Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)

The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), has forecasted a funding opportunity titled "Development of Medications to Prevent and Treat Substance Use Disorders and Overdose." This initiative will support research that accelerates the discovery and development of therapeutics targeting substance use disorders (SUDs) and overdose prevention. The grant uses the UG3/UH3 cooperative agreement mechanism, indicating a phased approach involving initial milestones followed by further development support based on progress. This opportunity aims to fund both preclinical and clinical research that can deliver impactful results quickly, advancing candidate therapies toward regulatory approval or clinical implementation. NIDA is particularly encouraging collaborative investigations across disciplines such as pharmacology, toxicology, medicinal chemistry, neuromodulation, digital health interventions, clinical trials, and regulatory sciences. The intent is to promote meaningful partnerships and integrated strategies to develop and validate interventions for SUDs and overdose. As of now, this grant is only in the forecast stage. NIDA is providing this early notice to allow sufficient time for potential applicants to develop robust and responsive proposals. Applications are not yet being accepted, and no awards have been made under this forecast. The anticipated application due date is October 16, 2025, with awards expected to be announced by July 1, 2026. The project start date is also projected to be July 1, 2026. The funding instrument is a cooperative agreement, meaning NIH will have substantial involvement in the project. The opportunity falls under the health category of funding activity and aligns with the Drug Use and Addiction Research Programs assistance listing (93.279). There are no cost-sharing or matching requirements for applicants. Eligibility for this funding includes a broad range of entities such as public and private institutions of higher education, state and county governments, tribal governments and organizations, nonprofits with 501(c)(3) status (excluding educational institutions), for-profit organizations other than small businesses, small businesses, independent school districts, and public housing authorities. This wide eligibility spectrum reflects NIDA's aim to foster diverse and innovative collaborations. The key contact for this opportunity is Dr. Drew Townsend, reachable via email at drew.townsend@nih.gov or by phone at 301-443-4577. The official estimated posting date for this opportunity is August 15, 2025.