Open · PAR-25-180 · CFDA 93.242 · Discretionary
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Federal grant opportunity posted by National Institutes of Health, cataloged on Grants.gov.
- Varies
- Award range
- Open
- Status
- 443d
- Days left
- -
- Expected awards
The verdict
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) is an open discretionary opportunity from National Institutes of Health, offering Varies by applicant. Applications close in 443 days.
- Varies
- award range
- Open
- 443 days left
- 93.242
- CFDA program
Opportunity snapshot. This Grants.gov announcement - First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) - is cataloged under number PAR-25-180 and tied to CFDA assistance listing 93.242, posted by National Institutes of Health. Grants.gov currently shows the opportunity as open, first posted on November 26, 2024 and last updated on November 27, 2024. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is Varies by applicant. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. Applications close on October 15, 2027 - roughly 443 days from today. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
Varies by applicant
Close Date
October 15, 2027
Posted
November 26, 2024
Instrument
Cooperative Agreement
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.
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Mental Health Research Grants
National Institutes of Health
Agency Contact
NIH Grants Information grantsinfo@nih.gov
Key Dates
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Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
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Related
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| Sources | the SAM.gov Assistance Listings and Grants.gov |