Tackling high-burden for patients and under-researched medical conditions

The Horizon Europe grant opportunity focuses on tackling high-burden, under-researched medical conditions such as autism and chronic fatigue syndrome. The eligible applicant types include universities, research institutes, SMEs, and multi-entity consortia. Funding is provided as a grant under the Horizon Europe Research and Innovation Actions model. A consortium is preferred for the application process, highlighting the need for collaboration among multiple stakeholders for multinational studies.

Geographic eligibility is open to EU member states and associated countries, with potential provisions for participation from legal entities in the United States. The target sector is primarily health, emphasizing research on conditions that are insufficiently studied despite their high prevalence. The proposed research actions should bridge gaps in scientific evidence, consider pathophysiological mechanisms, address societal impacts, and encourage the development of new diagnostics and therapeutic strategies.

Funding amounts typically range from €1 million to €5 million, derived from various individual topic budgets within the broader Horizon program. The application process is a single-stage open call, with submissions due by September 16, 2025. The grant aims to produce significant outcomes, including enhanced understanding of medical conditions, improved patient care, and increased collaboration across Europe.

Success rates vary, estimated between 10%-39%, due to the competitive nature of the funding. Co-funding requirements are not explicitly stated but synergies with other programs are encouraged. Overall, the grant seeks to foster collaborative research that aims to improve healthcare outcomes and develop innovative solutions for neglected medical conditions.

This is a description of the Horizon Europe (HORIZON) Call Cluster 1 Health (Single stage 2025) HORIZON HLTH 2025 01 DISEASE 07 topic, titled "Tackling high-burden for patients and under-researched medical conditions". It is a HORIZON RIA (Research and Innovation Actions) grant with a HORIZON Action Grant Budget Based [HORIZON AG] Model Grant Agreement. The call is currently open for submission as a single stage application, with the opening date being May 22, 2025, and a deadline of September 16, 2025, at 17:00 Brussels time.

The expected outcome of this topic is to support activities that contribute to the destination of "Tackling diseases and reducing disease burden". Proposals should aim to achieve the following outcomes:

Effective use of state-of-the-art information, data, technologies, tools, and best practices by the scientific and clinical communities to better understand medical conditions, leading to the development of diagnostics, therapeutics, and/or preventive strategies.

Data and knowledge exchange, strengthening collaboration, and building knowledge and care networks in Europe and beyond.

Wide use of newly established and open access databases, integrated with existing infrastructures for data storage and sharing, following FAIR principles.

Informing policymakers and funders about research advances and encouraging further support for study sustainability.

Constructive engagement of patients and caregivers in research, catering to their needs.

Improved clinical guidelines on diagnosis and/or treatment of conditions accessible to and used by health professionals.

The scope of this topic focuses on medical conditions that are often unrecognized or misdiagnosed, leading to inadequate treatment and chronic burdens for patients. These conditions, which may be insufficiently researched despite high prevalence, include myalgic encephalomyelitis/chronic fatigue syndrome, autism, gynecological diseases, low back pain, and other conditions. Applicants must specify which medical condition their proposal targets. Rare diseases, including rare cancers, and under-researched medical conditions already addressed by projects funded under topic HORIZON HLTH 2024 DISEASE 03 14 two stage are excluded.

Research actions should include the following activities:

Addressing gaps in scientific evidence for improved policies and practices to tackle the targeted medical condition.

Identifying pathophysiological mechanisms (e.g., genetic, cellular, and molecular) and potential risk factors (e.g., psychological and environmental) through basic, pre-clinical, and/or clinical research.

Demonstrating that the medical condition is poorly understood, inaccurately diagnosed, or inadequately treated, representing a high burden for patients and society.

Considering sex and gender-related aspects, age, ethnicity, socio-economic, lifestyle, and behavioral factors.

Addressing the emotional and societal long-term effects of chronic disorders.

Developing biomarkers and other technologies for diagnosis, patient monitoring, and patient group stratification, where applicable.

Developing clinically relevant (non-)human model systems to complement clinical investigations, where applicable.

Exploiting existing data, biobanks, registries, and cohorts, along with generating new data (e.g., genomics, epigenomics, transcriptomics, proteomics).

Utilizing existing European or national infrastructures for sharing samples, quality data, and advanced analytical tools.

Including patients or patient organizations in the research.

Encouraging participation of startups and SMEs.

The topic requires effective contribution from social sciences and humanities (SSH) disciplines, involving SSH experts and institutions to enhance the societal impact of research activities. Applicants should provide details of their clinical studies in the dedicated annex using the template in the submission system.

The general conditions include:

Admissibility Conditions: Described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal Page Limits and Layout: Described in Part B of the Application Form.

Eligible Countries: Described in Annex B of the Work Programme General Annexes. Specific provisions exist for non-EU/non-Associated Countries. Legal entities from the USA are eligible for Union funding.

Other Eligible Conditions: If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS.

Financial and Operational Capacity and Exclusion: Described in Annex C of the Work Programme General Annexes.

