Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required) | PAS 23 086

Opportunity Information: Apply for PAS 23 086

The NIH, through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is offering a grant opportunity designed specifically for small, early-stage clinical trials in humans. The goal is to fund pilot and feasibility studies that test an intervention in a real-world clinical trial setting and generate the kind of preliminary and operational evidence needed to justify and design a larger, more definitive trial later. In practical terms, this program is meant for proof-of-concept trials that are intentionally limited in scope and duration but still rigorous enough to inform next-step, hypothesis-driven clinical research aimed at preventing or treating diseases within the NIDDK mission area (for example, diabetes and other endocrine/metabolic disorders, digestive diseases, nutrition-related conditions, kidney and urologic diseases, and related public health concerns).

This opportunity is titled "Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)" and is issued under Funding Opportunity Number PAS-23-086. It uses the R01 grant mechanism, but with an emphasis on smaller, short-term trials rather than large multi-year efficacy studies. The announcement is explicit that the clinical trial must be conducted in humans and that the application should clearly lay out the study aims, objectives, and how the trial will be run. Reviewers will be looking for a strong rationale that the work is likely to produce actionable findings and, just as importantly, that it will meaningfully inform the planning of a larger trial that could improve understanding, diagnosis, prevention, or treatment of the targeted condition. The program is also positioned to support data collection around feasibility issues such as recruitment and retention, participant adherence, site performance, and other elements of study conduct that often determine whether a later, larger trial is realistic.

A key feature of this FOA is that applicants are not required to already have preliminary evidence that the intervention is efficacious. That is consistent with the pilot and feasibility focus: the grant is intended to help investigators learn whether the intervention shows promising signals and whether the trial design and logistics work in practice. At the same time, the application still needs to make a credible case that the study is well-designed, that the endpoints and procedures are appropriate for a small proof-of-concept trial, and that the expected outputs will directly support a future, more definitive clinical trial with clearer hypotheses and greater statistical power. In other words, even though prior efficacy data are not required, the work still needs to be framed as a serious clinical trial effort with a plausible pathway to impacting clinical practice and/or public health if subsequent studies confirm and expand on the findings.

From an administrative standpoint, this is a discretionary grant opportunity categorized under Food and Nutrition and Health, with CFDA number 93.847. The listed award ceiling is $200,000, signaling that budgets should align with the "small R01" concept and that projects should be scoped accordingly. The original closing date shown is 2026-05-07, so applicants should plan around that deadline while also checking the official NIH posting for any schedule updates, application cycles, or related submission windows that NIH may specify for this program.

Eligibility is broad and includes many common NIH applicant types across government, academia, nonprofit, and industry. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

The FOA draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicants, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may be able to include certain foreign activities or collaborations if they meet NIH definitions and requirements. This structure allows some international scientific participation while keeping the primary applicant organization domestic.

Overall, this opportunity is aimed at investigators who have a promising intervention and a well-reasoned clinical question within NIDDKs mission, but who need targeted support to run a smaller, tightly focused human trial that generates early signals and real operational experience. The most competitive projects will typically be those that treat the pilot trial as a stepping-stone: they are designed to yield interpretable results, to expose practical challenges in trial execution, and to produce concrete information that directly strengthens the design and justification for a subsequent larger-scale clinical trial that could ultimately change clinical decision-making or public health outcomes.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2023-02-01.
• Applicants must submit their applications by 2026-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAS 23 086

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