First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Updated
Cooperative agreement from the National Institutes of Health, open to small businesses. Closes Oct 15, 2027, 360 days left.
| Opportunity number | PAR-25-180 |
|---|---|
| Agency | National Institutes of Health |
| Funding type | Cooperative agreement |
| Field | Health |
| Cost sharing or matching | Not required |
| Assistance listing | 93.242 |
| Posted | Nov 26, 2024 |
| Closes | Oct 15, 2027 (360 days left) |
| Add the deadline to | Google Calendar |
Who can apply
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state controlled institutions of higher education
- Native American tribal governments (federally recognized)
- Public housing authorities and Indian housing authorities
- Native American tribal organizations (other than federally recognized tribal governments)
- Nonprofits with 501(c)(3) status, other than institutions of higher education
- Nonprofits without 501(c)(3) status, other than institutions of higher education
- Private institutions of higher education
- For-profit organizations other than small businesses
- Small businesses
- Others (see the eligibility notes)
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.
Description
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.
Full announcement and how to apply on Grants.gov
Health grants right now
There are 350 open federal grants in health that small businesses may apply for; 33 close within 30 days. The median award ceiling is $500,000. The agencies offering the most are National Institutes of Health, Centers for Disease Control and Prevention - ERA and Centers for Disease Control - NCBDDD. Grants in this field stay open a median of 1031 days; this one is open for 1053 days.
Who has won this program before
- University Of North Carolina AT Chapel Hill $977.0 million · from Jun 29, 2006
- The Johns Hopkins University $282.0 million · from Jun 29, 2006
- Rutgers, The State University $179.7 million · from Jul 1, 2003
- Salk Institute For Biological Studies, SAN Diego, California, The $92.4 million · from Sep 1, 2022
- Allen Institute $91.9 million · from Aug 22, 2022
The largest grants and cooperative agreements under assistance listing 93.242 with payments since Oct 1, 2025, from USAspending.gov. Amounts are each award's total.
Other open grants in the same program
Under assistance listing 93.242, the federal program this grant is paid from.
More open grants from the National Institutes of Health
340 open grants from this agency accept small businesses, with $356.4 million in total program funding listed.