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

The Trailblazer Award for New and Early Stage Investigators is a National Institutes of Health funding opportunity offered through the U.S. Department of Health and Human Services. It is managed jointly by the National Institute of Biomedical Imaging and Bioengineering, the National Eye Institute, and the National Institute on Aging. The award provides an entry point for new and early stage investigators to pursue research that integrates engineering and the physical sciences with biomedical science. Its intent is to accelerate innovation by supporting high-risk, high-impact ideas at the early developmental stage, particularly those that cross disciplinary boundaries and lack preliminary data. This opportunity is designed to stimulate novel, transdisciplinary research in areas such as biomedical imaging, computational modeling, biophysics, and device engineering. Projects may be exploratory or proof of concept, and may address fundamental biomedical challenges through quantitative, engineering, or physical-science approaches. The program specifically targets NIH-defined new and early stage investigators and excludes those who have already applied for R01, R15, or other R21 awards within the same review cycle. Applications that include extensive preliminary data are considered outside the scope of the Trailblazer mechanism, as the focus is on conceptual novelty rather than established feasibility. The total project period may not exceed three years, with a maximum of $400,000 in direct costs and no more than $200,000 in any single year. The number of awards will depend on available appropriations and the number of meritorious applications received. Cost sharing or matching funds are not required. The funding instrument is a grant, and NIH policies under 2 CFR Part 200 and the NIH Grants Policy Statement apply. Projects involving human subjects or clinical trials are eligible only if they fall within early-stage parameters, such as Phase I feasibility or first-in-human studies. Later-phase clinical trials focused on efficacy or effectiveness will not be supported. Eligible applicants include public and private institutions of higher education, nonprofit and for-profit organizations, small businesses, tribal entities, and units of state, local, and federal government within the United States. Non-U.S. organizations are not eligible to apply, though foreign components within U.S. institutions may participate. Applicants must have current registrations in SAM.gov, Grants.gov, and eRA Commons, and all principal investigators must hold active eRA Commons IDs. Applications must be submitted electronically via ASSIST, an institutional system-to-system interface, or Grants.gov Workspace. Applications follow NIH’s standard R21 format and must comply with the Research (R) Application Guide. No letter of intent is required. Application due dates follow the NIH standard cycle: February 16, June 16, and October 16 annually, with AIDS-related applications due approximately one month later. Applications are due by 5:00 PM local time of the applicant organization. Review and award cycles occur approximately every four months, and successful applicants may begin projects as early as December 2025. The current notice expires May 8, 2026. Evaluation criteria focus on the importance of the research, rigor and feasibility, and the expertise and environment of the applicant. Reviewers will assess conceptual innovation, potential for significant impact, and suitability for early-stage support. Contact persons for scientific questions include Dr. Randy King (NIBIB, 301-451-0707, Randy.King@nih.gov), Dr. Martha Flanders (NEI, 301-827-5191, martha.flanders@nih.gov), and Dr. Leonid Tsap (NIA, 301-594-0277, leonid.tsap@nih.gov). Administrative questions may be directed to the listed grants management officers.