Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap - LARVOL DELTA

Successful outpatient parenteral antimicrobial therapy with rezafungin for chronic pulmonary aspergillosis: a case report and health economic assessment. (PubMed, JAC Antimicrob Resist) - "Rezafungin may be a novel, well-tolerated and cost-effective echinocandin treatment for CPA in patients needing OPAT and with limited treatment options. Further clinical studies are required for robust evaluation of this novel echinocandin in CPA."

HEOR • Journal • Cough • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Evidence Based Approach of Antifungal Prophylaxis (AFP) in Hematological Malignancies (DGHO 2025) - "Ten trials with HMA monotherapy (n=1,185), 10 with HMA/venetoclax (n=956) and 4 with FLT3-inhibitors (n=273) were analyzed...No prospective RT for AFP with isavuconazole, rezafungin or olorofim are available.In pts receiving HMA therapy, IFI ranged between 1.6 and 10.3% while AFP was usually not given...In pts treated with midostaurin, two studies (n= 218 pts) reported 29 IFI (13.3%). A total of 20,753 AFP pts episodes (eps) were included since 1984 from 95 studies during CTx and 17,482 pts received AFP within a clinical trial for AFP from 1992 to 2022. Out of these, 7,586 received fluconazole (FLU), 4,080 were on trials with posaconazole (POS) or voriconazole (VOR), 1,717 received itraconazole (ITRA), 1,895 echinocandins and 1,594 amphotericin B (AmB)(AmB deoxycholate, liposomal AmB or inhalative AmB), respectively. In pts receiving novel targeted therapies (e.g."

Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology

40 Years of Preventing Fungal Infections in Hematological Malignancies - Lessons Learned from Clinical Trials with 20,753 Patients (ASH 2024) - "Out of these, 7,586 received fluconazole (FLU), 4,080 were included in trials with posaconazole (POS) or voriconazole (VOR), 1,717 received itraconazole (ITRA), 1,895 echinocandins and 1,594 amphotericin B (AmB)(AmB deoxycholate, liposomal AmB or inhalational AmB), respectively...No prospective studies for AFP with isavuconazole and new antifungal agents like rezafungin or olorofim are available...In those receiving venetoclax/HMA, AFP practices were heterogeneous and IFI incidence ranged from 5% to 16.1% (overall probable/proven IFI : n=102 (10.6%), possible IFI not reported in all studies). In pts treated with midostaurin, 2 studies (n= 218 pts) reported 29 probable/proven IFI (13.3%). In pts treated with gilteritinib, 2 studies reported 55 pts with an IFI rate of 27.2% (including possible IFI)...Despite numerous trials for prevention of IFI, only posaconazole and fluconazole proved reduction in OM rates. There is a need for prospective clinical trials addressing..."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology

First report of Candida (Candidozyma) auris infections in a human and a dolphin from the Dominican Republic: A One health perspective. (PubMed, Med Mycol Case Rep) - "Antifungal susceptibility testing from dolphin isolate showed elevated minimum inhibitory concentrations (MIC) of fluconazole but low MICs of other antifungals, including the novel drugs rezafungin, ibrexafungerp and manogepix. Whole genome sequencing (WGS) of the dolphin isolate allocated it to clade I, but surprisingly did not show any known mutations that confer azole resistance, suggesting a mechanism different from mutations in the genes studied. The concurrent emergence of C. auris in human and animal hosts underscores the importance of a One Health approach, emphasizing the interconnectedness of human, animal, and environmental health, and the need for strengthened surveillance and rigorous infection control measures across medical and veterinary settings."

Journal • Infectious Disease

Bad to the bone: Candida (Candidozyma) auris vertebral osteomyelitis treated with combination antifungal therapy followed by a novel long-acting echinocandin. (PubMed, ASM Case Rep) - "Initial treatment included dual antifungal therapy with liposomal amphotericin B and micafungin, selected based on in vitro susceptibility and preclinical synergy data. It also demonstrates the feasibility of using rezafungin as an option for long-term outpatient management. Given the limited clinical experience with combination therapy and rezafungin use, further data are needed to inform standardized treatment approaches."

Journal • CNS Disorders • Infectious Disease • Inflammation • Migraine • Pain

Management of invasive candidiasis in the ICU: Challenges and advances (Review). (PubMed, Med Int (Lond)) - "Improvements in innovative diagnostic methods, including rapid molecular testing, as well as developments in antifungal therapy, such as rezafungin and ibrexafungerp, help improve patient outcomes. The present review also discusses clinical guidelines emphasizing the need for early empirical therapy, species-specific definitive treatment, and proper treatment duration. Continuous research toward new diagnostic procedures, antifungal agents and vaccines is essential to overcoming the challenges posed by IC in critically ill patients."

