Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) | PAR 25 328

Opportunity Information: Apply for PAR 25 328

The Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) is a National Institutes of Health funding opportunity (PAR-25-328) designed to speed up the development of medications for treating substance use disorders (SUDs). The main intent is to support a wide range of targeted, high-impact projects that can generate decisive preclinical and/or clinical evidence needed to move candidate medications closer to eventual FDA approval. Unlike more traditional research grants that often support broader or longer-term scientific aims, this program is framed around getting critical, decision-driving data quickly, with an emphasis on studies that can materially advance a medication development pipeline.

This opportunity uses the U01 cooperative agreement mechanism, meaning awardees should expect substantial scientific involvement from the funding institute rather than a hands-off grant relationship. In practice, the cooperative structure signals close coordination with NIH staff, active project oversight, and meaningful participation by NIDA (the National Institute on Drug Abuse) in key scientific or operational aspects of the work. The program is explicitly positioned to fund medication development studies that might be difficult to execute under an R01 because they may be unusually time-sensitive, operationally complex, resource-intensive, or require intensive milestone monitoring and rapid-go/no-go decision-making.

The projects supported can be either preclinical, clinical, or a combination, and clinical trials are permitted but not required (hence "Clinical Trial Optional"). The central theme is medications development for SUDs, so applicants are generally expected to propose rigorous studies that directly strengthen the evidence base for a therapeutic candidate, such as studies that clarify efficacy signals, dosing, safety, mechanism, feasibility, or other data needed to justify later-stage trials and regulatory steps. The program prioritizes work that can quickly yield results with clear implications for next development decisions, rather than exploratory research that may not translate into a near-term development pathway.

Awards are intended to be relatively short in duration but large in scale. Projects are expected to run for up to three years, with a stated award ceiling of up to $5,000,000 per year. This reflects the program's focus on enabling major, high-cost activities (for example, complex clinical protocols, multi-site coordination, manufacturing or formulation-related work tied to a trial, or other expensive development-enabling studies) while keeping timelines tight so the field gets actionable answers quickly. Because these are cooperative agreements, applicants should anticipate strong expectations around planning, milestones, progress monitoring, and responsiveness to programmatic input during the project period.

Eligibility is broad and includes many types of U.S.-based organizations and certain non-U.S. entities. Eligible applicants include state, county, and local 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and additional unspecified "other" entities. The notice also highlights additional eligible applicant categories such as 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 agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, non-domestic (non-U.S.) entities (foreign organizations), and U.S. territories or possessions. This breadth suggests an interest in drawing strong medication development proposals from diverse institutional settings, including community-linked organizations that may be well positioned to conduct real-world clinical research.

Administratively, the opportunity is listed as a discretionary program with a cooperative agreement funding instrument type, in the Education and Health funding activity category, and is associated with CFDA number 93.279. The sponsoring agency is NIH, with NIDA scientific involvement referenced in the description. The original closing date provided is August 11, 2025. Overall, the program is best understood as a fast-moving, high-budget, tightly managed vehicle to push promising SUD medication candidates through key development steps by funding studies that can produce near-term, decision-grade results.

• 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 2025-01-03.
• Applicants must submit their applications by 2025-08-11. (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 25 328

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