A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Non-inferiority Trial to Investigate Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial

CanTEN is a multicenter, randomized, double-blind, placebo-controlled, adaptive, non-inferiority phase 4 trial investigating a shortened treatment duration in patients with uncomplicated candidemia. Current guidelines recommend a 14-day treatment after documented clearance of candidemia. The traditional 14-day treatment duration for uncomplicated candidemia is not sufficiently evidence-based. In a variety of bacterial infections, shorter treatment has been proven safe and efficacious, thus reducing resistance development, toxicity, and costs.
This study aims to demonstrate the non-inferiority of 10 days (Group B) of treatment compared to 14 days (Group A) in patients with a controlled source of candidemia. Once the primary endpoint have been assessed in 50% of the participants, an unblinded interim analysis will be conducted. If non-inferiority can be demonstrated, Group C will be initiated with a 7-day treatment duration.
The primary endpoint is the rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37). Secondary endpoints include the time from randomization to recurrent candidemia and/or other proven invasive candidiasis, clinical cure, radiological cure and mycological eradication at the end of study treatment (Day 7) and at 30 days after end of study treatment (Day 37). In addition, all-cause mortality and mortality attributable to candidemia and/or other proven invasive candidiasis will be measured at 30 days after end of study treatment (Day 37) . Additional secondary endpoints include candidemia-attributable healthcare resources use at 30 days after end of study treatment (Day 37), Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin and patient reported outcome measures (PROMs; EQ-5D-5L and WHODAS 2.0) on Day 1 and Day 37. As an exploratory endpoint, the study will examine the impact of age, sex, relevant comorbidities, SOFA and qSOFA score, use of vasopressors and Candida species on recurrence of candidemia.

Start Date01 Sep 2026

Sponsor / Collaborator

Universities of Cologne

[+1]

NCT06892951

/ Not yet recruitingPhase 1/2IIT

Phase I/II Safety lead-in Randomized Blind Placebo-controlled Clinical Trial: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia in Adjunction of Conventional Systemic Antifungal Therapy

To assess the efficacy of administrating daily caspofungin aerosols versus placebo for seven days, in adjunction of conventional systemic antifungal therapy during curative treatment of Pneumocystis pneumonia, on the clinical outcome at the end of the nebulized therapy, in order to support a "GO / NO GO" decision towards a phase III trial of nebulized caspofungin in those patients.

Start Date01 Jun 2025

Sponsor / Collaborator

Hopital Necker-Enfants Malades

[+18]

IRCT20231219060471N1

/ RecruitingPhase 2/3IIT

The comparison efficacy and safety of topical caspofungin ?.5% and topical voriconazole 1% in fungal keratitis

Start Date19 Jan 2024

Sponsor / Collaborator

Tehran University of Medical Sciences

[+1]

100 Clinical Results associated with Caspofungin Acetate

100 Translational Medicine associated with Caspofungin Acetate

100 Patents (Medical) associated with Caspofungin Acetate

3,070

Literatures (Medical) associated with Caspofungin Acetate

01 Sep 2026·HEART & LUNG

Pharmacological burden and chemical phlebitis associated with peripheral venous catheters: A nested case-control study. Results of the national Flebitis Zero project

Article

Author: Cernuda-Martínez, José Antonio ; Alarcón-Duque, Eva María ; Moreno-Rubio, Esther ; Suárez-Mier, María Belén ; Ferraz-Torres, Marta ; Río-Pisabarro, María Del Camino Del ; Cobo-Sánchez, José Luis

BACKGROUND:

Chemical phlebitis is a common preventable complication of peripheral venous catheters (PIVCs), yet multicenter evidence on intravenous product-related risk factors remains scarce.

OBJECTIVE:

To analyze the relationship between specific intravenous products, pharmacological burden, and the risk of chemical phlebitis.

METHODS:

An exploratory nested case-control study was conducted within a prospective cohort across 93 Spanish hospitals (February 2023), including patients aged ≥18 years receiving intravenous therapy through a PIVC. Phlebitis was assessed using the Visual Infusion Phlebitis scale. Baseline balance between cases and controls was assessed using standardised mean differences (SMD). Multivariable logistic regression identified independent risk factors, adjusting for age and catheter gauge.

