Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

The Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional), issued by the National Institutes of Health (NIH), aims to catalyze innovative and high-impact research at the interface of engineering, physical sciences, and biomedical sciences. This funding opportunity is managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), with participation from the National Eye Institute (NEI) and the National Institute on Aging (NIA). The goal is to attract new and early-stage investigators into translational biomedical research by supporting projects that are novel, exploratory, and potentially transformative. The award provides support for projects that may be technology design-directed, discovery-driven, or hypothesis-driven, with the distinctive feature that preliminary data are not required or expected. If included, such data must be unpublished, limited to one-half page with one figure, and clearly identified. Projects supported may include early-stage clinical trials (e.g., Phase I or feasibility studies) but must not propose efficacy or pivotal trials. Applicants should avoid submissions with extensive preliminary data, as these are outside the scope of this opportunity and better suited for traditional R01 mechanisms. Eligible applicants must be NIH-defined New or Early Stage Investigators. Multiple principal investigator applications are allowed, but all must meet this eligibility criterion. The program is open to a broad range of U.S.-based entities, including higher education institutions, nonprofit organizations, for-profits, state and local governments, and Native American tribal organizations. Foreign organizations are not eligible to apply, though foreign components are allowed. The application process mandates registration with several federal systems including SAM, eRA Commons, and Grants.gov. Applications must conform strictly to NIH application guides and follow page limits and submission instructions. Submission methods include NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system platform. There is no cost-sharing requirement for this award. Applications are accepted on NIH standard due dates, with upcoming deadlines on June 16 and October 16, 2025. Awards may request up to $400,000 in direct costs over a maximum three-year period, with no more than $200,000 in any single year. Awards will be made based on scientific merit, relevance to program priorities, and availability of funds. Inquiries can be directed to NIH contacts listed under the participating institutes, such as Randy King (NIBIB), Martha Flanders (NEI), and Leonid Tsap (NIA).