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更新于：2025-02-18

Amphotericin B

两性霉素B

更新于：2025-02-18

概要

基本信息

药物类型

小分子化药

别名

SinuNase、CM001、DKF-5122

+ [16]

靶点

Ergosterol

作用机制

Ergosterol 调节剂(麦角固醇调节剂)

治疗领域

感染神经系统疾病心血管疾病+ [4]

在研适应症

利什曼病粒细胞减少性发热念珠菌病+ [8]

非在研适应症

急性髓性白血病慢性皮肤黏膜念珠菌病侵袭性念珠菌病+ [7]

原研机构

Vestar Development Co.

在研机构

Sumitomo Pharma Co., Ltd.

Matinas Biopharma Nanotechnologies, Inc.

Matinas BioPharma Holdings, Inc.

+ [5]

非在研机构

Enzon Pharmaceuticals, Inc.

石药集团中奇制药技术（天津）有限公司

DongKook Pharmaceutical Co., Ltd.

最高研发阶段批准上市

首次获批日期

(1958-01-01),

真菌病

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、合格传染病产品 (美国)、孤儿药 (欧盟)

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结构/序列

分子式C47H73NO17

InChIKeyAPKFDSVGJQXUKY-INPOYWNPSA-N

CAS号1397-89-3

关联

115

项与两性霉素B 相关的临床试验

NCT06525389

/ Not yet recruiting临床3期IIT

Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)

LAmB-FAST is a factorial randomized controlled trial simultaneously testing two interventions in one trial. LAmB-FAST seeks to inform treatment guidelines on the induction and maintenance therapy of HIV-associated talaromycosis (formerly called penicilliosis) and will answer the following three questions:
1. Is induction therapy using a single 10 mg/kg dose of liposomal amphotericin B (LAmB) is more effective than 14 days of the conventional deoxycholate amphotericin B (DAmB)?
2. Is adding flucytosine (5FC) to amphotericin B more effective than amphotericin B alone?
3. Is HIV viral load guided stopping of itraconazole maintenance therapy as effective as the current CD4 guided strategy in the prevention of talaromycosis relapse?

开始日期2025-01-06

申办/合作机构

Duke University

[+6]

ChiCTR2400094386

/ Suspended临床4期IIT

Clinical study of amphotericin B nebulized inhalation in the prevention of invasive fungal infections of the lungs in artificial liver therapy

开始日期2025-01-01

申办/合作机构-

NCT06447402

/ Recruiting临床3期IIT

A Randomized Controlled Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Increasing Time to Relapse in Patients With Chronic Pulmonary Aspergillosis Treated With 12 Months of Oral Itraconazole

The treatment of CPA is with oral itraconazole for 6-12 months. Oral itraconazole results in better clinical outcomes in CPA compared to supportive care. A recent study comparing 6 months with 12 months of oral itraconazole for longer duration treatment found longer duration reduced CPA relapse and improved clinical outcomes. However, longer duration of itraconazole could cause emergence of drug resistant Aspergillus fumigatus and therapy related adverse event. A recent study found nebulized amphotericin B non-inferior to oral itraconazole for treating CPA as primary therapy. However, the study was small and included patients with simple aspergilloma and used nebulized amphotericin B for 7 days.To be effective, an inhaled drug should be delivered in sufficient quantity to achieve therapeutic levels.The minimum inhibitory concentration of amphotericin B for A.fumigatus is 0.5 mg/L. In one study, nebulization of 30 mg of amphotericin B deoxycholate achieved a mean concentration of 0.68 mg/L in the bronchoalveolar lavage fluid. Notably, the serum levels of amphotericin B after nebulization are 20 times less than after systemic administration and is safer. Further, there is a dose-response relation with nebulized amphotericin B, the higher the dose used for nebulization, the higher are the levels achieved in the lung tissue. Nebulized amphotericin B has been used in lung transplant recipients to prevent invasive aspergillosis. Also, two recent studies have demonstrated that use of nebulized amphotericin B as maintenance therapy led to a reduction in ABPA relapse rates and prolonged time to exacerbation. We believe that inhaled amphotericin B as a maintenance therapy could reduce CPA relapse and prolong time to relapse. In this study, we plan to evaluate nebulized amphotericin B as a maintenance therapy in clinically stable CPA patients treated with 12 months of oral antifungal therapy

