Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
Develop medications to prevent & treat substance use disorders/overdose through UG3/UH3 award phases; support high-impact, innovative projects for FDA approval fast-track.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: April 10, 2025 | August 11, 2025 (final)
Funding Amounts: Up to $3 million/year in direct costs; max project period 5 years (2 years UG3, 3 years UH3)
Summary: Supports preclinical and clinical research to develop medications for preventing and treating substance use disorders and overdose, advancing candidates toward FDA approval.
Key Information: Applicants must propose both UG3 (milestone-driven) and UH3 phases; foreign and domestic organizations eligible; clinical trials optional.
Description
This opportunity, issued by the National Institute on Drug Abuse (NIDA) at NIH, funds research to accelerate the discovery and development of medications to prevent and treat substance use disorders (SUDs) and overdose. The program uses a two-phase UG3/UH3 cooperative agreement mechanism:
- UG3 Phase (up to 2 years): Supports milestone-driven research to demonstrate feasibility and achieve specific, quantifiable goals.
- UH3 Phase (up to 3 years): Provides continued support for projects that successfully meet UG3 milestones, advancing them further toward FDA approval.
Projects may include preclinical or clinical studies of small molecules, biologics (e.g., vaccines, monoclonal antibodies), natural products, or new formulations/combinations of existing drugs. The goal is to fast-track promising candidates through the drug development pipeline for SUDs and overdose, including opioid, stimulant, cannabis, benzodiazepine, and polysubstance use.
Applications must address both phases and include clear, quantitative milestones for the UG3 phase. Only projects that meet these milestones will be considered for transition to the UH3 phase.
