European Partnership ERDERA Launches 2026 Clinical Trials Call for Early-Phase Rare Disease Research
On 1 July 2026, the European Partnership ERDERA – the European Rare Diseases Research Alliance – launched a clinical trials call supporting multinational early-phase clinical studies in the field of rare diseases. The call aims to help promising therapies progress into clinical development, generate robust clinical evidence and strengthen regulatory readiness.
The call is open to Phase I, Phase I/II and Phase II interventional clinical trials of investigational medicinal products for rare diseases. All studies must be conducted in accordance with Good Clinical Practice requirements.
Rare diseases affect up to 30 million people in Europe. Many begin early in life, reduce life expectancy or cause long-term disability, yet disease-modifying treatments are still unavailable for most of them. Patients are often offered only supportive or symptomatic care.
One of the most challenging steps for rare disease patients, researchers and clinicians is moving from a promising therapeutic concept to a clinical trial capable of generating reliable evidence. The ERDERA clinical trials call is specifically designed for projects that are ready to enter this stage.
The call does not fund discovery or preclinical research. It focuses on clinical studies involving human participants and evaluating investigational medicinal products where there is a clear therapeutic rationale, a well-defined patient population and a credible pathway for further development.
“When patient populations are small, knowledge is fragmented and every piece of data matters, the quality of a study depends on bringing together the right expertise, clinical trial sites, patient communities and regulatory considerations at a sufficiently early stage.
This call has been designed with that reality in mind. It supports studies that do not lower the standard of evidence simply because a disease is rare, but instead create the conditions needed to meet that standard: international patient recruitment, rigorous methodology, patient-relevant outcome measures, regulatory preparedness, and data that can be used beyond a single project. This is precisely where ERDERA can create added value – by helping to transform fragmentation into a structured pathway towards evidence,” says the ERDERA Coordinator.
Up to EUR 30 million in EU funding has been allocated to the call. Project budgets are expected to range from approximately EUR 1 million to EUR 5 million, although flexibility may be granted in duly justified cases. Funding will be administered centrally by Fondazione Telethon on behalf of the ERDERA consortium, using a common funding mechanism rather than separate national procedures.
Who Can Apply
Applications may be submitted by universities, higher education institutions and research institutes, hospitals and clinical centres, non-profit research organisations and foundations, patient advocacy organisations, and small and medium-sized enterprises, subject to the funding conditions set out in the call.
Private for-profit pharmaceutical companies that do not qualify as small or medium-sized enterprises are not eligible to receive ERDERA funding as beneficiaries or funded partners.
Institutions from the following countries are currently eligible to participate as funded partners: Austria, Belgium, Bulgaria, Canada, Cyprus, Czechia, 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.
Lithuanian institutions are eligible to participate as funded partners because Lithuania contributes to the initiative by allocating national budget funding for research projects and by supporting ERDERA activities in other ways. The Research Council of Lithuania and Vilnius University Hospital Santaros Klinikos are ERDERA partners.
Institutions from other countries may participate as self-funded partners where their involvement is scientifically justified. Under the conditions of this call, the clinical trial sponsor must be established in a Member State of the European Union or in Norway.
The mandatory Expression of Interest stage is open until 10 September 2026. Applicants are invited to consult the official call webpage, where they can find the full call text, application documents, national and regional information, registration details for the information webinar, and relevant contact information.
Last updated: 30-07-2026
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