First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
About
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 developm.
This grant program supports biomedical researchers, biotechnology companies, and psychiatric treatment innovators conducting early-stage clinical trials of novel investigational drugs and neuromodulatory device-based interventions for psychiatric disorders. The program is designed for organizations addressing unmet medical needs in mental health treatment across pediatric and adult populations. Funding supports First in Human (FIH) and Phase II studies that evaluate target engagement, brain exposure, pharmacological effects, safety, tolerability, and clinical efficacy. Researchers should apply if they're developing novel mechanism of action psychiatric drugs, new pediatric psychiatric treatments, or innovative neuromodulatory devices. The grant emphasizes collaborative partnerships between academic biomedical researchers and biotechnology or industry partners to accelerate psychiatric drug and device development. By supporting milestone-driven early-stage trials, this program helps de-risk novel treatments and generate data necessary to attract private or additional public funding for FDA approval pathways. The cooperative agreement structure encourages rigorous data collection on functional measures and clinical indicators of effect, making this ideal for innovators transitioning promising psychiatric treatments from laboratory to clinical practice.
Funding Facts
● Applications openDeadline
October 15, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by project scope and phase
Deadline
2027-10-15
Grant Type
federal
Application Cycle
Annual deadline (October 15, 2027)
Best For
Biomedical researchers, biotechnology companies, academic institutions, and industry partners conducting early-stage psychiatric drug and device clinical trials
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 Govern
Frequently Asked Questions
Who is eligible for First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)?
Eligible applicants include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), eligible Federal Government agencies, faith-based and community-based organizations, Hispanic-serving Institutions, and Historically Black Colleges and Universities (HBCUs). Indian/Native American Tribal Governments are also eligible. For complete and current eligibility requirements, applicants should consult the official Notice of Funding Opportunity (NOFO) on the funding agency's website.
How much funding does First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) provide?
Funding amounts vary based on the specific clinical trial phase, scope of research, and project requirements. Contact the funding agency directly or review the official NOFO for current funding ranges and budget guidelines for your specific project type.
How do I apply for First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)?
Applications should be submitted as cooperative agreement proposals through the official funding mechanism. The deadline for this funding opportunity is October 15, 2027. Applicants must prepare detailed research protocols including clinical trial designs, safety assessments, target engagement measures, and partnership agreements with industry or biotechnology collaborators. For application instructions, required forms, and submission portals, visit the official NOFO on the funding agency's website.
What can First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) funding be used for?
Funding supports early-stage clinical trials including First in Human (FIH) studies, Phase II proof-of-concept studies, and early feasibility studies of novel psychiatric treatments. Allowable expenses include research to assess target engagement, brain exposure, pharmacological effects, safety, tolerability, clinical efficacy, and functional measures. Funding may support trials of novel mechanism of action investigational drugs, pediatric psychiatric treatments, neuromodulatory devices, and combination treatments designed to generate data for FDA approval pathways and attract further private or public investment.
Last updated: July 5, 2026