Journal • Review • Candidiasis • Critical care • Infectious Disease

Efficacy and Safety of Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis in a China Cohort of a Double-Blind, Randomised, Phase 3 Trial (ReSTORE China). (PubMed, Mycoses) - P3 | "Rezafungin demonstrated similar efficacy and safety to caspofungin in the ReSTORE China cohort. These findings support the primary ReSTORE analysis and suggest that rezafungin could provide a new treatment option for candidemia/invasive candidiasis in China."

Clinical • Journal • P3 data • Candidiasis

FIRST CLINICAL EXPERIENCE WITH REZAFUNGIN AS ANTIFUNGAL PROPHYLAXIS IN 10 PAEDIATRIC PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES BETWEEN 6-18 YEARS (SIOP 2025) - "Once weekly prophylaxis with rezafungin in pediatric oncology patients between 6-18 years shows to be a promising alternative in case azoles are contra-indicated and offers an even more convenient approach than micafungin. Exposure was similar to adult patients. More clinical data are needed to provide information on safety, pharmacokinetics and efficacy in the paediatric population."

Clinical • Hematological Malignancies • Infectious Disease • Oncology • Pediatrics

Efficacy of Rezafungin on Candida albicans Endophthalmitis in a Rabbit Model. (PubMed, Pathog Immun) - "Additionally, significant increases in eye lesion scores were observed in rabbits given either micafungin or voriconazole, while no eye lesions were noted in rabbits that received rezafungin. Taken together, these results indicate that rezafungin was effective at reducing the acute fungal burden and subsequent eye lesions caused by C. albicans-induced endophthalmitis."

Journal • Preclinical • Candidiasis • Infectious Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Optimizing Antifungal Therapies for Candida Infections: Evidence, Resistance, and Emerging Approaches. (PubMed, Clin Microbiol Infect) - "The increasing burden of antifungal resistance highlights the need for optimized therapeutic strategies and improved diagnostic tools. Combination therapies and novel antifungals offer promising alternatives, but further research is essential to evaluate their clinical efficacy. Strengthening antifungal stewardship programs and enhancing surveillance for resistance patterns are critical to managing Candida infections effectively and mitigating the public health threat posed by resistant strains."

Journal • Review • Candidiasis • Infectious Disease

Antifungal treatment strategies and their impact on resistance development in clinical settings. (PubMed, J Antimicrob Chemother) - "New antifungal agents, such as rezafungin, olorofim and fosmanogepix, along with long-acting and advanced formulations plus combination regimens, show substantial promise for managing resistance and improving treatment outcomes. Addressing antifungal resistance demands a multifaceted 'One Health' approach that integrates robust diagnostics, antifungal stewardship (AFS), precision medicine and collaborative global efforts. By advancing drug formulations, enhancing diagnostic tools and implementing forward-thinking AFS practices, the healthcare community can better tackle the escalating burden of fungal infections and deliver improved patient outcomes."

IO biomarker • Journal • Infectious Disease

New and emerging drugs for the treatment of invasive fungal infections. (PubMed, Expert Opin Pharmacother) - "Data were identified using PubMed searches for the terms 'antifungal,' 'olorofim,' 'SUBA-itraconazole,' 'ibrexafungerp,' 'rezafungin,' 'fosmanogepix,' and 'encochleated amphotericin B.' Approved agents include ibrexafungerp, an oral triterpenoid inhibitor of 1,3-β-D-glucan synthase; rezafungin, a long-acting echinocandin with weekly dosing; and SUBA-itraconazole, a reformulation of itraconazole with more consistent absorption. Despite improvements, gaps remain in treatments for severe IFI, particularly given increasing resistance. These agents represent significant advances, but further research is needed to define their use in patient management."

Journal • Review • Dermatology • Infectious Disease

Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis: Results from the Double-blind, Randomized, Phase 3 ReSTORE Trial Including the China Extension Study. (PubMed, Open Forum Infect Dis) - P3 | "Safety was comparable between groups; 53.3% (64/120; rezafungin) and 53.7% (66/123; caspofungin) of patients experienced serious adverse events. This analysis confirmed the overall efficacy and safety of rezafungin demonstrated in ReSTORE, with early efficacy related to front-loaded exposure."

