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ERDERA’s Clinical Trial Call to advance early-phase clinical trials for rare diseases

EPTRI is pleased to share a new funding opportunity from ERDERA – the European Rare Diseases Research Alliance supporting multinational early-phase clinical trials in rare diseases. EPTRI encourages its community to explore this call and is available to support prospective applicants by facilitating access to its multidisciplinary paediatric research expertise, fostering collaborations across Europe, and helping identify relevant services and infrastructures that may strengthen project proposals.

ERDERA has launched its Clinical Trial Call allocating, up to 30€ million to support sponsor-led Phase I, Phase I/II and Phase II clinical trials of medicinal products, conducted in accordance with Good Clinical Practice.

The Call is intended for multinational interventional trials in rare diseases that focus on clinical studies in humans evaluating investigational medicinal products with a clear therapeutic rationale, a defined patient population and a credible development path.

Eligible applicants include Universities/research institutes, hospitals/clinical centres, non‑profit research organisations and foundations, Patient Advocacy Organisations (PAOs), and SMEs (subject to specific funding provisions). Each consortium must designate a Clinical Trial Sponsor and a Coordinating Investigator, include at least one funded patient partner (via a PAO or other organised patient group), and secure access to a qualified multinational Clinical Trial Management Organisation (CTMO).

Eligible interventions include small molecules (including repurposed drugs), ATMPs (with GMP‑validated manufacturing appropriate for Phase I/II), biologics/new biological entities, and repurposed biologics.

 

Call Phases:

Stage 0 – Expression of Interest (mandatory): deadline 10 September 2026

Stage 1 – Short Proposal: deadline 29 October 2026

Stage 2 – Support Phase: January – July 2027

Stage 3 – Full Proposal: August – September 2027

Funding decisions: February 2028

 

More information about the Call is available here and here.

The Call documents are available here.

 

Researchers interested in submitting a proposal are encouraged to contact EPTRI at [email protected] to explore how the infrastructure can support their application and foster potential collaboration opportunities.