Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) | PAR 22 202

Opportunity Information: Apply for PAR 22 202

The Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity, led through the National Institute on Drug Abuse (NIDA), designed to speed up the development of medications for Substance Use Disorders (SUDs). The program is built around the idea that some of the most important steps in moving a potential treatment toward FDA approval are difficult to fund under a standard research grant mechanism. To address that gap, this FOA supports a wide range of medication development projects, including preclinical and/or clinical research, with a clear emphasis on studies that can generate decisive, high-impact results quickly.

The award uses the U01 cooperative agreement mechanism, meaning it is not a typical “hands-off” research grant. Instead, NIDA staff are expected to have substantial scientific involvement throughout the life of the project, with close monitoring and active collaboration. This structure is intended to keep projects tightly focused on milestones that matter for real-world medication development, such as producing data that can support the next stage of development, inform regulatory strategy, or de-risk a candidate enough to justify larger confirmatory trials. While clinical trials are optional under this announcement, applications can include clinical studies when they are appropriate for advancing a medication candidate toward approval.

In practical terms, this is meant to be a fast-moving, well-resourced program. Awards are expected to be short-term (up to 3 years) but large in scale, with an award ceiling of up to $5,000,000 per year. That budget level signals that NIDA is looking for ambitious projects that can move the needle within a relatively compressed timeframe, rather than exploratory work that may take many years to mature. The FOA explicitly frames these U01 projects as enabling “critical medications development studies” that would be hard to accomplish under the traditional R01 model, which often supports more investigator-directed, longer-horizon research without the same level of agency partnership and milestone-driven management.

Eligibility is broad and includes many types of organizations that could contribute to medication development, spanning government, academia, nonprofit, and industry. Eligible applicants listed in the source data include 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; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal 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); small businesses; and other entities. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations. This wide eligibility is consistent with the program’s applied focus, since meaningful medication development often requires cross-sector capabilities (for example, discovery and preclinical testing, formulation work, clinical operations, regulatory planning, and access to patient populations).

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses a cooperative agreement as the funding instrument type. The funding activity category is listed as Education and Health, and the CFDA number associated with the program is 93.279. The Funding Opportunity Number is PAR-22-202, and the opportunity was created on 2022-09-01. The original closing date shown is 2025-09-01. The central theme across the announcement is acceleration: NIDA is seeking proposals that can efficiently deliver the kinds of results needed to push SUD medication candidates closer to FDA approval, supported by substantial resources and guided by an active, collaborative federal role.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Grand Opportunity in Medications Development for Substance-Use Disorders (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): 93.279.
• 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 $5,000,000.00 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 22 202

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