Notice of Intent to Publish a Funding Opportunity Announcement for Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (R41/R42 Clinical Trial Optional)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to publish a Notice of Funding Opportunity (NOFO) that is a re-issue of PAR-22-103 (entitled Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage [UT1/UT2 Clinical Trial Optional] ). The re-issued NOFO will continue to solicit Small Business Technology Transfer (STTR) applications that propose the development of therapeutic agents for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD). As a starting point, eligible applicants must identify a therapeutic candidate with a robust body of background data in the basic science and early discovery phases to be ready for transition to the preclinical and clinical phases of development. Data may include having sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application. Projects responsive to this announcement could be undertaken at any point along the drug development continuum, from late discovery (i.e., lead optimization/early safety) up to early-stage clinical trials. For small molecules, the earliest stage of eligibility for this Award is already having small-molecule compounds with proof of desired pharmacological activity. For biologics, the profiling of promising product candidates in animal models of AUD or AAOD will be allowed as the earliest entry point. The ultimate purpose and goal of this FOA is to advance molecules closer to U.S. Food and Drug Administration (FDA) approval. Milestones will be commensurate with the project proposed and the purpose of the NOFO. This NOFO will support early-phase clinical trials, although these are not required. Women-owned and socially or economically disadvantaged small business are encouraged to apply. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The NOFO is expected to be published on January 16, 2025, with an expected application due date on April 5, 2025. The NOFO will utilize the R41/R42 activity codes and will be termed Clinical Trial Optional . Details of the planned NOFO are provided below.