开始日期2024-06-03

申办/合作机构

Post Graduate Institute of Medical Education & Research

100 项与两性霉素B 相关的临床结果

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100 项与两性霉素B 相关的转化医学

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100 项与两性霉素B 相关的专利（医药）

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28,424

项与两性霉素B 相关的文献（医药）

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Characteristics of Endemic Mycoses Talaromyces marneffei Infection Associated with Inborn Errors of Immunity

Review

作者: Xing, Shubin ; Zhao, Xiaodong ; Tang, Xuemei ; Zhang, Zhenzhen ; An, Yunfei ; Liu, Cong ; He, Wuyang ; Chen, Yongwen ; Zhang, Wenjing ; Zhang, Zhiyong

BACKGROUND:

Talaromyces marneffei (T. marneffei) is an opportunistic pathogen that causes endemic mycoses, which could lead to multiple organ damage. Talaromycosis is frequently disregarded as an early cautionary sign of immune system disorders in non-HIV-infected children.

OBJECTIVE:

We conduct a comprehensive review of the genotypes and clinical features of talaromycosis in patients with IEI to enhance clinical awareness regarding T. marneffei as a potential opportunistic pathogen in individuals with immune deficiencies.

METHODS:

A systematic literature review was performed by searching PubMed, Cochrane Central Register of Controlled Trials, Web of Science, EMBASE, and Scopus. Data on IEI patients with talaromycosis, including genotypes and their immunological and clinical features, were collected.

RESULTS:

Fifty patients with talaromycosis and IEI were included: XHIM (30.0%), STAT3-LOF deficiency (20.0%), STAT1-GOF (20.0%), IL2RG (6.00%), IFNGR1 (6.0%), IL12RB1 (4.0%), CARD9 (4.0%), COPA (4.0%), ADA (2.0%), RELB deficiency (2.0%), and NFKB2 (2.0%). Common symptoms of respiratory (43/50, 86.0%), skin (17/50, 34.0%), lymph node (31/50, 62.0%), digestive (34/50, 68.0%), and hematologic (22/50, 44.0%) systems were involved. The CT findings of the lungs may include lymph node calcification (9/30), interstitial lesions (8/30), pulmonary cavities (8/30), or specific pathogens (4/30), which could be easily misdiagnosed as tuberculosis infection. Amphotericin B (26/43), Voriconazole (24/43) and Itraconazole (22/43) were used for induction therapy. Ten patients were treated with Itraconazole sequentially and prophylaxis. 68.0% (34/50) of patients were still alive, and 4.0% (2/50) of were lost to follow-up. The disseminated T. marneffei infection resulted in the deaths of 14 individuals.

CONCLUSIONS:

The XHIM, STAT1-GOF, and STAT3-LOF demonstrated the highest susceptibility to talaromycosis, indicating the potential involvement of cellular immunity, IL-17 signaling, and the IL-12/IFN-γ axis in T. marneffei defense. T. marneffei infection may serve as an early warning indicator of IEI. For IEI patients suspected of T. marneffei, metagenomic next-generation sequencing (mNGS) could rapidly and effectively identify the causative pathogen. Prompt initiation of antifungal therapy is crucial for optimizing patient outcomes.

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Disseminated Aspergillosis in X-linked Agammaglobulinemia: Beyond the norm

Article

作者: Rawat, Amit ; Vignesh, Pandiarajan ; Jindal, Ankur Kumar ; Thangaraj, Abarna ; Goel, Sumit ; Sil, Archan

X-linked agammaglobulinemia (XLA) due to a mutation in Bruton's tyrosine kinase (BTK), leads to the arrested development of B cells at the pro-B cell stage. This results in absent B cells and severe hypogammaglobulinemia. XLA patients usually present with recurrent sinopulmonary infection. Bacterial infections are the commonest [2], fungal infections like Pneumocystis jirovecii, Aspergillus and Candida species are rarely reported and they are associated with mortality in XLA [3]. We report a 3.5-year-old boy with disseminated aspergillosis, an uncommon presentation of XLA. Despite treatment with antifungals, including voriconazole and amphotericin B, the patient succumbed to the illness. Genetic analysis revealed a pathogenic variant in the BTK gene (R28H), confirming XLA diagnosis. This case highlights the potential for severe fungal infections in XLA patients and suggests broader immune system dysregulation beyond B-cell defects.

