment of adult patients with aspergillosis (invasive aspergillosis, chronic progressive pulmonary aspergillosis, and simple pulmonary aspergilloma), mucormycosis, and cryptococcosis.2 Isavuconazole is also approved in the European Union3, the United Kingdom4, the United States5, China and several additional countries including in the Asia Pacific region.6 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.com investor_relations@basilea.com This press release can be downloaded from www.basilea.com. References IQVIA Analytics Link, December 2024. In-market sales reported as moving annual total (MAT) in US dollar.PMDA List of Approved Drugs April 2022 to March 2023: https://www.pmda.go.jp/files/000267877.pdf [Accessed: April 23, 2025]European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 23, 2025]Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 23, 2025]Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 23, 2025]The registration status and approved indications may vary from country to country. Attachments Press release (PDF)

引进/卖出上市批准

2025-04-21

·GlobeNewswire-Health Care

Basilea reports presentation of new data for fosmanogepix, isavuconazole (Cresemba®) and ceftobiprole (Zevtera®) at ESCMID Global 2025

April 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 scientific presentations on Basilea’s clinical-stage novel antifungal fosmanogepix given at ESCMID Global 2025, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 11 to 15, 2025 in Vienna, Austria. Further presentations covered the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®). Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Invasive fungal infections are an increasing global health problem and novel antifungals are urgently needed. To date more than 250 patients suffering from difficult-to-treat invasive fungal infections have received fosmanogepix via expanded access. The data presented at ESCMID highlight the potential of fosmanogepix as a life-saving treatment option in severe fungal infections, based on the results from a large cohort of patients with invasive fusariosis, as well as from patients with mucormycosis, who received fosmanogepix via expanded access. We look forward to the start of our second phase 3 study with fosmanogepix covering a broad range of mold infections, including aspergillosis, fusariosis and mucormycosis.” More than 250 patients from 11 countries with serious or life-threatening invasive fungal infections, who progressed on antifungal standard-of-care treatment, experienced treatment-limiting toxicities, or had infections with resistant fungal pathogens, received fosmanogepix via expanded access to date (NCT06433128). As presented at ESCMID, treatment with fosmanogepix resulted in favorable response rates of 70% or higher in patients with invasive fusariosis or mucormycosis and it was tolerated for long treatment durations. Further presentations reported on the activity of fosmanogepix against diverse yeast and mold species collected as part of a worldwide surveillance program. — Presentation IPT13: Fosmanogepix – a novel clinical phase 3 stage antifungal agent – M. Engelhardt — Presentation O0419: Fosmanogepix expanded access in patients withFusariuminfections – S. Dadwal, A. Baluch, J. Dickter, J. R. Newman, M. H. Nguyen, R. Weihe, H. Schlamm, L. Ostrosky-Zeichner — Poster P4164: Fosmanogepix expanded access case series in patients with mucormycosis – A. Puing, A. Kaur, Y. J. Lee, P.Chang, A. Koff, D. Tyungu, M. Oldham, M. Shaughnessy, A. Tande, H. Schlamm, J. Maertens — Poster E0237:Activity of manogepix against a worldwide collection of mould isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2891:Activity of manogepix against a worldwide collection of yeast isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2944: Deciphering Connections between Isavuconazole (ISAV) Drug Exposures and Responses Among Different Infections: Mucorales – L. Kovanda, A. Desai — Poster P2945: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Dimorphic Fungi/Mould/Other Filamentous Fungi and Mixed Infections – A. Desai, L. Kovanda — Poster P2946: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Invasive Candidiasis – L. Kovanda, A. Desai — Poster E0050: Enhancing Isavuconazole Pharmacokinetics: A Comprehensive Population (PPK) Model from Three Phase 3 Trials and Covariate Exploration – A. Desai, L. Kovanda — Poster E0055: High-dose isavuconazole therapy is well-tolerated and significantly improves survival in a fruit fly model of invasive mucormycosis – S. Wurster, N. D. Albert, N. P. Wiederhold, R. E. Lewis, D. P. Kontoyiannis Ceftobiprole (Zevtera) data presented at ESCMID Global 2025 — Poster E0792: Ceftobiprole alone versus in combination with ampicillin against borderline penicillin-resistant, vancomycin-resistant Enterococcus faecalis – O. Funk, I. Khan, J. Li, J. Cusumano 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 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of 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. Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. In the 27 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged from 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.3 Isavuconazole is also approved in the United States (US)4 and several additional countries in Europe and beyond, including the United Kingdom5, the Middle East and North Africa region, the Asia Pacific region, China and Japan.6 It has orphan drug designation in the US, Europe and Australia for its approved indications. Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.7 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).7 In the United States, ZEVTERA® is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).8 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). 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), 239 Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC): ClinicalTrials.gov identifier: NCT05421858 European Public Assessment Report (EPAR) Cresemba: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 15, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 15, 2025] Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 15, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: April 15, 2025] The content above comes from the network. if any infringement, please contact us to modify.