Evaluation and Award: Award criteria, scoring, and thresholds are described in Annex D. Grants will be awarded to proposals based on ranking and the highest-ranked proposals in different medical conditions, provided that all thresholds are met. The thresholds for each criterion are 4 (Excellence), 4 (Impact), and 4 (Implementation), with a cumulative threshold of 12. Submission and evaluation processes are described in Annex F and the Online Manual. The indicative timeline for evaluation and grant agreement is also described in Annex F.

Legal and Financial Set-Up: Described in Annex G of the Work Programme General Annexes.

Specific Conditions: Described in the specific topic of the Work Programme.

Application and Evaluation Forms: Standard application form (HE RIA, IA) and standard evaluation form (HE RIA, IA) are available in the Submission System.

Guidance: HE Programme Guide and HE MGA (Model Grant Agreement) are provided.

Call-Specific Instructions: Information on clinical studies (HE).

Additional Documents: HE Main Work Programme 2025 – 1. General Introduction, HE Main Work Programme 2025 – 4. Health, HE Main Work Programme 2025 – 14. General Annexes, HE Programme Guide, HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, Decision authorising the use of lump sum contributions under the Horizon Europe Programme, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, EU Grants AGA — Annotated Model Grant Agreement, Funding & Tenders Portal Online Manual, Funding & Tenders Portal Terms and Conditions, and Funding & Tenders Portal Privacy Statement.

The budget overview includes several topics, each with its own budget, opening date, deadline, contribution amounts, and indicative number of grants. For HORIZON HLTH 2025 01 DISEASE 07, the budget is 30,000,000 EUR, the opening date is May 22, 2025, the deadline is September 16, 2025, the contribution is around 6,000,000 EUR, and the indicative number of grants is 5.

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This Horizon Europe call focuses on tackling high-burden, under-researched medical conditions. It seeks to improve the understanding, diagnosis, and treatment of conditions like chronic fatigue syndrome, autism, gynecological diseases, and low back pain, among others. The call encourages multidisciplinary research, involving clinical studies, data exploitation, and the inclusion of patients and SMEs. The ultimate goal is to translate research advances into improved healthcare policies, clinical guidelines, and patient outcomes, thereby reducing the burden of these conditions on individuals and society. The call provides funding and a framework for researchers to collaborate, share data, and develop innovative solutions in the field of under-researched medical conditions.

Eligible Applicant Types: The eligible applicant types are not explicitly stated but can be inferred to include a broad range of entities such as research organizations, universities, startups, SMEs, and patient organizations. The encouragement of participation from startups and SMEs suggests their eligibility. The mention of legal entities established in the United States of America also indicates that entities outside of the EU can be eligible under certain conditions.

Funding Type: The primary funding mechanism is a grant, specifically through HORIZON Research and Innovation Actions (RIA) and HORIZON Coordination and Support Actions (CSA) and HORIZON Innovation Actions (IA). The grants are budget-based.

Consortium Requirement: The opportunity encourages multidisciplinary approaches and broad representation of stakeholders in the consortia, indicating that a consortium is preferred, although not explicitly stated as mandatory.

Beneficiary Scope (Geographic Eligibility): Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. Any legal entity established in the United States of America is eligible to receive Union funding.

Target Sector: The target sector is health, specifically focusing on tackling diseases and reducing disease burden. The program targets high-burden, under-researched medical conditions, including myalgic encephalomyelitis/chronic fatigue syndrome, autism, gynaecological diseases, and low back pain. It also encourages the development of diagnostics, therapeutics, and preventive strategies.

Mentioned Countries: United States of America. The text also refers to European countries and non-EU/non-Associated Countries.

Project Stage: The project stage spans from basic and pre-clinical research to clinical studies, development of diagnostics, therapeutics, and preventive strategies. This suggests projects can be in the research, development, validation, or demonstration stages.

Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from €2,000,000 to €80,000,000 in total budget for each topic. The indicative number of grants and their contributions vary across topics. For example, HORIZON-HLTH-2025-01-CARE-01 has a budget of €40,000,000 and aims to provide 2 grants with contributions ranging from €15,000,000 to €20,000,000. HORIZON-HLTH-2025-01-DISEASE-07 has a budget of €30,000,000 and aims to provide around 5 grants with contributions around €6,000,000.

Application Type: The application type is a single-stage open call.

Nature of Support: Beneficiaries will receive money in the form of grants to support their research and innovation activities.

Application Stages: The application process is a single-stage process.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight. For instance, a topic with a budget of €50,000,000 and an indicative number of 5 grants suggests a potentially higher success rate compared to a topic with a similar budget but fewer grants.

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary: This Horizon Europe call, under Cluster 1 Health, focuses on "Tackling high-burden for patients and under-researched medical conditions." It aims to support research and innovation actions that contribute to better understanding, diagnosing, treating, and preventing insufficiently researched medical conditions. The call encourages multidisciplinary approaches, the inclusion of social sciences and humanities, and the participation of SMEs and patient organizations. Funding is provided through grants, with varying budgets and indicative numbers of grants across different topics within the call. Eligible applicants include a wide range of entities from EU and associated countries, as well as legal entities from the United States. The call emphasizes the use of FAIR data principles, exploitation of existing data and infrastructures, and the development of biomarkers and clinically relevant model systems. The application process is a single-stage open call with a deadline of September 16, 2025.