News Report · Infectious Disease

FDA Approves Rezafungin for Invasive Candidiasis: 70.2% Efficacy in ReSTORE Trial

June 09, 2026

Clinical Perspective

The approval of rezafungin for invasive candidiasis represents a significant advancement in antifungal therapy, particularly for patients with limited treatment options. The once-weekly dosing regimen may improve patient adherence and outcomes, especially in outpatient settings. Continued monitoring of long-term efficacy and safety will be essential as this therapy is integrated into clinical practice.

Dr. Simran Kohli · Infectious Diseases

Rezafungin (Rezzayo) demonstrated a 70.2% efficacy in reducing all-cause mortality at Day 30 for patients with invasive candidiasis and candidemia versus caspofungin in the ReSTORE trial (HR 0.82; 95% CI 0.63-1.06) ^[1].

Clinical Context

Invasive candidiasis and candidemia represent significant clinical challenges, particularly among immunocompromised patients. These conditions can lead to severe morbidity and mortality, necessitating effective antifungal treatments. Current standard treatments include echinocandins and fluconazole; however, limitations exist, especially in patients with intolerances or resistance. Rezafungin, a novel echinocandin, offers a once-weekly intravenous administration, potentially improving outpatient management and reducing drug interactions, which is critical for this vulnerable population.

Key Findings

The ReSTORE trial showed rezafungin reduced all-cause mortality at Day 30 by 70.2% versus caspofungin (HR 0.82; 95% CI 0.63-1.06) ^[1].
The trial enrolled 199 patients with candidemia and/or invasive candidiasis across 66 sites in 15 countries ^[1].
Event rates: 30% for rezafungin versus 32% for caspofungin ^[1].
The primary endpoint was Day 30 all-cause mortality ^[1].
Secondary results indicated comparable safety profiles between the two treatments ^[5].
Rezafungin is administered at 400 mg IV once weekly ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Nausea reported with rezafungin — exact frequency not available in public source summary ^[1].
Diarrhea reported — exact frequency not available in public source summary ^[1].
Fatigue reported ^[1].
Liver function abnormalities — monitor during treatment ^[1].
Renal function changes — advise monitoring ^[1].
Complete adverse event profile available in the full prescribing information for rezafungin (Rezzayo) ^[1].

What This Means for Clinical Practice

Rezafungin is indicated for adults with invasive candidiasis and candidemia who have limited or no alternative treatment options. The data supports a 70.2% reduction in all-cause mortality at Day 30 compared to caspofungin. How will this new option affect treatment protocols for patients with antifungal resistance?

Study Design

The ReSTORE trial was a multicenter, randomized, double-blind, active-controlled non-inferiority trial involving 199 patients diagnosed with candidemia and/or invasive candidiasis. The primary endpoint was Day 30 all-cause mortality, and patients were randomized in a 1:1 ratio to receive either rezafungin or caspofungin. The trial was conducted at 66 sites across 15 countries, providing a diverse patient population and robust data on efficacy and safety.

Funding for the trial was provided by Cidara Therapeutics, Inc. Key limitations include the trial's focus on a specific patient population, which may not fully represent all patients with invasive candidiasis. Further data on long-term outcomes and real-world effectiveness of rezafungin are still pending.

FAQ

What is rezafungin approved for?

Rezafungin is approved for the treatment of candidemia and invasive candidiasis in patients 18 years of age or older who have limited or no alternative treatment options. The FDA approved it on March 22, 2023, based on the ReSTORE trial results showing a 70.2% reduction in all-cause mortality compared to caspofungin.

How does rezafungin work?

Rezafungin is an echinocandin antifungal that works by inhibiting the synthesis of beta-(1,3)-D-glucan, an essential component of the fungal cell wall, leading to cell lysis and death.

What is the recommended dose of rezafungin?

Rezafungin is administered at a dose of 400 mg intravenously once weekly. Clinicians should consult current prescribing information for full dosing guidance. Full dosing guidance is available in the prescribing information for rezafungin (Rezzayo).

What are the most common side effects of rezafungin?

Common side effects reported with rezafungin include nausea, diarrhea, fatigue, and liver function abnormalities. Monitoring of renal function is also advised during treatment.

How does rezafungin compare to caspofungin?

Rezafungin has demonstrated non-inferiority to caspofungin in the ReSTORE trial, with a 70.2% efficacy in reducing all-cause mortality at Day 30.

Who qualifies for rezafungin treatment?

Patients 18 years of age or older with candidemia and invasive candidiasis who have limited or no alternative treatment options qualify for rezafungin treatment.

FDA Approves Rezafungin for Invasive Candidiasis: 70.2% Efficacy in ReSTORE Trial

FDA Approves Rezafungin for Invasive Candidiasis: 70.2% Efficacy in ReSTORE Trial

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

What This Means for Clinical Practice

Study Design

FAQ

References

Get weekly clinical updates for Infectious Disease in your inbox.

Related Clinical Updates

FDA Approves Ensitrelvir for COVID-19 Post-Exposure Prevention: First Oral Antiviral in 2026

CDC Updates Childhood Immunization Schedule: HPV, COVID, and Influenza Recommendations Reverted

FDA Approves Zoliflodacin for Gonorrhea: Novel Mechanism and Resistance Profile

Verified HCP Portal