Medications Development for the Treatment of Alcohol Use Disorder - CT optional (U01) | RFA AA 18 009

Opportunity Information: Apply for RFA AA 18 009

Medications Development for the Treatment of Alcohol Use Disorder - CT optional (U01) (RFA-AA-18-009) is a National Institutes of Health funding opportunity from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) that supports later-stage, human-focused medications development for Alcohol Use Disorder (AUD). It uses a cooperative agreement mechanism (U01), which means the funded project is expected to involve substantial scientific and programmatic involvement from NIAAA staff as the work progresses. The overall intent is practical and translational: to help move promising candidate compounds forward through key milestones in the drug development pipeline, rather than funding open-ended basic research.

The central goal of the FOA is to advance candidate medications through the steps needed to reach and progress beyond an Investigational New Drug (IND) submission and into early clinical testing. Projects are expected to focus on IND-enabling activities (as appropriate), Phase 1 clinical studies that establish human safety, tolerability, and dosing, and Phase 2 work that includes human laboratory studies and proof-of-concept trials in people. A defining feature is that each application should clearly state where the project enters the pipeline (the starting development stage) and what concrete endpoint it will reach (the exit criteria). In other words, applicants need to lay out a milestone-driven plan with well-defined go/no-go decision points that demonstrate how the award will de-risk the compound and advance it to the next stage of development.

This opportunity is aimed at organizations that can realistically execute clinical and regulatory development work, including entities that can show meaningful commitment of resources to the project. NIAAA explicitly invites applications from both for-profit and not-for-profit applicants, including academic institutions, pharmaceutical and biotechnology companies, foundations, and small businesses that are not using the SBIR/STTR pathway. The FOA also notes that a single entity may apply if it can demonstrate significant resource commitment to the project, such as providing salary support for key personnel or handling production and formulation of clinical trial materials. This emphasis signals that NIAAA is looking for proposals that are operationally ready, with access to the specialized capabilities needed for manufacturing, regulatory documentation, clinical operations, and data management.

A key limitation is that the FOA generally will not support animal efficacy studies intended to demonstrate that the candidate compound works, unless those studies are specifically required by the Food and Drug Administration or are otherwise deemed necessary through peer review. The program is therefore oriented toward development activities that directly support regulatory advancement and early-stage clinical evaluation, rather than preclinical discovery or broad exploratory animal testing. Applicants are also strongly encouraged to contact NIAAA Division of Medications Development staff before submitting, reflecting the cooperative nature of the award and the value of aligning development plans, milestones, and regulatory strategy with program expectations early on.

Eligibility is broad and includes many common government and research applicants: 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; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIS institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. This breadth indicates NIAAA is open to partnerships and applications from a wide range of capable organizations, provided the project is positioned to make tangible progress toward clinical testing and eventual treatment impact.

Administrative details from the source listing include that this is a discretionary funding opportunity in the health area (CFDA 93.273) run by NIH, with an original closing date of March 20, 2018, and a creation date of January 18, 2018. While the listing does not provide an award ceiling or expected number of awards in the excerpt provided, the defining features of the announcement are its cooperative agreement structure, its focus on IND-enabling and early human clinical development (Phase 1 and Phase 2), and its milestone-driven expectation that funded work will move an AUD medication candidate forward in a measurable, decision-oriented way.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Medications Development for the Treatment of Alcohol Use Disorder - CT optional (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2018-01-18.
• Applicants must submit their applications by 2018-03-20. (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 AA 18 009

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