National Cooperative Drug/Device Discovery/Development Groups (U01 Clinical Trial Optional) | PAR 18 230

Opportunity Information: Apply for PAR 18 230

The National Cooperative Drug/Device Discovery/Development Groups (U01 Clinical Trial Optional) funding opportunity (PAR-18-230) is an NIH cooperative agreement designed to push promising new treatments and research tools for mental health conditions, substance use disorders (SUDs), and alcohol addiction through the critical early stages of development. The core idea is to speed up the pipeline from scientifically grounded concepts to practical, testable drug or device candidates by supporting discovery, preclinical development, and early proof-of-concept work. Unlike a traditional grant where the applicant largely drives the project independently, the U01 cooperative agreement structure typically means substantial NIH involvement, with closer collaboration and milestone-driven progress to keep projects moving efficiently.

A major emphasis of the program is on advancing both pharmacologic and neuromodulatory approaches. On the drug side, that can include discovering and optimizing new candidate compounds, developing novel ligands, and building the evidence needed to justify next-step testing. On the device side, the focus includes neurostimulation or circuit-engagement technologies that can either become therapeutic candidates themselves or serve as tools to probe brain circuits and validate targets. The opportunity is not limited to creating entirely new therapies; it also supports new indications for agents that are already IND-ready, and devices that are PMA-ready, meaning the work can include repurposing or extending advanced candidates toward mental disorders, SUDs, or alcohol addiction when there is a strong scientific rationale.

Another key goal is to support experimental therapeutic studies and early-stage human research that can quickly answer practical questions about a candidate's safety, tolerability, and pharmacodynamics. In other words, the program is meant to help investigators move beyond interesting biology into studies that show whether a drug or device engages its target, affects relevant mechanisms, and looks feasible to advance. While the FOA is described as “Clinical Trial Optional,” it explicitly welcomes projects that include early human testing when it is appropriate and can accelerate decision-making about whether to proceed to larger trials.

The FOA strongly encourages partnerships between academia and industry, reflecting the reality that successful translation often requires combined strengths: academic innovation and mechanistic insight alongside industry experience in development, manufacturing, regulatory strategy, and scaling. Projects that bring together these capabilities are well aligned with the program’s intent to produce candidates and tools that are genuinely positioned for the next stages of development rather than remaining purely exploratory.

Eligibility is broad and includes many U.S.-based entities such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; independent school districts; special district governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, certain tribal governments that are not federally recognized, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions and non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, “foreign components” as defined by the NIH Grants Policy Statement may be included, which typically allows specific, justified elements of the work to occur abroad under a U.S. applicant organization.

Administrative details from the source listing include the opportunity category as discretionary, the funding instrument as a cooperative agreement (U01), and activity areas spanning education and health, with CFDA numbers 93.242, 93.273, and 93.279. The listing shows an original closing date of 2020-02-24 and a creation date of 2017-11-21. The award ceiling and expected number of awards are not specified in the provided data, which often means applicants need to consult the full FOA text for budget expectations, project period limits, milestones, and any institute-specific priorities tied to the announcement.

Taken together, this opportunity is aimed at teams that have a compelling, rationally based therapeutic or tool concept and can lay out a credible development path from discovery through preclinical work and, when appropriate, into early human testing. The most competitive projects are likely to be those that clearly define target or circuit engagement, specify measurable development milestones, and show how the proposed drug or device candidate will be de-risked efficiently for eventual clinical application in mental health, SUDs, or alcohol addiction.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (U01 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, 93.273, 93.279.
• This funding opportunity was created on 2017-11-21.
• Applicants must submit their applications by 2020-02-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 18 230

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