Rezafungin (Rezzayo™): A Comprehensive Pharmacological and Clinical Monograph

I. Introduction and Drug Classification

Rezafungin is a novel, second-generation echinocandin antifungal agent developed by Cidara Therapeutics.[1] It represents the first new approved treatment for candidemia and invasive candidiasis in over a decade, addressing a critical need for new therapeutic options against serious and often life-threatening fungal infections.[2] As a structural analogue of the first-generation echinocandin anidulafungin, rezafungin was specifically engineered to possess enhanced chemical and metabolic stability, resulting in a significantly improved pharmacokinetic profile.[6]

The central innovation and defining characteristic of rezafungin is its exceptionally long terminal half-life, which exceeds 130 hours.[1] This unique pharmacological property permits a once-weekly intravenous (IV) dosing regimen, a stark contrast to the once-daily administration required for all first-generation echinocandins, such as caspofungin and micafungin.[10] The development of rezafungin was not merely an incremental improvement in antifungal potency but a strategic effort to overcome the significant logistical and clinical challenges associated with daily IV infusions. This is particularly relevant for critically ill or hospitalized patients, for whom daily infusions can necessitate prolonged hospital stays, the use of central venous catheters (e.g., PICC lines), and complex outpatient parenteral antimicrobial therapy (OPAT) arrangements.[14] By shifting the treatment paradigm from a daily to a weekly intervention, rezafungin offers the potential to simplify patient management, enhance continuity of care, and optimize the use of healthcare resources.

The drug's development is framed within the context of the growing global threat of invasive fungal infections, especially among immunocompromised individuals, transplant recipients, and patients in intensive care units, populations where morbidity and mortality rates remain high.[8] Clinical trials have demonstrated that rezafungin is non-inferior to the standard-of-care echinocandin caspofungin, securing its place as a valuable new agent in the antifungal armamentarium.[1]

II. Physicochemical Properties and Identifiers

Rezafungin is classified as a small molecule, semi-synthetic cyclic lipopeptide and is a member of the echinocandin class of antifungal drugs.[8] Its complex structure is also described chemically as a quaternary ammonium ion, an azamacrocycle, a homodetic cyclic peptide, and an aromatic ether.[1] The molecule's design incorporates a specific modification—the replacement of the chemically labile hemiaminal moiety found in anidulafungin with a stable choline amine ether—which confers its high stability and is the basis for its long-acting pharmacokinetic properties.[8]

The drug is marketed under the brand name Rezzayo™ and has been referred to by several synonyms and developmental codes throughout its development, including Biafungin, CD101, and SP-3025.[6] It is a freely soluble, white to pale yellow solid (cake or powder) supplied for injection.[1]

Table 1: Key Identifiers and Physicochemical Properties of Rezafungin

Property/Identifier Type	Value/Code	Source/Registry
DrugBank ID	DB16310	DrugBank
CAS Number	1396640-59-7 (cation)	Chemical Abstracts Service
FDA UNII	G013B5478J	FDA Global Substance Registration System
ATC Code	J02AX08	WHO Anatomical Therapeutic Chemical
PubChem CID	78318119	PubChem
ChEBI ID	CHEBI:229680	Chemical Entities of Biological Interest
ChEMBL ID	CHEMBL3989945	ChEMBL
NCI Thesaurus Code	C152205	National Cancer Institute
Chemical Formula		N/A
Molar Mass	1226.412 g·mol⁻¹	N/A

III. Clinical Pharmacology

A. Mechanism of Action

The mechanism of action of rezafungin is consistent with that of the echinocandin class. It functions by selectively and noncompetitively inhibiting the 1,3-β-D-glucan synthase enzyme complex, which is essential for the synthesis of the fungal cell wall.[1] This enzyme complex, with key catalytic subunits including FKS1 and GSC2, is responsible for polymerizing UDP-glucose into 1,3-β-D-glucan, a critical structural polysaccharide that maintains the integrity and osmotic stability of the cell walls of many pathogenic fungi, including Candida and Aspergillus species.[5]

