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 of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
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 lists this opportunity for nonprofit applicant type listed. Review the coded eligibility, award range, source synopsis, and official notice before deciding whether to apply.
Deadline
October 15, 2027
359 days remaining
Award range
—
official range may be incomplete
Applicant signal
Nonprofit applicant type listed
the official notice controls eligibility
- 00 — State governments
- 01 — County governments
- 02 — City or township governments
- 04 — Special district governments
- 05 — Independent school districts
- 06 — Public and state-controlled institutions of higher education
- 07 — Federally recognized Native American tribal governments
- 08 — Public housing authorities and Indian housing authorities
- 11 — Native American tribal organizations other than federally recognized tribal governments
- 12 — 501(c)(3) nonprofits other than institutions of higher education
- 13 — Nonprofits without 501(c)(3) status other than institutions of higher education
- 20 — Private institutions of higher education
- 22 — For-profit organizations other than small businesses
- 23 — Small businesses
- 25 — Other applicants; see the official eligibility clarification
These are high-level Grants.gov codes. Additional eligibility text, geographic restrictions, and program-specific rules in the official notice can narrow them.
- Confirm entity eligibility in the full Notice of Funding Opportunity.
- Check SAM.gov and Grants.gov registration requirements and timing.
- Read every attachment for matching, cost-share, geography, and award conditions.
- Verify the exact deadline time and any agency-specific submission portal.
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Source: Grants.gov daily XML extract, 2026-10-21 extract. This page reproduces selected public listing fields for research convenience. The official Notice of Funding Opportunity and agency instructions control. This product uses the Grants.gov API but is not endorsed or certified by the U.S. Department of Health and Human Services.