NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
ID: 352163Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $1M

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/352163

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-116.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering the Natural Product Early Phase Clinical Trial Award (R33), aimed at funding early-phase clinical trials for promising natural products, including botanicals and dietary supplements. This funding opportunity encourages applications that assess target engagement and the relationship between the intervention and clinical outcomes over a maximum period of three years, with total funding not exceeding $1,050,000. The program emphasizes the importance of rigorous and reproducible trials, particularly in managing conditions such as pain and mental health disorders, while requiring a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity in research. Interested applicants must submit their proposals by November 14, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-116-Full-Announcement.html
    PAR-24-116.html
    The National Center for Complementary and Integrative Health (NCCIH) is offering the Natural Product Early Phase Clinical Trial Award (R33), aimed at funding early-phase clinical trials for promising natural products such as botanicals and dietary supplements. This funding opportunity encourages applications focused on trials that assess target engagement and the relationship between the intervention and clinical outcomes over a maximum period of three years, with total funding not exceeding $1,050,000. Key areas of interest include the management of conditions such as pain and mental health disorders. Applicants must adhere to strict regulatory guidelines and demonstrate adequate preliminary data to support their studies. A Plan for Enhancing Diverse Perspectives (PEDP) is also mandatory, ensuring diverse stakeholder engagement and inclusivity in the research approach. The program prioritizes rigor and reproducibility in trials, and only those that do not seek to assess efficacy or treatment of cancer will be considered. The deadline for application submissions is set for November 14, 2026, with multiple review cycles planned before the award decisions.
    Similar Opportunities
    NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NCCIH Natural Product Early Phase Clinical Trial Award (R33), aimed at supporting investigator-initiated clinical trials of natural products such as botanicals and dietary supplements. This funding opportunity encourages applications for early phase trials that assess the impact of these products on specific biological targets and their potential clinical outcomes, with a focus on optimizing study designs and dosage. The initiative is crucial for advancing research in complementary and integrative health approaches, ensuring that projects adhere to rigorous scientific standards and include a Plan for Enhancing Diverse Perspectives (PEDP). The total estimated funding for this program is $1,050,000, with applications due by November 13, 2026. For further inquiries, interested applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information page at https://grants.nih.gov/grants/guide/pa-files/PAR-25-270.html.
    NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), invites applications for 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 research that evaluates the pharmacokinetics, safety, and efficacy of these natural products, with a focus on advancing promising interventions backed by prior scientific evidence. The program is designed to foster innovative clinical research that enhances understanding of the beneficial impacts of natural products on health conditions, while ensuring inclusivity through a Plan for Enhancing Diverse Perspectives (PEDP). Applicants may request up to $350,000 per year, with a project duration of up to six years contingent upon successful milestone completion, and the application deadline is November 13, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    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.
    NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) titled "NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)" aimed at supporting mid-phase clinical trials of natural products, including botanicals, dietary supplements, and probiotics, that demonstrate promising preliminary evidence for health benefits. Applicants are required to provide sufficient preliminary data, adhere to FDA regulations, and develop a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity in research, with a focus on determining optimal dosing and patient responsiveness before advancing to larger efficacy trials. This funding opportunity is critical for addressing knowledge gaps in complementary health approaches, particularly in symptom management and health disparities. The estimated total program funding is $350,000, with applications due by November 13, 2026, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for the "NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)" grant, aimed at advancing research on natural products such as botanicals and dietary supplements. This funding opportunity encourages mid-phase clinical trials that are hypothesis-driven, focusing on determining optimal dosing or identifying patient phenotypes for future efficacy studies, while explicitly excluding trials for cancer treatment. Eligible applicants include a diverse range of organizations, such as historically black colleges, tribal colleges, and community-based organizations, with a funding ceiling of $350,000 and a submission deadline of November 13, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/pa-files/PAR-24-115.html.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on natural products, such as botanicals and dietary supplements. Applicants are required to submit a comprehensive plan detailing project management, participant recruitment, and clinical trial execution, while also ensuring alignment with NIH standards. This initiative emphasizes the importance of evidence-based research in natural products and mandates the submission of a corresponding Data Coordinating Center (DCC) proposal to oversee data management and analysis. Interested applicants should note that the application deadline is July 15, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For additional details, applicants can refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-123.html.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for cooperative agreements to establish a Clinical Coordinating Center (CCC) for multi-site, investigator-initiated clinical trials focused on the effects of natural products, such as botanicals and dietary supplements. Applicants are required to develop a comprehensive scientific and operational plan for the clinical trial, including project management, participant recruitment, and performance milestones, while also submitting a companion Data Coordinating Center (DCC) application. This initiative aims to generate robust clinical data to inform integrative health approaches and public health strategies, with applications opening on January 20, 2025, and closing on July 14, 2026. For further details, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-312.html.
    Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the Natural Product Multi-Site Clinical Trial Data Coordinating Center (DCC) through a cooperative agreement mechanism. This initiative invites applications for a DCC that will collaborate with a Clinical Coordinating Center (CCC) to conduct multi-site clinical trials focused on the efficacy and effectiveness of natural products, requiring simultaneous submission of both applications. The program emphasizes the importance of maintaining data integrity, promoting diversity in participant recruitment, and achieving specific milestones for continued funding, while also necessitating a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity in research. Interested applicants can find more information and application details on the NIH grants website, with a submission deadline of July 14, 2026, and a contact email for inquiries at grantsinfo@nih.gov.
    Discovery and Development of Natural Products for Cancer Interception and Prevention (UG3/UH3 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the Discovery and Development of Natural Products for Cancer Interception and Prevention, specifically through a cooperative agreement mechanism. This initiative aims to support the discovery and development of novel, safe, and effective natural products that target cancer prevention, structured in two phases: the UG3 phase for initial screenings and assay development lasting up to three years, followed by the UH3 phase for full-scale evaluations lasting up to two years. The program emphasizes the importance of high-throughput screening strategies and collaboration with existing NCI natural product libraries, with a total funding allocation of $4.5 million for approximately 12 awards. Interested applicants must submit their proposals by June 13, 2025, and can direct inquiries to grantsinfo@nih.gov for further information.
    Discovery and Development of Natural Products for Cancer Interception and Prevention (UG3/UH3 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Discovery and Development of Natural Products for Cancer Interception and Prevention" under the cooperative agreement mechanism. This initiative aims to support innovative projects that focus on the discovery and development of novel natural products that are safe, nontoxic, and effective in intercepting or preventing cancer, with a structured approach divided into two phases: the UG3 phase for initial target selection and assay validation, followed by the UH3 phase for large-scale evaluations and pharmacokinetic assessments. The total funding available for this program is $4.5 million over the fiscal years 2024 to 2026, with a deadline for applications set for June 14, 2025. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.