First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

National Institutes of Health · PAR-25-180 · Deadline: October 15, 2027

This listing sits under an agency-wide umbrella (CFDA 93.242, Mental Health Research Grants — ~863 awards/yr across many separate competitions). Program-level statistics would describe the whole umbrella, not this competition, so we don't show them as if they were this opportunity's history. Any tool showing "award history" for this listing at the program level is describing the umbrella.

Listing summary

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof o…

Eligibility: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations (other), Nonprofits with 501(c)(3), other than higher education, Nonprofits without 501(c)(3), Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others · Categories: Health · official listing ↗

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Sources: NIH RePORTER (opportunity-exact) and USAspending (program-level), labeled per section. GrantsDue computes summaries only; verify anything critical against the originals. Methodology.