Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01-Clinical Trial Optional) | PAR 19 318

Opportunity Information: Apply for PAR 19 318

The Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01 - Clinical Trial Optional) funding opportunity (PAR 19 318) is an NIH grant program, led by the National Institute on Drug Abuse (NIDA), aimed at speeding up the development of medications for substance use disorders (SUDs) by pairing NIDA support with the capabilities of external partners. The core idea is that medication development often stalls or slows when academic teams, small companies, or nonprofits lack the full set of resources needed to move a compound efficiently through later-stage development steps. This FOA is designed to close those gaps by encouraging projects built around strategic collaborations, where different partners contribute complementary assets such as drug development expertise, manufacturing, formulation, regulatory experience, clinical operations, or funding and in-kind support.

A defining feature of this program is its emphasis on advancing compounds toward FDA approval, not just generating basic knowledge. Projects are expected to sit clearly within the medication development pipeline and to be structured around a concrete starting point (an entry point) and a clear milestone-based destination (an exit point) that represents real progress in the FDA pathway. Depending on the maturity of the asset, an application could focus on developing a new molecular entity, optimizing and testing an existing candidate, or expanding the clinical indication of a medication that is already known but not yet approved (or not yet approved for a particular SUD-related use). The goal is to fund work that meaningfully de-risks the candidate and moves it forward in a way that would be recognizable to regulators, investors, and product-development organizations.

The FOA places strong weight on the concept of a "strategic alliance." That typically means an application should show how NIDA funds will be leveraged with substantial outside strengths and resources, which can come from academic institutions, pharmaceutical and biotechnology companies, foundations, small businesses, or other nonprofit and for-profit entities. Importantly, the program is also open to single-entity applications when that organization already has significant internal capacity for medication development, as long as it demonstrates a serious resource commitment to the project. The announcement gives concrete examples of what that commitment might look like, such as providing salary support for key personnel or covering production and formulation of clinical trial materials. In other words, the program is not only paying for research activities; it is looking for a partnership or sponsor-like commitment that increases the odds a medication can progress rapidly and successfully.

Another key point is that the project period and budget are intended to support acceleration compared to traditional R01-style research. While the mechanism is an R01 and the FOA notes that clinical trials are optional, the underlying expectation is not a slow, exploratory research program. Instead, applicants should frame the work as a development plan with defined deliverables and timelines that push the compound forward. The program is meant to reduce the usual friction that can happen when development tasks are spread across organizations without aligned incentives or when crucial capabilities (manufacturing, regulatory planning, clinical-grade materials, etc.) are missing.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including those other than small businesses); small businesses; and other entities. The FOA also explicitly calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and foreign (non-U.S.) entities. This breadth reflects NIDA's interest in bringing together the best-positioned teams regardless of sector, with the shared aim of moving SUD medications closer to real-world approval and use.

From an administrative standpoint, the opportunity is a discretionary NIH grant in the health and education activity area (CFDA 93.279). The original posting dates back to July 25, 2019, with an original closing date listed as September 1, 2022. Even though those dates are included in the source data, the bigger takeaway for anyone assessing fit is the program's purpose: support structured, resource-backed development efforts that measurably advance medication candidates for SUDs along an FDA-relevant path, using alliances that can move faster than a traditional, stand-alone research project.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01-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 2019-07-25.
• 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.)
• 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 19 318

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