2025-06-01·Journal of Stomatology Oral and Maxillofacial Surgery

Delayed maxillary reconstruction following mucormycosis: A comprehensive analysis of surgical strategies and outcomes

Article

作者: Garg, Paheli ; Goil, Pradeep ; Charan Pahari, Dr Kaushal ; Charan Pahari, Kaushal ; Goil, Dr Pradeep ; Vashistha, Aakansha ; Vashistha, Dr Aakansha ; Garg, Dr Paheli

STUDY DESIGN:

This study is a prospective observational study conducted over two years from December 2020 to March 2023 at the Department of Plastic and Reconstructive Surgery.

OBJECTIVE:

To evaluate the outcomes of delayed reconstruction in patients with maxillectomy defects post-COVID-19 associated mucormycosis, focusing on safety, morbidity, and aesthetic results.

METHODS:

Fifty patients with post-COVID-19 mucormycosis and maxillectomy defects without skin involvement were included. These patients underwent radical debridement and were treated with Amphotericin B followed by Posaconazole therapy until clinical and radiological resolution of the disease. Reconstruction was performed after a minimum of six months post-maxillectomy. Flaps used for reconstruction included the radial forearm free flap (RAFF), anterolateral thigh flap (ALT), and free fibula osteomyocutaneous flap, planned using a 3D-printed model. Follow-up was conducted weekly for the first month and monthly for the next two months, with semiannual visits thereafter.

RESULTS:

Of the 50 patients, 42 % were male, and 58 % were female, with a mean age of 43 ± 8.75 years. Most patients (88 %) were diabetic. Maxillectomy defects were categorized as type IIA, IIB, IIIA, IIIB, and IV based on the Cordeiro classification. Four flaps (8 %) required re-exploration, with three salvaged. Complications included marginal flap necrosis (4 %) and oro-nasal fistula (2 %). The average hospital stay was six days, extended to ten days for re-explored cases. Flap dimensions varied with the largest being 62 cm² for the free fibula flap.

CONCLUSIONS:

Delayed reconstruction using free flaps in patients with post-COVID-19 mucormycosis maxillectomy defects without skin involvement is a safe approach with minimal morbidity. This method allows confirmation of disease resolution before major reconstructive surgery, resulting in excellent aesthetic and functional outcomes.

