Norovirus Infection Pipeline: 8+ Leading Companies Advancing Breakthrough Vaccines and Antiviral Strategies | DelveInsight

The Norovirus infection pipeline is gaining momentum with 8+ pharmaceutical companies pursuing innovative solutions, including Prosit Sole Biotechnology, HilleVax, iosBio, and OstriGen. These players are developing next-generation oral and injectable vaccines, along with antiviral agents targeting viral replication and immune modulation. As Norovirus remains a leading cause of acute gastroenteritis worldwide, the pipeline aims to address critical gaps in prophylaxis and treatment, especially for vulnerable populations like young children and the elderly. Ongoing trials and platform-based technologies are poised to bring forward the first approved therapies in this underserved area.

DelveInsight's "Norovirus Infection Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the norovirus infection market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging norovirus Infection drugs, the norovirus infection pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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Key Takeaways from the Norovirus Infection Pipeline Report
• DelveInsight's norovirus infection pipeline analysis depicts a strong space with 8+ active players working to develop 8+ pipeline drugs for norovirus infection treatment.
• The leading norovirus infection companies include Vaxart, Cocrystal Pharma Inc, Prosit Sole Biotechnology, HilleVax, iosBio, OstriGen, and others are evaluating their lead assets to improve the norovirus infection treatment landscape.
• Key norovirus infection pipeline therapies in various stages of development include VXA-G1.1-NN, CDI 988, PSP 001, HIL 214, Norovirus vaccine, Research programme: antibodies, and others.
• In ​March 2025, the FDA expanded its warning regarding frozen oysters imported from South Korea due to a norovirus outbreak. Consumers are advised to avoid these products, and retailers should cease their sale and distribution.
• In January 2025, a study found that GLP-1 drugs like OZEMPIC may lower the risk of 42 health conditions but come with side effects like nausea and sleep issues. The FDA banned Red Dye No. 3 over cancer concerns, and Moderna advanced its norovirus vaccine to Phase III as U.S. flu cases remain high.
• In January 2025, the FDA unveiled a strategy to prevent norovirus and hepatitis A contamination in imported fresh and frozen berries. Key measures include enforcing food safety compliance, promoting sanitation practices, expanding research on virus persistence, and encouraging worker immunization. ​

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Norovirus Infection Overview
Norovirus infection, previously known as Norwalk-like virus, is a highly contagious illness that commonly causes acute gastroenteritis and food poisoning, often linked to the consumption of undercooked shellfish or contaminated food and water. It spreads easily through direct contact with infected individuals, touching contaminated surfaces, or being in close quarters such as schools, cruise ships, or nursing homes. Affecting all age groups and peaking in winter, symptoms typically appear 12 to 48 hours after exposure and include nausea, vomiting, stomach cramps, diarrhea, low-grade fever, and muscle aches, although some individuals may remain asymptomatic but still contagious. Diagnosis is usually based on clinical symptoms but may involve stool tests in immunocompromised patients. There is no specific treatment; management focuses on hydration through oral or intravenous fluids. Preventive measures include proper hand hygiene, thoroughly cooking seafood, avoiding contaminated food and water, and minimizing contact with infected individuals.

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Norovirus Infection Treatment Analysis: Drug Profile
VXA-G1.1-NN: Vaxart
Vaxart is developing a bivalent oral tablet vaccine targeting norovirus, a major cause of gastroenteritis in the U.S. and Europe. Following two successful Phase I trials of its monovalent GI.1-based candidate, which showed strong systemic and mucosal immune responses, a Phase 1b dose-optimization study confirmed 100% response in the high-dose group, with over 90% showing a two-fold increase in norovirus-specific antibodies after 56 days. The vaccine candidate is currently in Phase II development.

CDI-988: Cocrystal Pharma Inc
CDI-988 is an oral pan-viral protease inhibitor developed using Cocrystal's proprietary platform. It shows promise in treating both norovirus and coronavirus infections. In vitro studies demonstrated strong antiviral activity against GII.4 norovirus proteases and favorable GI-targeted pharmacokinetics. The candidate is currently in Phase I clinical development for norovirus infection.

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Norovirus Infection Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Norovirus Infection Pipeline Report
• Coverage: Global
• Key Norovirus Infection Companies: Vaxart, Cocrystal Pharma Inc., Prosit Sole Biotechnology, HilleVax, iosBio, OstriGen, and others.
• Key Norovirus Infection Pipeline Therapies: VXA-G1.1-NN, CDI 988, PSP 001, HIL 214, Norovirus vaccine, Research programme: antibodies, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Norovirus Infection Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Norovirus Infection Pipeline Therapeutics
6. Norovirus Infection Pipeline: Late-Stage Products (Phase III)
7. Norovirus Infection Pipeline: Mid-Stage Products (Phase II)
8. Norovirus Infection Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.