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

The First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (PAR-25-180) funding opportunity, offered by the National Institutes of Health (NIH), supports milestone-driven clinical trials of novel drugs or devices for psychiatric disorders. The program focuses on addressing unmet medical needs by de-risking investigational treatments, fostering collaboration between academic researchers and industry, and facilitating further development of therapies to achieve FDA approval. This funding opportunity targets early-stage trials, including First in Human (FIH) and Phase II studies, to assess novel mechanisms of action, safety, tolerability, pharmacological effects, and target engagement. Trials must explore feasibility for Phase II proof-of-concept (PoC) studies and evaluate the impact on clinically relevant physiological systems and clinical indicators. The program also supports early feasibility studies (EFS) of neuromodulatory devices, emphasizing the evaluation of safety, efficacy, and functional outcomes. Eligible applicants include U.S.-based entities such as public and private higher education institutions, nonprofits, for-profit organizations, small businesses, and tribal and local government entities. Specific minority-serving institutions, including Historically Black Colleges and Universities (HBCUs) and Hispanic-serving Institutions (HSIs), are encouraged to apply. Foreign organizations are not eligible, though foreign components of U.S.-based projects may be permissible under certain conditions. The funding mechanism is a cooperative agreement, enabling close collaboration between the grantee and NIH. The program does not have a specified funding ceiling or floor, and cost-sharing is not required. Applications are accepted on a rolling basis through October 15, 2027, with key milestones and deliverables essential for project success.