252

项与两性霉素B 相关的新闻（医药）

2025-02-09

·丁香园

患者认知障碍快速加重，多种治疗无效，只能转院了？

5 丁香园神经科讨论群（498） @所有人早查房：55 岁女性，快速进展性认知障碍，伴健忘、失语 2 月，双下肢无力数天。类风湿性关节炎病史。 CSF：单核细胞增多，蛋白增多。 MRI 如图，图 a：T2 FLAIR 序列；图 b：钆造影剂增强。接受氨曲南、磺胺甲𫫇唑、万古霉素和阿昔洛韦经验性治疗，效果一般。3 天后恶化，出现妄想和幻觉。新增两性霉素 B 治疗，48 小时后仍无反应，开始使用皮质类固醇进行免疫调节治疗，无反应后又使用了人非特异性免疫球蛋白，仍然无效。考虑什么诊断？怎么治疗？ MRI上看考虑炎症、肿瘤、脱髓鞘？看很多治疗无效，那我考虑肿瘤快速进展痴呆为主，逐渐出现精神症状，需要考虑感染性，肿瘤，代谢性，自身免疫性或朊病毒。既往类风关疾病，机会性感染的情况也有可能存在，但抗病毒，广谱抗生素，抗真菌效果不佳。激素及球蛋白效果不佳，脑脊液异常，需要进一步完善自身免疫性抗体。如果考虑感染，就要看是不是特殊感染，追问病史，看 NGS 结果 9:30 中年女性，快速进展性认知障碍，从核磁和临床表现考虑皮层和皮层下病变，强化提示血脑屏障破坏。影像学不太支持感染病变。原来有免疫异常基础，对于激素丙球效果不好。需要考虑pml，中枢神经系统血管炎，神经结节病，cadasil，血管内淋巴瘤。患者免疫系统疾病下快速脑功能障碍，头颅MR异常病灶，强化不明显，脑脊液单核细胞增多，常规抗生素及免疫治疗无效。考虑非常规细菌感染，建议穿刺活检，细菌学检查，针对性抗炎考虑自免脑可能性大，CSF炎症表现、对经验性抗感染治疗无效，免疫调节治疗可能因延迟或强度不足导致反应不佳。进一步检测CSF自身免疫/副肿瘤抗体分析该病例要抓住核心表现，再从具有特征的表现去把握大方向。该病例核心表现有两个： ①抗生素、抗病毒、抗真菌治疗无效；激素/丙球治疗无效； ②核磁显著的局灶脑膜强化，白质和皮层的病变明显是脑膜炎导致的。如果抓住的是“快速进展性认知障碍”，就会认为是“朊蛋白病”、“自免脑”。但是这些病会以脑膜炎为突出表现吗以脑膜炎为突出表现的，最主要还是感染，脑膜癌也需要考虑。系统性的免疫疾病，包括SLE、类风关等等都可以引起脑膜炎，不过像本利这么显著的，应该不多，而且免疫治疗没有反应，更是罕见。重点应该还是考虑感染。像本例这种局灶脑膜强化为主的，尤其要考虑会有肉芽肿性炎症为特点的感染类型，像结核、李斯特菌感染、真菌等。患者中年女性，有类风关病史，进展性起病，CSF：单核细胞增多，蛋白增多；MRI T2 FLAIR见右侧顶叶片状高信号，钆增强见局部增强信号，抗感染治疗无效，结合病史，免疫抑制剂导致的坏死性白质脑病不能排除，鉴别类风湿性血管炎、脑静脉窦血栓形成、结核性脑炎、动静脉畸形等。 @所有人公布答案：患者有类风湿性关节炎病史，结合认知障碍、行为变化和下肢无力的临床表现，首先考虑自身免疫性疾病或感染性疾病导致中枢神经系统症状。 MRI 示广泛皮质下病变，完全侵占双侧额叶，脑膜增厚，这些都提示可能存在脑膜炎。结合 CSF 单核细胞和蛋白增多，说明可能是病毒性脑膜炎、自身免疫性疾病或慢性感染（如结核或真菌感染）等导致的脑膜炎。对患者 CSF 进行细菌、真菌和分枝杆菌培养，结果均阴性。补充隐球菌抗原检查、胸部 CT、结核分枝杆菌复合体 PCR/mPCR 检查等，也均为阴性。无法确定病因，先进行经验性治疗，但本例患者先后接受抗生素、免疫调节治疗等，均表现出疗效差、症状恶化。取患者右侧额叶病灶活检，提示「非结核分枝杆菌」见图 e。最终确诊为：由非结核分枝杆菌引起的慢性脑膜炎。由非结核分枝杆菌引起的中枢神经系统感染非常罕见，一般会发生于免疫力低下或行脑室引流术的患者。 CSF 培养检测灵敏度一般，>6ml CSF 检测或连续检测可以有效提高灵敏度。对于这类在经验性治疗后临床症状仍然持续恶化的病例，脑活检有助于尽早确定病因。针对非结核分枝杆菌，目前尚无明确有效的治疗方法，一般采用多种抗生素联合治疗，包括大环内酯类、喹诺酮类或抗分枝杆菌治疗等。由于抗生素在血脑屏障中的穿透力较差，一般需要进行约 12 个月的长期治疗。后续治疗：本例患者确诊后开始接受莫西沙星 + 克拉霉素 + 利福平治疗，3 月后复查 MRI 显示脑膜强化有所改善，实质病变也已消除。

