RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Orphan Drug (European Union), Priority Review (European Union)

Structure/Sequence

Molecular FormulaC65H88N8O19

InChIKeyMXMWJAPNUIKPGF-YOFVRWEXSA-N

CAS Registry1631754-41-0

Sequence Code 14003067

Clinical Trials associated with Rezafungin acetate

NCT06774144

/ Enrolling by invitationPhase 3IIT

Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection

This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.

Start Date01 Sep 2025

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT06985758

/ Not yet recruitingPhase 4IIT

Phase IV, Open-label, Single Arm, Multicenter Trial to Evaluate Pharmacokinetic Parameters of Peritoneal Diffusion and Peritoneal Diffusion Activity.

Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried out mainly in patients with candidemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level in relation to isolates at the blood culture level.
Rezafungin, with its special pharmacokinetics, achieves higher tissue concentrations, including hepato-splenic and other abdominal organs, than the other echinocandins. Experimental studies have confirmed that the concentration of rezafungin at the level of the inflammatory focus in abdominal infections is higher than in the surrounding healthy tissue and higher than those achieved by micafungin. Finally, the biofilm activity of rezafungin is very high, clearly superior to fluconazole and possibly higher than that of other echinocandins.

Start Date01 Sep 2025

Sponsor / Collaborator

Hospital Universitario Ramón y Cajal

NCT06794554

/ RecruitingPhase 2

A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options

The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options.
The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging.
Participants will:
* Be given the drug rezafungin every week for 6 months.
* Visit the clinic once a month for checkups and tests.
* Complete questionnaires on thier health and wellbeing.

Start Date30 Jun 2025

Sponsor / Collaborator

Mundipharma Research Ltd.

100 Clinical Results associated with Rezafungin acetate

100 Translational Medicine associated with Rezafungin acetate

100 Patents (Medical) associated with Rezafungin acetate

131

Literatures (Medical) associated with Rezafungin acetate

01 Jan 2026·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Development of a rezafungin isolate verification panel and comparison of reference method to ThermoFisher Sensititre YeastOne panel MIC results

Article

Author: Koeth, Laura ; DiFranco-Fisher, Jeanna

Rezafungin is indicated for the treatment of adults with limited or no alternative treatment options for candidemia and invasive candidiasis. The development of a rezafungin isolate verification panel is described. A total of 35 Candida species isolates were chosen for initial testing and 30 isolates were selected for additional testing including C. albicans (n = 11), C. glabrata (n = 8), C. tropicalis (n = 7) and C. parapsilosis (n = 4). Modal MIC, range of results and categorical agreement results (based on an acceptable ±2 dilution from the modal MIC) were calculated. Both FDA STIC and CLSI breakpoints were applied to calculated categorical agreement. The replicate reference BMD (rBMD) MIC results spanned an average of 2.4-dilution range and were within ±1 dilution of the modal rBMD for 26/30 (86.7 %) isolates and within ±2 dilutions for all isolates (100 %). The final panel of isolates was used to compare rBMD MIC values with those generated using the Sensititre™ YeastOne™ panel. The correlation of YeastOne results to modal rBMD results was particularly good; 26 out of 30 isolates (86.7 %) were within ±1 dilution of the modal rBMD and 100 % were within ±2 dilutions. When categorical agreement was calculated using CLSI and FDA breakpoints, CLSI criteria performed better than FDA, albeit this was associated with a limited number of isolates with MIC results near the breakpoints. The availability of a curated verification panel with rezafungin modal MIC values will be a valuable resource for laboratories as they incorporate testing devices containing rezafungin into their yeast susceptibility testing paradigm.

01 Nov 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Rezafungin vs caspofungin for the treatment of invasive candidiasis: A systematic review and meta-analysis

Review

Author: Eltayeb, Abdalla Osman ; Alhamed, Arina ; Abdat, Wejdan ; Alshahrani, Norah Nasser A ; Alhothali, Amjad Salman A ; Alsheikh, Razan Shukr ; Almajed, Hind Mohammed ; Alhamdi, Sultan Ibrahim S ; Al Diab Al Azzawi, Mohammad

BACKGROUND:

Severe fungal infection known as invasive candidiasis primarily impacts critically ill alongside immunocompromised patients with high mortality and long hospital stays and creates substantial healthcare expenses. Echinocandins constitute the current standard first-line treatment for invasive candidiasis, with caspofungin being among the most widely used agents, caspofungin is used to treat invasive candidiasis but requires daily intravenous administration, and its pharmacokinetics may vary between patients. A new generation echinocandin antifungal drug called Rezafungin demonstrates an extended half-life through which medical personnel can administer treatment only once per week to improve patient adherence and minimize healthcare costs. This review aimed to compare rezafungin and caspofungin to evaluate their efficacy and safety, and to explore whether rezafungin's pharmacokinetics offer clinical advantages.