By inhibiting this enzyme, rezafungin disrupts the formation of glucan polymers, leading to a compromised and weakened cell wall structure.[5] This structural failure renders the fungal cell unable to withstand internal osmotic pressure, resulting in cell lysis and death.[18] This pharmacological effect is concentration-dependent and exhibits fungicidal activity against most Candida species and fungistatic activity against Aspergillus species.[10] A crucial aspect of this mechanism is its high degree of specificity; mammalian cells lack a cell wall and do not possess the 1,3-β-D-glucan synthase enzyme, which accounts for the targeted action of echinocandins and their favorable safety profile relative to other antifungal classes that may target cellular components shared with human cells.[10]

B. Pharmacodynamics

Rezafungin demonstrates a broad spectrum of in vitro activity against a wide range of clinically significant fungal pathogens. Its activity has been confirmed against common Candida species, including C. albicans, C. glabrata, C. parapsilosis, and C. tropicalis, as well as against Aspergillus and Pneumocystis species.[1] Notably, rezafungin has shown potent activity against difficult-to-treat and resistant fungal strains, including subsets of echinocandin-resistant Candida auris and azole-resistant Aspergillus isolates.[6] In vivo pharmacodynamic studies in neutropenic mouse models of invasive candidiasis caused by C. auris confirmed robust efficacy, with the area under the concentration-time curve to minimum inhibitory concentration ratio (AUC/MIC) identified as the key predictor of therapeutic effect.[30]

The unique pharmacokinetic profile of rezafungin, characterized by a high initial loading dose of 400 mg, results in "front-loaded" plasma exposure.[11] This high initial drug concentration is thought to contribute to a rapid onset of antifungal activity. This concept is supported by exploratory data from the pivotal ReSTORE clinical trial, which, although not powered for statistical significance on this endpoint, showed a trend towards faster mycological eradication and a shorter median time to negative blood culture in patients treated with rezafungin compared to caspofungin.[33] This rapid reduction in fungal burden early in the treatment course may have important clinical implications, including the potential for shorter duration of sepsis and reduced length of stay in the intensive care unit (ICU).[33]

In terms of cardiac safety, dedicated studies have shown that rezafungin does not cause clinically relevant prolongation of the QTc interval, even at doses significantly higher than the approved therapeutic dose, indicating a low risk for inducing cardiac arrhythmias.[10]

C. Pharmacokinetics (ADME)

The pharmacokinetic profile of rezafungin is its most distinguishing feature, underpinning its once-weekly dosing schedule.

• Absorption: Rezafungin is administered exclusively by intravenous infusion. Pharmacokinetic studies have demonstrated that its maximum concentration () and area under the curve (AUC) increase in a dose-proportional manner over a dose range of 50 mg to 400 mg.[1]
• Distribution: The drug exhibits a volume of distribution () of approximately 67 L, suggesting significant distribution into body tissues.[10] This volume is more than double that of caspofungin, a property that supports its potential utility in treating deep-seated infections.[18] Rezafungin is highly bound to plasma proteins, with binding ranging from 87.5% to 93.6% in patients.[10] Despite its distribution into tissues, it does not achieve therapeutic concentrations in sanctuary sites such as the central nervous system, the eye, or urine.[1]
• Metabolism: Rezafungin undergoes minimal metabolism and is not a clinically relevant substrate of cytochrome P450 (CYP) enzymes, which contributes to its low potential for drug-drug interactions.[10] The primary metabolic pathways identified involve hydroxylation of the terphenyl, pentyl ether side chain and O-dealkylation to form a despentyl metabolite.[10]
• Excretion: The primary route of elimination is through fecal excretion, with the majority of the drug eliminated unchanged.[10] Human mass balance studies using radiolabeled rezafungin estimated that approximately 73% of the administered dose is recovered in the feces and 27% in the urine (as inactive metabolites) over a 60-day period.[38] The drug is characterized by a very long terminal half-life () of approximately 152 hours and a low clearance (CL) of about 0.35 L/hr, which are the key parameters enabling its extended dosing interval.[10]

Table 2: Summary of Rezafungin Pharmacokinetic Parameters in Patients with Candidemia/IC