免疫疗法临床研究信使RNA

2025-02-06

·CPHI制药在线

黑热病治疗新靶点展望

关注并星标CPHI制药在线利什曼病，又被称为黑热病，是人体被利什曼原虫感染所致的播散性原虫病。有20个种类的利什曼原虫可引起利什曼病，大约30种不同的白蛉亚科沙蝇可以通过叮咬传播利什曼原虫，利什曼原虫感染已经成为许多热带和亚热带国家人群重要的卫生健康问题，是仅次于疟疾的最危险的且被忽视的热带病，每年可造成50,000例死亡和330万伤残。利什曼病疫苗接种是一种有吸引力且可行的替代方法，但迄今还没有疫苗或药物能完全根除或提供对利什曼病长期有效的免疫力。它有多种临床表现形式，如内脏利什曼病、皮肤利什曼病、粘膜利什曼病。世界卫生组织估计，该疾病每年影响 103 万人。目前临床治疗黑热病可供选择的药物种类少，治疗方法包括抗睾丸素、两性霉素 B 和米替福新，都受到了副作用、成本、耐药性和减毒等因素的制约。探索新的治疗靶点，如关键的代谢酶和表面活性蛋白，可能会开发出更有效和无毒的药物。治疗新靶点展望 1. 钙离子稳态调节剂钙是寄生虫生存所必需的，因此是治疗黑热病的一个靶点。钙离子在利什曼病菌的入侵和新陈代谢中起着至关重要的作用，钙离子浓度可以影响细胞内的信号通路。钙离子浓度的变化会触发寄生虫分化和细胞改变的信号通路。钙离子在调节寄生虫生命周期中的重要作用凸显了靶向钙转运体的潜在治疗作用。最近的研究表明，姜黄素等制剂能通过破坏钙离子转运体，诱导利什曼原虫的程序性细胞死亡。以前报道的钙通道阻滞剂，如芬地林、米贝地尔和利多法嗪等钙通道阻滞剂与常规化疗药物联合使用，具有很强的抗黑热病作用。 2. 铁离子稳态调节剂铁是参与新陈代谢的重要金属离子，通常以亚铁和铁两种状态存在。持续的氧化还原循环使生物体能够进行生存所需的各种重要生物过程。利什曼缺乏铁储存系统，是血红素辅助营养体，因此，铁清除对其生存和毒性至关重要。在缺铁条件下，会表达一种名为利什曼病菌铁转运体的铁转运体，通过提高铁的转运能力来获得所需的铁。铁是线粒体超氧化物歧化酶的关键成分，对氧化还原反应起关键作用，这种化合物可被视为药物开发的潜在目标。 3. 基因组靶点利什曼原虫的基因组结构与其他真核生物相比是独特的，没有内含子，并且由染色体中高度浓缩的基因密度组成在较小的核空间内。这些基因组负责编码各种蛋白质，这些蛋白质参与细胞的功能。其中一组蛋白质是利什曼原虫激酶，参与信号级联的调控，因此有可能成为有希望的分子靶标。最近研究人员开始研究蛋白激酶，如细胞周期蛋白依赖性激酶、糖原合酶激酶 3、双特异性酪氨酸调节激酶和丝裂原活化蛋白激酶等。 4. 蛋白酶体靶点蛋白酶体是一种复杂的蛋白质结构，负责调节蛋白质合成并分解折叠错误的蛋白质，而在原核生物中，被降解的蛋白质会被泛素标记。已经筛选了几种蛋白酶体抑制剂，其中一种是 GSK3494245/ DDD01305143/化合物，并在 2024 年完成了 I 期人体临床试验（https:// clinicaltrials.gov/study/NCT04504435）。此外，GNF6702 是一种细胞蛋白酶抑制剂化合物，诺华公司于 2020 年对其进行了化学优化，目前正在进行第二阶段人体临床试验。 5. 植物提取物从枸橼酸香蒲叶子中提取的精油，从柠檬香蒲叶中提取的精油在体外具有抗利什曼病的作用。此外，芦荟叶提取物通过诱导程序性细胞死亡发挥潜在抗利什曼病特性。 6. 宿主抗原疗法目前利什曼原虫感染的药物治疗效有限，需要长期用药，而且可能会导致严重的全身副作用，其严重程度超过了治疗效果。因此，要成功治疗由细胞内病原体引起的疾病，可能需要使用综合疗法和高效的给药方法。目前，咪喹莫特和雷喹莫特被用于治疗利什曼病AR-12 是塞来昔布的一种衍生物，可以增强宿主细胞对凋亡的抵抗力，可能破坏寄生虫诱导的 Akt 信号激活。辛伐他汀、洛伐他汀被用作局部或全身的宿主导向药物疗法，可抑制胆固醇的生成，促进巨噬细胞中吞噬体的成熟，从而提高寄生虫的清除率。 7. 纳米药物寄生虫的复杂生命周期和细胞内定位导致生物利用率较低，疗效降低。生物传感器和纳米载体辅助治疗和免疫，可彻底改变利什曼病的诊断、管理和预防。以纳米粒子为基础的递送系统通过改善靶向递送和抗原，纳米颗粒给药系统通过改善靶向给药和抗原呈递，刺激免疫系统，促进强大的 T 细胞反应，并在传染病防治中提供保障。脂质体纳米颗粒是一种水性支架，有助于亲水性和亲油性药物的附着，在体内的持久性更强，可在血液中停留较长时间，脂质体能以较低的剂量和给药频率持续、规范地释放药物。不同的纳米材料，如固体脂质纳米粒子、纳米悬浮剂、聚合物基纳米粒子、聚乙烯醇等不同的纳米材料，可以作为治疗利什曼病的各种药物的载体材料。参考文献 1. Singh VK, Tiwari R, Rajneesh, et al. Advancing Treatment for Leishmaniasis: From Overcoming Challenges to Embracing Therapeutic Innovations. ACS Infect Dis. 2024 Dec 31. 2. Kumar, R.; Chauhan, S. B.; Ng, S. S.; et al. Immune checkpoint targets for host-directed therapy to prevent and treat leishmaniasis. Front Immunol. 2017, 8, 1492. 3. Jamshaid, H.; Din, F. U.; Khan, G. M. Nanotechnology based solutions for anti-leishmanial impediments: a detailed insight. J. Nanobiotechnology. 2021, 19, 1?51. 扫码领取CPHI & PMEC China 2025展会门票【智药研习社近期直播】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

