Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa

The Global Health EDCTP3 TB Drug Development 2026 Call, designated HORIZON-JU-GH-EDCTP3-2026-01-TB-01, offers a competitive grant opportunity of €30 million aimed at accelerating the clinical development of new or improved tuberculosis (TB) treatments and prevention strategies in sub-Saharan Africa. It is part of the Horizon Europe program, specifically targeting the urgent health challenge posed by TB, particularly its multidrug-resistant forms.

Eligible applicants include universities, research institutions, SMEs, NGOs, healthcare organizations, public and private enterprises, and international organizations established in EU Member States, Horizon Europe associated countries, and certain sub-Saharan African nations that are EDCTP Association members. Proposals must form a consortium comprising at least three independent legal entities from diverse eligible countries, including at least one from an EU or associated country and one from a sub-Saharan African country.

The focus of the funding is on late-stage clinical development, specifically Phase II and Phase III trials, with a priority on generating evidence for regulatory approval and market authorization of TB drugs and treatments. Co-funding from contributing partners is mandatory, which can be financial or in-kind, and should match or exceed the requested grant amount. Applications proceed through a two-stage process, with the first stage proposal due by March 4, 2026, and the full proposal by September 17, 2026.

The program encourages innovative research and implementation strategies while engaging local communities to ensure access to effective TB treatments. It specifically targets high-burden regions, recognizing the need to enhance care in low-resource settings, integrating treatment for various forms of TB, and exploring co-infection strategies, such as for HIV/AIDS.

Successful projects will involve collaboration between European and African institutions, focusing on advancing treatments that can significantly reduce TB morbidity and mortality in vulnerable populations, including women and children. The expected outcome is to facilitate affordable access to new interventions following their development and testing.

This is a call for proposals under the Horizon Europe program, specifically targeting the development of Tuberculosis (TB) drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa (SSA). The call, titled "Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa," is designated as HORIZON-JU-GH-EDCTP3-2026-01-TB-01-two-stage. It is a HORIZON JU Research and Innovation Action (RIA) with a two-stage submission process.

The primary goal is to reduce the disease burden of TB in SSA through increased international cooperation, research synergies, and leveraged resources. Proposals should include financial or in-kind contributions from contributing partners to enhance the impact of research activities.

The call emphasizes the importance of addressing TB, which remains a significant global health challenge, particularly in SSA where a large percentage of global TB deaths occur. It acknowledges the disruption of TB services during the COVID-19 pandemic and the urgent need to close gaps in prevention, diagnosis, treatment, and care.

The call prioritizes research and innovation in new preventive drug treatments for TB, including treatments for latent TB infection, and simpler, shorter treatments for TB disease. It also recognizes the potential for integrated approaches to address both TB and leprosy, particularly in post-exposure prophylaxis (PEP).

Expected outcomes include improved TB-related outcomes in adults and children in SSA, reduced burden of disease related to multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), and improved TB interventions in vulnerable populations, especially children.

The scope of the proposals should include advancing clinical development by generating clinical data (Phase IIa trials and beyond) to progress towards registration of new TB drugs, improved or shorter therapeutics TB regimens, chemoprophylaxis, and/or more comprehensive interventions combining therapeutics and chemoprophylaxis.

Proposals are encouraged to generate clinical data with a focus on priority populations, including women of childbearing potential and pregnant women, and particularly children, especially for assets in late-stage development, and generate clinical data progressing development of new or improved treatment regimens for MDR-TB and XDR-TB.

The call covers pulmonary TB disease, extrapulmonary TB forms, latent TB, drug-resistant TB (DR TB), MDR TB, and XDR TB. It also includes combinations of chemoprophylaxis with vaccines and host-directed therapies. For latent TB treatment proposals, the focus should be on individuals with increased risk of progressing to active disease. Co-infections or co-morbidities of TB, including HIV/AIDS, can be addressed, but not as the primary objective.

Sex/gender differences and the effects of age should be considered. Phase III studies should ensure adequate statistical power for sex/gender and age-specific analysis. Treatment decision algorithms can be included, but not as the primary objective.

