This section highlights FDA-related milestones and regulatory updates for drugs developed by Polyrizon (PLRZ).
Over the past two years, Polyrizon has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PL-16 and PL-14. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
PL-16 FDA Regulatory Events
PL-16 is a drug developed by Polyrizon for the following indication: Influenza and Cold Viruses.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PL-16
- Announced Date:
- December 19, 2025
- Indication:
- Influenza and Cold Viruses
Announcement
Polyrizon Ltd announced 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.
AI Summary
Polyrizon Ltd. has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration for its PL-16 Viral Blocker, a non‑pharmacological intranasal spray designed to form a temporary physical barrier on the nasal mucosa to reduce exposure to airborne respiratory viruses such as influenza and common cold viruses. The Pre‑RFD starts a formal regulatory dialogue with the FDA to determine the appropriate review pathway based on PL‑16’s formulation and mechanical mode of action.
PL‑16 is a metered‑dose hydrogel made from biodegradable polymers and excipients that creates a thin, muco‑adhesive layer over the nasal epithelium. It is intended for local use only, with no systemic exposure and no intended pharmacological, immunological, or metabolic effects.
Preclinical in‑vitro studies support the submission: assays showed over 90% protection of cells from influenza A (H1N1) and human coronavirus 229E, while tests confirmed the product blocks viruses mechanically rather than killing them. Dynamic Transwell experiments demonstrated effective viral blocking for several hours. Polyrizon will work with the FDA after feedback to define next development steps for PL‑16.
Read Announcement
PL-14 FDA Regulatory Timeline and Events
PL-14 is a drug developed by Polyrizon for the following indication: For seasonal allergic rhinitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PL-14
- Announced Date:
- December 8, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd. announces that it has successfully completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding its PL-14 Allergy Blocker product, a novel nasal spray designed to provide protective intranasal barrier functionality.
AI Summary
Polyrizon announced it completed a pre-submission meeting with the U.S. Food and Drug Administration about PL-14 Allergy Blocker, a novel nasal spray meant to create a protective barrier in the nose. At the meeting the company presented its overall development plan, including the proposed manufacturing process, analytical and quality controls, and a stability program to support future regulatory filings. Polyrizon also reviewed its planned biocompatibility testing and additional preclinical studies, aligning them with the FDA’s “Guidance for Nasal Spray and Inhalation Drug Products” to address key safety and performance elements.
The company discussed its clinical development strategy, noting clinical trials are expected to begin in 2026 with study designs and endpoints intended to meet FDA expectations for safety and performance. Polyrizon said the meeting provided early regulatory alignment and clarity, and the constructive dialogue could help advance PL-14 efficiently while meeting regulatory standards. The company remains committed to developing PL-14 as a safe, effective barrier against airborne allergens and particulates.
Read Announcement- Drug:
- PL-14
- Announced Date:
- October 6, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd. announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation.
AI Summary
Polyrizon Ltd., a biotech company in Israel, reported positive pre‐clinical results for its PL-14 Allergy Blocker, part of its Capture & Contain hydrogel platform. The study used a lab model with the Der p 1 house dust mite allergen placed atop the PL-14 formula to test allergen penetration through a nasal-like barrier.
After one hour, only 1.07% of the allergen passed through. After two hours, penetration was 1.14%, and after four hours it remained low at 13.6%. These findings show PL-14 can form a strong nasal barrier that limits allergen diffusion over time.
The allergen doses in this study were tens of times higher than typical seasonal exposure, suggesting PL-14 may protect well even under extreme conditions.
Polyrizon plans to advance PL-14 into clinical trials as a potential frontline preventive solution for allergic rhinitis and other nasal allergies.
Read Announcement- Drug:
- PL-14
- Announced Date:
- September 19, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd announced the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product, designed to help individuals suffering from nasal allergies.
