Antibiotic lock therapy for salvaging catheters that cause bloodstream infections

Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line associated bloodstream infections (CLABSIs). CRBSIs/CLABSIs are life-threatening conditions, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.

Mino-Lok® is intended to salvage the CVC, avoiding the need to remove and replace the infected catheter. Currently, there are few alternatives to removing and replacing a CVC once it becomes infected. Studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. Mino-Lok® is being developed to address the complications, discomfort and cost of CVC removal and replacement. There are currently no FDA-approved products to salvage infected CVCs.

Program Highlights

  • Mino-Lok® is the first & only therapy under investigation to salvage infected CVCs
  • In a Phase 2b trial, Mino-Lok® demonstrated a 100% efficacy rate in salvaging colonized CVCs; Mino-Lok® had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced. Learn more…
  • A multicenter Phase 3 pivotal superiority trial was completed, meeting primary and secondary endpoints. Learn more…
  • Mino-Lok® was granted QIDP and Fast Track designation by the FDA and has formulation patent protection through 2036
  • Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center

Mino-Lok is a clinical phase product candidate. The results of the ongoing and any future clinical trials will determine whether we seek regulatory approval for Mino-Lok.

How it works

Mino-Lok® contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. Mino-Lok® is used in two-hour locking cycles, allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.

Infected double lumen catheter showing biofilm in both lumens.

Infected double lumen catheter showing biofilm in both lumens.