[Translation] A phase III, multicenter, prospective, randomized, double-blind study comparing two treatment regimens (IV echinocandin followed by oral ibrexafungerp vs. IV echinocandin followed by oral fluconazole) in patients with candidemia and/or invasive candidiasis (MARIO)

主要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第30 天的全因死亡率（All Cause Moritality, ACM）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；关键次要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第14 天的总体应答率（经数据审查委员会 [Data Review Committee, DRC] 判定的临床、影像学和真菌学方面的综合应答）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；其他次要目的：根据第30天和抗真菌治疗结束时的总体应答、临床应答、真菌学应答、无复发、患者存活且真菌学清除指标来评估有效性；评估IV棘白菌素后口服Ibrexafungerp治疗的安全性；评估Ibrexafungerp的药代动力学（PK）特征。

[Translation]

The primary study objective was to evaluate the non-inferiority of oral ibrexafungerp after IV echinocandin to oral fluconazole in terms of all-cause mortality (ACM) at day 30 in patients with candidemia and/or invasive candidiasis. The key secondary study objective was to evaluate the non-inferiority of oral ibrexafungerp after IV echinocandin to oral fluconazole at day 14 in patients with candidemia and/or invasive candidiasis (composite clinical, radiological, and mycological responses as assessed by the Data Review Committee [DRC]). Other secondary objectives were to evaluate the efficacy based on overall response, clinical response, mycological response, freedom from relapse, patient survival, and fungal clearance at day 30 and at the end of antifungal treatment; to evaluate the safety of oral ibrexafungerp after IV echinocandin; and to evaluate the pharmacokinetic (PK) characteristics of ibrexafungerp.

Start Date18 Mar 2023

Sponsor / Collaborator

SCYNEXIS, Inc.

[+1]

NCT04961593

/ RecruitingNot ApplicableIIT

Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection

Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

Start Date01 Oct 2022

Sponsor / Collaborator

Paediatrics Hospital Affiliated To Fudan University

100 Clinical Results associated with Caspofungin Acetate

100 Translational Medicine associated with Caspofungin Acetate

100 Patents (Medical) associated with Caspofungin Acetate

4,285

Literatures (Medical) associated with Caspofungin Acetate

01 Jun 2025·Synthetic and Systems Biotechnology

Metabolic engineering of Glarea lozoyensis for high-level production of pneumocandin B0

Article

Author: Bian, Guangkai ; Deng, Zixin ; Lu, Li ; Liu, Tiangang ; Cheng, Shu ; Yang, Jing ; Zhang, Xinyi

Pneumocandin B₀ (PB₀) is a lipohexapeptide synthesized by Glarea lozoyensis and serves as the precursor for the widely used antifungal drug caspofungin acetate (Cancidas®). However, the low titer of PB₀ results in fermentation and purification costs during caspofungin production, limiting its widespread clinical application. Here, we engineered an efficient PB₀-producing strain of G. lozoyensis by systems metabolic engineering strategies, including multi-omics analysis and multilevel metabolic engineering. We overexpressed four rate-limiting enzymes: thioesterase GLHYD, two cytochrome P450s GLP450s, and chorismate synthase GLCS; knocked out two competing pathways responsible for producing 6-methylsalicylic acid and pyranidine E; and overexpressed the global transcriptional activator GLHYP. As a result, the PB₀ titer increased by 108.7 % to 2.63 g/L at the shake-flask level through combinatorial strategies. Our study provides valuable insights into achieving high-level production of PB₀ and offers general guidance for developing efficient fungal cell factories to produce polyketide synthase-non-ribosomal peptide synthetase hybrid metabolites.

