National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional) | PAR 25 353

Opportunity Information: Apply for PAR 25 353

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional) funding opportunity (PAR-25-353) is an NIH cooperative agreement designed to push promising mental health and addiction treatment ideas further down the pipeline, from discovery through early development and into proof-of-concept (PoC) testing when appropriate. It is a reissue of PAR-20-119 and focuses on building coordinated, multi-project research programs that tackle a shared, high-impact objective such as developing a new therapeutic candidate, advancing a neurostimulation approach, or creating enabling tools that strengthen target validation and mechanistic understanding. The emphasis is on rationally based approaches, meaning applicants should ground candidate drugs, devices, or stimulation strategies in clear biological or circuit-level rationale rather than purely empirical screening without a strong mechanistic hypothesis.

Scientifically, the FOA encourages applications that advance the discovery and preclinical development of new candidate agents for mental disorders, substance use disorders (SUDs), and alcohol use disorder (AUD), along with the early evaluation steps needed to establish readiness for human testing or to demonstrate early clinical feasibility. In addition to therapeutics, it explicitly supports development of novel ligands and circuit-engagement devices that function as research tools. These tools can be used to better characterize existing targets or to validate new drug/device targets, which is often a critical bottleneck in neuropsychiatric therapeutics where target engagement and circuit mechanisms can be difficult to measure directly. Neurostimulation approaches are also within scope, particularly where applicants can show a logical path from mechanism to measurable engagement and meaningful outcomes.

Structurally, this is a U19 mechanism, which is intended for a multi-component program rather than a single standalone project. The FOA supports multiple integrated projects that together pursue one major objective or program goal and typically requires a broad, multidisciplinary team and a longer-term strategy. Because it is a cooperative agreement, NIH staff are expected to have substantial programmatic involvement compared to a standard research project grant, which usually implies closer coordination, milestone-driven progress, and collaborative problem-solving with the funding institute. Applicants who instead want support for a discrete, tightly circumscribed project led by a named investigator are directed to consider the companion U01 FOA, which is better suited for single-project efforts rather than an integrated group program.

The opportunity is described as “Clinical Trial Optional,” which generally means applicants may propose clinical trial activities if they fit the program’s goals, but a clinical trial is not required. In practice, this aligns with the FOA’s stated interest in proof-of-concept testing, while still allowing programs focused on discovery, preclinical optimization, translational validation tools, or device/ligand development to compete without committing to a clinical study component.

Partnerships between academia and industry are strongly encouraged. This reflects the translational nature of the program: industry partnerships can bring medicinal chemistry, manufacturing, regulatory experience, device engineering, or development infrastructure that helps candidates move more efficiently from lab concepts to development-ready packages. Likewise, academic groups often contribute foundational biology, model development, and innovative measurement tools. The FOA is therefore positioned to support team science arrangements that combine complementary strengths across sectors.

Eligibility is broad and includes many common U.S. applicant types such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible organizational categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, and U.S. territories or possessions. At the same time, it makes clear that non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, “foreign components” as defined in the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant can include certain well-justified international collaborations or activities under NIH rules even though a foreign organization cannot serve as the applicant institution.

Administratively, the agency is the National Institutes of Health, the funding instrument is a cooperative agreement, and the activity category is health (CFDA 93.242). The original closing date listed is 2027-10-25, and the FOA does not specify an award ceiling or expected number of awards in the provided excerpt, suggesting applicants should consult the full announcement for budget guidance, project period limits, and any institute-specific priorities or constraints. Overall, the program is best understood as a mechanism for building coordinated, milestone-oriented discovery and development teams aimed at producing tangible, decision-ready therapeutic candidates, neurostimulation strategies, or validated tools that can accelerate target engagement and translation for mental health and substance-related disorders.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2025-01-15.
• Applicants must submit their applications by 2027-10-25.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 353

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