COVID-19 Pipeline Insight 2025: Next-Generation Vaccines, Broad-Spectrum Antivirals, and Immunomodulators Reshape the Therapeutic Landscape | DelveInsight

COVID-19 Pipeline Insight 2025: Next-Generation Vaccines, Broad-Spectrum Antivirals, and Immunomodulators Reshape the Therapeutic Landscape | DelveInsight
COVID-19 Pipeline Insight
The COVID-19 therapeutic pipeline is expanding, focusing on next-gen vaccines, broad-spectrum antivirals, and host-directed immunomodulators to tackle viral evolution and long-term effects. While first-gen vaccines and repurposed antivirals have reduced severe cases and mortality, challenges like waning immunity, new variants, and post-acute sequelae highlight the need for more durable, variant-proof, and disease-modifying treatments.

DelveInsight’s “COVID-19 – Pipeline Insight, 2025” highlights a diverse set of candidates, including intranasal and pan-variant vaccines aiming to provide mucosal immunity and broad coverage, as well as oral and long-acting antivirals with improved resistance profiles. Mid- and late-stage programs feature novel polymerase and protease inhibitors, monoclonal antibody cocktails engineered for variant resilience, and combination therapies targeting multiple stages of viral replication. Immunomodulatory agents, including JAK inhibitors, complement blockers, and cytokine pathway modulators, are being investigated to mitigate hyperinflammatory responses and reduce long-COVID complications.

Innovations in delivery platforms, such as self-amplifying RNA, viral vector–based boosters, and controlled-release formulations, are enhancing vaccine durability and ease of administration. In parallel, research into long-COVID therapeutics is accelerating, with pipeline candidates addressing viral persistence, immune dysregulation, and organ-specific sequelae.

The 2025 pipeline signals a transition from emergency pandemic management to sustained, long-term disease control, leveraging advances in virology, immunology, and drug delivery. With regulatory agencies prioritizing pandemic preparedness, global investment in vaccine and antiviral R&D, and collaborative public–private partnerships, the next wave of COVID-19 treatments and preventives is poised to strengthen resilience against current and future coronavirus threats.

Interested in learning more about the current treatment landscape and the key drivers shaping the COVID-19 pipeline? Click here

 

Key Takeaways from the COVID-19 Pipeline Report

• DelveInsight’s COVID-19 pipeline analysis depicts a strong space with 180+ active players working to develop 200+ pipeline drugs for COVID-19 treatment.

• The leading COVID-19 companies include Ansun Pharm, Biophytis, MetrioPharm, GeneOne Life Science, Shionogi, Sinocelltech, Laurent Pharmaceuticals, Frontier Biotechnologies, Eyegene, aptaTargets, Veru Inc., Corvus Pharmaceuticals, Revive Therapeutics, Regeneron Pharmaceuticals, Hoffmann-La Roche, CytoDyn, Incyte Corporation/Novartis, SAB Biotherapeutics, Moderna Therapeutics, Pfizer, FibroGen, Arch Biopartners, Senhwa Biosciences, Ionis Pharmaceuticals, GlycoMimetics, Akari Therapeutics, Serpin Pharma, and others are evaluating their lead assets to improve the COVID-19 treatment landscape.

• Key COVID-19 pipeline therapies in various stages of development include DAS181, Sarconeos (BIO101), MP1032, GLS-5310, S-892216, SCTV01E, LAU-7b, FB2001, EG COVID vaccine, ApTOLL, VERU‑111, Mupadolimab (CPI-006), Bucillamine, REGN-COV2, Tocilizumab, Leronlimab, Ruxolitinib, SAB 185, mRNA 1083, Nirmatrelvir + ritonavir, Pamrevlumab, Metablok, Silmitasertib, Donidalorsen, Uproleselan, Nomacopan, SP 16, and others.

• In August 2025, Moderna received FDA approval for updated 2025–2026 formulas of Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of COVID-19, for high-risk individuals and adults 65+.

• In August 2025, Celltrion announced that the FDA approved an expanded use of AVTOZMA® (tocilizumab-anoh) IV to treat cytokine release syndrome (CRS) in adults and children aged 2 and older. This approval aligns AVTOZMA’s indications with those of ACTEMRA® IV, which includes rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, and COVID-19.

• In July 2025, BD (Becton, Dickinson and Company) received FDA 510(k) clearance for its BD Veritor™ System for SARS-CoV-2, a digital test that detects COVID-19 antigens in symptomatic individuals within 15 minutes. This clearance will replace the current Emergency Use Authorization version starting in early fall 2025.

• In July 2025, Moderna announced FDA approval of a supplemental Biologics License Application for Spikevax®, its COVID-19 vaccine, for children aged 6 months to 11 years at increased risk of COVID-19. Previously, the vaccine was available under Emergency Use Authorization for pediatric use.

