Cidara is developing a novel once-weekly echinocandin, rezafungin, for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism, enhancing its efficacy and safety potential for patients.
U.S. rights and Ex-U.S. rights to rezafungin have been partnered with Melinta Therapeutics and Mundipharma respectively. Cidara retains the rights to rezafungin in Japan. See Partnerships for more detail.
On March 22, 2023, the U.S. Food and Drug Administration (FDA) approved Cidara’s New Drug Application (NDA) for REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in patients 18 years of age or older who have limited or no alternative. For more information, including Important Safety Information, see rezzayo.com.
Mundipharma submitted a marketing authorization application (MAA) for rezafungin to the European Medicines Agency (EMA) for the treatment of invasive candidiasis in adult patients. The MAA was accepted on August 22, 2022 and the application review is ongoing.