Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research (U18 - Clinical Trial Not Allowed) | RFA DA 20 025

Opportunity Information: Apply for RFA DA 20 025

The Step Up for Substance Use Disorders (SUD) initiative is a National Institutes of Health (NIH) funding opportunity designed to help move basic, fundamental discoveries closer to real-world medicines for substance use disorders. The central idea is to strengthen the early evidence behind potential drug targets by funding focused, confirmatory studies that can clearly answer a practical go/no-go question: is this target strong enough to justify further therapeutic development, or should the effort stop and resources shift elsewhere? By concentrating on rigorous target validation or invalidation, the program aims to broaden the pipeline of viable SUD treatment mechanisms, rather than relying on a narrow set of traditional approaches.

This opportunity uses a cooperative agreement mechanism (U18), meaning awardees can expect an active partnership with the funding agency rather than a hands-off research grant. A key feature is that the initiative offers not only direct funding but also in-kind access to biomedical product development experts. In practice, that kind of support is meant to help researchers align their experiments with the expectations of translational science and early drug development, such as strengthening experimental rigor, improving reproducibility, and generating decision-grade data that can be used to justify the next development step (or confidently terminate a weak lead).

The program is intentionally structured to be short-term and nimble. Instead of supporting long, exploratory research arcs, it prioritizes tightly scoped projects that can deliver clear answers about whether a specific biological target, pathway, or mechanism is truly actionable for SUD therapeutics. The emphasis is on robust confirmatory work, which commonly implies careful study design, appropriate controls, replication where feasible, and metrics that meaningfully test the target hypothesis. The expected outcome is a better-vetted set of targets ready for subsequent medicinal chemistry, biologics engineering, or more advanced preclinical development efforts, while also reducing wasted effort on targets that do not hold up under stricter testing.

Only projects aimed at potential drug or biologic therapies are within scope at this stage. The solicitation explicitly does not support diagnostics or devices, and it is labeled “Clinical Trial Not Allowed,” indicating the work must remain in the preclinical or non-clinical research domain. In other words, the goal is not to run human studies under this award, but to generate the kind of foundational, high-confidence evidence that can justify later-stage development or future clinical research through other mechanisms.

Administratively, this is a discretionary funding opportunity under the NIH umbrella, aligned with health-related research and classified under CFDA 93.279. The funding opportunity number is RFA-DA-20-025, and the original closing date listed is February 13, 2020, with a creation date of November 14, 2019. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants would need to consult the full announcement or NIH documentation for budget and award planning details.

Eligibility is broad and includes many standard applicant types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; and public housing authorities/Indian housing authorities. It also includes federally recognized Native American tribal governments, and Native American tribal organizations that are not federally recognized. Both nonprofit organizations (with and without 501(c)(3) status) and for-profit organizations (including small businesses and other for-profits that are not small businesses) are eligible. In addition, the opportunity highlights inclusivity for a wide range of institutions and organizations, including 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, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations.

Taken together, this grant opportunity is best understood as a translational bridge for scientists doing fundamental research who have a promising SUD-relevant target and need support to run decisive, high-quality validation studies. The program’s combination of short, decision-focused funding and access to product development expertise is meant to produce clearer outcomes than typical exploratory grants: either a target emerges with stronger justification to move toward therapeutic development, or it is ruled out early, saving time and resources while sharpening the overall SUD treatment pipeline.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research (U18 - Clinical Trial Not Allowed)" 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 2019-11-14.
• Applicants must submit their applications by 2020-02-13. (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 RFA DA 20 025

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