Medications Development for the Treatment of Alcohol Use Disorder (U01 Clinical Trial Optional) | RFA AA 19 005

Opportunity Information: Apply for RFA AA 19 005

Medications Development for the Treatment of Alcohol Use Disorder (U01 Clinical Trial Optional), RFA-AA-19-005, is a National Institutes of Health funding opportunity administered through the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to push promising treatment compounds for Alcohol Use Disorder (AUD) further along the real-world drug development path. The mechanism is a cooperative agreement (U01), which generally means the project is led by the awardee but carried out with substantial scientific or programmatic involvement from NIH staff compared with a typical grant. The overall emphasis is on practical, milestone-driven development work that helps move candidate medications closer to being viable clinical options for AUD.

The FOA is focused on advancing candidate compounds through key late-preclinical and early clinical steps needed for human use and early signals of efficacy. Specifically, NIAAA is looking for projects that can support progress through Investigational New Drug (IND)-enabling requirements and into Phase 1 human studies assessing safety, tolerability, and dosing, followed by Phase 2 human laboratory studies and proof-of-concept trials. A central expectation is that each application clearly defines where the project enters the development pipeline and what the concrete exit point will be, so the work is bounded, measurable, and positioned to hand off into the next stage of development when complete.

A notable boundary in the scope is that the FOA is not intended to fund animal efficacy studies to demonstrate that a compound works, unless such studies are specifically required by the U.S. Food and Drug Administration or are requested as a condition of peer review. In other words, the program is aimed less at exploratory preclinical discovery and more at clearing regulatory and clinical-development hurdles that allow a compound to be tested rigorously in humans and to generate credible early clinical evidence.

NIAAA is explicitly inviting a wide range of applicants from both the nonprofit and for-profit sectors, reflecting the reality that medications development often requires capabilities found across academia and industry. Eligible or encouraged applicant types include academic institutions, pharmaceutical and biotechnology companies, private and public foundations, and small businesses (including some that may not fit the SBIR/STTR pathway for this particular opportunity). The announcement also recognizes that some projects may hinge on substantial support from a single committed entity, and it provides examples of what that could look like in practice, such as salary support for key personnel or provision of drug manufacturing, production, and formulation of clinical trial material.

Eligibility is broad and includes many organizational categories commonly allowed under NIH discretionary health funding. Examples listed include state, county, city, 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; small businesses; and other entities. The FOA also highlights inclusion of institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities.

From a practical application standpoint, the announcement strongly encourages prospective applicants to contact the NIAAA Division of Medications Development staff before submitting. That kind of pre-application discussion is often used to confirm fit with program goals, clarify expectations around IND readiness, clinical trial design, manufacturing plans, regulatory strategy, and what milestones and go/no-go criteria would be viewed as appropriate for the proposed entry and exit points.

Administrative details provided in the source include: Funding Opportunity Title: Medications Development for the Treatment of Alcohol Use Disorder (U01 Clinical Trial Optional); Funding Opportunity Number: RFA-AA-19-005; Opportunity Category: Discretionary; Funding Instrument Type: Cooperative Agreement; Funding Activity Category: Health; CFDA Number: 93.273; Agency: National Institutes of Health; and key dates including a creation date of 2018-11-15 and an original closing date of 2019-02-11. The source excerpt does not specify an award ceiling or expected number of awards, indicating those fields were not populated in the provided data.

• 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 (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): 93.273.
• This funding opportunity was created on 2018-11-15.
• Applicants must submit their applications by 2019-02-11. (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.

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