METHODS:

We conducted a systematic review and meta-analysis of randomized controlled trials comparing rezafungin and caspofungin for invasive candidiasis in adults. Studies were selected based on predefined PICOS criteria and sourced from PubMed, Scopus, Embase, Web of Science, and Cochrane Library. After removing duplicates using Rayyan, four eligible trials involving adult patients were included. Data on efficacy and safety outcomes were extracted. Risk of bias was assessed using ROB 2, and meta-analysis was performed using RevMan 5.4 to calculate risk ratios with 95 % confidence intervals.

RESULTS:

Four RCT with 677 patients included in our systematic review and meta-analysis. The pooled analysis revealed no statistically significant differences between rezafungin and caspofungin in key outcomes. Global cure at day 14 was similar between the two groups (RR = 1.04, 95 % CI: 0.90-1.20, p = 0.45), as were the rates subgroup anaylsis of blood culture negativity at 24 and 48 h and mycological eradication, and safety outcomes such as, Patients with ≥1 treatment-emergent adverse event, abdominal pain, hypokalemia, acute kidney injury, septic shock, and all-cause mortality at day 30.

CONCLUSION:

Rezafungin is noninferior to caspofungin in the treatment of invasive candidiasis, offering equivalent efficacy and safety outcomes. Its once-weekly dosing regimen presents potential advantages in terms of improved patient adherence and reduced healthcare resource utilization. Future research should focus on larger, more diverse populations and longer follow-up durations to further elucidate the long-term benefits and cost-effectiveness of rezafungin.

01 Oct 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design, synthesis and biological evaluation of natural product echinocandin derivatives

Article

Author: Zheng, Yan ; Chu, Shaojie ; Wu, Xuesong ; Wang, Hongbo ; Wang, Guoping ; Su, Shuangshuang ; Chen, Shaoxin

Fungal pathogen infections impose a great challenge for global public health, causing approximately 1.6 million deaths annually. Echinocandin-class drugs, with unique mechanism and favorable safety profile, have become the first-line anti-fungal therapeutic option for candidemia and invasive candidiasis. The present study successfully designed and synthesized a series of novel echinocandin derivatives, among which SIPI-18333 and SIPI-18334 exhibited a minimum inhibitory concentration (MIC) of 0.03125 μg/mL against Candida krusei in vitro, significantly surpassing existing echinocandin drugs. Furthermore, these optimized compounds demonstrated minimal dependence on CYP450 metabolism in liver microsomes, resulting in significantly reduced risk of drug-drug interactions. Meanwhile, plasma stability experiments indicated that the optimized compounds exhibited better stability in plasma compared with Micafungin. Subsequent pharmacokinetic studies in rats showed significantly higher plasma exposure levels [Cmax, AUC(0-t)] of the optimized compounds than those of Rezafungin. To sum up, SIPI-18333 and SIPI-18334 exhibit superior anti-fungal activity and enhanced bioavailability, which are promising candidates for the next-generation anti-fungal agents and warrant further development.

143

News (Medical) associated with Rezafungin acetate

29 Sep 2025

·www.globenewswire.com

CorMedix Announces Completion of Enrollment in Phase III ReSPECT Clinical Trial for REZZAYO

- Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant - - Topline Results from ReSPECT Study Expected in 2Q 2026 - BERKELEY HEIGHTS, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. “Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT,” said Joseph Todisco, CEO of CorMedix. Mr. Todisco continued, “While we have just recently closed our acquisition of Melinta Therapeutics, we believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population. We look forward to sharing topline results from this study next year.” The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. About REZZAYO® REZZAYO (rezafungin for injection) is a next generation echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market (“TAM”) of over $2B in this market segment. REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence ≥5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

