Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) | PAR 20 092

Opportunity Information: Apply for PAR 20 092

The NIH, through the National Institute on Drug Abuse (NIDA), released this cooperative agreement funding opportunity (PAR-20-092) to speed up the discovery and development of medications aimed at preventing and treating opioid use disorder (OUD) and opioid overdose. The central idea is to move promising candidates more efficiently toward the FDA drug development and approval pathway by supporting work that can produce decisive, high-impact results in a relatively short time frame. Projects can be either preclinical or clinical (clinical trials are optional), as long as the work is clearly positioned to advance a medication candidate toward being safe, effective, and ultimately approvable for OUD- or overdose-related indications.

The award uses a two-phase UG3/UH3 structure under a cooperative agreement mechanism, meaning there is substantial NIH/NIDA involvement and oversight compared to a standard research grant. The first phase (UG3) is a time-limited, milestone-driven “innovation” period lasting up to two years. Applicants are expected to propose clear, measurable milestones that demonstrate whether the project is truly ready to advance. If those UG3 milestones are successfully achieved, NIDA can administratively consider and prioritize the project for transition into the second phase (UH3), which provides up to three additional years of support to continue development activities that build directly on the UG3 progress. A key requirement is that applications must address both phases up front, laying out a coherent plan for what will be accomplished during UG3 and what the subsequent UH3 activities will be if milestones are met.

Scientifically, the opportunity is broad in the kinds of medication approaches it will support, as long as they have a credible path toward addressing OUD or overdose. Proposed compounds may be small molecules or biologics. They can be evaluated in preclinical models and/or in studies targeting clinical manifestations relevant to OUD, including withdrawal, craving, relapse, and overdose. The FOA also allows multiple development strategies, such as creating entirely new chemical entities, developing new formulations of medications that are already marketed for other indications (repurposing or reformulation), or testing combinations of medications that may work better together than alone. The emphasis is on practical medication development work that closes key knowledge gaps and generates the kind of evidence needed to progress through the FDA pipeline.

Programmatically, this FOA is framed as part of a larger NIH effort to confront the opioid crisis through public-private partnership approaches and by accelerating the translation of research into real-world interventions. In other words, the goal is not only scientific novelty, but also speed, rigor, and a clear line of sight to deployable treatments and overdose countermeasures. The cooperative agreement format aligns with that goal by enabling NIDA to coordinate, guide, and help keep projects aligned with the fast-track, milestone-based intent of the program.

Eligibility is expansive and includes many types of organizations that could contribute to medication development, spanning government, academia, nonprofits, and industry. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including other than small businesses) as well as small businesses; and additional entities categorized as “others.” The FOA also explicitly highlights additional eligible groups such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions, along with faith-based/community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations.

Administratively, the opportunity is listed as a discretionary program using the cooperative agreement funding instrument, within an education and health activity category, and associated with CFDA number 93.279. The source listing indicates an award ceiling of $3,000,000. The original closing date shown in the provided record is 2022-09-01, and the opportunity record creation date is 2020-01-24. Overall, the FOA is designed for teams that can define concrete milestones, execute rigorous development work quickly, and demonstrate readiness to move a candidate medication along a realistic path toward FDA review for preventing or treating OUD and/or opioid overdose.

• 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 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 2020-01-24.
• Applicants must submit their applications by 2022-09-01. (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 20 092

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