The global influenza therapeutic landscape is experiencing unprecedented expansion, with DelveInsight's latest analysis revealing 120+ companies actively developing over 120 treatment therapies across various clinical stages. This robust pipeline represents a significant advancement in addressing seasonal and pandemic influenza threats through innovative vaccine platforms, therapeutic antibodies, and novel delivery mechanisms.
Breakthrough Combination Vaccine Achieves Phase III Success
Moderna has achieved a major milestone with its mRNA-1083 combination vaccine, which demonstrated superior immune responses in Phase III trials compared to separate vaccine administrations. The single-dose vaccine integrates Moderna's seasonal influenza candidate mRNA-1010 with the next-generation COVID-19 vaccine mRNA-1283, both of which have shown promising outcomes in individual Phase III trials.
In June 2024, Moderna reported that mRNA-1083 achieved its primary endpoints, generating stronger immune responses than licensed comparator vaccines tested in the study. This advancement represents significant progress toward a combined flu and COVID-19 vaccine, potentially simplifying vaccination protocols and improving patient compliance.
First-of-Kind Home Administration Vaccine Launches
AstraZeneca made regulatory history in August 2025 by launching FluMist Home, the first FDA-approved influenza vaccine available for self-administration by adults aged 18-49 or administration by parents or caregivers to individuals aged 2-17. The FLUMIST (Influenza Vaccine Live, Intranasal) delivery service provides a convenient, household-based option for seasonal flu vaccination, eliminating traditional healthcare facility requirements.
Advanced Pipeline Candidates Show Promise
The influenza pipeline features several innovative therapeutic approaches across different development stages. Moderna's mRNA-1010, currently in Phase III trials, represents a seasonal vaccine encoding HA glycoproteins of WHO-recommended strains, targeting A/H1N1, A/H3N2, B/Yamagata, and B/Victoria lineages to generate broad protection against seasonal influenza.
SAB Biotherapeutics is developing SAB-176, a quadrivalent, broadly neutralizing polyclonal antibody therapy created through the DiversitAb platform. This treatment is designed to neutralize Type A and B influenza viruses and shows broad protection potential, particularly targeting severe cases and high-risk groups including elderly and immunocompromised patients.
ENA Respiratory's INNA-051, an immunomodulatory intranasal spray in Phase IIa trials, is intended for pre- and post-exposure prophylaxis of respiratory viral infections. The therapy demonstrates potential for use across multiple viruses and at-risk populations.
Universal Vaccine Approaches Advance
Codagenix is developing CODA-VAX H1N1, a live-attenuated universal flu vaccine in Phase I trials that shows promise for multi-season protection by targeting conserved viral antigens. The company is advancing this candidate into a quadrivalent formulation to broaden its protective scope.
AlloVir's ALVR106 represents an innovative allogeneic, off-the-shelf VST therapy in preclinical development. This treatment targets multiple respiratory viruses including RSV, influenza, PIV, and hMPV, with in vitro data showing strong antiviral activity and potential safety benefits.
Recent Regulatory and Development Milestones
SK bioscience submitted an Investigational New Drug application to South Korea's Ministry of Food and Drug Safety in July 2025 for Phase 1/2 clinical trials of NBP607B, a new influenza vaccine candidate that integrates an adjuvant into its existing cell-based influenza vaccine SKYCellflu to improve protective efficacy.
Vaxxas commenced a multi-center Phase I clinical trial in September 2024 evaluating a vaccine for the pre-pandemic avian influenza strain H7N9, utilizing its innovative high-density microarray patch (HD-MAP) technology. The HD-MAP platform administers vaccines via a small patch applied briefly to the skin, eliminating challenges associated with traditional needle-and-syringe methods while enhancing immune responses through direct delivery to immune cell-rich skin layers.
Diverse Therapeutic Modalities and Administration Routes
The pipeline encompasses various therapeutic approaches including monoclonal antibodies, peptides, polymers, small molecules, and gene therapy products. Administration routes span oral, parenteral, intravenous, subcutaneous, intranasal, and inhalation delivery methods, providing flexibility for different patient populations and clinical scenarios.
Key companies driving innovation include Pfizer, OSIVAX, Pneumagen, Valenta Pharmaceuticals, Raynovent, Codagenix, AlloVir, Cidara, Sinovac Biotech, and Novartis, among others. These organizations are developing therapies ranging from early-stage discovery through late-stage Phase III candidates.
Market Dynamics and Future Outlook
The influenza pipeline growth is driven by several factors including advancements in vaccine development, rising global awareness, government support, emerging antiviral therapies, and increased diagnostic capabilities. However, challenges remain including high R&D costs, viral mutation challenges, regulatory hurdles, limited access in low-income regions, and vaccine hesitancy.
The robust pipeline of 120+ therapies across various development stages signals a transformative decade ahead in influenza treatment and prevention, with innovative platforms like mRNA technology, universal vaccine approaches, and novel delivery systems poised to reshape the therapeutic landscape.