• In May 2025, the FDA granted full approval to Novavax’s COVID-19 vaccine (Nuvaxovid) for adults 65+ and for those aged 12–64 with underlying conditions, narrowing its previous emergency use authorization for all individuals 12 and older.

 

COVID-19 Overview

COVID-19 (Coronavirus Disease 2019) is an infectious disease caused by the novel coronavirus SARS-CoV-2, first identified in Wuhan, China, in late 2019. It rapidly escalated into a global pandemic, leading to widespread illness, disruption, and millions of deaths worldwide. The virus primarily spreads through respiratory droplets and affects the respiratory system, with symptoms ranging from mild (fever, cough, fatigue) to severe (pneumonia, acute respiratory distress syndrome, multi-organ failure).

Global response efforts have included mass testing, social distancing, lockdowns, and the rapid development of vaccines. Multiple vaccines, including mRNA (Pfizer-BioNTech, Moderna), viral vector (AstraZeneca, Johnson & Johnson), and inactivated virus (Sinovac, Covaxin) types, have been deployed globally. While vaccines and antivirals like Paxlovid and remdesivir have reduced severity and mortality, the virus continues to evolve, with new variants periodically emerging and prompting ongoing surveillance, booster campaigns, and updated vaccine formulations.

Find out more about COVID-19 medication at https://www.delveinsight.com/report-store/covid-19-pipeline-insight

 

COVID-19 Treatment Analysis: Drug Profile

DAS181 – Ansun Biopharma

DAS181 is a recombinant sialidase enzyme designed to prevent viral infection by removing sialic acid receptors from the surface of lung cells, thereby blocking the ability of viruses like influenza and SARS-CoV-2 to bind and infect. By targeting the host cell rather than the virus itself, DAS181 maintains efficacy against drug-resistant and multiple sialic acid–utilizing viruses. Administered via nebulization using Aerogen Solo aerosol delivery technology, DAS181 has received both Fast Track and Breakthrough Therapy Designation from the U.S. FDA. It is currently in Phase III clinical trials for the treatment of COVID-19.

Sarconeos (BIO101) – Biophytis

Sarconeos (BIO101) is an oral small molecule being developed for neuromuscular and age-related conditions. It acts by activating the MAS receptor, potentially enhancing muscle function, strength, mobility, and respiratory capacity. Its mechanism of action supports resilience in patients experiencing muscle decline. The drug is currently being evaluated in Phase III clinical trials for its potential to treat COVID-19–related complications.

MP1032 – MetrioPharm

MP1032 is a novel small molecule with a self-regulating mechanism that targets the metabolic response of overactive immune cells. It acts as a reactive oxygen species (ROS) scavenger only in areas of elevated pH, which is common in inflamed tissues. Once pH levels normalize, the drug becomes inactive, helping to avoid disruption of normal immune function. This targeted anti-inflammatory approach contributes to MP1032’s strong safety profile. The drug is currently in Phase II development for the treatment of COVID-19.

Learn more about the novel and emerging COVID-19 pipeline therapies.

 

COVID-19 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

• Intravenous

• Subcutaneous

• Parenteral

• Topical

 

By Molecule Type

• Recombinant fusion proteins

• Small molecule

• Monoclonal antibody

• Peptide

• Polymer

• Gene therapy

 

Scope of the COVID-19 Pipeline Report

• Coverage: Global

• Key COVID-19 Companies: Ansun Pharm, Biophytis, MetrioPharm, GeneOne Life Science, Shionogi, Sinocelltech, Laurent Pharmaceuticals, Frontier Biotechnologies, Eyegene, aptaTargets, Veru Inc., Corvus Pharmaceuticals, Revive Therapeutics, Regeneron Pharmaceuticals, Hoffmann-La Roche, CytoDyn, Incyte Corporation/Novartis, SAB Biotherapeutics, Moderna Therapeutics, Pfizer, FibroGen, Arch Biopartners, Senhwa Biosciences, Ionis Pharmaceuticals, GlycoMimetics, Akari Therapeutics, Serpin Pharma, and others.

• Key COVID-19 Pipeline Therapies: DAS181, Sarconeos (BIO101), MP1032, GLS-5310, S-892216, SCTV01E, LAU-7b, FB2001, EG COVID vaccine, ApTOLL, VERU‑111, Mupadolimab (CPI-006), Bucillamine, REGN-COV2, Tocilizumab, Leronlimab, Ruxolitinib, SAB 185, mRNA 1083, Nirmatrelvir + ritonavir, Pamrevlumab, Metablok, Silmitasertib, Donidalorsen, Uproleselan, Nomacopan, SP 16, and others.

Explore detailed insights on drugs used in the treatment of COVID-19 here.

 

Table of Contents

1. Introduction

2. Executive Summary

3. COVID-19 Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. COVID-19 Pipeline Therapeutics

6. COVID-19 Pipeline: Late-Stage Products (Phase III)

7. COVID-19 Pipeline: Mid-Stage Products (Phase II)

8. COVID-19 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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