First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)
- Posted
- March 2, 2021
- Closed
- October 15, 2024
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.242
- Category
- Health
- Archives
- November 14, 2024
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 Funding Opportunity Announcement (FOA) 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 FOA 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 FOA 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 FOA 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
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
- State governments
- Independent school districts
- Public and State controlled institutions of higher education
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Private institutions of higher education
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- County governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- City or township governments
- Special district governments
- Native American tribal governments (Federally recognized)
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 Institutions) 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.
The official record
Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.
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