Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional) | PAR 22 200

Opportunity Information: Apply for PAR 22 200

The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), is offering a cooperative agreement funding opportunity (PAR 22-200) to speed up the discovery and development of medications aimed at preventing and treating opioid use disorder (OUD), psychostimulant use disorders, and overdose. The program is designed for projects that can generate decisive results relatively quickly and push promising therapies closer to FDA approval by supporting the kinds of studies and development steps that often slow progress between early discovery and later-stage clinical readiness. Proposed therapeutics may include either small-molecule drugs or biologics, and the work can span preclinical development, clinical research, or a mix of both, depending on what is most likely to move the candidate medication forward in a credible and efficient way.

This opportunity uses a two-phase UG3/UH3 structure under a cooperative agreement, meaning the funding agency expects to have substantial involvement during the project (for example, through milestone tracking and collaborative oversight typical of cooperative agreements). The first phase, UG3, supports up to two years of milestone-driven work. Applicants must lay out clear, measurable milestones that can be evaluated at the end of the UG3 period. If those milestones are successfully achieved, the project can transition to the second phase, UH3, which provides up to three additional years of support to continue and expand the development pathway. Transition is not automatic, but UG3 projects that meet their targets are administratively reviewed by NIDA and prioritized for moving forward into the UH3 phase. Because of this structure, applications are expected to present an integrated plan that covers both phases, including what will be accomplished in UG3 to justify the larger UH3 effort.

On the scientific side, NIDA is looking for medication candidates that could meaningfully address real-world clinical needs tied to opioid and/or stimulant misuse and overdose. Studies may focus on key clinical manifestations and treatment targets such as withdrawal, craving, relapse prevention, and overdose mitigation. The FOA allows a range of development strategies, including entirely new chemical entities, repurposing or reformulating medications that are already marketed for other indications, and testing combination therapies where multiple agents together may improve outcomes. The intent is to support projects that can produce the evidence needed for advancement along the FDA drug development pipeline, emphasizing safety and effectiveness and encouraging approaches that can plausibly translate into approved treatments.

The announcement is labeled “clinical trial optional,” which generally means a project can be preclinical only, clinical only, or a staged plan that begins preclinically and moves into clinical evaluation if appropriate. The key expectation is that the proposed studies, whether in animal models, human laboratory settings, or clinical contexts, are designed to efficiently de-risk the candidate and generate the type of data that supports regulatory progression. In practical terms, applicants should be thinking not just about scientific novelty, but about whether the proposed work will materially strengthen the case for the medication’s next development step, such as IND-enabling work, early clinical testing, or other activities aligned with eventual FDA submission.

In terms of funding and timing, the opportunity is categorized as discretionary and uses a cooperative agreement as the funding instrument. The award ceiling listed is up to $3,000,000. The original closing date shown is 2025-09-01. The CFDA (now often referred to as Assistance Listing) number associated with this opportunity is 93.279, and the activity category is listed under education and health, reflecting NIH’s biomedical research mission and the public health focus of substance use disorder treatment development.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations (including those other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based and community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and foreign (non-U.S.) entities. This wide eligibility reflects NIDA’s interest in drawing from a diverse set of scientific, clinical, and translational development teams capable of moving medication candidates toward real-world impact.

Overall, the central theme of this FOA is acceleration with accountability: it funds projects that can show concrete progress in a defined early phase (UG3) and then scale into a longer development phase (UH3) once feasibility and readiness have been demonstrated. The program is positioned to support teams that are prepared to operate with a product-development mindset, using milestone-driven planning to move a medication candidate closer to being a safe, effective, and approvable option for preventing or treating opioid and/or stimulant use disorders and reducing overdose risk.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2022-09-01.
• Applicants must submit their applications by 2025-09-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
• 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 22 200

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