ERDERA launches Clinical Trial Call 2026 to advance early‑phase clinical trials for rare diseases
The ERDERA Clinical Trial Call 2026 is open to fund multinational, sponsor-led, GCP-compliant Phase I, Phase I/II and Phase II interventional Clinical trials in rare diseases. The call supports trials designed to generate high-quality clinical evidence and, where appropriate, data of regulatory relevance to support future EMA regulatory filings and subsequent clinical development.
Up to €30 million of the ERDERA budget is available for this call. Requested budgets are expected to be in the range of €1 million to €5 million per project, although projects outside this range may be eligible with adequate justification.
The call addresses the specific challenges of conducting clinical trials in rare diseases, particularly small and geographically dispersed patient populations, by enabling the multinational collaboration needed to deliver high-quality early-phase clinical evidence.
While proposals on all eligible rare diseases are welcome, the call particularly encourages applications addressing paediatric rare diseases, rapidly progressive rare diseases, and conditions lacking approved therapeutic options or with substantial residual unmet need. These priority areas are not eligibility criteria, but may be considered in final strategic prioritisation where proposals are otherwise of equivalent scientific quality.
Who can apply
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).
Only multinational trials will be funded (minimum of three independent eligible partner institutions from at least three different eligible countries; PAOs focused primarily on PPIE do not count towards this minimum).
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.
How it works
A multi‑stage process with a mandatory Stage 0 Expression of Interest (EOI) followed by Stage 1 Short Proposal, a structured Stage 2 Support Phase (regulatory, methodological and PPIE support), and invited Stage 3 Full Proposal.
Information webinar: 6 July 2026, 15:00–17:00 CEST. Information and registration here.
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
Researchers and organisations interested in applying can find detailed information, eligibility requirements, and registration for the information webinar on the official ERDERA Clinical Trial Call webpage HERE