This grant, offered by the National Institutes of Health (NIH), is for supporting early-stage clinical trials focused on novel investigational drugs and neuromodulatory devices designed to treat psychiatric disorders with unmet medical needs. It targets both pediatric and adult populations, emphasizing milestone-driven studies. The funding aims to facilitate first-in-human and Phase II trials for novel agents, assessing target engagement, pharmacological effects, safety, and tolerability. For devices, it supports early feasibility studies evaluating engagement, safety, tolerability, and efficacy. The overall objective is to generate crucial data, thereby “de-risking” these novel interventions to attract subsequent funding for FDA approval. A key component encourages collaborative partnerships between academic and industry researchers to accelerate development.
Opportunity ID: 357424
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-180 |
| Funding Opportunity Title: | First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 27, 2024 |
| Last Updated Date: | Nov 27, 2024 |
| Original Closing Date for Applications: | Oct 15, 2027 |
| Current Closing Date for Applications: | Oct 15, 2027 |
| Archive Date: | Nov 20, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities City or township governments State governments Native American tribal governments (Federally recognized) 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) Small businesses County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Private institutions of higher education Special district governments Independent school districts Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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. |
Additional Information
| 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-180.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357424 Full Announcement-PAR-25-180 -> PAR-25-180-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289146 | Jan 14, 2025 | Oct 15, 2027 | View |
Package 1
Mandatory forms
357424 RR_SF424_5_0-5.0.pdf
357424 PHS398_CoverPageSupplement_5_0-5.0.pdf
357424 RR_OtherProjectInfo_1_4-1.4.pdf
357424 PerformanceSite_4_0-4.0.pdf
357424 RR_KeyPersonExpanded_4_0-4.0.pdf
357424 PHS398_ResearchPlan_5_0-5.0.pdf
357424 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357424 RR_Budget_3_0-3.0.pdf
357424 RR_SubawardBudget30_3_0-3.0.pdf
357424 PHS398_ModularBudget_1_2-1.2.pdf
357424 PHS_AssignmentRequestForm_4_0-4.0.pdf
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