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Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocker Designed to Reduce the Exposure to Influenza and Cold Viruses
The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses Raanana, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal product designed to reduce exposure to airborne respiratory viruses,
About this update from Polyrizon Ltd.
[{"type":"text","content":"The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses","length":89,"tagName":"p"},{"type":"text","content":"Raanana, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal product designed to reduce exposure to airborne respiratory viruses, including influenza and cold viruses, by forming a temporary physical barrier on the nasal mucosa.","length":508,"tagName":"p"},{"type":"text","content":"The Pre-RFD submission initiates a formal regulatory dialogue with the FDA regarding the appropriate regulatory pathway for PL-16 Viral Blocker, based on its formulation and physical mode of action.","length":198,"tagName":"p"},{"type":"text","content":"This step comes at a time when seasonal respiratory infections remain a significant public health challenge. According to preliminary model-based estimates from the CDC, the 2025–2026 flu season has already resulted in at least 2.9 million symptomatic illnesses, 1.4 million medical visits, 30,000 hospitalizations, and 1,200 deaths (including about 12 pediatric deaths). These figures are early-season estimates and are expected to rise substantially as winter progresses; in a typical full flu season, illnesses can reach 9–41 million, with hundreds of thousands of hospitalizations.","length":585,"tagName":"p"},{"type":"text","content":"About PL-16 Viral Blocker","length":25,"tagName":"p"},{"type":"text","content":"PL-16 is a metered-dose intranasal spray containing a hydrogel formulation composed of biodegradable polymers, together with standard excipients. Upon application, PL-16 forms a thin, muco-adhesive hydrogel layer that acts as a physical barrier, mechanically reducing contact between inhaled airborne particles and the nasal epithelium.","length":336,"tagName":"p"},{"type":"text","content":"The product is intended for local, topical use only, with no systemic exposure and no intended pharmacological, immunological, or metabolic activity.","length":149,"tagName":"p"},{"type":"text","content":"Supporting Preclinical Evidence","length":31,"tagName":"p"},{"type":"text","content":"The ...