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

In plain English

National Institutes of Health (Department of Health and Human Services) is accepting applications for this cooperative agreement until Oct 15, 2027 (338 days left).

The listing does not state award amounts or the number of awards.

Eligible applicant types include nonprofits, small businesses, for-profit companies, state governments, local governments, tribal governments & organizations, colleges & universities, school districts and public housing authorities, plus others described in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

Browse similar: Nonprofits · Small businesses · For-profit companies · State governments · Local governments · Tribal governments & organizations · Colleges & universities · School districts · Public housing authorities

• 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 / 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 details in the listing)

Additional eligibility information (excerpt from the listing):

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. …

Excerpt from the official synopsis on Grants.gov (shortened; read the full text on the official listing):

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. …

Read the full listing on Grants.gov → · Agency's announcement page