Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocker

Polyrizon Ltd. has submitted a Pre-Request for Designation (Pre-RFD) to the FDA for its PL-16 Viral Blocker, a non-pharmacological intranasal product designed to reduce exposure to influenza and cold viruses by forming a physical barrier on the nasal mucosa. This submission initiates a regulatory dialogue with the FDA to determine the appropriate pathway for PL-16. The product is a metered-dose intranasal spray containing biodegradable polymers that form a thin, muco-adhesive hydrogel layer upon application. In-vitro studies have demonstrated its efficacy in blocking viral access to cells, with over 90% success in protecting cells against influenza A and human coronavirus 229E. The PL-16 Viral Blocker is part of Polyrizon’s strategy to develop non-medicated intranasal solutions based on its Capture and Contain (C&C) technology platform. The company is also developing PL-14 Allergy Blocker, which uses a similar approach for airborne allergens. The global nasal spray market is projected to grow significantly, and Polyrizon aims to address the large market for cold and flu prevention with its drug-free solution. Polyrizon will engage with the FDA following the Pre-RFD feedback to align on next development steps.