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CorMedix (CRMD) FDA Approvals

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CorMedix's Drugs in the FDA Approval Process

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.

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.

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.

CorMedix FDA Events - Frequently Asked Questions

In the past two years, CorMedix (CRMD) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, CorMedix (CRMD) has reported FDA regulatory activity for the following drugs: REZZAYO, DefenCath and LOCK IT-100.

The most recent FDA-related event for CorMedix occurred on September 29, 2025, involving REZZAYO. The update was categorized as "Enrollment Completion," with the company reporting: "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)."

Current therapies from CorMedix in review with the FDA target conditions such as:

  • in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). - REZZAYO
  • for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter. - DefenCath
  • in preventing Catheter Related Bloodstream Infections (CRBSIs) - LOCK IT-100

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:CRMD) was last updated on 10/1/2025 by MarketBeat.com Staff
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