The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement applications for research that advances promising compounds thorough the drug development pipeline for the treatment of Alcohol Use Disorder (AUD).
NIAAA is seeking applications for medications development
research projects from both for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, small businesses not eligible for the SBIR/STTR program and single entities able to demonstrate significant resource commitment to the proposed project.
A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material.
The aim of this FOA is to move candidate compounds through Investigational New Drug (IND) requirements, Phase 1 human safety, tolerability, and dosing studies, and Phase 2 human laboratory and proof-of-concept trials.
Within these phases of drug development, each proposed project should have a defined entry and exit point.
Finally, this FOA will not support animal studies to prove efficacy of the candidate compound unless required by the Food and Drug Administration or peer review.
Applicants are strongly encouraged to contact the NIAAA Division of Medications Development Staff prior to submitting to this FOA.