First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Can you apply?
This grant is for research institutions and organizations conducting early-stage clinical trials of novel psychiatric drugs or neuromodulatory devices. Eligible applicants include universities, research centers, faith-based organizations, HBCUs, tribal institutions, and federal agencies. Trials must be in humans (First in Human or Phase II studies) testing new mechanisms of action or devices for psychiatric disorders in pediatric and adult populations. International components are not allowed, though U.S.-based organizations may apply. Cost-sharing is not required.
This grant is for research institutions and organizations conducting early-stage clinical trials of novel psychiatric drugs or neuromodulatory devices. Eligible applicants include universities, research centers, faith-based organizations, HBCUs, tribal institutions, and federal agencies. Trials must be in humans (First in Human or Phase II studies) testing new mechanisms of action or devices for psychiatric disorders in pediatric and adult populations. International components are not allowed, though U.S.-based organizations may apply. Cost-sharing is not required.
Program 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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for research institutions and organizations conducting early-stage clinical trials of novel psychiatric drugs or neuromodulatory devices. Eligible applicants include universities, research centers, faith-based organizations, HBCUs, tribal institutions, and federal agencies. Trials must be in humans (First in Human or Phase II studies) testing new mechanisms of action or devices for psychiatric disorders in pediatric and adult populations. International components are not allowed, though U.S.-based organizations may apply. Cost-sharing is not required.
How to apply
Application links
Required documents
- SF-424 (R&R)
- Research Plan (including Study Design and Methods)
- Budget and Budget Narrative
- Biosketches of Key Personnel
- Letters of Commitment from Industry Partners
- Institutional Commitment Letter
- IRB/IEC Approval (or plan for approval)
- Preliminary Data on Drug/Device Safety and Target Engagement
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who can apply for this grant?
Universities, research institutions, faith-based organizations, HBCUs, tribal colleges, and eligible federal agencies may apply. Non-U.S. organizations and foreign components cannot apply.
What types of studies does this grant support?
First-in-Human trials, Phase II studies, and early feasibility studies of novel psychiatric drugs or neuromodulatory devices. Studies must assess target engagement, safety, tolerability, and clinical effects.
Are partnerships required?
Collaborative partnerships between biomedical researchers and biotechnology or industry partners are encouraged and strengthen applications. They increase feasibility of moving toward FDA-approved treatments.
What is the funding timeline?
The deadline is October 15, 2027. This is a cooperative agreement mechanism, requiring ongoing collaboration and milestone tracking with NIH.
How competitive are these awards?
These are highly competitive. Strong scientific rationale, feasible trial design, and evidence of industry/partnership interest significantly improve competitiveness.
💡 Tips for applicants
- Form partnerships with biotechnology or pharmaceutical companies early. Industry collaboration signals realistic commercial potential and strengthens your application.
- Clearly define milestone-driven endpoints. NIH expects specific, measurable targets for target engagement, safety, and clinical outcomes.
- Address unmet medical needs explicitly. Show why current psychiatric treatments are inadequate for your target population.
- Plan for target engagement assessment. Early trials must document that your drug or device actually engages the intended biological target.
- Budget conservatively for pediatric studies. If including minors, factor in extra regulatory requirements and informed consent complexity.
⚠️ Common mistakes
Weak industry partnership or no evidence of future funding pathway discredits the application. Vague trial endpoints or failure to separate Phase I and Phase II objectives delays review. Insufficient preliminary data on mechanism of action or off-target safety concerns causes rejection.
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