Opportunity Information: Apply for PAR 25 270
The NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required), Funding Opportunity Number PAR-25-270, is a National Institutes of Health grant program designed to move promising natural product research into early-stage testing in humans. The focus is on investigator-initiated clinical trials of natural products such as botanicals, dietary supplements, and probiotics, as well as certain nutritional regimens that standardize a specific naturally occurring compound (for example omega-3 fatty acids, anthocyanidins, or polyphenols) and are backed by compelling preliminary evidence. The core expectation is that applicants bring a strong scientific premise suggesting the product engages a biologically meaningful target and is ready for rigorous early clinical evaluation.
This opportunity is specifically aimed at early phase, hypothesis-driven, milestone-based clinical trials that generate results with clear decision value. NCCIH is looking for studies where the findings, whether positive or negative, will still be highly informative and will directly support go/no-go decisions about whether a natural product should advance to further development or additional clinical testing. Rather than asking applicants to run broad clinical outcome trials, the NOFO emphasizes mechanistic clarity and scientific utility: it prioritizes trials that can replicate and measure the natural product's impact on target engagement in humans, and then evaluate whether the degree of target engagement is associated with functional or clinical outcomes in a relevant patient population.
The award provides up to 3 years of support to conduct this kind of early translational clinical work. A major theme is optimizing how the natural product is delivered and used so that target engagement is maximized and reliably measured. Applications are encouraged to include designs that compare different doses or formulations to identify the most effective way to achieve the intended biological effect. The NOFO also allows strategies such as combining the natural product with another intervention that is already known to engage the same target, or testing the natural product in a population that may be more responsive, as long as the overall study remains anchored in target engagement and produces interpretable evidence that informs next-step development decisions.
Importantly, this program is not meant to fund efficacy or effectiveness trials. In other words, it is not intended for large-scale studies primarily designed to prove clinical benefit in the way a definitive Phase 3-style trial might. Instead, it supports early phase clinical testing that bridges emerging basic science to human studies, helping determine whether the mechanistic and translational evidence is strong enough to justify larger and more expensive clinical research later.
From an administrative standpoint, the opportunity is a discretionary NIH grant in the health funding activity category (CFDA 93.213). The listed award ceiling is $1,050,000, and the original closing date is 2026-11-13. A wide range of domestic applicant organizations may be eligible, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
At the same time, the NOFO includes notable eligibility limits. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. The NOFO also specifies that "Other Eligible Applicants" will not include several categories of institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and certain federal government agencies, among others as listed in the notice. Overall, the program is best understood as a targeted translational mechanism from NCCIH to accelerate careful, early human testing of natural products with strong mechanistic rationale, with an emphasis on target engagement, optimized delivery, and milestone-driven progress rather than broad claims of clinical effectiveness.Apply for PAR 25 270
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Natural Product Early Phase Clinical Trial Award (R33 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.)
- Each selected applicant is eligible to receive up to $1,050,000.00 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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FAQs: NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required) - PAR-25-270
What is PAR-25-270?
PAR-25-270 is the NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required), a National Institutes of Health (NIH) funding opportunity that supports early-stage, investigator-initiated clinical trials of natural products in humans.
What is the main goal of this funding opportunity?
The main goal is to move promising natural product research into early phase testing in humans by supporting hypothesis-driven, milestone-based clinical trials that generate clear decision-making evidence about whether a product should advance to additional development or further clinical testing.
What types of products are considered "natural products" under this opportunity?
The opportunity focuses on natural products such as botanicals, dietary supplements, and probiotics. It also includes certain nutritional regimens that standardize a specific naturally occurring compound (for example omega-3 fatty acids, anthocyanidins, or polyphenols) when supported by compelling preliminary evidence.
What does NCCIH mean by "early phase" clinical trials in this context?
In this NOFO, "early phase" refers to clinical trials designed to test mechanistic and translational questions in humans, especially whether a natural product engages a biologically meaningful target and whether the level of target engagement relates to functional or clinical outcomes in a relevant patient population.
Is a clinical trial required to apply?
Yes. The award is labeled "R33 Clinical Trial Required," indicating the application is expected to propose and conduct a clinical trial.
What is the emphasis of the proposed clinical trials?
The emphasis is on mechanistic clarity and scientific utility. The NOFO prioritizes trials that can replicate and measure the natural product's impact on target engagement in humans and then evaluate whether the degree of target engagement is associated with functional or clinical outcomes.
Are large efficacy or effectiveness trials supported?
No. This program is not meant to fund efficacy or effectiveness trials, such as large-scale studies primarily designed to prove clinical benefit in a definitive, Phase 3-style manner.
What kind of results does NCCIH want from funded studies?
NCCIH is looking for results with clear decision value. Studies should produce findings that are highly informative whether results are positive or negative, and that directly support go/no-go decisions about further development or additional clinical testing.
What is meant by "target engagement" in this NOFO?
Target engagement refers to demonstrating in humans that the natural product interacts with and meaningfully affects a biologically relevant target, and being able to measure that engagement reliably as part of the early clinical evaluation.
Does the NOFO encourage dose or formulation comparisons?
Yes. Applications are encouraged to include designs that compare different doses or formulations to identify the most effective way to achieve the intended biological effect and maximize measurable target engagement.
Can the study include combining the natural product with another intervention?
Yes. The NOFO allows strategies such as combining the natural product with another intervention already known to engage the same target, as long as the study remains anchored in target engagement and produces interpretable evidence that informs next-step development decisions.
Can the study be conducted in a population that may be more responsive?
Yes. The NOFO allows testing in a population that may be more responsive, provided the overall study remains focused on target engagement and generates interpretable evidence for development decisions.
What is the expected scientific starting point for an application?
The NOFO expects applicants to bring a strong scientific premise with compelling preliminary evidence suggesting the natural product engages a biologically meaningful target and is ready for rigorous early clinical evaluation.
How long can the award support the project?
The NOFO provides up to 3 years of support for this early translational clinical work.
What is the maximum award amount (ceiling) listed for this opportunity?
The listed award ceiling is $1,050,000.
Which NIH institute is associated with this opportunity?
This opportunity is associated with NCCIH, the National Center for Complementary and Integrative Health.
What is the Funding Opportunity Number (NOFO number)?
The Funding Opportunity Number is PAR-25-270.
What is the original closing date listed for this opportunity?
The original closing date is 2026-11-13.
What is the CFDA number and funding activity category?
The opportunity is listed under CFDA 93.213 and described as a discretionary NIH grant in the health funding activity category.
What types of U.S. organizations are eligible to apply?
Eligible domestic applicant organizations include: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
Are non-U.S. (non-domestic) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization apply if the work will be done through a non-U.S. component?
No. Non-domestic components of U.S. organizations are also not eligible under this NOFO.
Are there categories of organizations specifically excluded under "Other Eligible Applicants"?
Yes. The NOFO specifies that "Other Eligible Applicants" will not include several categories of institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and certain federal government agencies, among others as listed in the notice.
Does the NOFO prioritize broad clinical outcome trials?
No. Rather than prioritizing broad clinical outcome trials, the NOFO emphasizes mechanistic clarity, target engagement in humans, and decision-enabling evidence for next-step development.
What makes a trial "milestone-based" for this opportunity?
Based on the NOFO description, milestone-based means the study is structured to achieve clear, pre-planned translational objectives that yield interpretable results supporting go/no-go decisions about whether to proceed with further development or testing.
How should applicants think about the translational role of this award?
This award is positioned as a bridge from emerging basic science to human studies, designed to determine whether mechanistic and translational evidence is strong enough to justify larger and more expensive clinical research later.
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