Parameter	Value (Mean ± SD)	Context/Notes
(Day 1)	19.2 ± 5.9 mcg/mL	Following 400 mg loading dose
(Day 15)	11.8 ± 3.5 mcg/mL	At steady state with 200 mg weekly dose
(Day 1)	827 ± 252 mcg·h/mL	Following 400 mg loading dose
(Day 15)	667 ± 224 mcg·h/mL	At steady state with 200 mg weekly dose
Volume of Distribution ()	67 ± 28 L	N/A
Protein Binding	87.5% to 93.6%	In patients
Terminal Half-Life ()	152 ± 29 hours	N/A
Clearance (CL)	0.35 ± 0.13 L/hr	N/A

Data derived from population PK modeling following the approved dosing regimen.[35]

IV. Clinical Efficacy in the Treatment of Invasive Candidiasis

The clinical development program for rezafungin for the treatment of invasive candidiasis was anchored by two key multicenter, randomized, double-blind trials: the Phase 2 STRIVE trial and the pivotal Phase 3 ReSTORE trial.

A. Phase 2 STRIVE Trial Findings (NCT02734862)

The STRIVE trial was designed to evaluate the safety and efficacy of two different once-weekly dosing regimens of rezafungin compared to the standard daily regimen of caspofungin.[4] The trial randomized 183 patients in the microbiological intent-to-treat (mITT) population into three arms: rezafungin 400 mg once-weekly, rezafungin 400 mg as a loading dose followed by 200 mg once-weekly, and standard-dose caspofungin.[41]

The results demonstrated that the 400 mg/200 mg rezafungin regimen was associated with numerically superior outcomes compared to both the 400 mg flat dose and the caspofungin arm. Key efficacy findings for the 400 mg/200 mg regimen included an overall cure rate at Day 14 of 76.1% (versus 67.2% for caspofungin) and a notably lower 30-day all-cause mortality rate of 4.4% (versus 13.1% for caspofungin).[41] Based on this favorable efficacy and safety profile, the 400 mg loading dose followed by 200 mg weekly maintenance dose regimen was selected for advancement into the pivotal Phase 3 study.[41]

B. Pivotal Phase 3 ReSTORE Trial (NCT03667690)

The ReSTORE trial was a global, multicenter, randomized, double-blind, double-dummy, non-inferiority study that served as the primary basis for regulatory approval.[3] The trial was conducted across 66 centers in 15 countries and enrolled adult patients with confirmed candidemia and/or invasive candidiasis.[3] The final analysis included a cohort from China, bringing the total randomized population to 246 patients.[33] Patients were randomized 1:1 to receive either once-weekly rezafungin (400 mg loading dose, then 200 mg weekly) or once-daily caspofungin (standard dosing) for up to four weeks.[45]

The trial was designed with two distinct primary endpoints to meet the requirements of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Rezafungin successfully demonstrated non-inferiority to caspofungin for both endpoints.[2]

• FDA Primary Endpoint (Day 30 All-Cause Mortality): The mortality rate was 25.2% in the rezafungin group versus 24.8% in the caspofungin group. The treatment difference of 0.4% had a 95% confidence interval of [-10.8%, 11.6%], with the upper bound falling well below the pre-specified 20% non-inferiority margin.[33]
• EMA Primary Endpoint (Day 14 Global Cure): The global cure rate was 56.5% for rezafungin versus 57.3% for caspofungin. The weighted treatment difference of -1.0% had a 95% confidence interval of [-13.5%, 11.6%], with the lower bound remaining above the pre-specified -20% non-inferiority margin.[19]

Table 3: Efficacy Outcomes from the Pivotal Phase 3 ReSTORE Trial (Global + China Extension)

Endpoint	Rezafungin Arm (n=122)	Caspofungin Arm (n=124)	Treatment Difference (95% CI)	Result
Day 30 All-Cause Mortality	25.2%	24.8%	0.4% (-10.8, 11.6)	Non-inferiority met
Day 14 Global Cure	56.5%	57.3%	-1.0% (-13.5, 11.6)	Non-inferiority met
Day 5 Mycological Eradication	68.7%	63.2%	N/A	Numerically higher
Median Time to Negative Blood Culture	26.5 hours	38.8 hours	N/A	Numerically shorter

Data from the final analysis of the ReSTORE trial including the China extension study.[33]

