Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

The National Institutes of Health (NIH) is seeking applications for research projects that address critical needs for clinical trial readiness in rare diseases. The initiative will support the development and testing of rigorous biomarkers and clinical outcome assessment measures, or the definition of the presentation and course of a rare disease to enable the design of upcoming clinical trials. The funding opportunity will utilize the R21 activity code and will provide support for up to 2 years. • The initiative is intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials. • The funding opportunity is open to a variety of applicant types, including public and state controlled institutions of higher education, private institutions of higher education, nonprofits, and small businesses. • The application submission deadline is July 20, 2028. • The estimated award date is December 15, 2026.