01 Apr 2025·FOOD MICROBIOLOGY

Candida species covered from traditional cheeses: Characterization of C. albicans regarding virulence factors, biofilm formation, caseinase activity, antifungal resistance and phylogeny

Article

Author: Dishan, Adalet ; OZKAYA, Yasin ; TEMIZKAN, Mehmet Cevat ; Temizkan, Mehmet Cevat ; Gonulalan, Zafer ; Barel, Mukaddes ; Ozkaya, Yasin ; GONULALAN, Zafer ; BAREL, Mukaddes ; DISHAN, Adalet

This study has provided characterization data (carriage of virulence, antifungal resistance, caseinase activity, biofilm-forming ability and genotyping) of Candida albicans isolates and the occurrence of Candida species in traditional cheeses collected from Kayseri, Türkiye. Phenotypic (E-test, Congo red agar and microtiter plate tests) and molecular tests (identification, virulence factors, biofilm-formation, antifungal susceptibility) were carried out. The phylogenetic relatedness of C. albicans isolates was obtained by constructing the PCA dendrogram from the mass spectra data. Of 102 samples, 13 (12.7%) were found to be contaminated with C. albicans, 15 (14.7%), 10 (9.8%) and five (4.9%) were found to be contaminated with C. krusei, C. lusitane and C. paraplosis, respectively. While seven (16.2%) of 43 Candida spp. isolates were obtained from cheese collected from villages, 36 (83.7%) belonged to cheeses collected from traditional retail stores. The carriage rate of C. albicans isolates belonging to virulence factors HSP90 and PLB1 genes was 30.7%. ALST1, ALST3, BCR, ECE, andHWP (virulence and biofilm-associated) genes were harbored by 30.7%, 23%, 38.4%, 53.8%, and 38.4% of the 13 isolates. According to the microplate test, eight (61.5%) of 13 isolates had strong biofilm production. ERG11 and FKS1 (antifungal resistance genes) were found in 46.1% and 23% of 13 isolates, respectively. Due to missense mutations, K128T, E266D and V488I amino acid changes were detected for some isolates regarding azole resistance. As a result of the E-test, of the 13 isolates, one (7.6%) was resistant to flucytosine, four (30.7%) were resistant to caspofungin, and nine (69.2%) were resistant to fluconazole. The PCA analysis clustered the studied isolates into two major clades. C. albicans isolates of traditional cheese collected from villages were grouped in the same cluster. Among the C. albicans isolates from village cheese, there were those obtained from the same dairy milk at different times. Samples from the same sales points produced at different dairy farms were also contaminated with C. albicans. Concerning food safety standards applied from farm to fork, in order to prevent these pathogenic agents from contaminating cheeses, attention to the hygiene conditions of the sale points, conscious personnel, prevention of cross contamination will greatly reduce public health threats in addition to the application of animal health control, milking hygiene, pasteurization parameters in traditional cheese production.

01 Feb 2025·CLINICAL MICROBIOLOGY AND INFECTION

Clinical and mycological outcomes of candidaemia and/or invasive candidiasis by Candida spp. and antifungal susceptibility: pooled analyses of two randomized trials of rezafungin versus caspofungin

Article

Author: Manamley, Nick ; Castanheira, Mariana ; Soriano, Alex ; Carvalhaes, Cecilia G. ; Cornely, Oliver A ; Roilides, Emmanuel ; Carvalhaes, Cecilia G ; Arendrup, Maiken C ; Ramos-Martinez, Antonio ; Nseir, Saad ; Bassetti, Matteo ; Arendrup, Maiken C. ; Cornely, Oliver A. ; Honoré, Patrick M ; Locke, Jeffrey B ; Locke, Jeffrey B. ; Sandison, Taylor ; Honoré, Patrick M.

OBJECTIVES:

A post hoc analysis used pooled STRIVE/ReSTORE trial data to determine outcomes with rezafungin versus caspofungin by Candida species and antifungal susceptibility.

METHODS:

The efficacy and safety of once weekly rezafungin 400/200 mg versus once daily caspofungin 70/50 mg was demonstrated in the randomized, double-blind phase 2 STRIVE (NCT02734862) and phase 3 ReSTORE (NCT03667690) trials involving adults with candidaemia and/or invasive candidiasis. In this analysis, data were pooled for patients with a documented Candida infection within 96 hours of randomization who also received ≥1 dose of study drug. Treatment outcomes were evaluated by Candida species and baseline MICs. Susceptibility was determined using European Committee on Antimicrobial Susceptibility Testing E.Def 7.4 broth microdilution methodology, with Tween 20-supplemented medium for rezafungin.

