Data / Federal grants / PAR-25-180
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 (Department of Health and Human Services) is accepting applications until October 15, 2027.
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Key facts
- Opportunity number
- PAR-25-180
- Status
- Posted, open
- Posted
- November 26, 2024
- Closes
- October 15, 2027
- Cost sharing
- Not required
- Funding instrument
- Cooperative Agreement
- Category
- Health
- Assistance listing
- 93.242 Mental Health Research Grants; None None
- Contact
- National Institutes of Health · [email protected] · 301-402-2541
Who can apply
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Small businesses
- Public and State controlled institutions of higher education
- State governments
- City or township governments
- Special district governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
- Private institutions of higher education
- County governments
- Native American tribal organizations (other than Federally recognized tribal 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.
What the agency says
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.
Other open grants from the Department of Health and Human Services
| Opportunity | Status | Closes | Award ceiling | Total funding | Record |
|---|---|---|---|---|---|
| Long-term health outcomes of people living with spina bifida CDC-RFA-DD-26-0222 | Open | Oct 26 | $300,000 | $3,000,000 | grants.gov |
| GREGoRi Data Coordination and Outreach Center (U01, Clinical Trials Not Allowed) RFA-HG-27-011 | Open | Oct 30 | $1,250,000 | $2,000,000 | grants.gov |
| GREGoRi Innovation Projects (U01 Clinical Trial Optional) RFA-HG-27-013 | Open | Oct 30 | $500,000 | $7,500,000 | grants.gov |
| GREGoRi Technology Integration Center (U01, Clinical Trials Optional) RFA-HG-27-012 | Open | Oct 30 | $2,250,000 | $3,000,000 | grants.gov |
| HEAL Initiative: Whole Joint Health Program (R61/R33 Clinical Trial Required) PAR-27-045 | Open | Oct 30 | grants.gov | ||
| Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR-24-280 | Open | Nov 2 | grants.gov |
All grants open to Tribal governments · All grants open to Public housing authorities/Indian housing authorities · All grants open to Small businesses · Everything closing in October 2027
Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.