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

Due: Oct 15, 2027

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, sa...

Eligible Applicants- 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 having a 501 (c) (3) status with the IRS, other than institutions of higher education- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education- Private institutions of higher education- For-profit organizations other than small businesses- Small businesses- Others

Additional Eligibility Information

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 Cont...

Funding TypeCooperative AgreementCategories of Funding Activity- HealthOpportunity TypeDiscretionary

Grantor Contact InformationSee Section VII. Agency Contacts within the full opportunity announcement for all other inquires.Grantor Emailgrantsinfo@nih.govOther Grantor InformationNIH Grants Information<br/>grantsinfo@nih.gov

Additional Informationhttps://grants.nih.gov/grants/guide/pa-files/PAR-25-180.htmlSupporting Linkhttp://grants.nih.gov/grants/guide/pa-files/PAR-25-180.html

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