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

US National Institutes of Health (NIH) grant open #PAR-25-180
Response due Oct 15, 2027 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications for first-in-human and early stage clinical trials of novel investigational drugs or neuromodulatory device-based interventions targeting psychiatric disorders. This is a U01 cooperative agreement mechanism, meaning NIH will have substantial scientific and programmatic involvement. The opportunity is open from late 2024 through October 2027, suggesting a rolling or multi-cycle submission window. Applicants must propose and conduct clinical trials meeting the NIH definition of a clinical trial.

What they want

Applicants must design and conduct first-in-human (FIH) and/or early-stage clinical trials evaluating: (1) novel investigational drugs for psychiatric disorders, and/or (2) neuromodulatory device-based interventions for psychiatric disorders. The mechanism is a U01 (Research Project Cooperative Agreement – Clinical Trial Required), which mandates active NIH collaboration and involvement in the trial. Submissions must comply with all NIH clinical trial policies and requirements associated with the U01 activity code.
Technical requirements
  • Must propose and conduct NIH-defined clinical trials
  • Must meet U01 cooperative agreement requirements with active NIH programmatic involvement
  • Trials must involve novel investigational drugs or neuromodulatory device-based interventions
  • Target population must include individuals with psychiatric disorders
  • First-in-human or early stage trial design required

How they evaluate

  • Standard NIH peer review criteria apply to U01 cooperative agreements (Significance, Investigators, Innovation, Approach, Environment)
Submission: Grants.gov federal grants portal submission

Eligibility & certifications

NIH Grants.gov registrationInstitutional Review Board (IRB) approval required for clinical trialsIND (Investigational New Drug) or IDE (Investigational Device Exemption) as applicable from FDA

Risks & flags

  • No dollar value or award ceiling disclosed, making budget competitiveness difficult to assess
  • Rolling/multi-year open window (Nov 2024–Oct 2027) may favor established NIH-affiliated academic medical centers with existing infrastructure
  • U01 cooperative agreement mechanism implies NIH retains substantial programmatic control, which may disadvantage smaller or non-traditional applicants unfamiliar with this mechanism

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Health Care & Social Assistance
NAICS 621511
US market size
$2.7T
Typical award
$50K – $100M
Typical buyers
VAHHSDoD MHSIHS
Commonly required
Joint CommissionCMS

Sector-level estimate — full code lookup not yet in catalog.

First in Human and Early Stage Clinical Tr…
Due Oct 15
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