疫苗

2025-02-01

·GlobeNewswire-Health Care

Strong sales growth for Cresemba and Zevtera trigger further milestone payments to Basilea

January 28, 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 in 2024 of the antifungal Cresemba® (isavuconazole) and the antibiotic Zevtera® (ceftobiprole) exceeded thresholds triggering sales milestone payments from distribution partners to Basilea, in the total amount of approximately CHF 2.2 million. For Cresemba, this comprises a milestone payment for sales in Canada, by AVIR Pharma Inc, as well as the first sales milestone payment for the Middle East and North Africa (MENA) region, by Hikma Pharmaceuticals LLC. For Zevtera, this reflects a milestone payment in Europe, by Advanz Pharma. David Veitch, Chief Executive Officer, said: “We are very pleased with the commercial progress of our two commercialized brands in Canada, the MENA region and Europe. Their continued growth confirms that Cresemba and Zevtera are serving significant medical needs around the world.” Basilea’s commercial partnerships cover well over 100 countries worldwide. By year-end 2024, Cresemba was marketed in more than 70 countries while Zevtera was marketed in 20 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba®. In Canada, Cresemba is approved for use in adults and pediatrics from 1 year up to 18 years for the treatment of invasive aspergillosis and invasive mucormycosis.2 In countries of the MENA region, it is indicated in adults for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate. Isavuconazole is also approved in the United States (US),3 the EU4 and several additional countries in Europe and beyond, including Japan and China.5 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.6 In several countries in Europe, the brand is approved 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).6 Zevtera is also approved in the United States7, 8, China and several other countries.5 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. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. Health Canada, Cresemba® (isavuconazole) Product Monograph: https://pdf.hres.ca/dpd_pm/00077745.PDF [Accessed: January 27, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: January 27, 2025] European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: January 27, 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: January 27, 2025] The content above comes from the network. if any infringement, please contact us to modify.

