Media Kit | ERDERA Clinical Trial Call 2026 launch

A 2026 call to support multinational, GCP‑compliant Phase I, Phase I/II and Phase II interventional clinical trials in rare diseases, aiming to generate robust clinical evidence and, where appropriate, data of regulatory relevance to support future interactions with regulatory authorities and subsequent clinical development.

Why

To help address 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 all eligible rare diseases are welcome, the call particularly encourages proposals in paediatric rare diseases, rapidly progressive rare diseases, and rare diseases with no approved therapeutic options or substantial residual unmet need.

When

• Call opening (expected): 1 July 2026
• Information webinar: 6 July 2026, 15:00–17:00 CEST. Information and registration here.
• Stage 0 – Expression of Interest (mandatory): 1 July – 10 September 2026
• Stage 1 – Short Proposal: 15 September – 29 October 2026
• Stage 2 – Support Stage: January – July 2027
• Stage 3 – Full Proposal: July – September 2027
• Funding decisions: February 2028

Note: All dates and processes are indicative and may change in the official call documentation.

Who

Eligible organisations include:

• Universities, higher education institutions and research institutes
• Hospitals and clinical centres
• Non‑profit research organisations and foundations
• Patient Advocacy Organisations (PAOs)
• SMEs (subject to specific funding provisions applicable under the call)

Each consortium must designate:

• a Clinical Trial Sponsor
• a Coordinating Investigator
• at least one patient partner represented by a PAO or other organised patient group
• access to a qualified multinational Clinical Trial Management Organisation (CTMO)

Eligible interventions include:

• Small molecules, including repurposed drugs
• Advanced Therapy Medicinal Products (ATMPs) (provided the manufacturing process has been developed and validated under GMP conditions appropriate for Phase I/II use)
• Biologics and New Biological Entities (NBEs)
• Repurposed biologics

Where

Institutions from the following countries are currently expected to be eligible as funded partners: Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, The Netherlands, Türkiye and the United Kingdom.

The Clinical Trial Sponsor must be established in an EU Member State or Norway (per current draft provisions).