The National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health (NIH), has issued a notice of intent to publish a Funding Opportunity Announcement (FOA) aimed at supporting the investigational new drug (IND)-enabling and early-stage development of medications to treat Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD). This upcoming FOA will be a reissue of the previous PAR-22-103 and will use the Small Business Technology Transfer (STTR) R41/R42 activity codes with the designation of “Clinical Trial Optional.” The goal of this reissued opportunity is to support the advancement of therapeutic agents from early discovery through early clinical development with the aim of achieving FDA approval.
The purpose of this opportunity is to support small businesses in identifying and advancing therapeutic candidates that show promise in treating AUD and/or AAOD. Eligible projects must begin with a therapeutic candidate supported by robust preclinical data, including characteristics such as bioactivity, bioavailability, manufacturability, stability, in vivo efficacy, or target engagement. For small molecules, the minimum requirement for eligibility is demonstrating the desired pharmacological activity, while biologics may begin at the stage of profiling promising candidates in animal models. The scope of support may extend from lead optimization to early-stage clinical trials, though clinical trials are not mandatory.
Funding will be provided through grants and does not require cost sharing or matching funds. While detailed financial allocations have not yet been announced, this opportunity is categorized as discretionary and focuses on the health domain, especially substance abuse treatment innovations. The NOFO emphasizes that projects should aim to move molecules closer to FDA approval, and all projects must align their milestones with the proposed scope and objectives.
Eligible applicants are limited to small businesses, including those that are women-owned or socially/economically disadvantaged. This opportunity particularly encourages such businesses to apply. Applications will be reviewed for how effectively they translate promising drug candidates into viable clinical products, contributing to addressing significant public health concerns related to alcohol misuse and its physiological impacts.
The official FOA is scheduled to be published on January 16, 2025, with applications due by April 5, 2025. Awards are expected to be made by September 30, 2025, and funded projects are expected to begin by December 1, 2025. This notice has been issued in advance to give potential applicants ample time to build strong collaborations and prepare responsive and competitive proposals.
The primary contact for this opportunity is the NIH OPERA DGSI Systems Policy Branch, and inquiries can be directed via email to operasystemspolicy@nih.gov.
