First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Grant Notice from a government agency.
Data as of Oct 24, 2026. Sources: SAM.gov and Grants.gov. Snapshot govcon-directory-20261024T104923Z-2151694.
This product uses the Grants.gov API but is not endorsed or certified by the U.S. Department of Health and Human Services. Counts and totals are computed by DSE from public SAM.gov and Grants.gov notices. Text from Grants.gov may be shortened or have contact details removed. The original notice on Grants.gov is the authoritative version.
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Notice details
- Notice type
- Grant Notice
- Solicitation number
- PAR-25-180
- Posted
- Nov 26, 2024
- Response deadline
- Oct 15, 2027
- Source
- Grants.gov
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
Summarized from the official notice. The description is shortened; read the full text on the official notice. Text from Grants.gov may be shortened or have contact details removed. The original notice on Grants.gov is the authoritative version.
Official notice
Requirements and amendments are controlled by the official notice.
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