Influenza Pipeline Outlook 2025 - Clinical Trials, Treatment, ROA, Medication, MOA, Revenue Share, Companies by DelveInsight

The Influenza pipeline is experiencing unprecedented growth, driven by 120+ active players, breakthrough therapies, and recent FDA fast-track designations, signaling a transformative decade ahead in Influenza treatment.
Influenza Pipeline Summary

DelveInsight's Influenza Emerging Drugs report highlights innovative therapies advancing the treatment and prevention of influenza. Key candidates include Moderna's mRNA-1010, a Phase III vaccine encoding HA glycoproteins of WHO-recommended strains; SAB Biotherapeutics' SAB-176, a quadrivalent, broadly neutralizing polyclonal antibody for severe influenza; ENA Respiratory's INNA-051, an immunomodulatory intranasal spray in Phase IIa; Codagenix's CODA-VAX H1N1, a universal live-attenuated flu vaccine in Phase I; and AlloVir's ALVR106, an allogeneic, off-the-shelf VST therapy targeting multiple respiratory viruses.

The report further analyzes over 120+ pipeline drugs across various clinical stages, including Phase III, II, I, preclinical, and discovery. It categorizes therapies by route of administration (oral, intravenous, intranasal, inhalation, subcutaneous, etc.), molecule type (antibodies, vaccines, peptides, proteins, immunotherapies, small molecules, stem cells), and product type (mono, combination, or both). Moderna currently leads the late-stage pipeline, showcasing the growing diversity and innovation in influenza treatment strategies.

Discover the latest drugs and treatment options in the Influenza Pipeline. Dive into DelveInsight's comprehensive report today! @ Influenza Pipeline Outlook [https://www.delveinsight.com/sample-request/influenza-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Key Takeaways from the Influenza Pipeline Report

Influenza pipeline report depicts a robust space with 120+ active players working to develop 120+ pipeline therapies for Influenza treatment.

In August 2025, AstraZeneca launches the first FDA-approved influenza vaccine available for self- or caregiver administration, providing a convenient, household-based option for seasonal flu vaccination. AstraZeneca launches FluMist Home, the first-of-its-kind, at-home delivery service for FLUMIST Registered ( Influenza Vaccine Live, Intranasal ). FLUMIST is the first and only seasonal influenza vaccine approved to be self-administered by adults 18 to 49 years of age or administered by a parent or caregiver to individuals 2-17 years of age.

In July 2025, SK bioscience, a global innovative vaccine and biotech company dedicated to advancing human health from prevention to cure, announced that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for Phase 1/2 clinical trials of a new influenza vaccine candidate, 'NBP607B'. This candidate integrates an adjuvant into its existing cell-based influenza vaccine, 'SKYCellflu', to improve protective efficacy. SK bioscience previously applied adjuvant technology in its COVID-19 vaccine, 'SKYCovione', and now aims to extend this approach to influenza vaccines as part of its broader platform strategy.

In July 2025, GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent seasonal influenza vaccines to US healthcare providers and pharmacies in preparation for the 2025-26 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA). Both FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months and older.

In March 2025, Sanofi announced today the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the manufacturing and delivery of its vaccine portfolio for the 2025-26 flu season in the US. As the world leader in flu vaccines, Sanofi had already begun its annual production of vaccines to ensure that robust supply is ready for the coming season. Strains selected by the FDA match those already used in production by the company to help protect eligible patients against flu and its potentially severe complications.

In December 2024:- ModernaTX, Inc.- A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults greater than or equal to 50 Years of Age. The purpose the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).

In November 2024:- DiaSorin Molecular LLC- The DiaSorin Molecular LIAISON Registered NES FLU A/B, RSV & COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON Registered NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

In October 2024:- Pfizer- The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.

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 480g, 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 [https://www.delveinsight.com/sample-request/influenza-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Influenza Emerging Drugs

mRNA-1010 (Moderna):

A Phase III vaccine targeting WHO-recommended influenza strains (A/H1N1, A/H3N2, B/Yamagata, B/Victoria). Encodes HA glycoproteins to generate broad protection against seasonal influenza.

SAB-176 (SAB Biotherapeutics):

A quadrivalent polyclonal antibody therapy developed via DiversitAb Trademark platform. Designed to neutralize Type A and B influenza viruses, showing broad protection potential. Targeted for severe cases and high-risk groups like elderly and immunocompromised patients.

INNA-051 (ENA Respiratory):

An intranasal immunomodulatory spray in Phase IIa trials. Intended for pre- and post-exposure prophylaxis of respiratory viral infections, with potential use across multiple viruses and at-risk populations.

CODA-VAX H1N1 (Codagenix):

A live-attenuated universal flu vaccine in Phase I trials. Shows promise for multi-season protection by targeting conserved viral antigens and is being developed into a quadrivalent formulation.

ALVR106 (AlloVir):

An allogeneic, off-the-shelf VST therapy in preclinical development. Targets RSV, influenza, PIV, and hMPV, with in vitro data showing strong antiviral activity and potential safety benefits.

Explore groundbreaking therapies and clinical trials in the Influenza Pipeline. Access DelveInsight's detailed report now! @ New Influenza Drugs [https://www.delveinsight.com/sample-request/influenza-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Key influenza Companies:

The following are the leading companies in the influenza market. These companies collectively hold the largest market share and dictate industry trends.

* SNB 011: SyneuRx International
* naNO-Flu: Emergex Vaccines
* ARCT-2138: Arcturus Therapeutics
* PF-07985819: Pfizer
* OVX836: OSIVAX
* Neumifil: Pneumagen
* INNA-051: Ena Respiratory
* mRNA-1010: Moderna
* XC-221: Valenta Pharmaceuticals
* ZSP1273: Raynovent
* mRNA-1010: Moderna
* SAB-176: SAB Biotherapeutics
* INNA-051: ENA Respiratory Pty Ltd
* CODA-VAX H1N1: Codagenix
* ALVR106: AlloVir
* CD388: Cidara
* Quadrivalent influenza vaccine: Sinovac Biotech
* TIV: Novartis

Influenza Pipeline Drugs by Route of Administration

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 Pipeline Drugs by Molecule Types

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 [https://www.delveinsight.com/sample-request/influenza-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

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 480g, 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 Clinical Trials and FDA Approvals [https://www.delveinsight.com/sample-request/influenza-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Table of Content

1. Influenza Report Introduction

2. Influenza Executive Summary

3. Influenza Overview

4. Influenza- Analytical Perspective In-depth Commercial Assessment

5. Influenza Pipeline Therapeutics

6. Influenza Late Stage Products (Phase II/III)

7. Influenza Mid Stage Products (Phase II)

8. Influenza Early Stage Products (Phase I)

9. Influenza Preclinical Stage Products

10. Influenza Therapeutics Assessment

11. Influenza Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Influenza Key Companies

14. Influenza Key Products

15. Influenza Unmet Needs

16 . Influenza Market Drivers and Barriers

17. Influenza Future Perspectives and Conclusion

18. Influenza Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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