RAANANA, Israel, July 2, 2026
Polyrizon Ltd. announced the successful completion of its NASARIX™ biocompatibility evaluation program, marking an important milestone in advancing the investigational Allergy Blocker nasal spray toward a first-in-human clinical trial. The comprehensive biological safety program confirmed that NASARIX™ successfully met all predetermined acceptance criteria across the required safety assessments conducted in accordance with the ISO 10993 series, FDA guidance, and applicable European regulatory standards. The positive results strengthen the product’s non-clinical safety package and support continued progress through the clinical and regulatory pathway. NASARIX™ is a drug-free, mucoadhesive intranasal hydrogel designed to create a protective barrier within the nasal cavity, helping reduce exposure to airborne allergens associated with seasonal allergic rhinitis while offering a non-pharmacological approach to allergy management.
Biocompatibility Program Confirms Readiness for Clinical Advancement
The completed evaluation assessed all critical biological safety endpoints required before initiating clinical studies, including cytotoxicity, sensitization, irritation, intracutaneous reactivity, material-mediated pyrogenicity, and acute systemic toxicity. In addition, long-term systemic toxicity was evaluated through a comprehensive toxicological risk assessment conducted under ISO 10993-17, demonstrating substantial safety margins for the product’s materials under intended clinical use. The testing program was performed using the final commercial configuration of NASARIX™ and included assessments of formulation components, manufacturing processes, packaging materials, patient exposure, and biological risk management in accordance with ISO 10993-1 and ISO 14971. According to Polyrizon, all required endpoints successfully met predefined acceptance criteria, providing a strong scientific foundation for advancing the product into human clinical evaluation.
NASARIX™ Designed to Provide Drug-Free Allergy Protection
NASARIX™ is being developed as a drug-free nasal spray that forms a thin mucoadhesive hydrogel barrier inside the nasal cavity, helping prevent airborne allergens from reaching the nasal mucosa. Unlike traditional allergy medications that rely on active pharmaceutical ingredients, the investigational product is intended to provide a physical protective barrier that minimizes allergen exposure without delivering pharmacological therapy. The technology is being developed for individuals affected by seasonal allergic rhinitis, a common condition that impacts millions of patients worldwide. Successful completion of the biocompatibility program represents a critical regulatory milestone supporting the transition from preclinical development to first-in-human clinical testing, where the product’s safety and performance will be further evaluated.
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Clinical Development Program Continues Toward Regulatory Milestones
The successful completion of the NASARIX™ biocompatibility program significantly strengthens Polyrizon’s non-clinical development package while supporting future regulatory submissions required to initiate human studies. The company believes the positive biological safety results validate the product’s design, manufacturing process, and material selection, providing confidence as it advances toward its planned first-in-human clinical trial. Beyond NASARIX™, Polyrizon continues to expand its proprietary Capture and Contain™ hydrogel technology platform for additional intranasal medical applications, including protection against airborne pathogens and future drug delivery technologies. With this important development milestone achieved, the company is positioned to continue clinical advancement of NASARIX™, bringing the investigational allergy barrier technology closer to evaluation in patients and potential future commercialization.
Source: Polyrizon press release
