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 (R43/R44 Clinical Trial Optional)

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 initiative will reissue a previous NOFO (PAR-22-102) and will continue to solicit Small Business Innovation Research (SBIR) applications for the development of therapeutic agents targeting AUD and/or AAOD. The purpose of the FOA is to support small businesses in advancing therapeutic candidates with a robust background in basic science and early discovery phases toward preclinical and clinical development stages. Eligible projects can span the drug development continuum, from late discovery, such as lead optimization and early safety studies, to early-stage clinical trials. For small molecule candidates, eligibility begins with compounds that demonstrate the desired pharmacological activity. For biologics, the entry point includes profiling in animal models of AUD or AAOD. This opportunity will utilize the R43/R44 grant mechanisms, which are specific to SBIR Phase I and Phase II projects. The announcement will allow applicants to conduct early-phase clinical trials, although clinical trials are not a requirement for submission. The overarching goal of this FOA is to facilitate the progression of potential therapeutics toward FDA approval by supporting crucial early development activities. Women-owned and socially or economically disadvantaged small businesses are especially encouraged to apply. The notice has been issued in advance to provide potential applicants sufficient time to prepare responsive applications and establish relevant partnerships. The anticipated FOA will be published on January 16, 2025. Applications will be due by April 5, 2025. Awards are expected to be announced by September 30, 2025, with project start dates beginning December 1, 2025. This discretionary funding initiative aligns with the NIH’s ongoing efforts to foster innovation in treatment approaches for alcohol-related conditions. There are no cost-sharing or matching requirements for this grant. The detailed award ceiling, floor, and total funding available are not yet specified. The contact for further inquiries is the NIH OPERA DGSI Systems Policy Branch, and inquiries can be sent to operasystemspolicy@nih.gov.