Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2025-03-DISEASE-02-two-stage
- Programme
- Cluster 1 - Health (Two stage - 2025)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- May 22, 2025
- Deadline
- September 16, 2025
- Deadline Model
- two-stage
- Budget
- €40,000,000
- Min Grant Amount
- €7,000,000
- Max Grant Amount
- €8,000,000
- Expected Number of Grants
- 5
- Keywords
- HORIZON-HLTH-2025-03-DISEASE-02-two-stageHORIZON-HLTH-2025-03-two-stageBehavioural neuroscience (e.g. sleep, consciousness, handedness)Brain researchClinical neurologyClinical researchClinical trialsDevelopmental neurobiologyMental disordersMental healthNeurobiologyNeurochemistry and neuropharmacologyNeurosciences (including psychophysiology)Psychiatric disordersPsychiatric disorders (e.g. schizophrenia, autism, Tourette's syndrome, obsessive compulsive disorder, depression, bipolar disorder, attention deficit hyperactivity disorder)PsychiatryPublic healthSubstance abuse
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:
- The scientific and clinical communities make effective use of state-of-the-art knowledge, data, technologies, tools, methods, best practices, and trainings to underpin and complement the development of innovative interventions[1] aimed at achieving a lasting benefit.
- The scientific and clinical communities benefit from the exchange of data, knowledge and best practices, thereby strengthening their collaboration in the EU, the Associated Countries and beyond.
- The scientific and clinical communities make wide use of relevant databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR[2] principles, thereby encouraging further use of the data.
- Policymakers, funders, scientific and clinical communities, patient organisations, regulators, and other relevant bodies are informed of the research advances made and the requirements for a widespread implementation of the innovative therapeutic interventions and complementary approaches.
- Patients and caregivers are constructively engaged with the research, ensuring that their needs are catered for, with the aim of tangibly benefitting from the interventions.
Mental, behavioural and neurodevelopmental disorders, that include for example severe depression, anxiety, schizophrenia, psychosis, post-traumatic stress disorder (PTSD), addictive behaviours (drugs[3], alcohol, gaming and others), obsessive-compulsive disorder, eating disorders and autism spectrum disorder are a high burden for patients, health systems and society, and remain unmet medical needs. More innovative, safer and more effective therapeutic and relapse-preventing solutions based on active substances are required, as for example for mental disorders many available treatments show modest efficacy, non-negligible side effects, discontinuation problems and high relapse rates. Additionally, other non-invasive multidisciplinary and/or transdiagnostic approaches (e.g. neurostimulation, neuroimaging, digital, non-pharmaceutical, psychotherapy, psychosocial) should be further developed to complement the therapeutic and relapse prevention solutions. These approaches aim to further improve health outcomes, self-determination, autonomy and quality of life in the long-term.
The disorders within the scope of this topic fall under Chapter 6 of the International Classification of Diseases[4]. Rare diseases are excluded[5].
Proposals should address most of the following aspects:
- Perform rigorous clinical studies into the safety and efficacy of the innovative interventions and their mode of administration, ensuring adequate cohorts/sample sizes with adequate representation of the patient population, including in terms of age, sex and ethnicity.
- Through the clinical studies, gain further insight into the mechanism(s) of action of the innovative therapies and complementary approaches. This could entail analyses of imaging (e.g. MRI, ultrasound, nuclear imaging), as well as physiological, molecular, biochemical or omics signatures revealing potential perturbations prior to the intervention and recovery thereafter, and it could lead to the development of surrogate endpoints. This insight should open the path to more personalised interventions and approaches.
- Use and/or develop technologies, including digital ones (e.g., (generative) Artificial Intelligence - AI[6], wearable technologies) to help implement and monitor the long-term efficacy of the intervention(s), as well as manage the disorder and/or monitor their progression (e.g. with unobtrusive technologies suitable for patient monitoring at home and in real-world conditions), whilst also ensuring they are bias-free, inclusive, and ethically sound.
- Exploit existing data, biobanks, registries and/or cohorts, together with the generation of new data that should be managed in line with the FAIR principles.
