NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
NIAID offers funding for small businesses to conduct clinical trials related to its research mission, particularly encouraging high-risk studies involving non-routine interventions or administration of unlicensed products for unapproved indications.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health (NIH)
Due Dates: November 17, 2025
Funding Amounts: No published ceiling or floor; budget should be reasonable and appropriate for project scope. Typical Phase II SBIR awards last up to 2-3 years.
Summary: Supports small businesses in implementing investigator-initiated clinical trials aligned with the NIAID mission, including high-risk and mechanistic studies.
Key Information: Only U.S. small businesses are eligible; foreign organizations are not eligible to apply.
Description
This opportunity encourages Small Business Innovation Research (SBIR) Phase II applications from U.S. small business concerns to implement investigator-initiated clinical trials relevant to the mission of the National Institute of Allergy and Infectious Diseases (NIAID). The program supports hypothesis-driven, milestone-driven clinical trials, with a particular focus on high-risk studies—defined by non-routine interventions, use of unlicensed products, or novel uses of licensed products. Mechanistic studies may also be proposed. The aim is to accelerate the development and commercialization of innovative healthcare products, diagnostics, and interventions in infectious and immune-mediated diseases.