Clinical • Journal • P3 data • Candidiasis

Rezafungin Utilisation in Real Life-FungiScope Results From Europe and the United States. (PubMed, Mycoses) - "Rezafungin was effective and well tolerated in this cohort, particularly in patients requiring long-term treatment. Administrative and logistical hurdles remain significant barriers to its widespread use. Facilitated access and enhanced awareness may improve patient outcomes by supporting early initiation and continuity of care."

Journal • Retrospective data • Candidiasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Development of a rezafungin isolate verification panel and comparison of reference method to ThermoFisher Sensititre YeastOne panel MIC results. (PubMed, Diagn Microbiol Infect Dis) - "When categorical agreement was calculated using CLSI and FDA breakpoints, CLSI criteria performed better than FDA, albeit this was associated with a limited number of isolates with MIC results near the breakpoints. The availability of a curated verification panel with rezafungin modal MIC values will be a valuable resource for laboratories as they incorporate testing devices containing rezafungin into their yeast susceptibility testing paradigm."

Journal • Candidiasis

Clinical Characteristics of an Emerging Candida auris Infection Outbreak in Northwest Louisiana (CAP 2025) - "Drug susceptibility testing (5) revealed multidrug resistance, with sensitivity to micafungin and rezafungin. Candida auris causes severe infections with high morbidity and mortality in vulnerable patients. Strict infection control, early detection, and appropriate antifungal treatment are essential to improving outcomes and mitigating this public health threat."

Clinical • Cardiovascular • Infectious Disease • Inflammation • Musculoskeletal Diseases • Nephrology • Orthopedics • Pneumonia • Respiratory Diseases

Real-world Experience of Rezafungin in an Outpatient Infusion Center Upon Discharge (IDWeek 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease

Candidozyma auris Susceptibility from Michigan Hospitals to Rezafungin and Nine Other Antifungal Agents (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Efficacy and Safety of Rezafungin, A Long-Acting Echinocandin (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Real-World Utilization of Rezafungin in the Outpatient Setting (IDWeek 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease

Innovative antifungal strategies to combat drug-resistant Candida auris: recent advances and clinical implications. (PubMed, Front Cell Infect Microbiol) - "Notably, several synthetic compounds such as rezafungin and fosmanogepix are in clinical trials for C. auris infections. Despite these promising developments, majority of studies have been conducted in vitro, with a relative lack of in vivo or human research. Therefore, further investigation is needed to validate the efficacy and safety of these alternative antifungal strategies for the treatment of drug-resistant C. auris infections."

Journal • Review • Infectious Disease

Clinical impact of fluconazole-resistant Candida parapsilosis: a narrative review. (PubMed, Future Microbiol) - "Treatment options are limited: echinocandins and liposomal amphotericin B (L-AmB) are commonly used alternatives, but their use is challenged by intrinsic and emerging echinocandin resistance and L-AmB toxicity and cost. Novel agents such as rezafungin, fosmanogepix, and ibrexafungerp have shown promising activity against fluconazole-resistant C. parapsilosis, though further clinical studies are needed to confirm their efficacy. This narrative review aims to summarize current evidence on the epidemiology, clinical implications, and therapeutic approaches for fluconazole-resistant C. parapsilosis infections."

Journal • Review • Infectious Disease

Candidemia: An Update on Epidemiology, Risk Factors, Diagnosis, Susceptibility, and Treatment. (PubMed, Pathogens) - "Regarding treatment, the use of micafungin and anidulafungin in patients with obesity defined by a BMI > 30 kg/m2 has shown higher survival rates and therapeutic success. Meanwhile, newer antifungals such as rezafungin and fosmanogepix have demonstrated excellent results in the treatment of these patients. Therefore, this review aims to update the epidemiology and risk factors of candidemia, as well as analyze the diagnostic tools and treatments currently available."

Journal • Review • Dermatology • Genetic Disorders • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Neutropenia • Obesity • Oncology • Transplantation • CRP

Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mundipharma Research Limited | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2026 ➔ Dec 2026 | Initiation date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Feb 2026 ➔ Jun 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Pulmonary Disease • Respiratory Diseases

Antifungal Agents in the 21st Century: Advances, Challenges, and Future Perspectives. (PubMed, Infect Dis Rep) - "Promising developments include next-generation echinocandins (e.g., rezafungin), triterpenoids (ibrexafungerp), and orotomides (olorofim), which target resistant strains and offer improved safety profiles. The review also highlights the critical role of "One Health" strategies to mitigate environmental and clinical resistance. Future success hinges on multidisciplinary collaboration, enhanced surveillance, and accelerated drug development to address unmet needs in antifungal therapy."

Journal • Review • Infectious Disease