AI Summary
Polyrizon Ltd. announced it has submitted its full pre-submission package to the U.S. Food and Drug Administration for its PL-14 product, designed to help people with nasal allergies. The package includes detailed manufacturing plans, clinical development strategies, and proposed regulatory pathways. This step marks significant progress in Polyrizon’s plan to gain marketing clearance and address an important gap in allergy treatment.
PL-14 Allergy Blocker is a novel, non-invasive nasal spray that forms a thin hydrogel barrier inside the nose. By physically blocking allergens, it aims to deliver rapid, long-lasting relief from mild allergic rhinitis symptoms—such as itchy, runny, or congested nasal passages—caused by pollen, dust mites, animal hair, and other airborne triggers.
“We are pleased to submit this Pre-Sub to the FDA, a crucial step in our journey to bring PL-14 to market,” said Tomer Izraeli, CEO of Polyrizon. “Allergic rhinitis affects hundreds of millions worldwide, and we believe our approach can transform treatment options.”
Read Announcement- Drug:
- PL-14
- Announced Date:
- September 12, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd. announced encouraging preclinical results supporting the performance of its PL-14 Allergy Blocker, part of its proprietary Capture & Contain (C&C) platform.
AI Summary
Polyrizon Ltd., a biotech company in Ra’anana, Israel, reported encouraging preclinical results for its PL-14 Allergy Blocker, part of the Capture & Contain (C&C) platform. The intranasal spray is designed to form a hydrogel barrier in the nasal cavity to prevent allergen contact with nasal tissue.
In collaboration with the University of Parma, the study led by Professor Fabio Sonvico used a silicone-based human nasal cast and fluorescein imaging to assess spray deposition. Under clinically relevant conditions, PL-14 achieved over 60% deposition in the nasal vestibule—the first region exposed to airborne allergens—highlighting its targeted delivery and barrier-forming potential.
Polyrizon’s CEO, Tomer Izraeli, said these findings support the core principle of delivering a protective layer at the point of allergen entry. The formulation maintained good sprayability and coverage, demonstrating ease of self-administration. The company plans further preclinical work and aims to progress to clinical trials.
Read Announcement- Drug:
- PL-14
- Announced Date:
- April 25, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd.announced the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product's development path.
AI Summary
Polyrizon Ltd., an Israeli biotech company, announced a successful preliminary safety study for its PL-14 Allergy Blocker formulation. The study, conducted using a human nasal tissue model (MucilAir™), tested the nasal gel spray that is designed to form a physical barrier against airborne allergens. Researchers evaluated key safety indicators such as tissue integrity, cytotoxicity, cilia beating frequency, mucociliary clearance, and inflammatory response during a 4‑hour application period. The results showed strong local tolerability with no tissue damage or inflammation detected, marking an important milestone in the product’s development path.
This advancement supports Polyrizon’s goal of developing a drug-free nasal spray for daily protection against allergens. The positive results also lay the foundation for future clinical trials and further regulatory discussions as the company moves closer to bringing PL-14 Allergy Blocker to market.
Read Announcement- Drug:
- PL-14
- Announced Date:
- March 27, 2025
- Indication:
- For seasonal allergic rhinitis.
Announcement
Polyrizon Ltd announced the structuring of its clinical strategy for PL-14, the Company's proprietary intranasal allergy blocker for seasonal allergic rhinitis.
AI Summary
Polyrizon Ltd has structured its clinical strategy for PL-14, an innovative intranasal allergy blocker designed to treat seasonal allergic rhinitis. The company plans to conduct a series of clinical studies to gather key data on the product’s efficacy, safety, user experience, and nasal residence time. One study will evaluate the effectiveness of PL-14 during peak allergy season under natural conditions, while another will focus on human factors to assess usability and patient acceptance. An additional study will examine how long the formulation remains in the nasal cavity. Tomer Izraeli, CEO of Polyrizon, remarked that the updated plan is an important step toward regulatory approval and eventual commercialization. The company aims to begin clinical trials in the United States and Europe by late 2025 or early 2026, following completion of preclinical work and further regulatory consultations.
Read Announcement