Phase 3Drug ApprovalAcquisitionLicense out/inOrphan Drug

29 Sep 2025

·cormedix.com

CORMEDIX ANNOUNCES COMPLETION OF ENROLLMENT IN PHASE III RESPECT CLINICAL TRIAL FOR REZZAYO

– Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant – – Topline Results from ReSPECT Study Expected in 2Q 2026 – Berkeley Heights, NJ – September 29, 2025 – CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. “Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT,” said Joseph Todisco, CEO of CorMedix. Mr. Todisco continued, “While we have just recently closed our acquisition of Melinta Therapeutics, we believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population. We look forward to sharing topline results from this study next year.” The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. About REZZAYO® REZZAYO (rezafungin for injection) is a next generation echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market (“TAM”) of over $2B in this market segment. REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence ≥5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Phase 3AcquisitionDrug ApprovalOrphan DrugClinical Result

09 Sep 2025

·www.globenewswire.com

CorMedix Announces Strategic Minority Investment in Talphera

Sept. 08, 2025 -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it has made a $5 million strategic minority equity investment in Talphera, Inc. (Nasdaq: TLPH), acquiring 9,090,909 shares at an at-market price of $0.55 per share as part of Talphera’s concurrently announced private placement financing. Talphera expects to use the proceeds of the equity financing to fund the completion of its ongoing Phase 3 registrational study for Niyad™ and for pre-launch preparations. Talphera is a specialty pharmaceutical company developing Niyad, a lyophilized formulation of nafamostat which is currently being studied as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (“FDA”). Talphera’s randomized, double-blind, registrational study of Niyad, NEPHRO CRRT, aims to enroll and evaluate 70 adult patients undergoing continuous renal replacement therapy (“CRRT”), who cannot tolerate heparin or are at risk for bleeding. An estimated 165,000 acute kidney injury patients receive an average 5 to 7 day course of CRRT in the hospital ICU setting in a given year. In connection with the equity investment, Talphera has granted CorMedix (1) the exclusive right of first negotiation for a potential acquisition of the company with a 60 day exclusive negotiation period following completion and announcement of its Phase 3 study results for Niyad, and (2) the right to nominate one member to Talphera’s Board of Directors. “We are excited to announce this strategic investment and agreement with Talphera, as we see Niyad as a potential significant improvement above the current standard of care in CRRT,” said Joseph Todisco, CEO of CorMedix. “The investment in Talphera is consistent with our business development strategy to invest in highly synergistic and undervalued assets. We look forward to building a relationship with Talphera as it advances Niyad toward a potential approval in 2026.” Vince Angotti, Talphera CEO, stated. “We appreciate the interest CorMedix has in Talphera and the support from a company that has quickly established itself as a leader in acute care specialty products. The completion of this financing with CorMedix as well as other high quality institutional investors further validates the potential value of Niyad to become a new standard of care in the hospital acute care market. If approved, Niyad would become the first available FDA-approved regional anticoagulant for CRRT.” CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter related bloodstream infections in patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products including MINOCIN® (minocycline), REZZAYO™ (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath® in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath® as a catheter lock solution for use in other patient populations. REZZAYO™ is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO™ is expected in 1H 2026. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalAcquisitionBreakthrough Therapy

100 Deals associated with Rezafungin acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D11198	-	-	DB16310

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Candidemia	United States	Mundipharma GmbH	22 Mar 2023
Candidiasis, Invasive	United States	Mundipharma GmbH	22 Mar 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Invasive Fungal Infections	Phase 3	United States	Melinta Therapeutics, Inc.	01 Sep 2025
Pneumocystis Infections	Phase 3	Belgium	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Canada	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	France	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Germany	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Italy	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Spain	Cidara Therapeutics, Inc.	11 May 2020
Candidiasis, Oral	Phase 2	United States	Cidara Therapeutics, Inc.	08 Jun 2016
Candidiasis, Vulvovaginal	Phase 2	United States	Cidara Therapeutics, Inc.	08 Jun 2016
Yeast infection	Phase 2	United States	Cidara Therapeutics, Inc.	08 Jun 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02734862 \| NCT03667690 (ReSTORE;STRIVE, Pubmed \| Crit Care)	Phase 3	Candidemia \| Candidiasis, Invasive	294	Rezafungin	poyngpmzjx(cvkuhnehev) = zsbwzvgvam vfxxhsdxlf (zvymqvxgtd ) View more	Positive	11 Nov 2024
				Caspofungin	poyngpmzjx(cvkuhnehev) = ikzcvxpgda vfxxhsdxlf (zvymqvxgtd ) View more
NCT02734862 \| NCT03667690 (ReSTORE, Pubmed \| Crit Care)	Phase 2/3	Candidemia \| Candidiasis, Invasive	113	Rezafungin	ntdbefnjvo(wvwdabpymu) = hcvcffpcac xgbyujeaij (bowpaabrdy ) View more	Positive	28 Oct 2024
				Caspofungin	ntdbefnjvo(wvwdabpymu) = wstcgnbhnt xgbyujeaij (bowpaabrdy ) View more
NCT03667690 (ReSTORE, Pubmed \| Clin Infect Dis)	Phase 3	Candidemia positive culture	-	Rezafungin	sgfandqacu(qvvljztetc) = hfihlosivs ebjjfnudqt (qfyenkiqiv ) View more	Positive	26 Sep 2024
				Caspofungin	sgfandqacu(qvvljztetc) = euhbozxokv ebjjfnudqt (qfyenkiqiv ) View more
NCT02734862 \| NCT03667690 (ReSTORE, Biospace) Manual	Not Applicable	Candidemia \| Candidiasis, Invasive	-	REZZAYO	btyfnljfwt(ztdnipgodx) = REZZAYO was generally well tolerated and had a similar safety profile to caspofungin bsgpoyomwq (nxzpmluyrf )	Positive	05 Dec 2023
NCT02734862 \| NCT03667690 (ReSTORE, Pubmed 1 \| Pubmed 2 \| Lancet Infect Dis) Manual	Phase 2/3	Candidemia \| Candidiasis, Invasive	294	Rezafungin	slzrwnguvo(verwpstjbc) = erlfylesvd ypsgxpumta (bnxpbvzrvk ) View more	Positive	23 Nov 2023
				Caspofungin	slzrwnguvo(verwpstjbc) = wsyyglyjir ypsgxpumta (bnxpbvzrvk ) View more
NCT03667690 (FDA) Manual	Phase 3	Candidemia \| Candidiasis, Invasive	187	REZZAYO 400 mg/200 mg	bffqwfgczt(gaqvpdwxpk) = llyobyetyr thhtrhrtmp (vlqnwcsint ) View more	Superior	22 Mar 2023
				Caspofungin 70 mg/50 mg	bffqwfgczt(gaqvpdwxpk) = tojkadlwww thhtrhrtmp (vlqnwcsint ) View more
NCT03667690 (ReSTORE \| ReSTORE;STRIVE, CTgov)	Phase 3	Candidemia	199	oral placebo+Rezafungin (Group 1: Rezafungin for Injection)	hgwisqcuaq = jgubbfafuu zjilxfqmig (nvxgenpghj, wwdzhgkwzp - evbhmxchey) View more	-	06 Jan 2023
				intravenous placebo+Fluconazole+caspofungin (Group 2: Caspofungin)	hgwisqcuaq = bdpzejzarc zjilxfqmig (nvxgenpghj, wyqimiecld - qzlxdbnhfa) View more
NCT03667690 (ReSTORE, Pubmed \| Lancet)	Phase 3	Candidemia \| Candidiasis, Invasive	199	Rezafungin	txbkkvokhu(nudgxbmtrc) = pteunnodor mszvmpaeoj (gvgfrscevx ) View more	Positive	25 Nov 2022
				Caspofungin	txbkkvokhu(nudgxbmtrc) = bxsoccdaag mszvmpaeoj (gvgfrscevx ) View more
NCT03667690 (ReSTORE, Corporate Publications) Manual	Phase 3	Candidemia \| Candidiasis, Invasive	187	Rezafungin acetate	dkukptvgzi(mygbqdihck) = xsqswfdccq pqfwjspnmt (irswefqidj ) View more	Positive	14 Dec 2021
				Caspofungin	dkukptvgzi(mygbqdihck) = iabqprbatd pqfwjspnmt (irswefqidj ) View more
NCT02734862 (ReSTORE;STRIVE \| STRIVE, CTgov)	Phase 2	Candidemia	207	intravenous placebo+CD101 (Group 1)	yvhjhugnsr = wxrrisuylv wwwqaukotu (aybdzsgcdt, jrxducgwtr - qznpjvvsts) View more	-	08 Dec 2020
				intravenous placebo+CD101 (Group 2)	yvhjhugnsr = cchxumrriz wwwqaukotu (aybdzsgcdt, gilbgxxmsh - dvujobpgrz) View more

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