RESULTS:

A total of 294 patients were included (rezafungin: N = 139, caspofungin: N = 155). Susceptibility testing at baseline identified three rezafungin non-susceptible isolates. Day 14 global cure rates were numerically similar between groups for C. albicans (rezafungin: 61.0% [36/59], caspofungin: 65.2% [45/69]) and C. tropicalis (rezafungin: 70.4% [19/27], caspofungin: 63.6% [14/22]), but higher with rezafungin than caspofungin for C. glabrata (rezafungin: 71.1% [27/38], caspofungin: 60.0% [21/35]) and C. parapsilosis (rezafungin: 78.6% [11/44], caspofungin: 55.6% [15/27]). Day 30 all-cause mortality rates were numerically similar between groups for C. albicans (rezafungin: 22.0% [13/59], caspofungin: 18.8% [13/69]) and C. glabrata (rezafungin: 15.8% [6/38], caspofungin: 11.4% [4/35]), but higher with caspofungin than rezafungin for C. tropicalis (rezafungin: 18.5% [5/27], caspofungin: 31.8% [2/22]) and C. parapsilosis (rezafungin: 7.1% [1/14], caspofungin: 29.6% [8/27]). Day 5/14 mycological eradication rates were numerically similar between treatments for C. albicans and C. parapsilosis, but higher with rezafungin for C. glabrata and C. tropicalis. Outcomes by Candida species were not associated with treatment-specific MICs.

DISCUSSION:

Rezafungin appears to be an effective treatment for candidaemia/invasive candidiasis irrespective of baseline Candida species.

News (Medical) associated with Caspofungin Acetate

03 Jan 2025

·www.prnewswire.com

Genetic testing could improve treatment for patients with the virulent multidrug-resistant fungus Candida auris

Findings published in the special Clinical Chemistry issue, "Genomics: Current & emerging trends in the clinical laboratory" WASHINGTON, Jan. 3, 2025 /PRNewswire/ -- A new study shows that genetic testing could be used to determine which drugs will — and won't — work for patients with Candida auris (C. auris), a multidrug-resistant yeast that causes life-threatening disease. These findings could improve treatment for C. auris infections by enabling patients to start taking effective antifungal agents sooner. The study was published today in a special issue of the Association for Diagnostics & Laboratory Medicine's (formerly AACC's) Clinical Chemistry journal titled "Genomics: Current & emerging trends in the clinical laboratory." View the full study here: Since C. auris was identified in 2009, this pathogenic fungus has spread worldwide, causing severe illness in patients in healthcare facilities. Not only is it deadly, with an estimated mortality rate ranging from 30%-60%, but it is also particularly challenging to treat. One of the major reasons for this is that there are many different strains of C. auris, each of which has a different genetic profile that confers resistance to different antifungal drugs. Clinical labs currently use susceptibility testing to determine which drugs a specific strain of C. auris is resistant to. This involves growing a sample of a patient's C. auris in the presence of different antifungal agents and waiting to see which drug kills the fungus. However, it can be difficult to interpret C. auris susceptibility test results because minimum inhibitory concentration breakpoints — i.e., the lowest concentrations of different antifungal drugs that will stop its growth — have not been fully established. Altogether, this means that healthcare professionals might waste precious time trying to figure out which antifungal drug will clear a patient's infection — and that time could mean the difference between life and death. In order to improve testing for C. auris drug resistance, a team of researchers led by Dr. Marie C. Smithgall of the Columbia University Irving Medical Center in New York City examined antifungal resistance genes in samples of C. auris isolated from 66 patients at the researchers' institute. The samples underwent two types of genetic testing — whole-genome sequencing (WGS) and Sanger sequencing — which were used to identify each sample's genetic fingerprint. The samples also underwent traditional susceptibility testing and were grown in the presence of seven major antifungal drugs. By comparing the genomic and susceptibility test results, the researchers confirmed that a number of different mutations in C. auris's FKS1 gene cause resistance to echinocandins, which are the class of antifungal drugs that currently serve as the first line treatment for invasive C. auris infections. Specifically, the researchers showed that: The Ser639Tyr FKS1 mutation and Arg135Ser mutation are associated with resistance to the antifungal drugs micafungin and anidulafungin. The Met690Ile mutation is associated with resistance to caspofungin. This demonstrates that genomic sequencing can identify which drugs a strain of C. auris is resistant to and can serve as an alternative to susceptibility testing. "With potential resistance to all three major antifungal classes of drugs, C. auris is an emerging public health threat. Early detection of echinocandin resistance by molecular methods could impact treatment course to include novel antifungal agents," Smithgall said. "Overall WGS serves as a powerful tool for molecular surveillance to help monitor, detect, and curb the spread of C. auris." About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit . Clinical Chemistry (clinchem.org) is the leading international journal of laboratory medicine, featuring nearly 400 peer-reviewed studies every year that help patients get accurate diagnoses and essential care. This vital research is advancing areas of healthcare ranging from genetic testing and drug monitoring to pediatrics and appropriate test utilization. Christine DeLong ADLM Associate Director, Communications & PR (p) 202.835.8722 [email protected] Molly Polen ADLM Senior Director, Communications & PR (p) 202.420.7612 (c) 703.598.0472 [email protected] SOURCE Association for Diagnostics & Laboratory Medicine (ADLM) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical StudyClinical Result

