Influenza Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

April 07 22:38 2025
Influenza Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Influenza Pipeline Insight 2025” report provides comprehensive insights about 120+ companies and 120+ pipeline drugs in Influenza pipeline landscape. It covers the Influenza pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Influenza therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Influenza Pipeline. Dive into DelveInsight’s comprehensive report today! @ Influenza Pipeline Outlook

Key Takeaways from the Influenza Pipeline Report

  • In April 2025, Eurofarma Laboratories S.A announced a phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment. A Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
  • DelveInsight’s Influenza pipeline report depicts a robust space with 120+ active players working to develop 120+ pipeline therapies for Influenza treatment.
  • The leading Influenza Companies such as Moderna, SAB Biotherapeutics, ENA Respiratory Pty Ltd, Codagenix, AlloVir, Osivax, CureVac AG, GlaxoSmithKline, Cocrystal Pharma Inc, Viriom, Emergent BioSolutions, Pfizer, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Guangdong Raynovent Biotech Co., Ltd, FluGen Inc, BlueWillow Biologics, AVM Biotechnology LLC, Ansun Biopharma, Inc., Guangzhou Henovcom Bioscience, Sunshine Lake Pharma Co., Ltd., Emergex Vaccines, Vir Biotechnology, CSL Limited, Novavax, EMERGENT, Mitsubishi Chemical Group Corporation, Poolbeg Pharma, MYMETICS, CELLTRION INC., Avalia Immunotherapies, Meiji Holdings Co., Ltd., Clover Biopharmaceuticals, Airway Therapeutics, Inc., PrEP Biopharm, Ansun Biopharma, Cidara Therapeutics, Inc., and others.
  • Promising Influenza Therapies such as OVX836 480µg, mRNA-1010, Oseltamivir, Baloxavir, and others.

Stay ahead with the most recent pipeline outlook for Influenza. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Influenza Treatment Drugs

Influenza Emerging Drugs

  • mRNA-1010: Moderna

mRNA-1010 is a vaccine candidate that encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the World Health Organization (WHO) for the prevention of influenza, including influenza A/H1N1, A/H3N2, and influenza B/Yamagata- and B/Victoria-lineages. HA is a major influenza surface glycoprotein that is considered an important target to generate broad protection against influenza and is the primary target of currently available influenza vaccines. Currently, it is in Phase III stage of clinical trial evaluation to treat patients suffering from Seasonal Influenza.

  • SAB-176: SAB Biotherapeutics

SAB-176 is a quadrivalent broadly neutralizing fully-human polyclonal antibody therapeutic candidate that leverages the human biological immune response in development for the treatment of hospitalized patients with severe seasonal influenza. The novel specifically targeted therapeutic generated from the company’s proprietary technology, the DiversitAb™ platform, is designed to specifically bind to Type A and Type B influenza viruses. Pre-clinical data suggests that SAB-176 offers potentially broad protection against diverse influenza strains. A highly-potent, polyclonal antibody therapy for severe seasonal influenza, could potentially treat severely ill patients and provide protective antibodies for high-risk populations, such as the elderly and immune compromised.

  • INNA-051: ENA Respiratory Pty Ltd

INNA-051 is a broad-spectrum antiviral immunomodulatory nasal spray under clinical development for pre- and post-exposure prophylaxis of respiratory viral infections in populations at risk of severe complications. Based on its mechanism of action and intended route of administration, INNA-051 has the potential to address several viral respiratory pathogens across multiple patient populations with a variety of co-morbid conditions. INNA-051 antiviral efficacy is currently evaluated in a Phase 2a influenza-challenge conducted in healthy volunteers.

  • CODA-VAX H1N1: Codagenix

Codagenix has utilized a design platform to construct a live-attenuated, universal flu vaccine, CodaVax™-H1N1. The vaccine enables presentation of conserved antigens of the wild-type virus, demonstrating universal potential in primate models and thus the potential to provide multi-season protection when developed into its final quadrivalent formulation. Currently, it is being evaluated in Phase I stage of clinical trial evaluation to treat Influenza virus infections.

