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DefenCath FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 15, 2023.

FDA Approved: Yes (First approved November 15, 2023)
Brand name: DefenCath
Generic name: taurolidine and heparin
Dosage form: Catheter Lock Solution
Company: CorMedix Inc.
Treatment for: Prevention of Catheter-Related Bloodstream Infections

DefenCath (taurolidine and heparin) catheter lock solution is a thiadiazinane antimicrobial and anticoagulant combination indicated to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).

  • Catheter-related bloodstream infections (CRBSIs) are a common complication in patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter. CRBSIs are caused by a wide range of pathogens, many of which are antibiotic-resistant.
  • DefenCath is a catheter lock solution that contains taurolidine, a broad-spectrum non-antibiotic antimicrobial and antifungal agent, and heparin, an anticoagulant. Taurolidine works to prevent CRBSIs by binding to microbial cell walls to cause loss of cell wall integrity, which leads to cell death. Heparin is a well-established anticoagulant that is widely used in hemodialysis to prevent thrombosis and to maintain catheter patency.
  • FDA approval of DefenCath was supported by results of the Phase 3 LOCK-IT-100 clinical trial which demonstrated a 71% risk reduction in CRBSIs in patients who received DefenCath compared to those who received heparin as a catheter lock solution.
  • DefenCath is instilled in the lumen of a central venous catheter between sessions of dialysis.
  • Warnings and precautions associated with DefenCath include heparin-induced thrombocytopenia and drug hypersensitivity reactions.
  • Common adverse reactions include hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

Development timeline for DefenCath

Nov 15, 2023Approval FDA Approves DefenCath (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients
Jun 21, 2023Cormedix Inc. Announces FDA Acceptance of Resubmission Of New Drug Application for Defencath
Mar 28, 2022Cormedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for Defencath
Mar  1, 2021Cormedix Receives Complete Response Letter From FDA for Defencathâ„¢ Catheter Lock Solution
Nov 18, 2020CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
Aug 31, 2020CorMedix Inc. Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Defencath
Jul  8, 2020CorMedix Inc. Reports Submission of Defencathâ„¢ New Drug Application

Further information

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