Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (U44 - Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for disorders that fall under the mission of NIAAA. An identified candidate, 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, is required prior to application. The FOA supports Investigational New Drug (IND)-enabling studies for the therapeutic candidate. At the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA). The program supports early-phase clinical trials, although these are not required.