- Engage all relevant stakeholders (especially patients and patients’ representatives for the disorder, caregivers, clinicians, counsellors, regulators, etc.) to design end-user optimised interventions, applying gender-sensitive and intersectional approaches.
- Advance research by leveraging already existing and emerging state-of-the-art research infrastructures (e.g. ECRIN[7], EATRIS[8], EBRAINS[9], BBMRI[10], EuroBioImaging[11], European Genomic Data Infrastructure[12], etc.), as well as results stemming from EU-supported research projects, where applicable.
- Engage with national public health authorities and regulators to ensure a robust development pathway and further uptake of the intervention.
The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[13] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.
Funded projects should liaise with the European Partnership for Brain Health (covered by topic HORIZON-HLTH-2025-02-DISEASE-01) once launched.
The topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. Therefore, proposals should include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase.
Applicants invited to the second stage should provide details of their clinical studies[14] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
[1] Innovative interventions should be based on new and/or alternative approaches that are aimed at achieving a lasting therapeutic benefit. The innovative intervention should be a combination of a product based on an active substance that is complemented by another multidisciplinary approach.
[2] See definition of FAIR data in the introduction to this work programme part.
[3] If proposals concern drug addiction, they are encouraged to liaise with the EU Drugs Agency.
[4] International Classification of Diseases 11th Revision (ICD-11), developed by the World Health Organization (WHO); Chapter 6: ‘Mental, behavioural or neurodevelopmental disorders’.
[5] Rare diseases, as defined by the European Union Regulation on Orphan Medicinal Products (1999), being a disease that affects not more than 1 person per 2000 in the European population (https://www.orpha.net/).
[6] Generative AI is a type of AI technology that can generate various forms of new content such as text, images, sounds, and even code, such as for programming or gene sequencing (https://ec.europa.eu/newsroom/dae/redirection/document/101621).
[10] https://www.bbmri-eric.eu
[11] https://www.eurobioimaging.eu
[12] https://gdi.onemilliongenomes.eu
[13] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[14] Please note that the definition of clinical studies (see introduction to this work programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
Destination & Scope
Topics under this destination are directed towards the Key Strategic Orientation 3 “A more resilient, competitive, inclusive, and democratic Europe” of Horizon Europe’s strategic plan 2025-2027.
Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “healthcare providers improve their ability to tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) thereby reducing the disease burden on patients and enabling healthcare systems to perform more effectively. It can be achieved through better understanding, prevention, diagnostics, treatment, management, and cure of diseases and their co- and multi-morbidities, more effective and innovative health technologies and medical countermeasures, better ability and preparedness to manage pandemic and/or epidemic outbreaks, and improved patient safety”.
Communicable and non-communicable diseases cause the greatest amounts of premature death and disabilities and pose a major health, societal and economic threat and burden in the EU and worldwide. Many people are still suffering from these diseases and too often dying prematurely. Although many of these diseases are preventable to a large extend, only around 6% of the healthcare budgets are currently spent on preventive measures[1]. Therefore, there is the urgent need to develop new public health interventions, preventive, diagnostic and therapeutic approaches, alternatives to antimicrobials, as well as to improve existing preparedness and response strategies to create tangible impacts, taking into account sex/gender-related issues. In this regard, Research and Innovation will require international cooperation to pool the best expertise and know-how available worldwide, to access world-class research infrastructures and to leverage critical scales of investments on priority needs through a better alignment with other funders of international cooperation in health Research and Innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases, to address brain health, to respond to public health needs, including the global burden of non-communicable diseases.
