FDA Type C Meeting Propels Citius Pharmaceuticals' Mino-Lok® Towards Phase 3 Approval

Citius Pharmaceuticals, Inc., a biopharmaceutical company focused on developing innovative critical care products, announced a productive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). The discussion followed the successful completion of the pivotal Phase 3 clinical trial for Mino-Lok®, a groundbreaking catheter lock solution aimed at saving central venous catheters in patients with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI).

Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, said in a statement “We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program. The FDA's comprehensive feedback supports our commitment to advancing this novel solution for patients who face life-threatening complications from catheter-related infections. The Agency's guidance provides a strong framework for completing the remaining steps toward an NDA submission.”

During the meeting, the FDA provided detailed and actionable guidance to support a future New Drug Application (NDA) for Mino-Lok. Key topics included clinical trial results, safety and efficacy data, and regulatory requirements. Citius Pharma emphasized Mino-Lok's potential to meet a critical medical need and reaffirmed its commitment to advancing the program.

Mazur added, "We believe Mino-Lok has demonstrated compelling clinical outcomes in the Phase 3 trial, supporting its potential to significantly enhance the management of catheter-related bloodstream infections. As a groundbreaking alternative to catheter removal, Mino-Lok, if approved, could reduce healthcare costs, mitigate patient risks, and improve clinical outcomes for individuals requiring central venous catheterization. Citius Pharmaceuticals remains committed to advancing the Mino-Lok® program and will continue to provide updates on regulatory and clinical developments as they unfold.”