This section highlights FDA-related milestones and regulatory updates for drugs developed by CorMedix (CRMD).
Over the past two years, CorMedix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
REZZAYO, DefenCath, and LOCK. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
REZZAYO FDA Regulatory Events
REZZAYO is a drug developed by CorMedix for the following indication: in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- REZZAYO
- Announced Date:
- September 29, 2025
- Indication:
- in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
Announcement
CorMedix Inc.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).
AI Summary
CorMedix Inc. announced completion of enrollment in its ongoing global Phase III ReSPECT trial evaluating the antifungal drug REZZAYO® (rezafungin) for adults undergoing allogeneic blood and marrow transplantation. REZZAYO is a once-weekly echinocandin being tested to prevent Candida, Aspergillus, and Pneumocystis infections. The study is randomized, double-blind, and compares REZZAYO with a standard antifungal regimen.
Participants receive a 400 mg loading dose in week one, followed by 200 mg weekly for 13 weeks alongside matching placebos. The primary endpoint is fungal-free survival at day 90. Secondary objectives include the incidence of invasive fungal disease, treatment discontinuation due to toxicity, and mortality adjusted for patients’ other health conditions.
Sponsored by Mundipharma in the UK, the trial’s US distribution rights are licensed through CorMedix’s collaboration with Melinta Therapeutics. CEO Joseph Todisco said completing enrollment is a key step toward seeking FDA approval for REZZAYO’s prophylaxis indication. Topline results are expected in the second quarter of 2026.
Read Announcement- Drug:
- REZZAYO
- Announced Date:
- September 29, 2025
- Estimated Event Date Range:
- April 1, 2026 - June 30, 2026
- Target Action Date:
- Q2 2026
- Indication:
- in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
Announcement
CorMedix Inc. announced that Topline Results from ReSPECT Study Expected in 2Q 2026
AI Summary
CorMedix Inc. has finished enrolling patients in its global Phase III ReSPECT study, which is testing REZZAYO® (rezafungin) as a once-weekly prevention for invasive fungal infections in adults receiving allogeneic blood and marrow transplants. The randomized, double-blind trial compares a loading dose of rezafungin followed by weekly doses against a standard antifungal regimen. The main goal is to measure fungal-free survival at day 90, with secondary measures including infection rates, treatment tolerability and adjusted mortality. Topline results from the ReSPECT study are expected in the second quarter of 2026.
REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis in adults. CorMedix believes a positive prophylaxis indication could meet a critical unmet need and expand its market opportunity. The company looks forward to sharing the study’s key findings in mid-2026 as it advances toward potential FDA approval.
Read Announcement
DefenCath FDA Regulatory Events
DefenCath is a drug developed by CorMedix for the following indication: for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DefenCath
- Announced Date:
- June 6, 2024
- Indication:
- for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
Announcement
CorMedix Inc. announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years.
AI Summary
CorMedix Inc. announced that the Center for Medicare & Medicaid Services (CMS) has given DefenCath® pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). This decision means that hospitals will receive separate Medicare Part B payments for using DefenCath in outpatient settings. The pass-through status is granted for a period of at least two years and up to three years, helping ensure that providers are adequately reimbursed when performing procedures like HD-CVC placements in less-invasive, ambulatory settings.
This development is important as it supports a shift toward outpatient treatments for hemodialysis patients, who are at risk of catheter-related bloodstream infections. By securing distinct payment, the move aims to enhance patient care during the critical initial period following catheter placement, encouraging the broader use of DefenCath to reduce potentially life-threatening infections.
Read Announcement- Drug:
- DefenCath
- Announced Date:
- April 15, 2024
- Indication:
- for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
Announcement
CorMedix Inc. announced DefenCath® (taurolidine and heparin) catheter lock solution (CLS) is now commercially available for U.S. inpatient use.
AI Summary
CorMedix Inc. announced that its DefenCath® catheter lock solution is now commercially available for U.S. inpatient use. DefenCath® is a specialized product formulated with a combination of taurolidine and heparin. This solution is designed to prevent infections and improve catheter care in hospital settings. Hospitals can expect that the product will help reduce the risk of catheter-related bloodstream infections, which is a common problem among patients receiving long-term catheter treatments.
The availability of DefenCath® marks an important step forward in patient safety and infection control. With this launch, CorMedix aims to provide a more effective option for maintaining catheter hygiene. The announcement highlights the company’s commitment to offering innovative healthcare solutions that can improve patient outcomes in the U.S. inpatient environment.
Read Announcement
LOCK IT-100 FDA Regulatory Events
LOCK IT-100 is a drug developed by CorMedix for the following indication: in preventing Catheter Related Bloodstream Infections (CRBSIs).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LOCK IT-100
- Announced Date:
- April 11, 2024
- Indication:
- in preventing Catheter Related Bloodstream Infections (CRBSIs)
Announcement
CorMedix Inc. announced that two abstracts have been accepted for presentation at the Society for Healthcare Epidemiology of America (SHEA) conference being held in Houston, Texas, April 16 – 19, 2024.
AI Summary
CorMedix Inc. announced that two abstracts have been accepted for presentation at the upcoming Society for Healthcare Epidemiology of America (SHEA) conference in Houston, Texas, from April 16 to 19, 2024. The first abstract reports on a study examining the in vitro antimicrobial activity of taurolidine against various clinical isolates, including gram-positive bacteria, gram-negative bacteria, non-tuberculosis mycobacteria, and fungal strains. Researchers found that taurolidine demonstrated broad antimicrobial action and maintained its effectiveness even against bacteria resistant to common antibiotics.
The second abstract details a retrospective analysis focused on hospital acquired bloodstream infections (HA-BSI) in patients undergoing hemodialysis through a central venous catheter. The study highlights that patients with HA-BSI had a higher all-cause mortality rate of 27.8% and a significantly longer hospital stay compared to those without infections.
Read Announcement
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