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Last update 26 May 2025

Amphotericin B

Last update 26 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SinuNase, CM001, DKF-5122

+ [14]

Target

Ergosterol

Action

modulators

Mechanism

Ergosterol modulators(Ergosterol modulators)

Therapeutic Areas

Infectious DiseasesNervous System DiseasesCardiovascular Diseases+ [4]

Active Indication

LeishmaniasisFebrile NeutropeniaCandidiasis+ [7]

Inactive Indication

Acute Myeloid LeukemiaCandidiasis, Chronic MucocutaneousCandidiasis, Invasive+ [8]

Originator Organization

Vestar Development Co.

Active Organization

Sumitomo Pharma Co., Ltd.

Fuji Pharma Co., Ltd.Gilead Sciences Ireland UC

+ [4]

Inactive Organization

Matinas BioPharma Nanotechnologies, Inc.

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

Enzon Pharmaceuticals, Inc.

+ [1]

License Organization

Matinas BioPharma, Inc.

Matinas BioPharma Nanotechnologies, Inc.

Satellos Bioscience, Inc.

+ [5]

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1958),

Mycoses

RegulationFast Track (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC47H73NO17

InChIKeyAPKFDSVGJQXUKY-INPOYWNPSA-N

CAS Registry1397-89-3

118

Clinical Trials associated with Amphotericin B

NCT06525389

/ Not yet recruitingPhase 3IIT

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?

Start Date01 Sep 2025

Sponsor / Collaborator

Duke University

[+4]

ChiCTR2400094386

/ SuspendedPhase 4IIT

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

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT05865743

/ RecruitingPhase 3IIT

PERi-operative Selective Decontamination of the Digestive Tract to Prevent Severe Infectious Complications After Esophagectomy: a Randomized Multicenter Clinical Trial in Patients with Primary Resectable Esophageal Carcinoma (cT1-4, N0-3, M0)

The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Start Date21 Oct 2024

Sponsor / Collaborator

Radboud University Medical Center

[+2]

100 Clinical Results associated with Amphotericin B

100 Translational Medicine associated with Amphotericin B

100 Patents (Medical) associated with Amphotericin B

26,692

Literatures (Medical) associated with Amphotericin B

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

Author: Bernauer, Mark ; Dorman, Stephanie ; Roth, Joshua A. ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

31 Dec 2025·Emerging Microbes & Infections

Chronic cutaneous and mucosal mucormycosis: Rhizopus arrhizus as a major pathogenic fungus

Article

Author: Yu, Jinlei ; Guo, Yanyang ; Li, Xingyu ; Miao, Chang ; Zhu, Zhenlai ; Liu, Fang ; Fu, Meng ; Hai, Luming ; Yan, Dong ; Gao, Jixin ; Ma, Yubo ; Wang, Gang

Chronic cutaneous mucormycosis is a rare condition distinct from the acute form, characterized by a prolonged, indolent course and varied clinical presentations. This study presents a 5-year experience from a tertiary dermato-mycology clinic, identifying six cases, the majority of whom were immunocompetent, with trauma history reported in four patients. The median duration from symptom onset to diagnosis was 60 months. The primary pathogens identified were Rhizopus arrhizus, Mucor variabilis, and Lichtheimia ramosa. Histopathological analysis demonstrated the absence of fungal angioinvasion, a hallmark of acute mucormycosis, which likely accounts for the slower progression observed in chronic cases. Systemic Amphotericin B treatment achieved favourable outcomes in most patients though significant morbidity persisted in some cases. This case series underscores the clinical and pathological distinctions of chronic cutaneous mucormycosis, highlighting the potential influence of host factors and environmental conditions on chronicity. The predominance of Rhizopus arrhizus suggests that chronicity is driven more by hostpathogen interactions than fungal species-specific factors. Increased recognition of the atypical clinical features, such as diverse cutaneous manifestation and slower progression course, as well as the utilization of diagnostic tools including histopathology, fungal culture, and advanced molecular techniques, is essential for the timely diagnosis of this rare presentation.

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

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

Review

Author: Xing, Shubin ; Zhao, Xiaodong ; Tang, Xuemei ; Zhang, Zhenzhen ; He, Wuyang ; Liu, Cong ; An, Yunfei ; 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.

113

News (Medical) associated with Amphotericin B

21 Apr 2025

·www.globenewswire.com

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.

