NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
This grant supports early-stage clinical trials of natural products (botanicals, supplements, probiotics) to assess their impact and inform further research.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health (NIH)
Due Dates: June 23, 2025 | October 21, 2024 | March 4, 2024
Funding Amounts: Up to $1,050,000 total direct costs over 3 years
Summary: Supports early-phase, investigator-initiated clinical trials of natural products to replicate target engagement and assess associations with clinical outcomes.
Key Information: Clinical trial (R33) mechanism; hypothesis-driven, milestone-based; excludes efficacy/effectiveness or cancer treatment trials; requires FDA regulatory compliance if applicable.
Description
This funding opportunity from the National Center for Complementary and Integrative Health (NCCIH) at NIH supports early-phase clinical trials (R33 mechanism) of natural products, including botanicals, dietary supplements, probiotics, and standardized nutritional regimens with compelling preliminary evidence. The goal is to replicate the impact of the natural product on a defined biological or mechanistic target ("target engagement") in humans and to assess whether changes in this target are associated with functional or clinical outcomes in a patient population.
Applications should propose randomized controlled trials with at least one intervention and one comparator arm (placebo, usual care, or active comparator). Wait-list controls are not supported. Studies may include dose-response assessments, pharmacokinetic evaluations, safety and tolerability testing, combination treatments targeting the same mechanism, or testing in more responsive populations.
This R33 award is intended to generate rigorous, hypothesis-driven, milestone-based data to inform whether further clinical development, including fully powered efficacy trials, is warranted. It is not intended to support efficacy or effectiveness trials or trials focused on cancer treatment or prevention.
Applicants must provide strong preliminary data demonstrating biological mechanisms and target engagement in humans, as well as evidence of bioavailability of the natural product. For multi-component interventions including mind-body approaches, prior efficacy data for the mind-body component is required.
Regulatory compliance with FDA requirements is mandatory for trials involving FDA-regulated products, including obtaining or referencing an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) with no clinical hold prior to award.
NCCIH prioritizes studies addressing symptom management (e.g., sleep disorders, pain, gastrointestinal disorders, mental health), microbiome-brain interactions, cannabinoids, psychedelics, minority health, and HIV-related comorbidities.
