Polyrizon Ltd. announced today the structuring of its clinical strategy for PL-14, the company’s proprietary intranasal allergy blocker for seasonal allergic rhinitis. This updated strategy is in preparation for a planned pre-submission meeting with the U.S. Food and Drug Administration (FDA).
The comprehensive clinical studies are expected to assess efficacy, safety, user experience, and nasal residence time of PL-14. This rigorous approach aims to generate strong data to support regulatory approval and eventual commercialization.
Polyrizon anticipates initiating clinical trials in the U.S. and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation. CEO Tomer Izraeli stated that this plan brings the company closer to its goal of advancing PL-14 to provide meaningful value to millions suffering from allergic rhinitis.
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