Orphan DrugClinical ResultDrug ApprovalFast Track

22 Mar 2025

·pharma.economictimes.indiatimes.com

Experimental antibiotic kills drug-resistant fungi

By Nancy Lapid London: A experimental antibiotic can kill dangerous drug-resistant fungi that are spreading around the world, Chinese researchers reported in Nature. Antibiotics are usually ineffective against fungal infections. Unlike conventional antibiotics, the new drug, mandimycin , targets the lipid membrane that encases the fungus, disrupting its physiological processes and circumventing resistance mechanisms. Mandimycin belongs to a class of drugs known as glycosylated polyene macrolides, which also includes the last-resort antifungal amphotericin B. In test tubes, mandimycin killed multiple types of drug-resistant fungi including species of Candida, Cryptococcus neoformans and Aspergillus fumigatus, researchers from China Pharmaceutical University reported. All of the tested fungi were resistant to at least two existing drugs, and all are on the World Health Organization's fungal priority pathogens list, which includes infectious fungi with significant unmet need and public health importance, the researchers noted. In mice, mandimycin was effective against a strain of Candida auris that is resistant to all major types of antifungals, the researchers said. A commentary published with the report called mandimycin "a probable treasure trove of actionable intelligence in the battle against drug-resistant fungal infections." The new antifungal molecule is so radically different from existing drugs that it "breaks the mold," the commentary authors said. EARLY BREAST CANCER MIGHT NOT WARRANT LYMPH NODE SURGERY The practice of removing armpit lymph nodes in patients with early breast cancer may not be necessary or particularly beneficial, a new study in The New England Journal of Medicine suggests. Early-stage breast cancer has traditionally been treated with removal of the primary tumor and nearby lymph nodes. Pathologists then examine the nodes that were closest to the tumor for evidence that cancer cells have started to spread to other parts of the body. So-called axillary nodal status has long been regarded as one of the most important prognostic factors in breast cancer and is used to guide therapy. But lymph node removal often comes with pain, swelling, numbness, and risks of infection and fluid buildup. As medical therapies for breast cancer have improved, the need for lymph node removal is being questioned. To learn more, researchers recruited 5,502 patients with breast tumors no greater than 5 centimeters and normal-appearing lymph nodes and randomly assigned half of them to skip armpit lymph node removal. At five years, 91.7% of the retained-lymph node group and 91.9% of the removed-lymph node group were still free of invasive disease, and 98.2% and 96.9%, respectively, were still alive. Patients whose lymph nodes were removed were less likely to eventually have a recurrence found in a lymph node, but that did not afford them any benefit in terms of survival without invasive disease, or overall survival. An editorial published with the study notes that the findings are in line with those of a similar trial reported in 2023. While noting that more study is needed, Dr. Eric Rubin, Editor-in-Chief of the journal, said in a statement, "We are beginning to see a future where many women with early-stage breast cancer are going to be able to avoid axillary-node dissection and its attendant complications." OVARIAN CANCER SCREENING MISSES CASES IN MINORITY GROUPS Current blood test thresholds for patients with possible ovarian cancers are likely contributing to underdiagnosis in U.S. minority groups, according to a new study. International guidelines use blood levels of a protein produced by ovarian cancer cells, called cancer antigen 125, to recommend which patients with pelvic masses should undergo evaluation for ovarian cancer. The thresholds were developed from studies in white patients, according to a report in JAMA Network Open. When researchers reviewed data on 212,477 U.S. patients with ovarian cancer diagnosed from 2004 through 2020, they found that Black patients and Native American patients had significantly lower odds of having an elevated CA-125 level when their ovarian cancer was diagnosed. After accounting for individual risk factors, Native American and Black patients were 23% less likely to have an elevated CA-125 level at diagnosis. Ovarian cancer patients with misleadingly low CA-125 levels started chemotherapy an average of nine days later than patients with elevated CA-125 levels, the researchers also found. Earlier studies found that Black patients are more likely to be diagnosed with late-stage ovarian cancer than white patients, the authors noted. "Current CA-125 thresholds may miss racially and ethnically diverse patients with ovarian cancer," they said. "With 19,000 new ovarian cancer diagnoses annually in the U.S. and 314,000 worldwide, if the CA-125 thresholds were updated to have similar sensitivity for Black patients as White patients, we estimate that at least 60 patients each year would be diagnosed at an earlier stage in the U.S. and 1,500 worldwide." (Reporting by Nancy Lapid; editing by Bill Berkrot)

Clinical Result

01 Feb 2025

·www.globenewswire.com

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.

