Rezzayo
Evidence Grade A — Regulatory approved. 201 published studies. 11 registered clinical trials.
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Rezafungin (sold as Rezzayo) is the first once-weekly antifungal in the echinocandin class — all previous echinocandins required daily intravenous infusions. It treats serious bloodstream and deep-organ Candida infections. Its extended half-life (about 5.5 days) was achieved by chemically stabilising the molecule to prevent the breakdown that limits older drugs in this class.
201 published studies: 120 human, 4 animal, 45 in-vitro, 83 reviews
Rezafungin is marketed as Rezzayo (approved March 2023) for candidaemia and invasive candidiasis in adults with limited or no alternative treatment options. It is administered as a once-weekly intravenous infusion.
In the ReSTORE trial, rezafungin was non-inferior to daily caspofungin, the existing standard. The once-weekly dosing is the primary advance — older echinocandins require daily infusions, which is burdensome for patients and hospital resources. A second trial studying rezafungin as prophylaxis in stem cell transplant patients did not meet its primary endpoint. The echinocandin class as a whole is considered first-line for invasive Candida infections, and rezafungin's weekly dosing may expand their use in outpatient settings.
Rezafungin blocks the production of beta-(1,3)-D-glucan, a sugar polymer that is essential for fungal cell walls but absent from human cells. Without this structural component, fungal cells lose their integrity and die from osmotic stress. The drug is fungicidal (kills) against Candida species and fungistatic (stops growth) against Aspergillus. The key innovation is a chemical modification that prevents the ring-opening degradation that limits the half-life of older echinocandins.
In the ReSTORE trial, once-weekly rezafungin was non-inferior to daily caspofungin (the existing standard) for treating invasive candidiasis. The weekly dosing is the primary advance — reducing infusion frequency from daily to weekly is meaningful for both patients and hospital resources, and could enable outpatient completion of antifungal courses. A second trial studying rezafungin as preventive therapy in stem cell transplant patients did not meet its primary endpoint, limiting the drug to treatment rather than prevention. Side effects include liver enzyme elevations, infusion reactions, and low potassium. Data for Aspergillus infections and paediatric patients are limited.
Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
Rezafungin Prophylaxis in Liver Transplant
Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis
Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
FDA ORIG 1
EMA Marketing Authorisation
FDA SUPPL 8
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