孤儿药临床结果上市批准快速通道

2025-03-23

·信狐药迅

恒瑞1类创新药JAK1抑制剂艾玛昔替尼片获批上市| 新获批(3.17-3.23）

每周药品注册获批数据，分门别类呈现，一目了然。(3.17-3.23）新药上市申请药品名称企业注册分类受理号SHR0302片江苏恒瑞医药股份有限公司1CXHS2300071特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2400070特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2400069 新药临床申请药品名称企业注册分类受理号BG-68501片百济神州(苏州)生物科技有限公司1CXHL2500064BG-68501片百济神州(苏州)生物科技有限公司1CXHL2500063BG-68501片百济神州(苏州)生物科技有限公司1CXHL2500062BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2500069BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2500068BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2500066KHN702片成都康弘药业集团股份有限公司1CXHL2500057KHN702片成都康弘药业集团股份有限公司1CXHL2500056KHN702片成都康弘药业集团股份有限公司1CXHL2500055HRS-9813胶囊广东恒瑞医药有限公司1CXHL2500052HRS-5817注射液上海拓界生物医药科技有限公司1CXHL2500040HS-10516胶囊江苏豪森药业集团有限公司1CXHL2500031HS-10516胶囊江苏豪森药业集团有限公司1CXHL2500030ABSK061胶囊装微片上海和誉生物医药科技有限公司1CXHL2500039ABSK061胶囊装微片上海和誉生物医药科技有限公司1CXHL2500038ABSK061胶囊装微片上海和誉生物医药科技有限公司1CXHL2500037ABSK061胶囊装微片上海和誉生物医药科技有限公司1CXHL2500036SYH2067胶囊石药集团百克(山东)生物制药股份有限公司1CXHL2500027SYH2067胶囊石药集团百克(山东)生物制药股份有限公司1CXHL2500026SYH2067胶囊石药集团百克(山东)生物制药股份有限公司1CXHL2500025HRS-1738注射液天津恒瑞医药有限公司1CXHL2500012QLS1209片齐鲁制药有限公司1CXHL2500011QLS1209片齐鲁制药有限公司1CXHL2500010ETS-006片无锡奕拓医药科技有限责任公司1CXHL2500015ETS-006片无锡奕拓医药科技有限责任公司1CXHL2500014SIR2501片维泰瑞隆(北京)生物科技有限公司1CXHL2500009SIR2501片维泰瑞隆(北京)生物科技有限公司1CXHL2500008SRSD216注射液靖因药业(上海)有限公司1CXHL2401496IPG8294片南京艾美斐生物医药科技有限公司1CXHL2401484IPG8294片南京艾美斐生物医药科技有限公司1CXHL2401483IPG8294片南京艾美斐生物医药科技有限公司1CXHL2401482IPG8294片南京艾美斐生物医药科技有限公司1CXHL2401481IPG8294片南京艾美斐生物医药科技有限公司1CXHL2401480IPG8294片南京艾美斐生物医药科技有限公司1CXHL2401479QY201片启元生物(杭州)有限公司1CXHL2401459QY201片启元生物(杭州)有限公司1CXHL2401458QY201片启元生物(杭州)有限公司1CXHL2401457GW906注射液成都国为生物医药有限公司1CXHL2401452QLM2011齐鲁制药(海南)有限公司2.2CXHL2500041BN170614山东百诺医药股份有限公司2.2CXHL2500003KLA514-2片四川科伦药业股份有限公司2.2CXHL2401466BCM235双释干混悬剂上海云晟研新生物科技有限公司2.2CXHL2401409BCM235双释干混悬剂上海云晟研新生物科技有限公司2.2CXHL2401408BCM882胶囊上海云晟研新生物科技有限公司2.3CXHL2500006BCM882胶囊上海云晟研新生物科技有限公司2.3CXHL2500005TQB2210