Funding Opportunity for NIH Directors Pioneer Award Program (DP1 Clinical Trial Optional)

The National Institutes of Health (NIH), an agency under the Department of Health and Human Services, is announcing a forthcoming Notice of Funding Opportunity (NOFO) for the NIH Director’s Pioneer Award, part of the High-Risk, High-Reward Research program. This initiative is managed by the Office of Strategic Coordination (Common Fund) and is designed to support scientists of exceptional creativity proposing groundbreaking research. The award specifically encourages bold, innovative projects with the potential for significant impact in broad areas relevant to the NIH mission. This funding opportunity is discretionary and focuses on high-risk, high-impact research. The program places significant emphasis on the innovativeness of the proposed research and the potential of the principal investigator (PI) to make transformative advancements. Applicants are not required to submit preliminary data or detailed experimental plans, distinguishing this opportunity from traditional NIH funding mechanisms. The anticipated funding mechanism is a grant under activity code DP1, with optional clinical trials. Approximately seven awards are expected, with an estimated total program funding of $8.1 million. The projected start date for awarded projects is September 1, 2026. The Pioneer Award is unique in that it seeks proposals significantly different from the applicant's ongoing research, emphasizing novel directions and approaches. Eligibility for this opportunity is broad and includes a range of organizations such as state and county governments, higher education institutions (both public and private), public housing authorities, Native American tribal organizations, nonprofit organizations, and for-profit businesses. Applicants must be individual investigators (PD/PIs) who can commit at least 51% of their research effort to the proposed project. Only single PD/PI applications will be accepted. The forecasted dates include an estimated posting date of June 9, 2025, with applications due by September 9, 2025. Awards are expected to be announced by September 1, 2026. Interested applicants are advised that this is a forecast notice and applications are not being solicited at this time. This advance notice is intended to provide potential applicants with sufficient preparation time. For more information, applicants may contact Dr. Patricia Labosky at 301-594-4863 or via email at PioneerAwards@mail.nih.gov. Additional information will be made available upon the formal publication of the NOFO.