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

Federal funding opportunity PAR-25-180 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes October 15, 2027

Posted: November 26, 2024
Closes: October 15, 2027
Cost sharing: No
Instrument: Cooperative Agreement
Assistance listing: 93.242
Category: Health
Archives: November 20, 2027

Program funding history

Awards made under Assistance Listing 93.242 across FY2025–FY2027, from public federal spending records.

FY2025 obligated: $1.8B
FY2026 obligated: $1.8B
FY2027 (to date) obligated: $0
Awards in window: 6,272

Top recipients: Yale Univ, University of Pittsburgh - of the Commonwealth System of Higher Education, Icahn School of Medicine at Mount Sinai, Trustees of the University of Pennsylvania, the, Washington University, the

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

Synopsis

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.

Who can apply

Others (see text field entitled "Additional Information on Eligibility" for clarification)
City or township governments
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
County governments
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Private institutions of higher education
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Independent school districts

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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