First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
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
See official grant page for eligibility requirements
Industry Tags
About This Grant
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.
Funding Information
Eligibility Overview
This opportunity from National Institutes of Health is open to eligible applicants nationwide. Organizations working in Healthcare are especially encouraged to review the requirements.
Federal grant opportunities like this one are typically open to a range of applicant types. Common eligible organizations include:
- Nonprofits and 501(c)(3) organizations
- Small businesses and startups (especially for SBIR/STTR programs)
- State, local, and tribal governments
- Colleges, universities, and research institutions
- Individuals (for select programs in education, arts, and research)
Eligibility requirements vary by opportunity. Always review the official listing before investing time in an application.
How to Apply
- 1
Review the full opportunity
Read the complete Notice of Funding Opportunity (NOFO) for this National Institutes of Health program on its official page (https://www.grants.gov/search-results-detail/357424).
- 2
Confirm eligibility
Check that your organization meets every requirement set by National Institutes of Health — applicant type, location, registration status, and any prior-award restrictions.
- 3
Prepare required documents
Gather your budget narrative, needs statement, organizational details, SAM.gov registration, and any required certifications.
- 4
Submit before the deadline
This opportunity closes on October 15, 2027. Submit at least 48 hours early — portal systems are often slow near closing time.
Grant Writing Tips
Proposals for healthcare programs such as those from National Institutes of Health are competitive — these tips can strengthen your application:
- ✓Start your application at least 4 weeks before the deadline — rushed proposals score lower.
- ✓Tailor your needs statement to match the funder's stated priorities, using their exact language where possible.
- ✓Have a colleague outside your team review your budget narrative before submitting — fresh eyes catch errors reviewers penalize.
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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)?
This opportunity from National Institutes of Health is open to eligible applicants nationwide. Organizations working in Healthcare are especially encouraged to review the requirements. Always confirm the full eligibility criteria on the official listing before applying.
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?
A specific award amount is not listed 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). See the official grant page for funding details.
When is the deadline 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)?
The application deadline 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) is October 15, 2027. Submit at least 48 hours early to avoid last-minute portal issues.
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)?
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) through the official grant page (https://www.grants.gov/search-results-detail/357424). Confirm your eligibility and prepare your application materials before the deadline.
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