上市批准

100 项与两性霉素B 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00203	两性霉素B	G01AA03 J02AA01 A01AB04	DB00681

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
利什曼病	日本	Sumitomo Pharma Co., Ltd.	2009-06-17
粒细胞减少性发热	日本	Sumitomo Pharma Co., Ltd.	2006-04-20
念珠菌病	日本	Fuji Pharma Co., Ltd.	1997-01-31
侵袭性真菌感染	日本	Clinigen KK	1963-04-18
真菌病	-	Bristol Myers Squibb Co.	1958-01-01
复杂的尿路感染	中国	-	-
细菌性心内膜炎	中国	-	-
脑膜炎	中国	-	-
脓毒症	中国	-	-

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
隐球菌脑膜炎	临床3期	-	Matinas Biopharma Nanotechnologies, Inc.	2023-01-01
肺部疾病	临床3期	美国	Enzon Pharmaceuticals, Inc.	2005-10-01
侵袭性念珠菌病	临床2期	-	石药集团中奇制药技术（天津）有限公司	2020-01-01
侵袭性曲霉菌病	临床2期	-	石药集团中奇制药技术（天津）有限公司	2020-01-01
急性髓性白血病	临床2期	-	Matinas Biopharma Nanotechnologies, Inc.	2019-08-01
前体B细胞急性淋巴细胞白血病	临床2期	-	Matinas Biopharma Nanotechnologies, Inc.	2019-08-01
外阴阴道念珠菌病	临床2期	美国	Matinas Biopharma Nanotechnologies, Inc.	2016-11-01
酵母菌感染	临床2期	美国	Matinas Biopharma Nanotechnologies, Inc.	2016-11-01
慢性皮肤黏膜念珠菌病	临床2期	美国	Matinas Biopharma Nanotechnologies, Inc.	2016-09-27
口腔念珠菌病	临床2期	美国	Bristol Myers Squibb Co.	2001-08-31

