Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 - Clinical Trials Not Allowed) | RFA DA 26 020

Opportunity Information: Apply for RFA DA 26 020

This funding opportunity (RFA-DA-26-020) from the National Institutes of Health supports the creation of a dedicated Center that functions as a flexible, service-oriented drug development infrastructure for substance use disorder (SUD) therapeutics. The core purpose is to strengthen and expand the SUD medication pipeline by speeding up the evaluation, validation, and advancement of existing drugs that can be repurposed or repositioned for SUD treatment. Rather than funding a single therapeutic candidate or a single disease area, the program is designed to stand up an ongoing capability that can assist many investigators and many projects over time, with the expectation that this shared infrastructure will reduce duplication, shorten timelines, and raise the quality and readiness of repurposing efforts across the field.

The award mechanism is a U54 cooperative agreement, which typically means substantial scientific and/or programmatic involvement from NIH staff in coordination with the awardee. The NOFO explicitly states clinical trials are not allowed, so the Center is expected to focus on preclinical, translational, and enabling activities that prepare candidates for later-stage testing, or on other non-trial activities that de-risk and advance repurposing projects. The emphasis is on building a dynamic and adaptable platform: in practical terms, a Center that can take in a steady flow of new project ideas from the community, quickly triage and select the most promising ones, and then provide the specialized expertise and coordinated support needed to move those candidates forward through key development milestones.

A major feature of this opportunity is the provision of comprehensive drug development services delivered by a team of subject matter experts. The NOFO highlights specific support functions such as creating Target Product Profiles (TPPs), which help define the intended patient population, indication, dosing and delivery considerations, efficacy expectations, safety requirements, and differentiation goals that guide development decisions. It also calls out Freedom-to-Operate (FTO) analyses and intellectual property consultations, reflecting a practical focus on whether a repurposing concept can realistically be advanced and later commercialized or otherwise deployed without blocking patent barriers. In addition, the Center is expected to provide regulatory guidance and technical pipeline support, which can include planning for required studies, aligning evidence packages with likely regulatory pathways, and helping investigators understand what data are needed to justify progression to later phases even if the U54 itself does not fund clinical trials.

Another central expectation is robust outreach and community engagement. The Center is not meant to operate passively; it is expected to connect actively with academic researchers, biotech teams, and other potential contributors working on SUD indications, solicit project proposals, and maintain transparent processes for evaluating, selecting, and advancing projects. This implies the need for an organized intake system (for example, periodic calls for proposals), clear selection criteria, and an internal governance model that can make defensible, timely decisions about which projects receive support. Because SUD is a broad umbrella covering different substances and patterns of use, the NOFO anticipates a portfolio approach where the Center supports multiple projects across different SUD indications, thereby increasing the chance that at least some candidates will progress toward meaningful impact and reducing reliance on any single scientific bet.

In terms of who can apply, eligibility is broad and includes many types of U.S. organizations and governmental entities: state, county, city, township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses. The NOFO also lists additional eligible applicants such as eligible federal agencies, faith-based or community-based organizations, tribal governments that are not federally recognized, non-U.S. (foreign) entities, regional organizations, and U.S. territories or possessions. This wide eligibility reflects the infrastructure nature of the award and the value of drawing expertise from many settings, including organizations with strong translational, regulatory, intellectual property, and community engagement capabilities.

Administratively, the opportunity is categorized as discretionary funding and sits within health-related activity (CFDA 93.279). The application due date listed is January 28, 2026, and the posting date provided is September 24, 2025. While the excerpt does not provide an award ceiling or expected number of awards, the structure and scope imply a sizable, multi-component Center effort with coordinated expert services and ongoing project support. Overall, the program is aimed at creating an enabling engine for the field: a well-organized Center that helps researchers move repurposed or repositioned medication ideas from concept toward development readiness for SUDs, while building a repeatable process for outreach, selection, and advancement that can serve the broader research community over time.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 - Clinical Trials 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 2025-09-24.
• Applicants must submit their applications by 2026-01-28. (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 26 020

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