Cidara Therapeutics. Pipeline. 2023. https://www.cidara.com/pipeline/. Accessed 19 Apr 2023.

Garcia-Effron G. Rezafungin—mechanisms of action, susceptibility and resistance: similarities and differences with the other echinocandins. J Fungi. 2020;6(4):262.

Article  CAS  Google Scholar 

James KD, Laudeman CP, Malkar NB, et al. Structure-activity relationships of a series of echinocandins and the discovery of CD101, a highly stable and soluble echinocandin with distinctive pharmacokinetic properties. Antimicrob Agents Chemother. 2017;61(2).

Cidara Therapeutics. Cidara Therapeutics and Melinta Therapeutics announce FDA Approval of REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis [media release]. 22 Mar 2023. https://www.cidara.com.

Melinta Therapeutics. REZZAYO™ (rezafungin for injection), for intravenous use: US prescribing information. 2023. https://rezzayo.com/. Accessed 19 Apr 2023.

Mundipharma. European Medicines Agency accepts rezafungin marketing authorisation application for the treatment of invasive candidiasis [media release]. 22 Aug 2022. http://www.mundipharma.com.

Nyirjesy P, Alessio C, Jandourek A, et al. CD101 topical compared with oral fluconazole for acute vulvovaginal candidiasis: a randomized controlled trial. J Low Genit Tract Dis. 2019;23(3):226–9.

Article  PubMed  Google Scholar 

Cidara Therapeutics. Cidara Therapeutics reports unfavorable results of phase 2 RADIANT trial of CD101 topical in VVC [media release]. 21 Feb 2017. http://www.cidara.com.

Cidara Therapeutics. Cidara receives Orphan Drug Designation for novel echinocandin, CU101 IV, in candidemia and invasive candidiasis [media release]. 10 Feb 2016. http://www.cidara.com.

Cidara Therapeutics. FDA grants QIDP and Fast Track Designations to CD101 IV, Cidara Therapeutics’ lead antifungal product candidate [media release]. 11 May 2015. http://www.cidara.com.

Cidara T. FDA grants QIDP and Fast Track Designations to Cidara Therapeutics’ rezafungin prophylaxis development program [media release]. 25 Sep 2018. http://www.cidara.com.

Mundipharma. Orphan Drug Designation granted to rezafungin in EU for the treatment of invasive candidiasis [media release]. 26 Jan 2021. http://www.mundipharma.com.

Cidara Therapeutics. Melinta Therapeutics and Cidara Therapeutics announce licensing agreement to commercialize rezafungin in the US [media release]. 27 Jul 2022. http://www.cidara.com.

Cidara Therapeutics. Cidara Therapeutics submits NDA for rezafungin and announces license agreement with Melinta Therapeutics for commercialization of rezafungin in the US [media release]. 27 Jul 2022. http://www.cidara.com.

Cidara Therapeutics. Cidara Therapeutics and Mundipharma form strategic partnership to develop and commercialize rezafungin [media release]. 3 Sep 2019. http://www.cidara.com.

Cidara Therapeutics. Annual report for the fiscal year ended December 31, 2015 (Form 10-K). 2016. https://dd7pmep5szm19.cloudfront.net/2734/0001564590-16-015007.htm. Accessed 19 Apr 2023.

Ong V, Hough G, Schlosser M, et al. Preclinical evaluation of the stability, safety, and efficacy of CD101, a novel echinocandin. Antimicrob Agents Chemother. 2016;60(11):6872–9.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Carvalhaes CG, Klauer AL, Rhomberg PR, et al. Evaluation of rezafungin provisional CLSI clinical breakpoints and epidemiological cutoff values tested against a worldwide collection of contemporaneous invasive fungal isolates (2019 to 2020). J Clin Microbiol. 2022;60(4): e0244921.

Article  PubMed  Google Scholar 

Pfaller MA, Carvalhaes C, Messer SA, et al. Activity of a long-acting echinocandin, rezafungin, and comparator antifungal agents tested against contemporary invasive fungal isolates (SENTRY Program, 2016 to 2018). Antimicrob Agents Chemother. 2020;64(4):e00099-e120.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Pfaller MA, Messer SA, Rhomberg PR, et al. CD101, a long-acting echinocandin, and comparator antifungal agents tested against a global collection of invasive fungal isolates in the SENTRY 2015 Antifungal Surveillance Program. Int J Antimicrob Agents. 2017;50(3):352–8.

Article  CAS  PubMed  Google Scholar 

Pfaller MA, Messer SA, Rhomberg PR, et al. Activity of a long-acting echinocandin (CD101) and seven comparator antifungal agents tested against a global collection of contemporary invasive fungal isolates in the SENTRY 2014 Antifungal Surveillance Program. Antimicrob Agents Chemother. 2017;61(3):e02045-e2116.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Carvalhaes CG, Rhomberg PR, Strand GD, et al. Rezafungin activity against Candida spp. and Aspergillus spp. isolates causing invasive infections worldwide in 2021 [abstract no. 1731]. Open Forum Infect Dis. 2022;9(Suppl 2):ofac492.1361.

Article  PubMed Central  Google Scholar 

CLSI. Performance standards for antifungal susceptibility testing of yeasts—3rd edition. CLSI document M27M44S. Wayne, PA: Clinical and Laboratory Standards Institute. 2022.

Cidara Therapeutics. Rezafungin for injection for treatment of candidemia and invasive candidiasis: Antimicrobial Drugs Advisory Committee briefing materials. 2023. https://www.fda.gov/media/164668/download. Accessed 19 Apr 2023.

Carvalhaes CG, Rhomberg PR, Pfaller MA, et al. Evaluation of the post-antifungal effect of rezafungin and micafungin against Candida albicans, Candida parapsilosis and Candida glabrata. Mycoses. 2022;65(11):1040–4.

Article  CAS  PubMed  Google Scholar 

Kovács R, Tóth Z, Locke JB, et al. Comparison of in vitro killing activity of rezafungin, anidulafungin, caspofungin, and micafungin against four Candida auris clades in RPMI-1640 in the absence and presence of human serum. Microorganisms. 2021;9(4):863.

Article  PubMed  PubMed Central  Google Scholar 

Lakota EA, Bader JC, Ong V, et al. Pharmacological basis of CD101 efficacy: exposure shape matters. Antimicrob Agents Chemother. 2017;61(11):e00758-e817.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Miesel L, Lin KY, Ong V. Rezafungin treatment in mouse models of invasive candidiasis and aspergillosis: insights on the PK/PD pharmacometrics of rezafungin efficacy. Pharmacol Res Perspect. 2019;7(6): e00546.

Article  PubMed  PubMed Central  Google Scholar 

Lepak AJ, Zhao M, Andes DR. pharmacodynamic evaluation of rezafungin (CD101) against Candida auris in the neutropenic mouse invasive candidiasis model. Antimicrob Agents Chemother. 2018;62(11):e01572-e1618.

Article  PubMed  PubMed Central  Google Scholar 

Hager CL, Larkin EL, Long LA, et al. Evaluation of the efficacy of rezafungin, a novel echinocandin, in the treatment of disseminated Candida auris infection using an immunocompromised mouse model. J Antimicrob Chemother. 2018;73(8):2085–8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lepak AJ, Zhao M, Andes DR. Determination of pharmacodynamic target exposures for rezafungin against Candida tropicalis and Candida dubliniensis in the neutropenic mouse disseminated candidiasis model. Antimicrob Agents Chemother. 2019;63(11):e01556-e1619.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Miesel L, Cushion MT, Ashbaugh A, et al. Efficacy of rezafungin in prophylactic mouse models of invasive candidiasis, aspergillosis, and Pneumocystis pneumonia. Antimicrob Agents Chemother. 2021;65(3):e01992-e2020.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bader JC, Lakota EA, Flanagan S, et al. Overcoming the resistance hurdle: pharmacokinetic-pharmacodynamic target attainment analyses for rezafungin (CD101) against Candida albicans and Candida glabrata. Antimicrob Agents Chemother. 2018;62(6):e02614-e2617.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Locke JB, Almaguer AL, Zuill DE, et al. Characterization of in vitro resistance development to the novel echinocandin CD101 in Candida species. Antimicrob Agents Chemother. 2016;60(10):6100–7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Flanagan S, Goodman DB, Jandourek A, et al. Lack of effect of rezafungin on QT/QTc interval in healthy subjects. Clin Pharmacol Drug Dev. 2020;9(4):456–65.

Article  CAS  PubMed  Google Scholar 

Sandison T, Ong V, Lee J, et al. safety and pharmacokinetics of CD101 IV, a novel echinocandin, in healthy adults. Antimicrob Agents Chemother. 2017;61(2):e01627-e1716.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Data on file, Cidara Therapeutics, 2023.

Rubino CM, Flanagan S. Population pharmacokinetics of rezafungin in patients with fungal infections. Antimicrob Agents Chemother. 2021;65(11):e00842-e921.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jang SM, Hough G, Mueller BA. Ex vivo rezafungin adsorption and clearance during continuous renal replacement therapy. Blood Purif. 2018;46(3):214–9.

Article  CAS  PubMed  Google Scholar 

Flanagan S, Walker H, Ong V, et al. Absence of clinically meaningful drug–drug interactions with rezafungin: outcome of investigations. Microbiol Spectr. 2023. https://doi.org/10.1128/spectrum.01339-23.

Article  PubMed  Google Scholar 

Thompson GR 3rd, Soriano A, Cornely OA, et al. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial. Lancet. 2023;401(10370):49–59.

Article  CAS  PubMed  Google Scholar 

Thompson GR, Soriano A, Cornely OA, et al. Outcomes by baseline pathogen and susceptibility in the ReSTORE phase 3 trial of rezafungin once weekly compared with caspofungin once daily in patients with candidemia and/or invasive candidiasis [abstract no. 231]. Open Forum Infect Dis. 2022;9(Suppl 2):ofac492.309.

Article  Google Scholar 

Thompson GR, Soriano A, Skoutelis A, et al. Rezafungin versus caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis: the STRIVE trial. Clin Infect Dis. 2021;73(11):e3647–55.

Article  CAS  PubMed  Google Scholar 

Soriano A, Thompson III GR, Cornely OA, et al. Patient-level meta-analysis of efficacy and safety from STRIVE and ReSTORE: randomized, double-blinded, multicenter phase 2 and phase 3 trials of rezafungin in the treatment of candidemia and/or invasive candidiasis In: 32nd European congress of clinical microbiology and infectious diseases. 2022.