注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2500136注射用TQB2934正大天晴药业集团南京顺欣制药有限公司1CXSL2500044JSKN016注射液江苏康宁杰瑞生物制药有限公司1CXSL2500033JSKN016注射液江苏康宁杰瑞生物制药有限公司1CXSL2500027注射用SHR-9803江苏恒瑞医药股份有限公司1CXSL2500026注射用JS212上海君实生物医药科技股份有限公司1CXSL2500023注射用ZL-1310再鼎医药(上海)有限公司1CXSL2500025SYS6040石药集团巨石生物制药有限公司1CXSL2500016DS010注射液达石药业(广东)有限公司1CXSL2500018MNO-863肠溶胶囊慕恩(广州)生物科技有限公司1CXSL2500011MNO-863肠溶胶囊慕恩(广州)生物科技有限公司1CXSL2500010MNO-863肠溶胶囊慕恩(广州)生物科技有限公司1CXSL2500009HLX79 注射液上海复宏汉霖生物技术股份有限公司1CXSL2500008注射用SSS59沈阳三生制药有限责任公司1CXSL2500006DNTH103注射液元羿生物科技(上海)有限公司1CXSL2400933注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2400915HS-20117注射液上海翰森生物医药科技有限公司1CXSL2400917人脐带间充质干细胞注射液广州达博生物制品有限公司1CXSL2400912依苏帕格鲁肽α注射液上海银诺生物医药工程有限公司1CXSL2400908依苏帕格鲁肽α注射液上海银诺生物医药工程有限公司1CXSL2400907依苏帕格鲁肽α注射液上海银诺生物医药工程有限公司1CXSL2400906依苏帕格鲁肽α注射液上海银诺生物医药工程有限公司1CXSL2400905IMC001注射液成都易慕峰生物科技有限公司1CXSL2400901NWRD09注射液诺未生物技术(无锡)有限公司1CXSL2400899NCR102注射液中盛溯源(广州)生物科技有限公司1CXSL2400897注射用YB-01元本(珠海横琴)生物科技有限公司1CXSL2400895SENL103自体T细胞注射液河北森朗生物科技有限公司1CXSL2400892注射用重组A型肉毒毒素北京博特维克生物技术有限公司2.4CXSL2500043 仿制药申请药品名称企业注册分类受理号硝普钠注射液中润药业有限公司3CYHS2500433硫酸特布他林口服溶液宝利化(南京)制药有限公司3CYHS2500186西格列汀二甲双胍缓释片南京易亨制药有限公司3CYHS2404322顺铂注射液华夏生生药业(北京)有限公司3CYHS2401913乙酰半胱氨酸注射液湖南华纳大药厂股份有限公司3CYHS2401507复方聚乙二醇电解质散(II)陕西丽彩药业有限公司3CYHS2401307腺苷钴胺胶囊杭州康恩贝制药有限公司3CYHS2400042氟[18F]脱氧葡糖注射液广东高尚医药科技有限公司3CYHS2303442盐酸布比卡因注射液南京海融制药有限公司3CYHS2303207盐酸布比卡因注射液南京海融制药有限公司3CYHS2303206吡格列酮二甲双胍片寿光富康制药有限公司3CYHS2302323米诺地尔搽剂杭州民生健康药业股份有限公司3CYHS2301940米诺地尔搽剂杭州民生健康药业股份有限公司3CYHS2301939盐酸多巴酚丁胺注射液仁合益康集团有限公司3CYHS2301904复方聚乙二醇(3350)电解质口服溶液重庆迈川医药科技有限公司3CYHS2301787铝碳酸镁混悬液太康海恩药业有限公司3CYHS2301710西格列汀二甲双胍缓释片宁波美舒医药科技有限公司3CYHS2301432黄体酮注射液丽珠集团利民制药厂3CYHS2301111羧甲司坦口服溶液浙江易泽达医药科技有限公司3CYHS2300804地塞米松磷酸钠注射液湖南醇健医药有限公司3CYHS2300779骨化三醇注射液河南泰丰生物科技有限公司4CYHS2500496利伐沙班片拜耳医药保健有限公司4CYHS2402846利伐沙班片拜耳医药保健有限公司4CYHS2402845利伐沙班片拜耳医药保健有限公司4CYHS2402844利伐沙班片拜耳医药保健有限公司4CYHS2402843美沙拉秦肠溶片江西山香药业有限公司4CYHS2401219聚乙烯醇滴眼液吉林敖东药业集团延吉股份有限公司4CYHS2400434多索茶碱注射液湖北午时医药研究院有限公司4CYHS2400172妥布霉素