Fondazione Telethon to Lead €30 Million ERDERA Call for Rare Disease Clinical Trials
Key Insights
Fondazione Telethon will manage a €30 million ERDERA (search) funding call supporting Phase I, I/II, and II clinical trials for rare diseases with limited or no therapeutic options.
The call requires international consortia of at least three partners from three different countries, with mandatory patient organization involvement in trial design and conduct.
Applications open with a mandatory Expression of Interest phase from July 1 to September 10, 2026, with the full selection process expected to conclude by February 2028.
Fondazione Telethon will oversee the funding of a major new international call launched by ERDERA (search), the European rare disease research alliance, making up to €30 million available to support early-phase clinical studies for rare diseases where therapeutic options remain limited or entirely unavailable. The initiative brings together over 170 organizations spanning 37 countries, representing one of the most ambitious coordinated efforts to accelerate rare disease therapy development in Europe.
The selection of Fondazione Telethon to coordinate this call was confirmed by the UK Ministry of Research and Innovation's decision to entrust the Foundation with the management of its financial contribution to the initiative. "Being selected to coordinate this call is a source of great pride for the Foundation: it represents international recognition of our expertise and our role as a catalyst for the development of therapies for rare and ultra-rare diseases," said Graciana Diez-Roux, Scientific Director of Fondazione Telethon.
Scope and Eligibility
The ERDERA (search) Clinical Trial Call 2026 will fund Phase I, Phase I/II, and Phase II interventional clinical trials of medicinal products, with the goal of generating robust clinical evidence and accelerating the development of new therapies for patients with rare diseases. Eligible therapeutic modalities span a broad range, from small molecules to advanced therapies, provided applicants can demonstrate robust preclinical or preliminary data and a well-defined clinical development pathway.
Applications are open to universities, research institutes, hospitals, non-profit organizations, patient advocacy groups, and small and medium-sized enterprises (SMEs). Projects must involve partners from at least three eligible countries, forming international consortia capable of leveraging cross-border expertise and resources.
Patient Involvement as a Core Requirement
A defining feature of the call is the systematic and meaningful involvement of patient organizations throughout the trial lifecycle. Patient representatives will actively contribute to the design, conduct, and dissemination of study results. This approach is considered essential to ensure both scientific quality and the real-world feasibility of clinical trials in the rare disease field, where patient recruitment and retention present persistent challenges.
Application Timeline and Process
The application process begins with a mandatory Expression of Interest (EOI) phase, open from July 1 to September 10, 2026. Submission of an EOI is a prerequisite for any applicant intending to submit a Short Proposal at Stage 1. The entire evaluation process will be managed by Fondazione Telethon through a centralized model designed to overcome the fragmentation typical of nationally funded projects and to facilitate the sharing of expertise, data, and resources among clinical centers in different countries.
The selection process is described as long and complex, spanning over one year, with an expected conclusion in February 2028. Full details of the call and application procedures are available on the ERDERA (search) website.