The European Rare Diseases Research Alliance (ERDERA)is pleased to pre‑announce the upcoming launch of the ERDERA Clinical Trial Call 2026, expected to open on 1 July 2026. You can read the pre-announcement document here and the draft Call text here.
The ECTC aims to support multinational, Good Clinical Practice (GCP)‑compliant Phase I, Phase I/II and Phase II interventional clinical trialsin rare diseases. The purpose is to generate robust clinical evidence and, where appropriate, data of regulatory relevance to support future interactions with regulatory authorities and subsequent clinical development.
The call is designed to address specific challenges of clinical trials in rare diseases, where patient populations are often small and geographically dispersed, making multinational collaboration essential.
Scope and strategic encouragements
Applications addressing all eligible rare diseases are welcome. The call particularly encourages proposals targeting:
- Paediatric rare diseases
- Rapidly progressive rare diseases
- Rare diseases lacking approved therapeutic options or with substantial residual unmet medical need despite existing treatments
These priority areas are not eligibility criteria, but may be considered during strategic prioritisation where proposals are otherwise of equivalent scientific quality.
Who can apply and what consortia need to include
Eligible organisations include universities and research institutes, hospitals and 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
- 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
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
Eligibility and indicative timeline
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.
In accordance with current draft call provisions, the Clinical Trial Sponsor must be established in an EU Member State or Norway.
The ECTC is expected to follow a multi‑stage process, beginning with a mandatory Stage 0 Expression of Interest (EOI). Indicative key dates currently include:
- Stage 0 – EOI (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
Information webinar
An information webinar for prospective applicants will take place on 6 July 2026 (15:00–17:00 CEST) and will provide an overview of the call objectives, eligibility requirements, evaluation process and indicative timeline. More information and registration here.
Important notice
This pre‑announcement is provided for information purposes only. The call documentation is currently in preparation and has not yet been formally adopted by the relevant ERDERA governance bodies.
All information is therefore provisional, non‑binding and subject to change. Only the official Call Text and associated application documents published at call launch will constitute the authoritative and legally applicable version of the call.