滴眼液浙江视方极医药科技有限公司4CYHS2400049美阿沙坦钾片山东朗诺制药有限公司4CYHS2303658美阿沙坦钾片山东朗诺制药有限公司4CYHS2303656卡泊三醇倍他米松软膏重庆华邦制药有限公司4CYHS2303655卡泊三醇倍他米松软膏重庆华邦制药有限公司4CYHS2303654莫匹罗星软膏重庆苯立方医药科技有限公司4CYHS2303525盐酸尼卡地平注射液成都旭阳永健医药科技有限公司4CYHS2303436伏立康唑干混悬剂石家庄四药有限公司4CYHS2303395吡仑帕奈口服混悬液江西科睿药业有限公司4CYHS2303309艾拉莫德片扬子江药业集团有限公司4CYHS2303123间苯三酚注射液亚宝药业四川制药有限公司4CYHS2303073培哚普利氨氯地平片(III)江苏万珺医药科技有限公司4CYHS2303047乳果糖口服溶液云鹏医药集团有限公司4CYHS2303044复方电解质注射液辽宁民康制药有限公司4CYHS2302982多巴丝肼片武汉人福药业有限责任公司4CYHS2302919洛索洛芬钠凝胶贴膏武汉法玛星制药有限公司4CYHS2302894拉坦噻吗滴眼液兆科(广州)眼科药物有限公司4CYHS2302869聚乙烯醇滴眼液珠海联邦制药股份有限公司中山分公司4CYHS2302860利丙双卡因乳膏南京长澳制药有限公司4CYHS2302778玻璃酸钠滴眼液宁夏康亚药业股份有限公司4CYHS2302642玻璃酸钠滴眼液宁夏康亚药业股份有限公司4CYHS2302641硝酸甘油舌下片南京斯泰尔医药科技有限公司4CYHS2302396他达拉非片金鸿药业股份有限公司4CYHS2302336注射用硫酸艾沙康唑齐鲁制药(海南)有限公司4CYHS2302040盐酸二甲双胍片重庆吉斯瑞制药有限责任公司4CYHS2302053聚乙二醇4000散福州基石医药科技有限公司4CYHS2301943钆特酸葡胺注射液华润双鹤药业股份有限公司4CYHS2301695硝酸甘油舌下片山东威智百科药业有限公司4CYHS2301551硝酸甘油舌下片山东威智百科药业有限公司4CYHS2301550依维莫司片浙江康润制药有限公司4CYHS2301019依维莫司片浙江康润制药有限公司4CYHS2301018四价流感病毒裂解疫苗安徽智飞龙科马生物制药有限公司3.3CXSS2300059利拉鲁肽注射液珠海联邦制药股份有限公司3.3CXSS2300067利多卡因软膏北京中泰邦医药科技有限公司3CYHL2500013利多卡因软膏北京中泰邦医药科技有限公司3CYHL2500012丙酸倍氯米松吸入气雾剂合肥力成药业有限公司3CYHL2500009注射用盐酸兰地洛尔天津红日药业股份有限公司3CYHL2400285雷美替胺片四川科瑞德制药股份有限公司3CYHL2400276注射用盐酸兰地洛尔中山万汉制药有限公司3CYHL2400272甲苯磺酸卢美哌隆胶囊宜昌人福药业有限责任公司3CYHL2400269羟乙基淀粉130/0.4电解质注射液山东齐都药业有限公司4CYHL2400284羟乙基淀粉130/0.4电解质注射液山东齐都药业有限公司4CYHL2400283 进口申请药品名称企业注册分类受理号阿可替尼胶囊AstraZeneca Pty Ltd.5.1JXHS2400047氢溴酸他泽司他片Epizyme, Inc.5.1JXHS2400046注射用戈沙妥珠单抗Gilead Sciences, Inc.3.1JXSS2400008达格列净片Hetero Labs Limited5.2JYHS2400017达格列净片Hetero Labs Limited5.2JYHS2400016AZD2936AstraZeneca AB1JXSL2500007AZD2936AstraZeneca AB1JXSL2500006TremelimumabMedImmune LLC2.2JXSL2500005TremelimumabMedImmune LLC2.2JXSL2500004 中药相关申请药品名称企业注册分类受理号ZYY-742凝胶扬子江药业集团江苏龙凤堂中药有限公司1.1CXZL2500001养巢颗粒漳州片仔癀药业股份有限公司1.1CXZL2400098连参更年颗粒江苏康缘药业股份有限公司1.1CXZL2400095散热止咳颗粒新奇康药业股份有限公司1.1CXZL2400091玉屏风袋泡茶广州白云山陈李济药厂有限公司2.3CXZL2400100三七通舒胶囊成都神鹤药业有限责任公司4CYZS2400002 注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请