Drug Approval

100 Deals associated with Amphotericin B

External Link

KEGG	Wiki	ATC	Drug Bank
D00203	Amphotericin B	G01AA03 J02AA01 A01AB04	DB00681

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Leishmaniasis	Japan	Sumitomo Pharma Co., Ltd.	17 Jun 2009
Febrile Neutropenia	Japan	Sumitomo Pharma Co., Ltd.	20 Apr 2006
Candidiasis	Japan	Fuji Pharma Co., Ltd.	31 Jan 1997
Invasive Fungal Infections	Japan	Clinigen KK	18 Apr 1963
Mycoses	-	Bristol Myers Squibb Co.	01 Jan 1958
Complicated urinary tract infection	China	-	-
Endocarditis, Bacterial	China	-	-
Meningitis	China	-	-
Sepsis	China	-	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Cryptococcal	Phase 3	-	Matinas BioPharma Nanotechnologies, Inc.	01 Jan 2023
Lung Diseases	Phase 3	United States	Enzon Pharmaceuticals, Inc.	01 Oct 2005
Candidiasis, Invasive	Phase 2	-	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	01 Jan 2020
Invasive aspergillosis	Phase 2	-	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	01 Jan 2020
Acute Myeloid Leukemia	Phase 2	-	Matinas BioPharma Nanotechnologies, Inc.	01 Aug 2019
Pre B-cell acute lymphoblastic leukemia	Phase 2	-	Matinas BioPharma Nanotechnologies, Inc.	01 Aug 2019
Candidiasis, Vulvovaginal	Phase 2	United States	Matinas BioPharma Nanotechnologies, Inc.	01 Nov 2016
Yeast infection	Phase 2	United States	Matinas BioPharma Nanotechnologies, Inc.	01 Nov 2016
Candidiasis, Chronic Mucocutaneous	Phase 2	United States	Matinas BioPharma Nanotechnologies, Inc.	27 Sep 2016
Candidiasis, Oral	Phase 2	United States	Bristol Myers Squibb Co.	31 Aug 2001

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04059770 (CTgov)	Phase 2	Histoplasmosis \| Acquired Immunodeficiency Syndrome	118	single dose of L-AmB (Single Dose of L-AmB)	cmbegpvqgu = qruevlelrg eqfrqhvpzt (rscemdptso, dpddwyillc - rzmfudnejh) View more	-	14 Mar 2025
				2 doses of L-AmB (2 Doses of L-AmB)	cmbegpvqgu = hroceucmzw eqfrqhvpzt (rscemdptso, mrwjenlbrw - vikyxdrqdb) View more
NCT06376201 (NEWS) Manual	Phase 4	Invasive Fungal Infections	55	两性霉素B胆固醇硫酸酯复合物	xfxzmzeezo(dytezovhmw) = djcyntptiu yxrqdewmbq (vonmhzumzf ) View more	Positive	11 Mar 2025
NCT04031833 (ISRCTN72509687, Pubmed \| Clin Infect Dis)	Phase 1/2	Meningitis, Cryptococcal human immunodeficiency virus (HIV)	498	Liposomal Amphotericin B	hmvcpnonuv(vttdxcnwwy) = qsbpgjcdvl iqaxbbtffj (lojbvlkjef, 0.355 - 0.634) View more	Positive	05 Feb 2025
				Amphotericin B Deoxycholate	hmvcpnonuv(vttdxcnwwy) = kuunljrdrk iqaxbbtffj (lojbvlkjef, 0.360 - 0.445) View more
SNMMI2024	Not Applicable	-	-	Amphotericin B	pcetqxobyn(bpremtsfgj) = stwkjhbdfl bxmogjezif (frtesczxtg )	-	09 Jun 2024
EHA2024	Not Applicable	Hematologic Neoplasms	21	Liposomal Amphotericin B (L-AMB) (Group A (poor response to other antifungal drugs))	fthlstkaul(upbjgrpefr) = pgdcnirllu exeqfuwkii (pwwnxphtzx )	Positive	14 May 2024
				Liposomal Amphotericin B (L-AMB) (Group B (cannot tolerate adverse reactions))	fthlstkaul(upbjgrpefr) = yyxohnmsuv exeqfuwkii (pwwnxphtzx )
GlobeNewswire Manual	Not Applicable	Fusariosis	3	MAT2203	zfhxuaxzpd(rcrdktfqlw) = dtkxfigdyu incomxtnat (moyyltsmfw )	Positive	22 Mar 2024
GlobeNewswire Manual	Not Applicable	Invasive Fungal Infections	19	MAT2203	nevyoozhjh(xmtxnjbjkb) = vmfwmrjvkp qewbvewpkr (euhrnjqnhv ) View more	Positive	26 Feb 2024
APAO2024	Not Applicable	-	-	Optisol-GS with amphotericin B supplementation	vgbxzltitr(jhquzikwnx) = hanebisfey xtuolzbvdk (qsohutxatc ) View more	-	22 Feb 2024
				Optisol-GS without amphotericin B supplementation	vgbxzltitr(jhquzikwnx) = mbxcweyjah xtuolzbvdk (qsohutxatc ) View more
NCT04031833 (Pubmed \| Clin Infect Dis)	Phase 1/2	Meningitis, Cryptococcal	80	Oral LNC Amphotericin B + Flucytosine	jcpiewpbnz(nwvygniurn) = dtwnbqzzyk arysspctmc (jaecokexmk ) View more	-	22 Aug 2023
				IV Amphotericin + Flucytosine	jcpiewpbnz(nwvygniurn) = nfvhtiqrin arysspctmc (jaecokexmk ) View more
WCD2023	Not Applicable	Leishmaniasis, Cutaneous	28	Liposomal amphotericin B 12 mg/kg	tkdqvfoyup(lriuknjpux) = drejxlbbho mkykvhklol (kupxskmbbs ) View more	Positive	06 Jul 2023
				Liposomal amphotericin B 18 mg/kg	tkdqvfoyup(lriuknjpux) = ghqnmlplbd mkykvhklol (kupxskmbbs ) View more

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