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Peptide

Rezafungin (Rezzayo)

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.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
6
Graded outcomes
3210

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Candidemia and Invasive Candidiasis: outcomes studied for Rezafungin (Rezzayo)
GradeOutcomeEffectSizeStudiesPeopleStudies list
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.

Improves (the measure goes up)Moderate effect39 studies

Studies that measured efficacy by candida species

and 29 more in the citations list

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.

Improves (the measure goes up)Moderate effect34 studies

Studies that measured day-14 global cure

and 24 more in the citations list

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.

NoneNo effect34 studies

Studies that measured 30-day all-cause mortality

and 24 more in the citations list

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.

Improves (the measure goes up)Moderate effect34 studies

Studies that measured weekly dosing convenience

and 24 more in the citations list

General

General: outcomes studied for Rezafungin (Rezzayo)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Antimicrobial Activity

14 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect19 studies

Studies that measured antimicrobial activity

and 9 more in the citations list

Safety/Tolerability

4 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect13 studies

Studies that measured safety/tolerability

and 3 more in the citations list

Key findings

  • Efficacy by Candida SpeciesCandidemia and Invasive CandidiasisImproves (the measure goes up)
  • Day-14 Global CureCandidemia and Invasive CandidiasisImproves (the measure goes up)
  • 30-Day All-Cause MortalityCandidemia and Invasive Candidiasis

Safety notes in the studies

  • May avoid need for central venous catheter.

Studies cited

31 studies from PubMed

  1. 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.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2025 · PMID 39581541
  2. Long-term Safety and Effectiveness of Rezafungin Treatment in Candidemia and Invasive Candidiasis: Results From an Early Access Program in Italy and Germany.Open forum infectious diseases, 2025 · PMID 40110419
  3. Rezafungin: A Review in Invasive Candidiasis.Drugs, 2025 · PMID 39913021
  4. Early use of the novel antifungal rezafungin: a case series and literature review.The Journal of antimicrobial chemotherapy, 2025 · PMID 40366630
  5. 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.Open forum infectious diseases, 2025 · PMID 41018703
  6. Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasisAntimicrob Agents Chemother, 2024 · PMID 38526046
  7. Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in AdultsClin Infect Dis, 2024 · PMID 38502709
  8. Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trialsIntensive Care Med, 2024 · PMID 39468640
  9. Formulary Drug Review: RezafunginAnn Pharmacother, 2024 · PMID 38689583
  10. Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE StudyClin Infect Dis, 2024 · PMID 38889162
  11. New antifungals development: rezafungin in candidiasis treatment.The Lancet. Infectious diseases, 2024 · PMID 38008098
  12. A Mini-Review of In Vitro Data for Candida Species, Including C. auris, Isolated during Clinical Trials of Three New Antifungals: Fosmanogepix, Ibrexafungerp, and Rezafungin.Journal of fungi (Basel, Switzerland), 2024 · PMID 38786717
  13. Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials.The Lancet. Infectious diseases, 2024 · PMID 38008099
  14. Safety of rezafungin as a long-term treatment option in two patients with complicated fungal infections: two cases from Lecco Hospital (Italy).Antimicrobial agents and chemotherapy, 2024 · PMID 38995032
  15. Pneumocystis jirovecii pneumonia in people living with HIV: a review.Clinical microbiology reviews, 2024 · PMID 38235979
  16. Formulary Drug Review: Rezafungin.Hospital pharmacy, 2024 · PMID 38764996
  17. Game Changer or More of the Same? A Comparative Meta-analysis of Rezafungin and Caspofungin in Treating Candidemia and Invasive Candidiasis.Journal of community hospital internal medicine perspectives, 2024 · PMID 39399196
  18. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trialLancet, 2023 · PMID 36442484
  19. An exciting time for antifungal therapyJ Antimicrob Chemother, 2023 · PMID 37093212
  20. Rezafungin and invasive candida infections: a new game changing antifungal?Lancet (London, England), 2023 · PMID 36442483
  21. Echinocandins - structure, mechanism of action and use in antifungal therapy.Journal of enzyme inhibition and medicinal chemistry, 2022 · PMID 35296203
  22. Evaluation of the Post-Antifungal Effect of Rezafungin and Micafungin against Candida albicans, Candida parapsilosis and Candida glabrata.Mycoses, 2022 · PMID 35778886
  23. A phase I randomized, double-blind, single subcutaneous dose escalation study to determine the safety, tolerability, and pharmacokinetics of rezafungin in healthy adult subjects.Clinical and translational science, 2022 · PMID 35439347
  24. Rezafungin: a novel antifungal for the treatment of invasive candidiasis.Future microbiology, 2021 · PMID 33438477
  25. The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin.Drugs, 2021 · PMID 34626339
  26. Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021 · PMID 32955088
  27. Erratum to: Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021 · PMID 34165553
  28. Activity of a Long-Acting Echinocandin, Rezafungin, and Comparator Antifungal Agents Tested against Contemporary Invasive Fungal Isolates (SENTRY Program, 2016 to 2018).Antimicrobial agents and chemotherapy, 2020 · PMID 32015043
  29. Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data.Journal of fungi (Basel, Switzerland), 2020 · PMID 32998224
  30. Rezafungin: First-in-Class Echinocandin for Invasive Candidiasis and Invasive Aspergillosis ProphylaxisDrugs, 2018 · PMID 30395507
  31. Rezafungin (CD101), a next-generation echinocandin: A systematic literature review and assessment of possible place in therapy.Journal of global antimicrobial resistance, 2018 · PMID 29486356