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,

后查看更多信息

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.初创企业	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	Basilea Pharmaceutica AG	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	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	構獵齋獵蓋繭淵鬱窪窪(齋願範獵襯獵鹹廠鬱獵) = 鹹衊鑰遞簾鏇遞繭蓋糧憲艱簾築選壓遞廠齋壓 (積鹽艱鏇獵糧醖壓鑰遞 ) 更多	积极	2024-12-07
				Voriconazole	構獵齋獵蓋繭淵鬱窪窪(齋願範獵襯獵鹹廠鬱獵) = 願壓窪衊構製鹹襯選觸憲艱簾築選壓遞廠齋壓 (積鹽艱鏇獵糧醖壓鑰遞 ) 更多
NCT04550936 (Pubmed \| Infect Dis Ther)	N/A	-	218	Isavuconazole monotherapy	製壓憲範淵鏇繭簾遞願(蓋遞艱選簾願網鏇窪鏇) = 45 patients (21%) experienced at least one adverse event (AE) 觸築醖壓製憲遞襯製淵 (憲構積顧簾窪衊簾積廠 ) 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	願鹽鹽糧鑰遞鹽觸衊鹹 = 選積憲構鏇顧鏇顧膚願醖鹹繭範醖糧膚糧積鏇 (壓膚膚繭膚選蓋廠遞衊, 糧築鹽衊憲醖願齋壓夢 ~ 壓鹽選艱艱鹹積遞糧願) 更多	-	2023-09-21
EBMT2023	N/A	造血干细胞移植	50	Isavuconazole	糧遞壓衊餘鹽壓襯襯簾(選壓範膚餘鹹齋願壓願) = No adverse events related to ISA were reported 鹹顧遞選鬱願願淵膚鹹 (餘廠衊築鏇範鏇壓窪醖 )	-	2023-04-23
ASN2022	N/A	低钠血症	-	Isavuconazonium sulfate	齋鏇獵遞觸鑰鑰觸膚獵(餘製衊觸壓膚鑰獵願選) = 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. 鑰獵憲齋齋遞艱齋窪襯 (鑰網構餘艱餘觸願願願 )	-	2022-11-05
				Voriconazole
NCT03471988 (Pubmed)	临床3期	真菌病	103	Isavuconazole	壓觸觸齋醖範鹽淵襯壓(糧鹹衊醖齋鑰糧淵簾夢) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 構願壓憲蓋製鹹製鑰鏇 (範夢夢壓願憲積憲願壓 ) 更多	积极	2022-10-25
				Voriconazole
EBMT2022	N/A	造血干细胞移植	166	Isavuconazole for treatment of IFI	範繭鏇網衊觸鬱範積糧(鑰積艱獵獵積糧蓋膚艱) = 築壓鹹築膚壓糧齋築獵製簾壓醖製糧鏇窪製衊 (選獵膚繭網鹽繭憲選齋 ) 更多	-	2022-03-19
				Isavuconazole for off-label prophylaxis	範繭鏇網衊觸鬱範積糧(鑰積艱獵獵積糧蓋膚艱) = 餘構糧衊製夢鏇蓋夢膚製簾壓醖製糧鏇窪製衊 (選獵膚繭網鹽繭憲選齋 ) 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	襯鏇鬱鹽鬱蓋鏇築顧積 = 餘範憲網艱憲鹹築願鏇築網觸窪醖衊鹽齋鹽餘 (鬱觸醖築鹹醖網膚艱齋, 構膚餘廠壓獵齋網窪淵 ~ 膚鏇鏇簾醖獵糧顧範範) 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	製壓獵餘繭襯艱鹽積製(膚鏇顧遞獵艱選鏇構鏇) = 構繭選襯夢淵鏇淵獵醖衊夢鏇醖選鬱範窪繭窪 (觸遞鏇遞鹽膚襯鏇醖範 )	积极	2021-05-18
				venetoclax+Isavuconazole	製壓獵餘繭襯艱鹽積製(膚鏇顧遞獵艱選鏇構鏇) = 糧鑰淵鹹蓋積願壓醖鹽衊夢鏇醖選鬱範窪繭窪 (觸遞鏇遞鹽膚襯鏇醖範 )