Media Kit | ERDERA Clinical Trial Call launch

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.

Why

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.

When

• Call status: The call is now open
• 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

Note: Unless otherwise stated, submission deadlines are at 17:00 CET. The timeline is indicative and applicants should consult the official call documentation and ERDERA website for the definitive schedule.

Who

Eligible organisations include:

• Universities, higher education institutions and research institutes
• Hospitals, clinical centres, clinical research organisations and other healthcare settings
• Non-profit research organisations and foundations
• Patient Advocacy Organisations (PAOs)
• Small and Medium Enterprises (SMEs), subject to the applicable eligibility and funding provisions

Private for-profit companies other than SMEs are not eligible to receive ERDERA funding as beneficiaries or funded partners. SMEs established in Canada are not eligible to receive funding from ERDERA or CIHR.

Each consortium must involve at least three independent eligible-for-funding partner institutions from at least three different ERDERA member countries. Each consortium must also designate:

• a Clinical Trial Sponsor
• a Coordinating Investigator
• at least one funded patient partner, represented by a PAO or another organised patient group
• a qualified multinational Clinical Trial Management Organisation (CTMO), or a formal access arrangement with such an organisation

Patient Advocacy Organisations participating in Patient and Public Involvement and Engagement (PPIE) activities do not count towards the minimum consortium composition requirement of three partners from three different countries, unless the PAO acts as the Clinical Trial Sponsor and fulfils the Sponsor eligibility and capacity requirements.

Eligible therapeutic interventions include:

• Small molecules, including new chemical entities and 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

For proposals involving repurposed drugs or repurposed biologics, applicants must demonstrate a credible investigational medicinal product supply strategy, a contingency plan for supply disruption, and an appropriate post-trial access and implementation strategy.

Where

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

The Clinical Trial Sponsor must be established in an EU Member State or Norway. The Coordinating Investigator may be based in an EU country, Norway, the United Kingdom or Canada, provided the Sponsor requirements are met.

For consortia involving Canadian partners, a Canadian sub-sponsor or equivalent institutional structure must be identified for the Canadian component of the trial. A Canadian CTMO must also be identified, or access to such an organisation must be demonstrated, in line with the overall consortium requirements for multinational trial management.

Canadian partners are primarily funded through the Canadian Institutes of Health Research (CIHR), which provides a dedicated national envelope of CAD 3.75 million. CIHR funding is awarded to eligible Canadian partners according to CIHR national rules and financial administration requirements. If CIHR funds are exhausted, additional eligible Canadian partners may be funded through the ERDERA central fund, subject to the applicable arrangements.