In this work programme part, Destination “Tackling diseases and reducing disease burden” will focus on major societal challenges linked to the Commission’s political priorities such as the fight against non-communicable and communicable diseases, mental health and better treatment of mental, behavioural and neurodevelopmental diseases, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment of the number of antimicrobial-resistant infections. In particular, the topics under this destination will support activities aiming at: i) new effective treatment options for patients suffering from antimicrobial resistant (AMR) infections; ii) innovative therapeutic interventions and complementary approaches for patients suffering from mental, behavioural and neurodevelopmental disorders; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) Artificial Intelligence (AI) based tools and technologies for pandemic preparedness and response; v) implementation research on strengthening health systems in the context of non-communicable diseases; vi) supporting the Global Research Collaboration for Infectious Disease Preparedness; vii) setting up the European Partnership for Brain Health; and viii) supporting efforts of the European Partnership fostering a European Research Area for health research (ERA4Health)[2] in particular in funding large-scale multi-country Investigator-Initiated Clinical Studies (IICS) on various health interventions addressing important public health needs.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, Cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other Clusters (under pillar II of Horizon Europe). For instance, with Cluster 3 “Civil security for society” such as on health security/emergencies (preparedness and response, medical countermeasures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with Cluster 4 “Digital, Industry and Space” such as on AI-based tools and technologies (e.g. detection, management and monitoring of an epidemic at population levels, and the diagnosis, treatment, and prevention at the level of individuals); or with Cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on antimicrobial resistance - AMR (e.g. new effective treatment options, alternatives to antibiotics).
Some Research and Innovation actions under this destination should support the mission of the European Health Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the availability and access to key medical countermeasures. Furthermore, synergies will be sought between this destination and the implementation of the EU4Health Programme (2021-2027)[3]. These synergies and complementarities could be achieved, notably through mechanisms based on feedback loops, enabling on the one hand to identify policy needs that should be prioritised in Research and Innovation actions and facilitating on the other hand the implementation of research results into policy actions and clinical practice, thereby providing an integrated response across sectors and policy fields.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts:
- Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare.
- Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs[4] 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs)[5],[6],[7].
- Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation.
- Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[8],[9].
- Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).
The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers[10] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[1] Preventive healthcare expenditure as a share of the current expenditure on healthcare https://ec.europa.eu/eurostat/statistics-explained/index.php?title=File:Preventive_healthcare_expenditure_as_a_share_of_current_expenditure_on_healthcare,_2021_(%25)_HCE2024.png
_HCE2024.png){kind=link}
[3] https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en
[4] Non-communicable diseases
[5] https://www.who.int/publications/i/item/9789241506236
[6] Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non-communicable diseases in both public and private facilities.
[7] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.
[8] WHO global action plan on antimicrobial resistance, 2015
[9] EU One Health Action Plan against AMR, 2017
[10] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).
Eligibility & Conditions
General conditions
1. Admissibility Conditions, Proposal page limit and layout
Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E).
2. Eligible Countries
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. See the information in the Horizon Europe Programme Guide.
3. Other Eligible Conditions
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
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 (other data and services may additionally be used).
The following exceptions apply: subject to restrictions for the protection of European communication networks.
Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly.
Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget.
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents:
Application and evaluation form templates
Standard application form (HE RIA IA Stage 1) - the application form specific to this call is available in the Submission System
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1) - will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreement (MGA)
Call-specific instructions
Additional documents1
HE Main Work Programme 2025 – 1. General Introduction
HE Main Work Programme 2025 – 4. Health
HE Main Work Programme 2025 – 14. General Annexes
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
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search help you find a partner organisation for your proposal.
Latest Updates
First stage of call HORIZON-HLTH-2025-03-two-stage closed on 16 September 2025. 695 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2025-03-STAYHLTH-01-two-stage: 128 proposals
- HORIZON-HLTH-2025-03-DISEASE-02-two-stage: 190 proposals
- HORIZON-HLTH-2025-03-ENVHLTH-01-two-stage: 102 proposals
- HORIZON-HLTH-2025-03-ENVHLTH-02-two-stage: 120 proposals
- HORIZON-HLTH-2025-03-IND-03-two-stage: 155 proposals
Evaluation results are expected to be communicated on Wednesday 21 January 2026 at the earliest.
Please note that due to a technical issue, during the first days of publication of this call, the topic page did not display the description of the corresponding destination. This problem is now solved. In addition to the information published in the topic page, you can always find a full description of the relevant destination in the Work Programme 2025 part for "Health". Please select from the work programme the destination relevant to your topic and take into account the description and expected impacts of that destination for the preparation of your proposal.