RESULTS:

The study included 9409 patients and 13,820 PIVCs. Groups were well-balanced across baseline characteristics. The highest independent risks for phlebitis were associated with caspofungin (aOR=10.81; CI95%: 2.89-40.49), ganciclovir (aOR=8.14; CI95%: 1.63-40.55), amiodarone (aOR=4.14; CI95%: 2.40-7.16), tobramycin (aOR=3.71; CI95%: 1.42-9.67), and parenteral nutrition (aOR=2.93; CI95%: 1.63-5.25). A gradient of increasing risk was observed across pharmacological burden categories: compared to patients receiving no products, risk more than doubled with two simultaneous products (aOR=2.19; CI95%: 1.82-2.65).

CONCLUSIONS:

High-risk irritants such as caspofungin, ganciclovir, and amiodarone were independently associated with the highest phlebitis risk. The use of any intravenous irritant product was associated with an increased risk of phlebitis; additional products did not produce a consistent further increase. These findings support incorporating pharmacological risk assessment into vascular access decision algorithms to prioritize central or midline routes for high-risk therapies.

01 Sep 2026·PEDIATRIC INFECTIOUS DISEASE JOURNAL

Breakthrough Invasive Fungal Infections in Pediatric Acute Myeloid and Lymphoblastic Leukemia Receiving Mold-active Prophylaxis

Article

Author: Konca, Hatice Kübra ; Bayhan, Turan ; Yarali, Neşe ; Özbek, Namik Yaşar ; Özen, Seval ; Gülhan, Belgin ; Ünal, Fatma ; Yahşi, Aysun ; Arman Bilir, Özlem ; Erat, Tuğba ; Özkaya Parlakay, Aslinur ; Bayhan, Gülsüm İclal ; Kanik Yüksek, Saliha

Background::

Breakthrough invasive fungal infections (IFIs) remain a major challenge in children with acute leukemia, even under mold-active prophylaxis. Data on the epidemiology, risk factors and outcomes of breakthrough IFIs in pediatric populations are limited.

Methods::

This study included patients 0–18 years of age with acute leukemia who were diagnosed and followed at the Pediatric Hematology Clinic of Ankara Bilkent City Hospital between February 2019 and December 2023. We conducted a retrospective cohort study of 147 pediatric patients with acute leukemia who received mold-active antifungal prophylaxis. Demographic and clinical features, antifungal prophylactic regimens, infection classifications (proven, probable and possible), microbiological and radiological findings and outcomes were analyzed. IFIs were defined and classified according to the EORTC/MSGERC 2020 criteria.

Results::

Among 147 patients (43.5% female, 56.5% male; mean age 9.5 years), 68.0% had acute lymphoblastic leukemia and 32.0% had acute myeloid leukemia. All patients received mold-active prophylaxis, most commonly voriconazole (84.4%, n = 124). Overall, 29.3% (n = 43) of patients developed an IFI. Among those with IFI, 81.4% (n = 35) were classified as possible, 11.6% (n = 5) as probable and 7.0% (n = 3) as proven. Infection incidence was similar between acute lymphoblastic leukemia (29.0%) and acute myeloid leukemia (31.2%) ( P = 0.779). A total of 7 patients died because of the fungal infections, yielding a case-fatality rate of 16.3% (7/43) among patients with IFI. Mortality varied markedly by diagnostic certainty: 5.7% in possible, 60.0% in probable and 66.7% in proven IFIs. Proven/probable infections were mainly due to Aspergillus spp. The most frequently used therapeutic agents were liposomal amphotericin B (43.2%) and caspofungin (30.9%), alone or in combination.

Conclusion::

Despite mold-active antifungal prophylaxis, nearly one-third of pediatric leukemia patients developed IFIs, with high mortality in probable and proven cases. The predominance of breakthrough mold infections underscores the limitations of current prophylactic strategies. Optimized prophylaxis, therapeutic drug monitoring and early diagnostic approaches are urgently needed to reduce the burden of IFIs in this high-risk population.

23 Jul 2026·CLINICAL INFECTIOUS DISEASES

Trends in Antifungal Resistance and Mechanistic Insights Into Azole Resistance in Candida (Candidozyma) auris : A 13-Year Study of a Comprehensive Set of Clinical Isolates From India

Article

Author: Chakrabarti, Arunaloke ; Ghosh, Anup ; Rudramurthy, Shivaprakash M ; Meis, Jacques F ; Spruijtenburg, Bram ; Singh, Shreya ; Meijer, Eelco F J ; Walia, Kamini ; de Groot, Theun ; Das, Sourav ; Tawde, Yamini ; Kaur, Harsimran

Abstract:

Background:

The objective of the study was to elucidate antifungal resistance and associated azole resistance mechanisms in Candida (Candidozyma) auris isolates across India over a period of 13 years (2009–2021).

