Opportunity Information: Apply for PAR 25 271
The NCCIH Natural Product Mid Phase Clinical Trial opportunity (PAR 25-271) is an NIH grant program that funds investigator-initiated, mid-phase clinical trials focused on natural products. In this context, natural products include botanicals, dietary supplements, probiotics, and also well-defined nutritional regimens that standardize a specific naturally occurring compound such as omega-3 fatty acids, anthocyanidins, or polyphenols. The central goal is to support studies that are ready for more rigorous clinical testing because they are backed by a strong scientific rationale and convincing early evidence, but that still need key mid-phase answers before moving to a larger, multi-site efficacy trial.
A major emphasis of this NOFO is that proposed trials must be grounded in mechanistic and translational evidence, not just general signals of benefit. Applications are expected to include sufficient preliminary data showing bioavailability when relevant (for example, evidence the compound or its active metabolites can be detected at meaningful levels in the body) and, critically, documentation that the product produces a reproducible and measurable impact on target engagement. Target engagement here means a measurable indicator that the product is acting on the intended biological pathway or mechanism of action, helping justify why the intervention should work and providing a way to interpret clinical outcomes. NCCIH notes that this requirement may be waived only in limited situations, such as when measuring target engagement in the intended patient population is not feasible or practical, or when the mechanism of action is fundamentally well understood.
The clinical trials supported under this program are specifically mid-phase and are meant to generate information that makes a later definitive trial feasible and well-designed. Proposed studies should be built to do one or both of the following: (1) determine the optimal dose or formulation of a natural product to carry forward into a future multi-site efficacy trial, or (2) identify which patient phenotypes are likely to respond versus not respond, so that inclusion and exclusion criteria for a future efficacy trial can be sharpened. In other words, the program is geared toward de-risking the next stage by refining dose, formulation, and patient selection based on biologically informed evidence rather than trial-and-error.
NCCIH also sets clear boundaries on what it will not fund through this NOFO. It is not intended to support single-site or multi-site efficacy or effectiveness trials, meaning the program is not paying for the final, confirmatory test of whether the product works in the broad sense. It also will not support trials testing natural products for the treatment or prevention of cancer. Studies are expected to be hypothesis-driven and milestone-based, aligning directly with NCCIH research priorities and mission, with clear go/no-go decision points and measurable progress markers appropriate for clinical trial management.
On eligibility and administrative details, this is a discretionary NIH grant mechanism using the R01 format with the designation "Clinical Trial Required," meaning applicants must be proposing an actual clinical trial rather than a non-trial clinical study. The activity category is Health (CFDA 93.213). A wide range of U.S.-based applicants can apply, including state and local governments, public and private institutions of higher education, federally recognized tribal governments, tribal organizations (including those other than federally recognized), nonprofits with or without 501(c)(3) status, for-profit organizations other than small businesses, and small businesses, among others. The NOFO also highlights inclusion of institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribal colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions. However, foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible.
Timing-wise, the listed original closing date is 2026-11-13, and the funding opportunity was created on 2024-12-02. The posting does not specify an award ceiling or expected number of awards in the provided source text. Finally, NCCIH encourages prospective applicants to contact the relevant NCCIH scientific or research program contact before submitting, which is a practical signal that program staff input is valued to ensure the proposed trial fits the institute's scope and the mid-phase intent of the NOFO.Apply for PAR 25 271
- 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 2024-12-02.
- 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.)
- 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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FAQs: NCCIH Natural Product Mid Phase Clinical Trial (PAR-25-271)
What is PAR-25-271?
PAR-25-271 is an NIH/NCCIH funding opportunity that supports investigator-initiated, mid-phase clinical trials focused on natural products.
Which NIH institute is offering this opportunity?
This opportunity is offered by the National Center for Complementary and Integrative Health (NCCIH), part of the NIH.
What is the main purpose of this funding opportunity?
The main purpose is to fund mid-phase clinical trials that are ready for more rigorous clinical testing based on strong scientific rationale and convincing early evidence, but that still need key mid-phase answers before moving to a larger, multi-site efficacy trial.
What kinds of interventions count as "natural products" under this NOFO?
