NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
ID: 357490Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $350K

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357490

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-269.html
Timeline
    Description

    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), has announced the NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33), aimed at supporting early-phase clinical trials of natural products such as botanicals and dietary supplements. This funding opportunity encourages applications that demonstrate a strong scientific basis for further testing, focusing on pharmacokinetics, bioavailability, and measurable effects on target mechanisms rather than just clinical symptoms. The award consists of two phases: the R61 phase provides up to three years of funding for milestone-driven studies, while the R33 phase may extend funding for an additional three years contingent upon achieving R61 milestones. Interested applicants can find more details and submit inquiries via the NIH Grants Information email at grantsinfo@nih.gov, with a total estimated program funding of $350,000 and a closing date for applications set for November 13, 2026.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-269-Full-Announcement.html
    PAR-25-269.html
    The Department of Health and Human Services, through the National Center for Complementary and Integrative Health (NCCIH), has issued a funding opportunity for the NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33). This initiative encourages applications for early-phase clinical trials involving natural products such as botanicals and dietary supplements, emphasizing a strong scientific basis for further testing. The award consists of two phases: the R61 phase, which provides up to three years of funding for milestone-driven pharmacokinetics and target engagement studies, and the R33 phase, which may add another three years contingent on achieving the R61 milestones. Trials must focus on demonstrating measurable effects on target mechanisms rather than solely clinical symptom changes. Key aspects include guidelines for demonstrating target engagement, necessary preliminary data, and a plan for enhancing diverse perspectives. Applications are expected to include hypotheses, statistical methods, safety measurements, and a strong recruitment strategy. The project's ultimate aim is to inform decisions about further development or full-scale efficacy trials of the proposed natural products, aligning with NCCIH's goals of rigorous research in complementary and integrative health approaches.
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