Methods:

A total of 596 C. auris isolates from 37 healthcare centers were collected. Antifungal susceptibility was performed and ERG11 gene was sequenced for 45 representative isolates. The ERG11 and efflux pump (MDR1 and CDR1) expression under fluconazole drug pressure was assessed by quantitative reverse-transcription polymerase chain reaction (n = 20) along with cell wall ergosterol content estimation. Short tandem repeat (STR) genotyping was done on 235 isolates.

Results:

The highest number of isolates (50.1%) was recovered from northern India, followed by eastern (27.6%) and southern India (13.6%). The majority of the isolates were recovered from private sector hospitals. A total of 80.0% and 27.9% of isolates were resistant to fluconazole and voriconazole, respectively. A notable increase in resistance to amphotericin B and caspofungin was observed, with 3.2% of isolates being multidrug resistant. In ERG11, Y132F and K143R mutations were present in both fluconazole-susceptible and -resistant isolates; in addition, 50% of fluconazole-susceptible isolates showed elevated ERG11 expression and ergosterol content upon fluconazole treatment. Basal level cell wall ergosterol was higher in fluconazole-susceptible isolates. All isolates belonged to clade I with STR genotyping.

Conclusions:

Our study demonstrates high levels of antifungal resistance in the largest collection of Indian C. auris clinical isolates reported to date. Besides mutations and gene expressions, other pathways conferring drug resistance, such as stress response, must be studied to further understand the evolution of this pathogen.

