🚀 Apply for £10k+ grants with our Startup Launch Kit
shadow shadow shadow shadow shadow
    Country
    Opportunity Status
    Funding Instrument Type
    Category
    Clear

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

    PAR-25-180

    National Institutes of Health

    Opening date 26 Nov 2024, 12:00AM

    Closing date 15 Oct 2027, 12:00AM

    Funding Opportunity Number: PAR-25-180

    Opportunity Category: Discretionary

    CFDA Number(s): 93.242 -- Mental Health Research Grants

    Cost Sharing or Matching Requirement: No

    Posted Date: Nov 26, 2024 12:00:00 AM EST

    Closing Date: Oct 15, 2027 12:00:00 AM EDT

    Award Ceiling: none

    Award Floor: none

    Eligible Applicants: Independent school districts,Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education,Private institutions of higher education,Special district governments,Others (see text field entitled "Additional Information on Eligibility" for clarification),City or township governments,Small businesses,For profit organizations other than small businesses,Public housing authorities/Indian housing authorities,Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,Native American tribal organizations (other than Federally recognized tribal governments),State governments,County governments,Public and State controlled institutions of higher education,Native American tribal governments (Federally recognized)

    Additional Information on Eligibility: 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.

    Agency Name: National Institutes of Health

    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.

    Grantor Contact Information: NIH Grants Information grantsinfo@nih.gov

    We use cookies and similar technologies that are necessary to operate the website.Please read our cookie policy.

    We use cookies and similar technologies that are necessary to operate the website. Additional cookies are only used with your consent. We use the additional cookies to perform analyses of website usage and to check marketing measures for their efficiency. These analyses are carried out to provide you with a better user experience on the website. You are free to give, deny, or withdraw your consent at any time by using the "cookie settings" link at the bottom of each page. You can consent to our use of cookies by clicking "Agree". For more information about what information is collected and how it is shared with our partners, please read our cookie policy.

    • Required to run the website
    • Monitoring website usage and optimizing the user experience
    • Evaluation of marketing actions
    • Storage of your preferences from previous visits
    • Collecting user feedback to improve our website
    • Recording of your interests in order to provide customised content and offers
    Cookie Settings Accept