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Polyrizon Files FDA Pre-Request for Designation of PL-16 Intranasal Viral Blocker

Story Highlights
  • Polyrizon has filed a Pre-Request for Designation with the FDA for PL-16, a non-drug nasal hydrogel spray designed to physically block influenza and cold viruses, supported by in-vitro data showing over 90% cell protection.
  • The PL-16 program advances Polyrizon’s broader strategy to build a portfolio of drug-free, barrier-based intranasal products, positioning the company in a rapidly growing nasal spray market driven by persistent seasonal respiratory infections and demand for preventive solutions.
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Polyrizon Files FDA Pre-Request for Designation of PL-16 Intranasal Viral Blocker

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Polyrizon Ltd. ( (PLRZ) ) has issued an update.

On December 19, 2025, Polyrizon Ltd. announced it has submitted a Pre-Request for Designation to the U.S. Food and Drug Administration for PL-16 Viral Blocker, a non-pharmacological, metered-dose intranasal hydrogel spray intended to reduce exposure to airborne respiratory viruses such as influenza and common cold viruses by forming a temporary physical barrier on the nasal mucosa. The submission, backed by preclinical in‑vitro data showing over 90% protection of cells against influenza A (H1N1) and human coronavirus 229E and confirming a purely mechanical, non-virucidal mode of action, initiates formal regulatory dialogue on PL-16’s approval pathway and underscores Polyrizon’s strategy to expand its drug‑free nasal barrier portfolio alongside products like PL-14 Allergy Blocker in a fast-growing global nasal spray market, where seasonal respiratory infections represent a significant and recurring commercial and public‑health opportunity.

More about Polyrizon Ltd.

Polyrizon Ltd., based in Raanana, Israel, is a pre-clinical-stage biotechnology company specializing in innovative medical device hydrogels delivered via nasal sprays. Its proprietary Capture and Contain (C&C) platform is designed to form a thin, bioadhesive hydrogel barrier in the nasal cavity that functions as a “biological mask,” blocking viruses and allergens, while an earlier-stage Trap and Target (T&T) platform targets intranasal delivery of active pharmaceutical ingredients for additional respiratory and drug-delivery indications.

Average Trading Volume: 3,077,282

Technical Sentiment Signal: Sell

Current Market Cap: $16.19M

For an in-depth examination of PLRZ stock, go to TipRanks’ Overview page.

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