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	China	Merck GmbH	17 Jun 2013
Pulmonary Aspergillosis	Japan	Merck GmbH	18 Jan 2012
Aspergillosis	China	Merck Sharp & Dohme (Australia) Pty Ltd.	29 Oct 2002
Neutropenia	China	Merck Sharp & Dohme (Australia) Pty Ltd.	29 Oct 2002
Candidiasis	United States	Merck & Co., Inc.	20 Sep 2002
Candidiasis, Invasive	European Union	Merck Sharp & Dohme BV	23 Oct 2001
Candidiasis, Invasive	Iceland	Merck Sharp & Dohme BV	23 Oct 2001
Candidiasis, Invasive	Liechtenstein	Merck Sharp & Dohme BV	23 Oct 2001
Candidiasis, Invasive	Norway	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	European Union	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	Iceland	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	Liechtenstein	Merck Sharp & Dohme BV	23 Oct 2001
Mycoses	Norway	Merck Sharp & Dohme BV	23 Oct 2001
Candidemia	Canada	Merck Canada, Inc.	23 Aug 2001
Candidiasis of the esophagus	Canada	Merck Canada, Inc.	23 Aug 2001
Invasive aspergillosis	United States	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	Italy	Merck Sharp & Dohme Corp.	01 May 2009
Febrile Neutropenia	Phase 2	-	Merck Sharp & Dohme Corp.	01 May 2004
Fever	Phase 2	-	Merck Sharp & Dohme Corp.	01 Apr 2004
Invasive Fungal Infections	Phase 2	Spain	Merck Sharp & Dohme Corp.	01 Oct 2003
Candidiasis, Oral	Phase 2	United States	Merck Sharp & Dohme Corp.	31 Aug 2001
HIV Infections	Phase 2	United States	Merck Sharp & Dohme Corp.	31 Aug 2001
Oropharyngeal candidiasis	Phase 2	United States	Merck Sharp & Dohme Corp.	31 Aug 2001
Candidiasis, Vulvovaginal	Preclinical	Ghana	University of Health and Allied Sciences	01 Jun 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EBMT2025	Not Applicable	Fusariosis	5	Liposomal amphotericin B	kcwqtswtin(bahsgsdfhq) = cspnmpgiab ywafcoadpo (hrjrzxjxuu )	Negative	30 Mar 2025
NCT03667690 (ReSTORE, Pubmed \| Clin Infect Dis)	Phase 3	Candidemia positive culture	-	Rezafungin	oialwzvkpz(aiehkkspxr) = hsgmnrfcsp nmdgwxivsc (jkwrwgfnbl ) View more	Positive	26 Sep 2024
				Caspofungin	oialwzvkpz(aiehkkspxr) = gdxawcgfsa nmdgwxivsc (jkwrwgfnbl ) View more
NCT01503515 (CTgov)	Phase 3	Hematologic Neoplasms \| Invasive Fungal Infections	292	Laboratory Biomarker Analysis+Caspofungin Acetate (Arm I (Caspofungin Acetate))	pkbtmqpzha = giwqbagqsl ebbuokgjyv (okyspwsdun, cxcnltfqbf - xrvejrtqtt) View more	-	07 Jan 2021
				Laboratory Biomarker Analysis+Fluconazole+Voriconazole (Arm II (Fluconazole or Voriconazole))	pkbtmqpzha = kmpypliozh ebbuokgjyv (okyspwsdun, quasynymyi - ohqqexzxfc) View more
NCT01503515 (Pubmed \| J Pediatric Infect Dis Soc)	Phase 3	Invasive Fungal Infections	290	Caspofungin	lbdvghxyzw(djflbdpaig) = obgtepbyoy uqhljpjegq (unqxbaaner, 0.3% - 5.4%)	-	02 Nov 2020
				Triazole (fluconazole or voriconazole)	lbdvghxyzw(djflbdpaig) = lablpeolay uqhljpjegq (unqxbaaner, 0.4% - 5.5%)
NCT03399032 (Pubmed \| Antimicrob Agents Chemother)	Not Applicable	-	30	Caspofungin 70 mg i.v.	rymmvlture(bkiffrpydq) = tptirrglao vvyjlpfxux (iffbomyeus )	-	20 Aug 2020
				Caspofungin 50 mg i.v.	rymmvlture(bkiffrpydq) = mwatdxbrkv vvyjlpfxux (iffbomyeus )
NCT03798600 (CEAVC, 32366/2015; OSS.15.114, Pubmed \| J Chemother)	Not Applicable	Critical Illness	20	Caspofungin (Low-AUC group)	rrwqujymcy(wbscofgsra) = syayalvobq lbfnzkjoih (kuvbueruwe )	-	01 May 2020
				Caspofungin (High-AUC group)	rrwqujymcy(wbscofgsra) = tmpihfnfrk lbfnzkjoih (kuvbueruwe )
NCT01945281 (MK0991-064, Pubmed \| J Antimicrob Chemother) Manual	Phase 2	Candidiasis, Invasive	47	caspofungin	fwraqzyhyj(ccnfjougjy) = diznddtknp jdvuewmchx (vyzuvaguyp ) View more	Similar	01 Jan 2020
				amphotericin B deoxycholate	fwraqzyhyj(ccnfjougjy) = iunggoqmqf jdvuewmchx (vyzuvaguyp ) View more
NCT01307579 (Pubmed \| JAMA)	Phase 3	Acute Myeloid Leukemia	517	Caspofungin	jvqhpzacyu(zoeymmpizg) = gzpsgpossz irdxmprjmm (vtpsegtxgw ) View more	-	05 Nov 2019
				Fluconazole	jvqhpzacyu(zoeymmpizg) = dlyhfutxwn irdxmprjmm (vtpsegtxgw ) View more
NCT01307579 (CTgov)	Phase 3	Myeloid Tumor \| Treatment related acute myeloid leukaemia \| Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia ... View more	517	Laboratory Biomarker Analysis+Caspofungin Acetate (Arm I (Caspofungin Acetate))	hbajvqabpr = aeutozffwc adeuddatkm (vhradkxkch, hvthzwjliz - ugzihkmfvv) View more	-	17 Sep 2019
				Laboratory Biomarker Analysis+Fluconazole (Arm II (Fluconazole))	hbajvqabpr = dkvgucklkj adeuddatkm (vhradkxkch, grdcljwvjx - zbcxmbauqe) View more
EBMT2018	Not Applicable	-	84	Caspofungin	nwizlzvnjt(qrzigkzkmo) = gthdtkahfq dhcvugkyfr (xwdbegrtst, 11 - 28) View more	Positive	19 Nov 2018
				Itraconazole	tkpcbbdwsm(qkqpdnaofr) = dqfdltcfpk pxjlilavhj (moaazjckil, 8 - 26)

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