The granting authority will base its funding decision on the ranking of proposals, considering a portfolio approach that balances late-stage (phase III) proposals with valuable early-stage proposals, all graded above the threshold.

The development of prophylactic vaccines, diagnostics and monoclonal antibodies, Phase I a/b clinical trials of single and/or combination drugs, and implementation research in early phase studies are not in scope. Preclinical studies are also out of scope. However, preparatory activities conducted during the preclinical phase can be considered in scope if they enable the conduct of the clinical study/ies in scope (these activities include but are not limited to protocol writing, development/evaluation of laboratory tests, Chemistry, Manufacturing, and Controls (CMC) related activities, etc.).

Proposals are expected to leverage financial and/or in-kind contributions from contributing partners. Activities and related costs covered by these contributions should be clearly identified. Applicants must describe prior relevant research findings and explain how the proposal builds on available data. Full details of development milestones, including go/no-go criteria, plans for regulatory approval, and an access strategy for low-resource settings are required.

Applicants are encouraged to consider innovations in clinical trial design and research methods, follow WHO guidance for best practices for clinical trials, engage communities and relevant stakeholders, and provide methodologies for translating research findings into public health practice and policy guidelines.

Collaboration and coordination with the AU-EU Health Partnership’s – Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub or similar African initiatives is encouraged. Applicants could show willingness to enter into technology transfer agreements, early engagement with regulators, or with African manufacturers.

Research consortia should have strong representation from institutions and researchers from SSA countries, including active participation of Franco/Lusophone countries, if possible. Collaboration with other international research groups is encouraged, as is reaching out to institutions/organizations in countries with high disease burden but lower research capacities.

The Leprosy Research Initiative will co-fund projects also targeting leprosy post-exposure prophylaxis (PEP), with a total indicative JU budget of 5 million EUR.

The call is a two-stage process. The opening date is January 14, 2026. The deadline for the first stage is March 4, 2026, and for the second stage, it is September 17, 2026. All deadlines are at 17:00:00 Brussels time. The total budget for this topic is 30,000,000 EUR, and the indicative number of grants is around 3.

Eligible countries include EU Member States, Overseas Countries and Territories (OCTs), countries associated with Horizon Europe, and constituent states of the EDCTP Association. Specific conditions apply to the eligibility of legal entities and consortium composition, including the requirement for at least three independent legal entities from different countries, one from a Member State or associated country that is a member of the EDCTP Association, and one from a sub-Saharan African country that is a member of the EDCTP Association.

If the coordinator is not established in a country in SSA, the designation of a scientific project leader established in a SSA country member of the EDCTP Association is mandatory.

Evaluation scores will be awarded for Excellence, Impact, and Quality and Efficiency of the implementation, with specific thresholds for each criterion.

Grants awarded under this topic must include a plan for the exploitation and dissemination of results, including an access plan to ensure that products and services developed are affordable, available, and accessible to the public at fair and reasonable conditions.

Global Health EDCTP3 may object to a transfer of ownership or exclusive licensing of results up to four years after the end of the action.

Applicants should be aware that information regarding their proposals may be shared with members of the JU Committee of the EDCTP Association and contributing partners.

This funding opportunity aims to bolster research and development efforts focused on TB treatment and prevention in sub-Saharan Africa. It seeks to foster collaboration between European and African research institutions to develop and implement effective strategies against TB, including drug development, clinical trials, and improved access to healthcare. The emphasis on involving local communities and stakeholders ensures that the research is relevant and impactful, addressing the specific needs of the region. The call also encourages the development of sustainable solutions, including technology transfer and local manufacturing, to ensure long-term access to TB treatments in Africa.

Eligible Applicant Types: The eligible applicant types include legal entities established in specific countries, international organizations, and contributing partners. Specifically, legal entities must be established in one of the following: EU Member States (including outermost regions), Overseas Countries and Territories (OCTs) linked to Member States, countries associated with Horizon Europe, and constituent states of the EDCTP Association. Legal entities from countries not listed, including low- and middle-income countries not members of the EDCTP Association, are eligible if provided for in the specific call topic conditions or if their participation is essential for implementing the action. Contributing partners, which can be countries, international organizations, or any public or private legal entity other than Global Health EDCTP3 members, also become part of the applicant consortium under certain conditions, particularly when providing in-kind contributions.