V. Safety Profile and Tolerability

The overall safety profile of rezafungin observed in the clinical development program was comparable to that of caspofungin and consistent with the known safety profile of the echinocandin class.[3]

The most frequently reported adverse reactions (incidence ≥5%) in pooled data from the Phase 2 and 3 trials were electrolyte disturbances and gastrointestinal issues. These included hypokalemia (low potassium), pyrexia (fever), diarrhea, anemia, vomiting, nausea, hypomagnesemia (low magnesium), abdominal pain, constipation, and hypophosphatemia (low phosphate).[2]

Table 4: Summary of Adverse Reactions (Incidence ≥5%) from Pooled Clinical Trials

Adverse Reaction	Rezafungin (400/200 mg) % Incidence	Caspofungin % Incidence
Hypokalemia	15%	9%
Pyrexia	12%	5%
Diarrhea	11%	Not specified
Anemia	10%	9%
Vomiting	Not specified	Not specified
Nausea	Not specified	Not specified
Hypomagnesemia	Not specified	Not specified
Abdominal Pain	Not specified	Not specified
Constipation	Not specified	Not specified
Hypophosphatemia	Not specified	Not specified

Incidence data from prescribing information and trial publications.[2]

Specific warnings and precautions associated with rezafungin use include:

• Infusion-Related Reactions: Patients may experience reactions such as flushing, a sensation of warmth, urticaria, nausea, or chest tightness. These can typically be managed by slowing or temporarily pausing the infusion.[2]
• Photosensitivity: Rezafungin has been associated with photosensitivity. Patients should be counseled to use sun protection and avoid exposure to UV radiation during treatment and for seven days following the final dose.[2]
• Hepatic Adverse Reactions: Abnormalities in liver function tests have been observed. It is recommended to monitor liver tests in patients receiving rezafungin and to evaluate the risk-benefit of continuing therapy if abnormalities develop.[10]

Rezafungin is contraindicated in patients with a known hypersensitivity to rezafungin or any other echinocandin.[49] Due to its minimal metabolism via CYP450 pathways, rezafungin has a low potential for clinically significant drug-drug interactions, a considerable advantage in the management of critically ill patients who are often on multiple concomitant medications.[11]

No dose adjustments are necessary for patients based on age, sex, race, weight, or the presence of renal or hepatic impairment (including those on hemodialysis).[10] There is a lack of adequate data on its use in pregnant or lactating women.[23] Animal studies have suggested a potential for impaired male fertility at high doses, though the relevance to humans is unknown.[10]

VI. Dosage, Administration, and Approved Indications

The recommended dosage regimen for rezafungin is designed to leverage its unique long-acting pharmacokinetic profile.

• Dosing Regimen: Treatment is initiated with a single 400 mg loading dose on Day 1, followed by a 200 mg maintenance dose administered once weekly thereafter. The safety of the drug has not been established for treatment durations beyond four weekly doses.[35]
• Administration: Rezafungin is for intravenous use only and should be administered as an infusion over approximately one hour.[36]
• Preparation: The drug is supplied as a 200 mg lyophilized powder in a single-dose vial. It requires reconstitution with sterile water for injection, followed by further dilution in a 250 mL IV bag containing a compatible solution (0.9% Sodium Chloride, 0.45% Sodium Chloride, or 5% Dextrose) prior to administration.[36]

The approved indications for rezafungin differ between major regulatory agencies, a nuance that reflects differing interpretations of the pivotal trial data. This divergence stems from the non-inferiority margin of 20% used for the mortality endpoint in the ReSTORE trial.[14] While this margin was acceptable to both agencies, the FDA's guidance suggests that such a margin warrants a more restrictive indication compared to what would be granted with a narrower margin (e.g., 10%).[37]

• United States (FDA): Rezafungin is indicated for the treatment of candidemia and invasive candidiasis in patients 18 years of age or older who have limited or no alternative options.[1] This "limited use" language positions the drug as a second-line or specialized option in the U.S. market.
• European Union (EMA): Rezafungin is indicated for the treatment of invasive candidiasis in adults.[17] This broader indication does not carry the "limited options" qualifier, allowing for its consideration as a first-line alternative to daily echinocandins in Europe.

