Drug repurposing is attracting growing attention as a strategy to address unmet medical needs by identifying new uses for existing medicines. Against this backdrop, the Reagan-Udall Foundation for the FDA, in collaboration with the National Center for Advancing Translational Sciences (NCATS) and the FDA, convened a hybrid public meeting on 5 August 2026 to explore approaches for selecting and prioritising promising drug repurposing opportunities.
The event brought together representatives from US federal agencies, clinicians, researchers and patient organisations to discuss how promising repurposing opportunities can be identified and advanced. Discussions covered evidence generation, regulatory requirements, real-world data and evidence, and the scientific, policy and practical barriers that can make it difficult to move existing medicines towards new therapeutic uses.
Among the contributors was Don Lo, Director of Medicines Development at EATRIS and Scientific Lead at REMEDi4ALL, who was invited to bring a European perspective to the discussion and reflect on similarities and differences between the US and European approaches to drug repurposing.
Don highlighted that many of the regulatory challenges are shared across both regions, while pointing to reimbursement as an important difference in Europe. He explained that the need for an indication to be recognised on the label can create a stronger incentive to build drug repurposing into the formal medicines development pathway.
He also outlined the role REMEDi4ALL plays in helping promising repurposing ideas move beyond discovery and towards development, regulatory approval and, ultimately, patient access.
“Translation is a team sport.”
Don explained that REMEDi4ALL, which has received funding from the European Union’s Horizon Europe Research & Innovation programme (grant agreement number 101057442), is designed to work with drug repurposing projects at different stages of development, helping teams turn promising scientific ideas into feasible development plans and connect with the expertise needed to progress them. A key part of this is translating scientific plans into regulatory-directed development strategies, so that available resources are used to build a credible route towards approval and patient access.
This reflects a recurring theme throughout the meeting: identifying a promising new use for an existing medicine is only the beginning. Moving from an idea to evidence, regulatory acceptance, reimbursement and clinical use requires coordinated expertise across research, regulation, industry, funders, clinicians and patients.
The meeting forms part of the US government’s broader focus on the role drug repurposing could play in addressing unmet medical needs. Recent FDA activity has invited stakeholder input on promising repurposing opportunities, evidence requirements and barriers to implementation, alongside discussion of how existing regulatory pathways and data sources can be used more effectively.
For REMEDi4ALL, these discussions closely reflect the challenges the initiative was established to address. Through its European network, REMEDi4ALL brings together expertise from across drug development to support repurposing projects from early scientific concepts through clinical development, regulatory strategy and routes towards patient access.
Don emphasised that its perspective and activities extend beyond Europe. The initiative is already working with projects originating in the US, demonstrating the value of international exchange in a field where many of the underlying scientific and regulatory challenges are shared.
REMEDi4ALL was therefore able to share its experiences in driving and enabling impact across the ecosystem as interest in drug repurposing continues to expand in US, Europe and globally for turning promising opportunities into treatments that benefit patients.
Explore the meeting agenda and watch Don’s contribution to Session 3: Evidence and Submission Expectations
