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NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

US National Institutes of Health – National Center for Complementary and Integrative Health (NCCIH) grant open #PAR-25-269
Response due Nov 13, 2026 · 00:00 UTC

Summary

The National Center for Complementary and Integrative Health (NCCIH), a component of NIH/HHS, is soliciting applications for phased innovation awards (R61/R33) to support early phase clinical trials involving natural products. The R61 phase is intended for milestone-driven developmental work, while the R33 phase supports the expanded clinical trial following successful completion of R61 milestones. Applicants must propose a clinical trial as a required component of the research plan. The opportunity is open for an extended period from December 2024 through November 2026, suggesting multiple submission cycles.

What they want

Applicants must design and conduct an early phase clinical trial focused on natural products. The award uses a phased mechanism: the R61 phase supports preparatory/developmental activities with defined go/no-go milestones, and the R33 phase supports the full early phase clinical trial contingent on milestone achievement. A clinical trial is required (not optional) as stated in the opportunity title and document type.
Technical requirements
  • Clinical trial must be included as a required component of the research plan
  • R61 phase must include defined milestones for progression to R33 phase
  • Natural product(s) must be the focus of the clinical investigation
  • Phased R61/R33 grant mechanism applies

How they evaluate

  • Scientific and technical merit (NIH peer review)
  • Milestone feasibility and rigor
  • Clinical trial design quality
  • Significance and innovation of natural product research
Submission: Grants.gov electronic submission portal (PAR-25-269)

Risks & flags

  • Extremely long open window (nearly 2 years) suggests rolling/multiple submission cycles rather than a single competitive award — individual application competitiveness may vary widely depending on submission cycle
  • Limited metadata provided; full FOA text not supplied, so specific eligibility restrictions, budget caps, or carve-outs cannot be confirmed

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

NCCIH Natural Product Early Phase Clinical…
Due Nov 13
Onboard ↗