24 Sep 2024

·www.globenewswire.com

Basilea initiates clinical phase 3 study with antifungal fosmanogepix in candidemia and invasive candidiasis

Allschwil, Switzerland, September 24, 2024 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 it has initiated the Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC) phase 3 study. This registrational study evaluates the efficacy and safety of Basilea’s broad-spectrum antifungal fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, that is Candida yeast bloodstream or deep-seated tissue infections.1 Fosmanogepix is a first-in-class antifungal treatment candidate with a novel mechanism of action. It is available in intravenous and oral formulations and has been evaluated for efficacy and safety in a phase 1 / phase 2 program, including three open-label phase 2 studies for the treatment of Candidemia, including Candida auris, and invasive mold infections.2, 3, 4, 5 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very pleased to have activated the first study center in the phase 3 program for fosmanogepix and look forward to enrolling patients into FAST-IC. Invasive Candida infections are life-threatening complications for many hospitalized patients and associated with high mortality, and fosmanogepix offers a potential new treatment option in this high medical need area. In addition, we are working towards starting the second phase 3 study investigating fosmanogepix in the treatment of adult patients with invasive mold infections around year-end.” FAST-IC is a global, multi-center, randomized, active-controlled, double-blind phase 3 study and investigates intravenous (i.v.) fosmanogepix versus a standard-of-care regimen of i.v. caspofungin in adult patients with candidemia and/or invasive candidiasis. The study is expected to enroll approximately 450 patients, who will be randomized in a 2:1 ratio to either fosmanogepix or caspofungin. There is an optional oral switch to fosmanogepix in the fosmanogepix group and to fluconazole in the caspofungin group. The Swiss-based global company PSI CRO AG will manage the phase 3 program. Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc., in November 2023. Under the terms of the asset purchase agreement, Basilea assumed all rights and obligations from previous agreements, and will make a USD 6.0 million milestone payment under these obligations, upon the enrolment of the first patient, which is fully reflected in Basilea’s most recent financial guidance for the full year 2024. 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. 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.2 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris, and invasive mold infections.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). 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.6, 7 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.8 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate as high as 40%, even when patients receive antifungal therapy.9 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, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone+41 61 606 1102 E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This press release can be downloaded from www.basilea.com. References ClinicalTrials.gov identifier: NCT05421858K. 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), 239M. R. Hodges, E. Ople, P. Wedel et al. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22J. A. Vazquez, P. G. Pappas, K. Boffard et al. Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480J. 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 23, 2024)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF).pdf

Phase 2Phase 3Orphan DrugFast TrackClinical Result

23 May 2024

·www.biospace.com

Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups. The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections. Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, "We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.” She added, "Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses." Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma. About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . About Melinta Therapeutics, LLC Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit .

Phase 3Drug ApprovalLicense out/inClinical Result

100 Deals associated with Caspofungin Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D02501	Caspofungin Acetate	J02AX04	DB00520

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Invasive Pulmonary Aspergillosis	CN	Merck GmbH	17 Jun 2013
Pulmonary Aspergillosis	JP	Merck GmbH	18 Jan 2012
Aspergillosis	CN	Merck Sharp & Dohme (Australia) Pty Ltd.	29 Oct 2002
Neutropenia	CN	Merck Sharp & Dohme (Australia) Pty Ltd.	29 Oct 2002
Candidiasis	US	Merck & Co., Inc.	20 Sep 2002
Candidiasis, Invasive	EU	Merck Sharp & Dohme BV	23 Oct 2001
Candidiasis, Invasive	IS	Merck Sharp & Dohme BV	23 Oct 2001
Candidiasis, Invasive	LI	Merck Sharp & Dohme BV	23 Oct 2001
Candidiasis, Invasive	NO	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	EU	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	IS	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	LI	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	NO	Merck Sharp & Dohme BV	23 Oct 2001
Candidemia	CA	Merck Canada, Inc.	23 Aug 2001
Candidiasis of the esophagus	CA	Merck Canada, Inc.	23 Aug 2001
Invasive aspergillosis	US	Merck & Co., Inc.	26 Jan 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Persistent Infection	Phase 3	-	Merck Sharp & Dohme Corp.	01 Jun 2005
Fungemia	Phase 2	IT	Merck Sharp & Dohme Corp.	01 May 2009
Febrile Neutropenia	Phase 2	-	Merck Sharp & Dohme Corp.	01 Apr 2004
Fever	Phase 2	-	Merck Sharp & Dohme Corp.	01 Apr 2004
Invasive Fungal Infections	Phase 2	ES	Merck Sharp & Dohme Corp.	01 Oct 2003
Candidiasis, Oral	Phase 2	US	Merck Sharp & Dohme Corp.	31 Aug 2001
HIV Infections	Phase 2	US	Merck Sharp & Dohme Corp.	31 Aug 2001
Oropharyngeal candidiasis	Phase 2	US	Merck Sharp & Dohme Corp.	31 Aug 2001

