INTREPID Alliance Releases New Report Highlighting Urgent Gaps in Antiviral Preparedness

Global antiviral R&D is slowing when the world can least afford it, new analysis shows

CAMBRIDGE, Mass., May 5, 2025 /PRNewswire/ -- The INTREPID Alliance today released the fourth edition of its Antiviral Clinical and Preclinical Development Landscape, a comprehensive analysis of the global pipeline of small-molecule antiviral compounds. The findings reveal a concerning trend: rather than accelerating in response to global preparedness goals, antiviral R&D momentum is stalling. Drawing on data from over 200 clinical and preclinical antiviral programs across 13 viral families prioritized for pandemic preparedness, the report provides a timely snapshot of where progress is being made – and where gaps remain.

The landscape still shows that the majority of clinical and preclinical compounds under investigation are targeting the viruses where infection can lead to outbreaks of COVID-19 and influenza. Other indications where limited clinical and/or preclinical development work is underway include Mpox, Dengue, Ebola, and Lassa fever, among others. However, there are several viral families of pandemic potential with no compounds in clinical or preclinical development at this time leaving the world at risk of future outbreaks.

"We are going backwards, not forwards," said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Chair of the INTREPID Alliance Board. "Despite the lessons of COVID-19, global investment in small-molecule antivirals is declining just when we need to be scaling up. Without a robust antiviral pipeline, the world remains dangerously exposed to emerging viral threats. This landscape is both a wake-up call and a roadmap for smarter, faster preparedness."

Key Findings from the 4th Edition Landscape:*

• Clinical pipeline: 67 distinct antiviral compounds are currently in active clinical development, with 22 approved compounds and 42 of those being novel, unapproved candidates. However, the overall number of promising new clinical candidates has not increased since the previous edition, highlighting a plateau in progress.
• Preclinical pipeline: 168 novel compounds are in preclinical development, associated with 189 virus-disease indications. Yet the majority of these still target SARS-CoV-2, leaving many pandemic-priority viral families under-addressed.
• R&D concentration: While nearly 90% of clinical development activity is being led by biopharmaceutical companies, early-stage research is more diverse, with contributions from academia and government labs. Still, most programs are concentrated in high-income countries, underscoring the need for more widespread global engagement.

The recent outbreaks of Mpox disease, which sparked the World Health Organization to declare public health emergencies of international concern,^1,2 should be a wake-up call to the international community that the world is not immune to emerging and future outbreaks. The INTREPID Alliance Report on Direct-Acting Antivirals for Mpox, published last month highlights the urgent need for increased research and development of antiviral treatments for monkey pox virus and other orthopoxviruses with pandemic potential.

"In our interconnected world, a strong antiviral pipeline is not just a scientific issue – it's a global security issue," said Kelly Chibale, Ph.D., Professor, Neville Isdell Chair in African-centric Drug Discovery and Development, University of Cape Town. "We need to make sure innovation is not only happening but also reaching the places most vulnerable to future outbreaks. The INTREPID Landscape is a critical tool for making smarter, more informed decisions." As a member of its Scientific Advisory Board, Professor Chibale is one of the scientific experts from around the world who advises INTREPID's work.

INTREPID's bi-annual antiviral pipeline reports are a key contribution to the 100 Days Mission, whose aim is to be prepared as much as possible so that within the first 100 days of a new pandemic threat being identified, interventions can be made available, safe, effective, and affordable. INTREPID's research is freely available and is intended to support policymakers, funders, and the global scientific community in identifying the most urgent needs and highest-impact opportunities in antiviral R&D.

The full landscape report, study methodology, and an interactive antiviral clinical development pipeline are available at the INTREPID website. The INTREPID Alliance deep dive report focused on direct-acting antivirals for Mpox is also available through the website's Deep Dive Reports section.

Disclaimer

The INTREPID Alliance is a non-profit consortium of innovative biopharmaceutical companies and associations committed to accelerating the development of antivirals for epidemic and pandemic threats. Through independent landscape analysis and policy engagement, the Alliance supports science-based investment and preparedness strategies aligned with global public health goals. 

As part of our efforts, the INTREPID Alliance maintains and publishes a centralized list of promising investigational candidate compounds, with the purpose of knowledge-sharing and to support better pandemic preparedness. These compounds have been selected based on objective, scientific criteria, using publicly available sources, and at arm's length from commercial influence of our member companies. See criteria listed in the report "Antiviral Clinical Development Landscape and Promising Clinical Compounds." The designation of certain compounds as promising is based upon currently available information, and exclusively upon an assessment against these criteria. "Promising" is not a promotional claim. Candidate compounds have not been assessed by regulatory authorities to be safe and efficacious for the treatment of disease in humans. Our content is designed to be factual, informative, and non-commercial. It is not designed or intended to advertise or promote any pharmaceutical product or therapy or to advance the commercial interests of any company.

ABOUT THE INTREPID ALLIANCE

The INTREPID Alliance aims to accelerate the development of new treatments for emerging viral pandemic agents through facilitating early science and R&D, policy and advocacy, and stakeholder engagement. Led by a not-for-profit consortium of innovative biopharmaceutical companies and associations and working with the public, private and not-for-profit sectors, INTREPID works to bridge key gaps and unmet needs to ensure delivery of antiviral solutions to viral pathogens with the greatest pandemic potential.

INTREPID was launched in March 2023 at a high-level summit bringing together more than 100 thought leaders in virology and global health. For a read-out from the summit and additional information, visit www.intrepidalliance.org.

* As of December 18, 2024

¹ World Health Organization (WHO). WHO Director-General declares the ongoing monkeypox outbreak a Public Health Emergency of International Concern. (23 July 2022).
² World Health Organization (WHO). WHO Director-General declares mpox outbreak a public health emergency of international concern. (14 August 2024).

Logo - https://mma.prnewswire.com/media/2324961/INTREPID_Alliance_Logo.jpg