Funding Type: The primary financial mechanism is a grant, specifically a HORIZON Action Grant Budget-Based [HORIZON-AG] under the HORIZON JU Research and Innovation Actions (RIA).

Consortium Requirement: A consortium of multiple applicants is required. The consortium must include at least three legal entities independent from each other and each established in a different country where legal entities are eligible to receive funding. It must also include at least one independent legal entity established in a Member State or in an associated country to Horizon Europe that is a member of the EDCTP Association, and at least one independent legal entity established in a sub-Saharan African country that is a member of the EDCTP Association.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States, Overseas Countries and Territories (OCTs) linked to Member States, countries associated with Horizon Europe, and constituent states of the EDCTP Association, with a particular emphasis on the participation of entities from sub-Saharan Africa (SSA).

Target Sector: The program targets the health sector, specifically focusing on tuberculosis (TB) drug development for therapy and chemoprophylaxis, and leprosy post-exposure prophylaxis (PEP) research.

Mentioned Countries: The following countries and regions are explicitly mentioned: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Aruba, Bonaire, Curacao, French Polynesia, French Southern and Antarctic Territories, Greenland, New Caledonia, Saba, Saint Barthelemy, Sint Eustatius, Sint Maarten, St. Pierre and Miquelon, Wallis and Futuna Islands, Albania, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Serbia, Republic of Korea, Switzerland, Tunisia, Turkey, Ukraine, United Kingdom, Egypt, Morocco, Benin, Burkina Faso, Burundi, Cameroon, Cote d’Ivoire, Democratic Republic of the Congo, Ethiopia, Eswatini, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe, Sub-Saharan Africa (SSA).

Project Stage: The expected maturity of the project is advanced clinical development, specifically Phase IIa trials and beyond, aiming to progress towards registration of new TB drugs, improved therapeutics TB regimens, chemoprophylaxis, and/or more comprehensive interventions combining therapeutics and chemoprophylaxis.

Funding Amount: The funding amount for the HORIZON-JU-GH-EDCTP3-2026-01-TB-01-two-stage topic is 30,000,000 EUR, with an indicative grant amount of around 10,000,000 EUR.

Application Type: The application type is a two-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 involves two stages.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants suggests that the funding is highly competitive. For the TB topic, approximately 3 grants are expected to be awarded out of the pool of applicants.

Co-funding Requirement: Co-funding is required. Proposals are expected to leverage financial and/or in-kind contributions from contributing partners. The leveraging of financial and/or in-kind contributions from contributing partners that are equal or greater than the requested JU contribution is taken into consideration during the evaluation of second-stage proposals.

This opportunity is a call for proposals under the Horizon Europe program, specifically targeting the development of new tuberculosis (TB) drugs and therapies for adults and children in sub-Saharan Africa (SSA). The call, managed by the Global Health EDCTP3 Joint Undertaking, aims to reduce the disease burden of TB by fostering international cooperation, catalyzing research synergies, and leveraging resources and investments. It focuses on advancing clinical development, particularly Phase IIa trials and beyond, to bring new TB drugs, improved treatment regimens, and chemoprophylaxis options closer to registration and implementation. The call encourages proposals that generate clinical data for priority populations, including women and children, and those that address multi-drug resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). Applicants must form a consortium with at least three independent legal entities from different eligible countries, including a member state or associated country of Horizon Europe and a sub-Saharan African country that is a member of the EDCTP Association. The call emphasizes the importance of engaging local communities and stakeholders, translating research findings into public health practice, and ensuring affordable access to the resulting health technologies and services. A total of 30 million EUR is allocated to the TB topic, with individual grants expected to be around 10 million EUR. The application process is a two-stage process, and co-funding through financial or in-kind contributions from contributing partners is a key evaluation criterion.