Discovery and Development of Novel Therapeutics for Select Fungal Pathogens (R21/R33 Clinical Trial Not Allowed)
This funding opportunity provides financial support for researchers and institutions to discover and develop new treatments for serious fungal infections that are difficult to treat due to resistance and safety issues.
Description
The National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID) is seeking applications for the discovery and development of novel therapeutics targeting priority fungal pathogens. This initiative, titled "Discovery and Development of Novel Therapeutics for Select Fungal Pathogens," is part of a phased research effort that will provide milestone-driven support through R21 and R33 awards. The goal is to advance drug discovery against fungal pathogens, such as *Candida auris*, *Aspergillus fumigatus*, *Coccidioides*, and Mucorales species, which are currently limited in treatment options due to resistance and safety concerns.
This funding opportunity is structured to first support early-stage, proof-of-concept research under the R21 phase, focusing on new therapeutic targets and promising candidates. Successful R21 projects may transition to the R33 phase, supporting additional development toward preclinical-stage candidates. Proposed projects should aim to identify novel drug mechanisms, develop agents that bypass known resistance mechanisms, or improve safety and tissue specificity of existing antifungal approaches. The program is especially interested in innovative approaches that may include host-targeted therapeutics, broad-spectrum antifungals, or compounds addressing multiple fungal pathogen categories. Importantly, projects must include defined transition milestones for progressing from the R21 to R33 phase.
The R21 phase of funding provides a maximum of $275,000 over two years, with no single year exceeding $200,000 in direct costs. Upon successful completion and approval of transition milestones, applicants may receive up to three years of additional funding under the R33 phase, capped at $300,000 in direct costs annually. NIH expects to fund approximately 8 to 10 awards through this NOFO, with the total funding set at $2.4 million for FY 2026.
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and some government agencies, including public housing authorities and tribal organizations. Both U.S. and non-U.S. institutions are eligible to apply. Key submission requirements include a detailed project description for both R21 and R33 phases, transition milestones, and a Data Management and Sharing Plan. Applications are required to follow the NIH application guide and may not exceed specified page limits. Projects involving clinical trials, vaccine development, or GMP manufacturing are outside the scope of this opportunity.
Applications are due by January 28, 2025, with a mandatory letter of intent suggested 30 days before this deadline. Review and award cycles are planned for scientific merit review in June 2025, advisory review in October 2025, and an earliest start date of December 2025. NIH peer reviewers will assess applications based on significance, innovation, rigor, feasibility, expertise, and resource adequacy. Selected projects will align with NIH’s focus on addressing antimicrobial resistance and supporting the development of effective, safe antifungal treatments.