Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required) | PAS 25 102

Opportunity Information: Apply for PAS 25 102

The NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is offering this funding opportunity to support small, short-term R01 clinical trials that are specifically designed as pilot and feasibility studies in humans. The central goal is to help investigators generate the kind of early, practical evidence needed to justify and design a larger, more definitive clinical trial. These projects are meant to be proof-of-concept in nature, with a clear focus on diseases and conditions that fall within NIDDK's mission areas, which broadly include diabetes and other endocrine or metabolic diseases, digestive diseases, nutrition-related conditions, and kidney, urologic, and hematologic diseases.

This Notice of Funding Announcement (PAS-25-102) is aimed at clinical trials that test prevention and/or treatment interventions and that can produce two main categories of outcomes: preliminary information about how the intervention affects relevant outcomes in humans, and feasibility information that demonstrates the study can realistically be carried out. Feasibility data can include evidence that recruitment strategies work, retention is achievable, participants will adhere to study procedures, sites can deliver the intervention consistently, and data collection processes are workable. A key point is that applicants do not need to already have preliminary efficacy data showing that the intervention works. Instead, the program is structured to let researchers run a small, well-justified trial to obtain the early signals and operational lessons that would support a later, larger hypothesis-driven trial with stronger power and broader impact.

Applications are expected to be tightly designed, with clearly stated aims, objectives, and an overall plan that makes it believable the study will produce actionable results. NIDDK is looking for trials where the findings are likely to lead to a more definitive next step, such as a larger multi-site trial or a more rigorous efficacy/effectiveness study. Reviewers will be looking for a strong rationale that the pilot will meaningfully de-risk the next phase of research and that it has a plausible path toward improving understanding, diagnosis, prevention, or treatment in ways that could ultimately influence clinical practice or public health.

The funding instrument is a grant using the R01 activity code, but it is explicitly a "Clinical Trial Required" opportunity, meaning the application must propose a clinical trial rather than an observational study or preclinical work. The award ceiling listed in the source data is $200,000, reinforcing that this opportunity is intended for smaller-scale projects rather than large, long-duration trials. The funding activity category is listed under Food and Nutrition and Health, and the CFDA number associated with the program is 93.847.

A wide range of organizations are eligible to apply. This includes state, county, city/township, and 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; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education, since those are listed separately); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Eligibility rules for non-U.S. entities are restrictive. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply directly, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined under the NIH Grants Policy Statement, which generally means a U.S.-based applicant organization can include certain foreign elements in the project when scientifically justified and compliant with NIH policy.

The agency is the National Institutes of Health, and the original closing date listed for this opportunity is May 7, 2026. Overall, this NOFO is best suited for investigators who have a credible intervention idea and a strong clinical rationale, but who still need a limited, well-structured human trial to confirm feasibility and gather early signals before moving into a larger, more definitive NIDDK-relevant clinical trial program.

• 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 2025-01-08.
• 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.

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