NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required) | PAR 24 115

Opportunity Information: Apply for PAR 24 115

The NCCIH Natural Product Mid Phase Clinical Trial funding opportunity (PAR-24-115) is an NIH R01 program that supports investigator-initiated, mid-phase clinical trials focused on natural products. In this context, "natural products" includes botanicals, dietary supplements, and probiotics, as well as well-defined nutritional regimens that standardize exposure to a specific naturally occurring compound (for example, omega-3 fatty acids, anthocyanidins, or polyphenols). The central idea is to move promising natural products forward when there is a strong scientific rationale and enough early evidence to justify more rigorous clinical testing, while still staying short of full-scale efficacy or effectiveness trials.

A key requirement is that applications be grounded in solid preliminary data. Applicants are expected to show bioavailability when it is relevant to the product (for instance, evidence the active constituents can be absorbed and reach the body compartment where they are supposed to act). Beyond that, the NOFO emphasizes target engagement, meaning applicants should document that the natural product produces a reproducible, measurable effect on the intended biological target or pathway tied to its proposed mechanism of action. This target engagement evidence is meant to demonstrate that the intervention is doing something biologically meaningful and measurable, not just that it is associated with changes in symptoms. NCCIH notes that this requirement may be waived only in limited situations, such as when target engagement cannot reasonably be measured in the patient population of interest or when the mechanism of action is already fundamentally understood well enough that the additional documentation is not practical or necessary.

The clinical trials supported under this NOFO are specifically "mid-phase" studies with a clear, hypothesis-driven purpose aimed at de-risking and designing a later, larger multi-site efficacy trial. Proposed trials should be designed to either (1) determine the optimal dose or formulation of a natural product to take forward into a future multi-site efficacy trial, or (2) identify which patient phenotypes are likely to respond versus not respond, so future studies can refine inclusion and exclusion criteria and increase the chances of detecting true treatment effects. In other words, the program is oriented toward selecting the right product version and dosing strategy, and toward understanding heterogeneity of response, rather than attempting to prove definitive clinical benefit at scale.

NCCIH expects projects to be milestone-driven and aligned with NCCIH research priorities and mission. The milestone-driven expectation signals that applicants should lay out clear go/no-go criteria, measurable benchmarks, and decision points that indicate whether the product is ready for a larger efficacy trial. Just as important are the boundaries of what will not be supported: this NOFO does not fund single-site or multi-site efficacy or effectiveness trials, and it does not support trials evaluating natural products for the treatment or prevention of cancer. Applicants are also encouraged to contact the relevant NCCIH scientific or research program contact before submitting, which typically helps ensure the proposed trial fits the institute's scope and expectations.

Eligibility is broad and includes many domestic organization types such as state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; school districts; public housing authorities; and federally recognized tribal governments, among others. The NOFO also highlights additional eligible applicants such as Historically Black Colleges and Universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and other community-based or faith-based organizations. However, non-U.S. (foreign) organizations are not eligible to apply directly, and non-U.S. components of U.S. organizations are not eligible. At the same time, foreign components as defined in the NIH Grants Policy Statement may be allowed, meaning a U.S. applicant organization can sometimes include certain well-justified foreign elements (such as specialized assays or recruitment resources) under NIH rules.

Administrative details provided include that this is a discretionary grant opportunity under the NIH, within the health activity category (CFDA 93.213). The opportunity was created on February 1, 2024, and the listed closing date is November 13, 2026. The award ceiling shown in the source data is $350,000.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Natural Product Mid Phase Clinical Trial (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): 93.213.
• This funding opportunity was created on 2024-02-01.
• Applicants must submit their applications by 2026-11-13. (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 $350,000.00 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 PAR 24 115

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: