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

Overview

Funding for clinical development of tuberculosis (TB) drugs, including new therapeutics, shorter treatment regimens, and chemoprophylaxis, with a focus on adults and children in sub-Saharan Africa (SSA). Targets research consortia advancing Phase IIa trials and beyond to reduce TB burden, particularly multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB) strains, while addressing priority populations such as children and pregnant women.

Who Can Apply

Consortia comprising at least three independent legal entities from different countries, including:

• One entity from an EU Member State or Horizon Europe-associated country that is also an EDCTP Association member.
• One entity from a sub-Saharan African country that is an EDCTP Association member.

Additional entities from non-eligible countries may participate if their involvement is deemed essential. Contributing partners (e.g., countries, international organizations, or private entities) must provide financial or in-kind contributions, with endorsement letters submitted before the second-stage deadline.

Funding Details

• Maximum grant amount: 10,000,000 EUR per project.
• Total indicative budget for leprosy-related PEP research: 5,000,000 EUR (co-funded by the Leprosy Research Initiative).
• Funding rate: Not specified; proposals must leverage contributions from partners equal to or exceeding the requested EU funding.
• Co-funding: Mandatory financial and/or in-kind contributions from contributing partners.

What Is Funded

• Clinical development (Phase IIa and beyond) of:

- New TB drugs or improved therapeutics regimens. - Shorter treatment regimens for TB disease. - Chemoprophylaxis and combined interventions (e.g., chemoprophylaxis with vaccines or host-directed therapies). - Treatment for latent TB in high-risk individuals, MDR-TB, and XDR-TB.

• Focus on priority populations, including children, women of childbearing potential, and pregnant women.
• Integrated approaches for TB and leprosy post-exposure prophylaxis (PEP), where applicable.
• Activities enabling clinical trials (e.g., protocol development, laboratory test evaluation, CMC-related tasks).
• Community and stakeholder engagement, policy translation, and access strategies for low-resource settings.

Technology / Maturity Requirements

• TRL/maturity: Proposals must focus on clinical trials (Phase IIa and beyond). Preclinical studies are excluded, except for preparatory activities directly enabling clinical trials.
• Exclusions: Phase I trials, prophylactic vaccines, diagnostics, monoclonal antibodies, and early-phase implementation research.

Key Dates

• Open date: 2026-01-13
• Deadline: 2026-03-03 (two-stage process; second-stage deadline not specified)

Application Process (High-Level)

• Two-stage process:

- Stage 1: Submission of a short proposal (no anonymization required). - Stage 2: Full proposal invited for selected Stage 1 applicants, including endorsement letters from contributing partners.

• Portal: Submissions via the EU Funding & Tenders Portal.

Post-Award Obligations

• Access plan: Mandatory submission of a plan for exploitation and dissemination of results, including strategies for affordable, equitable access to developed products in low-resource settings. Must be updated annually and submitted with the final report.
• Exploitation obligations: Best efforts to ensure broad availability of resulting health technologies for up to four years post-project. Non-exclusive licensing may be required if results are not exploited within one year.
• Annual reporting: Status updates on product development and exploitation for four years post-project.
• Scientific project leadership: If the coordinator is not from SSA, a scientific project leader from an SSA EDCTP member country must be designated, with dedicated budget and work package.

Geographic Scope & Language

• Eligible countries: EU Member States, Horizon Europe-associated countries, EDCTP Association members (including SSA countries), and other countries if their participation is essential.
• Language: English.

Notes

• Consortium composition: Must include strong representation from SSA institutions, with encouragement to engage Franco/Lusophone countries and institutions from high-burden, low-research-capacity countries.
• Contributing partners: Must submit endorsement letters before the second-stage deadline; in-kind contributors may join as beneficiaries or affiliated entities.
• Regulatory and access focus: Proposals must include plans for regulatory approval and market access in low-resource settings.
• Portfolio approach: Funding decisions may balance late-stage (Phase III) and early-stage proposals based on overall impact.