OpenFederal grantOpen to for-profit businessesPAR-25-180

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

National Institutes of HealthCloses Oct 15, 2027(367 days left)

Does this fit your business?

This is an NIH cooperative agreement for early-stage clinical trials — first-in-human and Phase II/proof-of-concept studies — of novel drugs or neuromodulatory devices for psychiatric disorders. It is for organizations that can actually run clinical trials, typically biotech firms, universities, and research nonprofits with industry partners. If you are not running biomedical R&D on psychiatric treatments, do not apply; nothing here funds general business needs.

Best for
Biotech and pharma companies with a novel psychiatric drug or device ready for first-in-human or Phase II testing, Universities and academic medical centers running early-stage clinical trials, Nonprofits with biomedical research capacity and industry partners, Small businesses developing neuromodulatory devices or investigational drugs for psychiatric disorders
Not for
Businesses with no clinical trial or biomedical R&D capability, Organizations outside the US or with foreign components, Projects unrelated to psychiatric drug or device development
Estimated fit by industry, best first
IndustryEstimated fit
Healthcare & BiotechMatches your industry (medical, biomedical, clinical)
91
Strong Match
Technology & SoftwareMatches your industry (technology, tech)
77
Strong Match
Education & TrainingMatches your industry (stem)
69
Good Match
Agriculture & FarmingLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Arts & CultureLimit: Nothing in this notice points to arts & culture
54
Possible Match
Energy & Clean TechLimit: Nothing in this notice points to energy & clean tech
54
Possible Match
Show all 15 industries
Estimated fit by industry, best first
IndustryEstimated fit
Environment & ConservationLimit: Nothing in this notice points to environment & conservation
54
Possible Match
Finance & BankingLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Food & BeverageLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Housing & Real EstateLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
ManufacturingLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Retail & E-CommerceLimit: Nothing in this notice points to retail & e-commerce
54
Possible Match
Social Services & NonprofitLimit: Nothing in this notice points to social services & nonprofit
54
Possible Match
Transportation & LogisticsLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Construction & InfrastructureLimit: Nothing in this notice points to construction & infrastructure
51
Possible Match

These are our matcher’s estimates for a typical business in each industry. A real match depends on your size, your state and what you need the money for — check your own fit.

What this funds

Money can be used for
Research, R&D
Who can apply
Small businesses, For-profit companies, Nonprofits, State and local governments, Tribal governments and organizations, Colleges and universities, Other applicants (see eligibility)

Questions about this grant

When is the application deadline?
October 15, 2027.
Who can apply for this grant?
State, local, and tribal governments, public and private higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations including small businesses, independent school districts, public housing authorities, and certain other entities such as HBCUs, Hispanic-serving institutions, and faith-based or community-based organizations. Foreign organizations and non-U.S. components of U.S. organizations are not eligible.
Can a sole proprietor or single-member LLC apply?
The facts do not say. Small businesses are listed as eligible, but the notice does not spell out whether a sole proprietor or single-member LLC qualifies, so check with NIH before assuming.
Can a nonprofit apply?
Yes. Nonprofits with 501(c)(3) status and nonprofits without it (other than institutions of higher education) are both listed as eligible applicants.

Summary

NIH cooperative agreement supporting early-stage clinical trials (first-in-human, Phase II/proof-of-concept) of novel investigational drugs and neuromodulatory devices for psychiatric disorders. Eligible applicants include state/local/tribal governments, higher education institutions, nonprofits, and for-profit organizations including small businesses.

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.

Who can apply

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 Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Topics and uses of funds

Topics

  • Health
  • Science
  • Technology

Program contact

National Institutes of Healthgrantsinfo@nih.gov301-402-2541

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