  • ALVR106: AlloVir

ALVR106 is an allogeneic, off-the-shelf, multi-virus specific VST therapy candidate designed to target diseases caused by the respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). In vitro data demonstrates that ALVR106 reactive cells have antiviral activity against each of the targeted viruses with minimal or no activity against non-virus-infected cells. This preclinical data supports the potential for antiviral benefit and safety of ALVR106 when administered to patients.

The Influenza Pipeline Report Provides Insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Influenza with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Influenza Treatment.
  • Influenza Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Influenza Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Influenza market

Explore groundbreaking therapies and clinical trials in the Influenza Pipeline. Access DelveInsight’s detailed report now! @ New Influenza Drugs

Influenza Companies

Moderna, SAB Biotherapeutics, ENA Respiratory Pty Ltd, Codagenix, AlloVir, Osivax, CureVac AG, GlaxoSmithKline, Cocrystal Pharma Inc, Viriom, Emergent BioSolutions, Pfizer, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Guangdong Raynovent Biotech Co., Ltd, FluGen Inc, BlueWillow Biologics, AVM Biotechnology LLC, Ansun Biopharma, Inc., Guangzhou Henovcom Bioscience, Sunshine Lake Pharma Co., Ltd., Emergex Vaccines, Vir Biotechnology, CSL Limited, Novavax, EMERGENT, Mitsubishi Chemical Group Corporation, Poolbeg Pharma, MYMETICS, CELLTRION INC., Avalia Immunotherapies, Meiji Holdings Co., Ltd., Clover Biopharmaceuticals, Airway Therapeutics, Inc., PrEP Biopharm, Ansun Biopharma, Cidara Therapeutics, Inc and others.

Influenza pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

  • Inhalation
  • Inhalation/Intravenous/Oral
  • Intranasal
  • Intravenous
  • Intravenous/ Subcutaneous
  • NA
  • Oral
  • Oral/intranasal/subcutaneous
  • Parenteral
  • Subcutaneous

Influenza Products have been categorized under various Molecule types such as

  • Antibody
  • Antisense oligonucleotides
  • Immunotherapy
  • Monoclonal antibody
  • Peptides
  • Protein
  • Recombinant protein
  • Small molecule
  • Stem Cell
  • Vaccine

Unveil the future of Influenza Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Influenza Market Drivers and Barriers

Scope of the Influenza Pipeline Report

  • Coverage- Global
  • Influenza Companies- Moderna, SAB Biotherapeutics, ENA Respiratory Pty Ltd, Codagenix, AlloVir, Osivax, CureVac AG, GlaxoSmithKline, Cocrystal Pharma Inc, Viriom, Emergent BioSolutions, Pfizer, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Guangdong Raynovent Biotech Co., Ltd, FluGen Inc, BlueWillow Biologics, AVM Biotechnology LLC, Ansun Biopharma, Inc., Guangzhou Henovcom Bioscience, Sunshine Lake Pharma Co., Ltd., Emergex Vaccines, Vir Biotechnology, CSL Limited, Novavax, EMERGENT, Mitsubishi Chemical Group Corporation, Poolbeg Pharma, MYMETICS, CELLTRION INC., Avalia Immunotherapies, Meiji Holdings Co., Ltd., Clover Biopharmaceuticals, Airway Therapeutics, Inc., PrEP Biopharm, Ansun Biopharma, Cidara Therapeutics, Inc., and others.
  • Influenza Therapies- OVX836 480µg, mRNA-1010, Oseltamivir, Baloxavir, and others
  • Influenza Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Influenza Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Influenza Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Influenza Companies, Key Products and Unmet Needs

Table of Content

  1. Introduction
  2. Executive Summary
  3. Influenza: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Influenza – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. mRNA-1010: Moderna
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. INNA-051: ENA Respiratory Pty Ltd
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. CODA-VAX H1N1: Codagenix
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name: Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Influenza Key Companies
  21. Influenza Key Products
  22. Influenza- Unmet Needs
  23. Influenza- Market Drivers and Barriers
  24. Influenza- Future Perspectives and Conclusion
  25. Influenza Analyst Views
  26. Influenza Key Companies
  27. Appendix

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