For both indications, it is noted that rezafungin has not been studied in patients with deep-seated Candida infections such as endocarditis, osteomyelitis, or meningitis.[4]

VII. Comparative Analysis and Therapeutic Context

Rezafungin enters a therapeutic landscape dominated by first-generation echinocandins. Its primary value proposition lies not in superior in vitro potency, which is largely comparable to existing agents, but in its fundamentally different pharmacokinetic profile and the resulting convenience of its dosing schedule.[6]

The most significant differentiator is its once-weekly administration, enabled by a terminal half-life of approximately 152 hours, compared to the once-daily dosing required for caspofungin, micafungin, and anidulafungin due to their much shorter half-lives.[1] This distinction has profound clinical and logistical implications. The once-weekly regimen may facilitate earlier hospital discharge, simplify OPAT, reduce the need for indwelling central venous catheters and their associated risks, and decrease the burden on nursing resources.[14]

While rezafungin's approved indications are currently narrower than those of some first-generation agents (e.g., micafungin for prophylaxis, caspofungin for empirical therapy in febrile neutropenia), its low potential for drug-drug interactions is a shared and significant advantage of the echinocandin class, making it a suitable option for critically ill patients on complex medication regimens.[26]

Table 5: Comparative Profile of Rezafungin and First-Generation Echinocandins

Feature	Rezafungin (Rezzayo)	Caspofungin (Cancidas)	Micafungin (Mycamine)	Anidulafungin (Eraxis)
Dosing Frequency	Once-Weekly	Once-Daily	Once-Daily	Once-Daily
Terminal Half-Life	~152 hours	~9-11 hours	~11-17 hours	~24-26 hours
Indication for Candidemia/IC	Yes (Limited use in US)	Yes	Yes	Yes
Prophylaxis Indication	No (Under investigation)	No	Yes	No
Empirical Therapy Indication	No	Yes	No	No
DDI Potential (CYP-mediated)	Low	Low	Low	Low
Generic Availability	No	Yes	Yes	No

Data compiled from.[10]

VIII. Regulatory Status and Future Directions

Rezafungin has successfully navigated the regulatory pathways in the United States and the European Union, marking a significant development in antifungal therapy.

• United States (FDA): The New Drug Application (NDA) for rezafungin received Priority Review, Fast Track, Qualified Infectious Disease Product (QIDP), and Orphan Drug designations.[4] Following a favorable recommendation from the Antimicrobial Drugs Advisory Committee, the FDA approved Rezzayo on March 22, 2023.[20] It is commercialized in the U.S. by Melinta Therapeutics.[2]
• European Union (EMA): The Marketing Authorization Application (MAA) was accepted for review in August 2022. The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in October 2023, leading to full approval by the European Commission on December 22, 2023.[17] It was also granted Orphan Drug Designation in the EU and is commercialized by Mundipharma.[17]
• Australia (TGA): A review of the provided documentation, including searches of the Australian Register of Therapeutic Goods (ARTG), found no evidence that rezafungin (Rezzayo) is currently approved or registered for supply in Australia.[60]

The clinical development of rezafungin is ongoing. The most significant future direction is its investigation for prophylaxis. The Phase 3 ReSPECT trial (NCT04368559) is currently evaluating the efficacy and safety of once-weekly rezafungin for the prevention of invasive fungal diseases caused by Candida, Aspergillus, and Pneumocystis in adult patients undergoing allogeneic blood and marrow transplantation.[2] Positive results from this trial could significantly expand rezafungin's approved indications and establish it as a key prophylactic agent in high-risk immunocompromised populations. Further research may also explore its utility in other deep-seated fungal infections, leveraging its favorable tissue distribution.[5]