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2024	N/A	-	-	Amphotericin B	獵夢鹹願範醖淵廠觸繭(鹹艱製範築選積繭繭廠) = 構構顧壓鹽餘遞鏇鑰艱獵糧鹽積顧築網襯蓋築 (壓構選鑰淵願鹹窪顧鹽 )	-	2024-06-09
EHA2024	N/A	血液肿瘤	21	Liposomal Amphotericin B (L-AMB) (Group A (poor response to other antifungal drugs))	膚網餘鏇選醖鬱繭餘選(醖鏇鹹選糧觸蓋選簾醖) = 膚繭艱構壓觸膚選構構壓廠齋齋壓壓遞繭糧製 (憲鏇簾鹹齋襯襯構顧鑰 )	积极	2024-05-14
EHA2024	N/A	血液肿瘤	21	Liposomal Amphotericin B (L-AMB) (Group B (cannot tolerate adverse reactions))	膚網餘鏇選醖鬱繭餘選(醖鏇鹹選糧觸蓋選簾醖) = 積衊遞艱齋積衊構鹽製壓廠齋齋壓壓遞繭糧製 (憲鏇簾鹹齋襯襯構顧鑰 )	积极	2024-05-14
GlobeNewswire 人工标引	N/A	镰刀菌病	3	MAT2203	鹽窪觸膚衊艱簾鑰壓網(製衊顧糧夢範蓋觸鹽憲) = 窪膚築選襯選鬱憲壓範觸築鏇襯觸遞廠醖繭膚 (艱願襯淵餘積艱膚艱願 )	积极	2024-03-22
GlobeNewswire 人工标引	N/A	侵袭性真菌感染	19	MAT2203	鏇艱鏇壓艱獵淵齋願鬱(遞觸糧夢鬱鏇顧艱糧鏇) = 遞艱構顧鑰鹹膚鑰壓餘鏇憲獵網蓋膚鏇簾齋齋 (繭齋夢鏇糧壓範鏇構淵 ) 更多	积极	2024-02-26
APAO2024	N/A	-	-	Optisol-GS with amphotericin B supplementation	顧艱製餘襯鏇顧衊鏇壓(製壓淵醖淵構壓築淵膚) = 觸壓構繭網鹹鏇襯襯願糧淵襯餘糧選鏇膚憲選 (餘廠廠鏇選選鹽襯鏇襯 ) 更多	-	2024-02-22
APAO2024	N/A	-	-	Optisol-GS without amphotericin B supplementation	顧艱製餘襯鏇顧衊鏇壓(製壓淵醖淵構壓築淵膚) = 窪鏇壓願遞簾鏇廠壓衊糧淵襯餘糧選鏇膚憲選 (餘廠廠鏇選選鹽襯鏇襯 ) 更多	-	2024-02-22
NCT05814432 (not available, Pubmed \| Clin Infect Dis)	临床2期	组织胞浆菌病 \| HIV感染 CD4+	118	Single dose 10 mg/kg of L-AmB	構鹽鏇遞築鏇遞窪鑰鬱(範網鹽窪觸餘構顧構獵) = 築願網選壓網夢醖襯遞繭觸獵鹹廠鑰範網繭鹹 (網壓淵構衊築淵憲夢夢 ) 更多	积极	2023-10-13
NCT05814432 (not available, Pubmed \| Clin Infect Dis)	临床2期	组织胞浆菌病 \| HIV感染 CD4+	118	10 mg/kg of L-AmB on D1, and 5 mg/kg of L-AmB on D3	構鹽鏇遞築鏇遞窪鑰鬱(範網鹽窪觸餘構顧構獵) = 蓋糧憲襯網鹽窪顧膚鑰繭觸獵鹹廠鑰範網繭鹹 (網壓淵構衊築淵憲夢夢 ) 更多	积极	2023-10-13
WCD2023	N/A	皮肤利什曼病	28	Liposomal amphotericin B 12 mg/kg	鏇積製醖繭積壓憲壓壓(鹹膚夢膚範壓糧鹹齋蓋) = 鹽範鬱顧範夢廠憲鏇糧觸積醖構願窪壓遞積糧 (淵鏇艱構醖夢繭淵糧願 ) 更多	积极	2023-07-06
WCD2023	N/A	皮肤利什曼病	28	Liposomal amphotericin B 18 mg/kg	鏇積製醖繭積壓憲壓壓(鹹膚夢膚範壓糧鹹齋蓋) = 積遞製糧願糧顧鏇淵淵觸積醖構願窪壓遞積糧 (淵鏇艱構醖夢繭淵糧願 ) 更多	积极	2023-07-06
ISN WCN2023	N/A	毛霉菌病	-	Liposomal amphotericin (LAmB)	淵鑰積蓋夢餘糧築遞簾(鹽積顧繭膚壓簾願網觸) = 鏇餘憲範網築艱壓夢網簾廠憲艱餘選襯淵鏇鏇 (願顧襯淵獵鹹衊齋餘壓 ) 更多	-	2023-03-01
APAO2023	N/A	新型冠状病毒感染 \| 毛霉菌病	-	Transcutaneous Retrobulbar Amphotericin B	鹽願簾糧積觸齋繭繭餘(簾廠積醖醖遞願積簾鬱) = 鹹鑰築鹽鏇餘蓋艱壓鹹網壓鬱積壓夢鏇觸遞簾 (構範蓋鑰觸繭憲獵顧網 )	积极	2023-02-23
ASN2022	临床2期	艾滋病相关机会致病菌感染 cystatin C \| fractional excretion of sodium \| fractional excretions of potassium	90	Liposomal Amphotericin B 3 mg/kg for 14 days	鹹獵構淵淵壓顧選觸顧(糧築繭構製齋鬱積鏇鹹) = 獵淵壓繭鹹鬱鑰夢築觸願廠艱憲襯鬱製選築範 (簾遞糧範簾艱鹽遞簾蓋 ) 更多	积极	2022-11-03