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PO046 (AAO2022)	Not Applicable	Corneal Ulcer	21	Topical capsofungin 0.5%	walwjrdeaj(zavjtgpnln) = pehgvvvcuf ylgrzdfamc (arrkxzxwrb )	Positive	29 Sep 2022
				Topical voriconazole 1%	walwjrdeaj(zavjtgpnln) = ipqevvinjo ylgrzdfamc (arrkxzxwrb )
NCT01503515 (CTgov)	Phase 3	Hematologic Neoplasms \| Invasive Fungal Infections	292	Laboratory Biomarker Analysis+Caspofungin Acetate (Arm I (Caspofungin Acetate))	aunoegypyq(roxkokaskx) = vueldkwtph qnbqocfckc (onfmlwogbi, rsqyhdqlod - mpaggpodpe) View more	-	07 Jan 2021
				Laboratory Biomarker Analysis+Fluconazole+Voriconazole (Arm II (Fluconazole or Voriconazole))	aunoegypyq(roxkokaskx) = qchpyhjtqo qnbqocfckc (onfmlwogbi, lsmpecbepa - pcepvmqxds) View more
NCT01503515 (Pubmed \| J Pediatric Infect Dis Soc)	Phase 3	Invasive Fungal Infections	290	Caspofungin	xlhufxqkmi(jvtpxkdqju) = civggyyczz kscusvysty (lsdrpyvvsa, 0.3% - 5.4%)	-	02 Nov 2020
				Triazole (fluconazole or voriconazole)	xlhufxqkmi(jvtpxkdqju) = wwytrlrsom kscusvysty (lsdrpyvvsa, 0.4% - 5.5%)
NCT03399032 (Pubmed \| Antimicrob Agents Chemother)	Not Applicable	-	30	Caspofungin 70 mg i.v.	wlithoyspc(dxkrnpalef) = tbthyeqmcz mvriiauwdr (rwnzzfdukk )	-	20 Aug 2020
				Caspofungin 50 mg i.v.	wlithoyspc(dxkrnpalef) = pszzufvzeh mvriiauwdr (rwnzzfdukk )
NCT03798600 (CEAVC, 32366/2015; OSS.15.114, Pubmed \| J Chemother)	Not Applicable	Critical Illness	20	Caspofungin (Low-AUC group)	qpxljpoqmj(fflpriktdm) = favftslfou xeekbjtfgh (nvuljbylwu )	-	01 May 2020
				Caspofungin (High-AUC group)	qpxljpoqmj(fflpriktdm) = lixsgfnosh xeekbjtfgh (nvuljbylwu )
NCT01945281 (MK0991-064, Pubmed \| J Antimicrob Chemother) Manual	Phase 2	Candidiasis, Invasive	47	caspofungin	nxdchjmvkn(vqeshcoixr) = ritducewll yxofvvgvbr (nikyphbqtg ) View more	Similar	01 Jan 2020
				amphotericin B deoxycholate	nxdchjmvkn(vqeshcoixr) = zehrjwquen yxofvvgvbr (nikyphbqtg ) View more
NCT01307579 (Pubmed \| JAMA)	Phase 3	Acute Myeloid Leukemia	517	Caspofungin	gjuchexwrb(fmhclvrnvn) = rexqxpxttk ktzmpxgord (xfzdibzkdw ) View more	-	05 Nov 2019
				Fluconazole	gjuchexwrb(fmhclvrnvn) = wzzbfumplo ktzmpxgord (xfzdibzkdw ) View more
NCT01307579 (CTgov)	Phase 3	Myeloid Tumor \| Relapsing acute myeloid leukemia \| Treatment related acute myeloid leukaemia ... View more	517	Laboratory Biomarker Analysis+Caspofungin Acetate (Arm I (Caspofungin Acetate))	hedjtycflp(gjzclbtvwe) = cmyabkmtoy vigigixptu (iefkuolyrh, lwkiimarbb - cuwafuhxeu) View more	-	17 Sep 2019
				Laboratory Biomarker Analysis+Fluconazole (Arm II (Fluconazole))	hedjtycflp(gjzclbtvwe) = ifwenwgqbx vigigixptu (iefkuolyrh, tkeuwgmoiu - mhzvjvpkar) View more
P585 (EBMT2018)	Not Applicable	-	84	Caspofungin	grteonwilz(njbuyvxxlq) = pzhbqlirut ocprhxvdka (ogssdsvdqj, 11 - 28) View more	Positive	19 Nov 2018
				Itraconazole	mrzmfagnto(czusehriai) = cgztxkarsd itkftgzonh (rfveivpkzs, 8 - 26)
NCT01945281 (MK0991-064, CTgov)	Phase 2	Candidiasis, Invasive	51	caspofungin (Caspofungin)	sklaxppxvo(bpylixftsg) = uilqeritnm qqtnwkbbbx (sjgkyawcrl, vslwzvkhms - vfusnitdzx) View more	-	28 Aug 2018
				Amphotericin B Deoxycholate (Amphotericin B Deoxycholate)	sklaxppxvo(bpylixftsg) = xjlscyirbe qqtnwkbbbx (sjgkyawcrl, ymrurtqwtw - zbloolfpbv) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Caspofungin Acetate

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation