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Rezafungin (Rezzayo)

Peptide

Rezafungin is a second-generation cyclic lipopeptide echinocandin antifungal. FDA-approved March 2023 for candidemia and invasive candidiasis - first new echinocandin in over a decade. ReSTORE Phase 3 trial (n=199): Noninferior to caspofungin for day-14 global cure and 30-day mortality. Weekly dosing (vs daily for other echinocandins) enables outpatient treatment. Inhibits (1,3)-beta-D-glucan synthase to disrupt fungal cell wall.

Quick Answer

What it is

Rezafungin is a second-generation cyclic lipopeptide echinocandin antifungal. FDA-approved March 2023 for candidemia and invasive candidiasis - first new echinocandin in over a decade.

Key findings

  • Grade A: Day-14 Global Cure (Candidemia and Invasive Candidiasis)
  • Grade A: 30-Day All-Cause Mortality (Candidemia and Invasive Candidiasis)
  • Grade A: Efficacy by Candida Species (Candidemia and Invasive Candidiasis)

Safety

  • May avoid need for central venous catheter.
⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Rezafungin (Rezzayo)

Quick Facts: Rezafungin (Rezzayo)

  • Best Evidence:Grade A
  • Conditions Studied:1
  • Research Outcomes:6
  • Grade A Findings:3
  • Grade B Findings:2
  • Key Effect:Candidemia and Invasive Candidiasis
A3
B2
C1
D0
1 conditions · 6 outcomes

Detailed Outcomes

A
Day-14 Global Cure
ReSTORE Phase 3 (n=187): 59% rezafungin vs 61% caspofungin achieved global cure at day 14 (EMA primary endpoint). Noninferiority demonstrated. First new echinocandin approved in >10 years.
moderate↑Improves
A
30-Day All-Cause Mortality
ReSTORE Phase 3: 24% rezafungin vs 21% caspofungin mortality at day 30 (FDA primary endpoint). Noninferior within 20% margin. Similar safety profile to other echinocandins.
none
A
Efficacy by Candida Species
Species subanalysis: Effective against C. albicans (42%), C. glabrata (26%), and C. tropicalis (20%). Consistent efficacy across major Candida species causing invasive disease.
moderate↑Improves
B
Weekly Dosing Convenience
Unique weekly dosing (vs daily for caspofungin/micafungin) enables outpatient parenteral therapy. May avoid need for central venous catheter. Improves patient convenience and reduces healthcare resource use.
moderate↑Improves
B
Antimicrobial Activity
14 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderate↑Improves
C
Safety/Tolerability
4 human trials support this finding. Human clinical trial data available.
small↑Improves

Research Citations (31)

Clinical and mycological outcomes of candidaemia and/or invasive candidiasis by Candida spp. and antifungal susceptibility: pooled analyses of two randomized trials of rezafungin versus caspofungin.
(2025)
PMID: 39581541
Long-term Safety and Effectiveness of Rezafungin Treatment in Candidemia and Invasive Candidiasis: Results From an Early Access Program in Italy and Germany.
(2025)
PMID: 40110419
Rezafungin: A Review in Invasive Candidiasis.
(2025)
PMID: 39913021
Early use of the novel antifungal rezafungin: a case series and literature review.
(2025)
PMID: 40366630
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.
(2025)
PMID: 41018703
Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis
(2024)
PMID: 38526046
Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults
(2024)
PMID: 38502709
Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trials
(2024)
PMID: 39468640
Formulary Drug Review: Rezafungin
(2024)
PMID: 38689583
Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study
(2024)
PMID: 38889162

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1 shared condition · 10 outcomes

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Anidulafungin

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1 shared condition · 6 outcomes

Anidulafungin is a cyclic lipopeptide echinocandin antifungal for invasive candidiasis and candidemia. FDA-approved 2006. A-GRADE evidence: Phase 3 trial showed 76% success vs 60% fluconazole (P=0.01). Potent activity against Candida albicans, C. glabrata, C. tropicalis, C. krusei (MIC90 0.06-0.12 μg/ml). Crucially, 99% of fluconazole-resistant isolates remain susceptible. No hepatic or renal dose adjustment needed due to non-CYP450 metabolism - advantageous in critically ill patients. PRESCRIPTION ONLY - IV administration.