In this context, natural products include botanicals, dietary supplements, probiotics, and well-defined nutritional regimens that standardize a specific naturally occurring compound (for example omega-3 fatty acids, anthocyanidins, or polyphenols).
Does the program fund any clinical trial about natural products?
No. The NOFO emphasizes that trials must be grounded in mechanistic and translational evidence and be designed to answer mid-phase questions that make a later definitive trial feasible and well-designed.
What does "mid-phase clinical trial" mean in this program?
Here, "mid-phase" refers to trials intended to generate information needed to plan a later definitive, multi-site efficacy trial. The focus is on refining dose/formulation and/or identifying which patient phenotypes are most likely (or unlikely) to respond, rather than delivering a final confirmatory efficacy or effectiveness result.
What kinds of study aims are expected for supported trials?
Proposed studies should be built to do one or both of the following: (1) determine the optimal dose or formulation of a natural product to carry forward into a future multi-site efficacy trial, and/or (2) identify patient phenotypes likely to respond versus not respond to sharpen inclusion and exclusion criteria for a future efficacy trial.
What is the NOFO's emphasis on mechanistic and translational evidence?
NCCIH emphasizes that applications must be grounded in mechanistic and translational evidence, not just general signals of benefit. The expectation is that the proposed trial is biologically informed and interpretable in terms of how and why the natural product is expected to work.
What preliminary data is expected regarding bioavailability?
Applications are expected to include sufficient preliminary data showing bioavailability when relevant. An example given is evidence that the compound or its active metabolites can be detected at meaningful levels in the body.
What is "target engagement" and why is it required?
Target engagement is a measurable indicator that the product is acting on the intended biological pathway or mechanism of action. NCCIH highlights target engagement as critical because it helps justify why the intervention should work and provides a way to interpret clinical outcomes.
Is documentation of target engagement always required?
NCCIH indicates this requirement may be waived only in limited situations, such as when measuring target engagement in the intended patient population is not feasible or practical, or when the mechanism of action is fundamentally well understood.
Are trials expected to be hypothesis-driven?
Yes. Studies are expected to be hypothesis-driven and aligned directly with NCCIH research priorities and mission.
Are milestones and go/no-go decision points required?
Yes. The NOFO describes studies as milestone-based, with clear go/no-go decision points and measurable progress markers appropriate for clinical trial management.
What types of trials are explicitly not supported by this NOFO?
This NOFO is not intended to support single-site or multi-site efficacy or effectiveness trials (that is, final confirmatory trials). It also will not support trials testing natural products for the treatment or prevention of cancer.
Does this opportunity support cancer treatment or prevention trials using natural products?
No. Trials testing natural products for the treatment or prevention of cancer are not supported under this NOFO.
What grant mechanism is used for this opportunity?
This is a discretionary NIH grant mechanism using the R01 format with the designation "Clinical Trial Required."
What does "Clinical Trial Required" mean here?
"Clinical Trial Required" means applicants must be proposing an actual clinical trial, rather than a non-trial clinical study.
What is the activity category and CFDA number?
The activity category is Health, and the CFDA listing is 93.213.
Who is eligible to apply?
A wide range of U.S.-based applicants are eligible, including state and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations (including those other than federally recognized); nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses, among others.
Are certain institution types specifically encouraged or highlighted?
Yes. The NOFO highlights inclusion of institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribal colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions.
Are foreign organizations eligible to apply?
No. Foreign organizations are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible.
What is the listed closing date?
The listed original closing date is 2026-11-13.
When was this funding opportunity created?
The opportunity was created on 2024-12-02.
Is there an award ceiling or an expected number of awards listed?
Not in the provided source text. The posting does not specify an award ceiling or the expected number of awards in the information provided.
Should applicants contact NCCIH before submitting?
Yes. NCCIH encourages prospective applicants to contact the relevant NCCIH scientific or research program contact before submitting, which signals that program staff input is valued to confirm fit with the institute's scope and the mid-phase intent of the NOFO.
What is the overall "fit" NCCIH seems to be looking for?
Based on the description, NCCIH is looking for biologically grounded, mid-phase natural product trials with convincing early evidence, appropriate preliminary data (including bioavailability when relevant), and measurable target engagement (unless a limited waiver applies), all structured around milestones that help decide whether and how to move to a later definitive multi-site efficacy trial.
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