Works cited

1. Rezafungin | C63H85N8O17+ | CID 78318119 - PubChem, accessed October 15, 2025, https://pubchem.ncbi.nlm.nih.gov/compound/78318119
2. Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval of REZZAYO™ (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis, accessed October 15, 2025, https://www.cidara.com/news/cidara-therapeutics-and-melinta-therapeutics-announce-fda-approval-of-rezzayo-rezafungin-for-injection-for-the-treatment-of-candidemia-and-invasive-candidiasis/
3. New treatment for invasive fungal infection candidiasis approved by FDA - UC Davis Health, accessed October 15, 2025, https://health.ucdavis.edu/news/headlines/new-treatment-for-invasive-fungal-infection-candidiasis-approved-by-fda/2023/03
4. FDA Approves Rezafungin Injection for the Treatment of Candidemia, Invasive Candidiasis, accessed October 15, 2025, https://www.pharmacytimes.com/view/fda-approves-rezafungin-injection-for-the-treatment-of-candidemia-invasive-candidiasis
5. What are the approved indications for Rezafungin? - Patsnap Synapse, accessed October 15, 2025, https://synapse.patsnap.com/article/what-are-the-approved-indications-for-rezafungin
6. Rezafungin acetate | CAS#1396640-59-7 | β-glucan synthase inhibitor | MedKoo, accessed October 15, 2025, https://www.medkoo.com/products/25511
7. Rezafungin chloride | CAS#1396640-59-7| β-glucan synthase inhibitor | MedKoo, accessed October 15, 2025, https://www.medkoo.com/products/41648
8. Full article: Echinocandins – structure, mechanism of action and use in antifungal therapy, accessed October 15, 2025, https://www.tandfonline.com/doi/full/10.1080/14756366.2022.2050224
9. Rezafungin—Mechanisms of Action, Susceptibility and Resistance: Similarities and Differences with the Other Echinocandins - PubMed Central, accessed October 15, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC7711656/
10. Rezafungin: Uses, Interactions, Mechanism of Action | DrugBank ..., accessed October 15, 2025, https://go.drugbank.com/drugs/DB16310
11. CAS 1396640-59-7 Rezafungin - BOC Sciences, accessed October 15, 2025, https://www.bocsci.com/product/rezafungin-cas-1396640-59-7-313998.html
12. Rezafungin, a New Second-Generation Echinocandin - CLSI, accessed October 15, 2025, https://clsi.org/resources/insights/rezafungin-a-new-second-generation-echinocandin/
13. Rezafungin: A Review in Invasive Candidiasis - PubMed, accessed October 15, 2025, https://pubmed.ncbi.nlm.nih.gov/39913021/
14. Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults - PubMed, accessed October 15, 2025, https://pubmed.ncbi.nlm.nih.gov/38502709/
15. Long-term Safety and Effectiveness of Rezafungin Treatment in Candidemia and Invasive Candidiasis: Results From an Early Access Program in Italy and Germany - PubMed Central, accessed October 15, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11920862/
16. Invasive candidiasis management, simplified with once-weekly REZZAYO, accessed October 15, 2025, https://rezzayo.com/once-weekly-rezzayo/
17. Cidara Therapeutics Announces European Approval of REZZAYO® (rezafungin) for the Treatment of Invasive Candidiasis in Adults, accessed October 15, 2025, https://www.cidara.com/news/cidara-therapeutics-announces-european-approval-of-rezzayo-rezafungin-for-the-treatment-of-invasive-candidiasis-in-adults/
18. Rezafungin - New Drug Approvals, accessed October 15, 2025, https://newdrugapprovals.org/2025/05/15/rezafungin/
19. Rezzayo™'s Latest EU Approval for Invasive Candidiasis Breaks Ground in Antifungal Therapy - PharmaFeatures, accessed October 15, 2025, https://pharmafeatures.com/rezzayos-latest-eu-approval-for-invasive-candidiasis-breaks-ground-in-antifungal-therapy/
20. Rezafungin - Wikipedia, accessed October 15, 2025, https://en.wikipedia.org/wiki/Rezafungin
21. Rezafungin | Echinopsin | Antifungal - TargetMol, accessed October 15, 2025, https://www.targetmol.com/compound/rezafungin
22. Rezafungin (Biafungin) | Echinocandin - MedchemExpress.com, accessed October 15, 2025, https://www.medchemexpress.com/rezafungin.html
23. View - European Medicines Agency - Europa.eu, accessed October 15, 2025, https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rezzayo-epar-product-information-tracked-changes_en.docx
24. This label may not be the latest approved by FDA. For current ..., accessed October 15, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217417s000lbl.pdf
25. What is the mechanism of Rezafungin acetate? - Patsnap Synapse, accessed October 15, 2025, https://synapse.patsnap.com/article/what-is-the-mechanism-of-rezafungin-acetate
26. Formulary Drug Review: Rezafungin - PMC, accessed October 15, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11097930/
27. Pharmacology of Rezafungin (Rezzayo); Mechanism of action, Pharmacokinetics, Uses, Effects - YouTube, accessed October 15, 2025, https://www.youtube.com/watch?v=GvnPVymK_es
28. Public Assessment Report National Procedure Rezzayo 200 mg powder for concentrate for solution for infusion rezafungin acetate PLGB - NET, accessed October 15, 2025, https://mhraproducts4853.blob.core.windows.net/docs/59081b042ab2804e873328b2a3ab82be265e9dcc
29. Activity of rezafungin against Candida auris | Journal of Antimicrobial Chemotherapy | Oxford Academic, accessed October 15, 2025, https://academic.oup.com/jac/article/80/6/1482/8122730
30. Pharmacodynamic Evaluation of Rezafungin (CD101) against Candida auris in the Neutropenic Mouse Invasive Candidiasis Model, accessed October 15, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC6201117/
31. distinctive pharmacokinetic profile of rezafungin, a long-acting echinocandin developed in the era of modern pharmacometrics | Journal of Antimicrobial Chemotherapy | Oxford Academic, accessed October 15, 2025, https://academic.oup.com/jac/article/80/1/18/7900481
32. Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis | Antimicrobial Agents and Chemotherapy - ASM Journals, accessed October 15, 2025, https://journals.asm.org/doi/10.1128/aac.01584-23
33. 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 - Oxford Academic, accessed October 15, 2025, https://academic.oup.com/ofid/article/12/9/ofaf555/8253965
34. Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis, accessed October 15, 2025, https://www.cidara.com/news/cidara-therapeutics-and-mundipharma-announce-positive-topline-results-from-the-global-phase-3-pivotal-restore-trial-of-rezafungin-for-the-treatment-of-candidemia-and-invasive-candidiasis/
35. FDA News: Issue 11-1 May 2023 - ASCPT, accessed October 15, 2025, https://www.ascpt.org/Resources/ASCPT-News/View/ArticleId/28216/FDA-News-Issue-11-1-May-2023
36. Rezzayo (rezafungin) dosing, indications, interactions, adverse effects, and more, accessed October 15, 2025, https://reference.medscape.com/drug/rezzayo-rezafungin-4000328
37. Rezafungin (REZZAYO™) National Drug Monograph April 2024 - VA.gov, accessed October 15, 2025, https://www.va.gov/formularyadvisor/DOC_PDF/MON_Rezafungin_REZZAYO_Monograph_May_2024.pdf
38. Metabolism, Excretion, and Mass Balance of [ 14 C]-Rezafungin in Animals and Humans, accessed October 15, 2025, https://journals.asm.org/doi/10.1128/AAC.01390-21
39. Metabolism, Excretion, and Mass Balance of [14C]-Rezafungin in Animals and Humans | Antimicrobial Agents and Chemotherapy - ASM Journals, accessed October 15, 2025, https://journals.asm.org/doi/abs/10.1128/AAC.01390-21
40. FDA News: Issue 11-1 May 2023 - ASCPT, accessed October 15, 2025, [https://www.ascpt.org/Resources/ASCPT-News/View/articleid/28216?dnnprintmode=true&mid=16095&SkinSrc=[G]Skins%2F_default%2FNo+Skin&ContainerSrc=[G]Containers%2F_default%2FNo+Container](https://www.google.com/url?q=https://www.ascpt.org/Resources/ASCPT-News/View/articleid/28216?dnnprintmode%3Dtrue%26mid%3D16095%26SkinSrc%3D%255BG%255DSkins/_default/No%2BSkin%26ContainerSrc%3D%255BG%255DContainers/_default/No%2BContainer&sa=D&source=editors&ust=1760513719205426&usg=AOvVaw2Ot916d085mWiQd0x8jdBR)
41. Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial - PubMed Central, accessed October 15, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC8662762/
42. Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double ..., accessed October 15, 2025, https://pubmed.ncbi.nlm.nih.gov/32955088/
43. New Perspectives on Antimicrobial Agents: Rezafungin - ASM Journals, accessed October 15, 2025, https://journals.asm.org/doi/10.1128/aac.00646-23
44. Cidara Therapeutics Reports Positive Topline Results in Phase 2 STRIVE B Trial of Antifungal Rezafungin, accessed October 15, 2025, https://www.cidara.com/news/cidara-therapeutics-reports-positive-topline-results-in-phase-2-strive-b-trial-of-antifungal-rezafungin/
45. Drug Trials Snapshots: REZZAYO - FDA, accessed October 15, 2025, https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rezzayo
46. Rezafungin Elicits Non-Inferior Outcomes to Caspofungin in Treating a Serious Fungal Infection | CancerNetwork, accessed October 15, 2025, https://www.cancernetwork.com/view/rezafungin-elicits-non-inferior-outcomes-to-caspofungin-in-treating-a-serious-fungal-infection
47. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial - Find an Expert - The University of Melbourne, accessed October 15, 2025, https://findanexpert.unimelb.edu.au/scholarlywork/1748299-rezafungin-versus-caspofungin-for-treatment-of-candidaemia-and-invasive-candidiasis-(restore)--a-multicentre--double-blind--double-dummy--randomised-phase-3-trial
48. ReSTORE PHASE 3 TRIAL RESULTS FOR REZAFUNGIN, accessed October 15, 2025, https://docs.publicnow.com/viewDoc?hash_primary=5E72A6C4EAF1BF7B8F137A503B759818BD2521CA
49. Dosing-and-Administration.pdf - Rezzayo, accessed October 15, 2025, https://rezzayo.com/wp-content/uploads/2025/06/Dosing-and-Administration.pdf
50. 217417Orig1s000 - accessdata.fda.gov, accessed October 15, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000IntegratedR.pdf
51. Safety - Rezzayo, accessed October 15, 2025, https://rezzayo.com/safety/
52. Rezafungin: Side Effects, Uses, Dosage, Interactions, Warnings, accessed October 15, 2025, https://www.rxlist.com/rezafungin/generic-drug.htm
53. Rezafungin Injection: MedlinePlus Drug Information, accessed October 15, 2025, https://medlineplus.gov/druginfo/meds/a623021.html
54. Rezzayo 200 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc) | 15479, accessed October 15, 2025, https://www.medicines.org.uk/emc/product/15479/smpc
55. Rezafungin acetate for the treatment of candidemia and invasive candidiasis: a pharmacokinetic evaluation - PubMed, accessed October 15, 2025, https://pubmed.ncbi.nlm.nih.gov/39552377/
56. Formulary Pack - Napp Pharmaceuticals, accessed October 15, 2025, https://www.napphcp.co.uk/sites/mundipharmagb/files/2024-04/UK%20REZZAYO%20abbreviated%20formulary%20pack%20%28branded%29.pdf
57. Union Register of medicinal products - Public health - European Commission - EC Europa, accessed October 15, 2025, https://ec.europa.eu/health/documents/community-register/html/h1775.htm
58. Cidara Therapeutics and Melinta Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis, accessed October 15, 2025, https://www.cidara.com/news/cidara-therapeutics-and-melinta-therapeutics-announce-fda-advisory-committee-recommends-approval-of-rezafungin-for-the-treatment-of-candidemia-and-invasive-candidiasis/
59. Rezzayo | European Medicines Agency (EMA), accessed October 15, 2025, https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo
60. Australian Register of Therapeutic Goods (ARTG) | Therapeutic ..., accessed October 15, 2025, https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg
61. Therapeutic Goods Administration (TGA) | Australian Government Department of Health, Disability and Ageing, accessed October 15, 2025, https://www.tga.gov.au/
62. Fungus Diseases Recruiting Phase 3 Trials for Rezafungin (DB16310) | DrugBank Online, accessed October 15, 2025, https://go.drugbank.com/indications/DBCOND0032261/clinical_trials/DB16310?phase=3&status=recruiting