HEAL Initiative: Non-addictive Analgesic Therapeutics Development Small Molecules and Biologics to Treat Pain (UG3/UH3 Clinical Trial Optional)
Funding available for developing safe and effective non-addictive pain treatments through optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug applications.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: April 23, 2025 (Letter of Intent) | May 7, 2025 (AIDS) | May 23, 2025 (Application) | August 25, 2025 (Letter of Intent) | September 7, 2025 (AIDS) | September 24, 2025 (Application) | January 7, 2026 (AIDS) | January 23, 2026 (Application) | May 7, 2026 (AIDS) | May 22, 2026 (Application) | September 7, 2026 (AIDS) | September 24, 2026 (Application)
Funding Amounts: Estimated $11M total in FY24; up to 4 awards; UG3 phase up to 2 years, UH3 phase up to 4 years, max 5 years total; budgets must reflect project needs.
Summary: Supports preclinical optimization and development of safe, effective, non-addictive small molecule and biologic therapeutics for pain, advancing candidates to IND and Phase I clinical testing.
Key Information: Strict milestone-driven, phased cooperative agreement; nonresponsive if missing required elements (milestones, TPP, IP plan, etc.); foreign organizations not eligible to apply.
Description
This NIH funding opportunity supports the preclinical optimization and development of non-addictive small molecule and biologic therapeutics for pain. The program aims to accelerate the translation of promising early-stage pain therapeutics toward clinical readiness, including Investigational New Drug (IND) application and Phase I clinical testing. The initiative is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative, which addresses the opioid crisis by advancing safer, more effective pain management options.
The program uses a milestone-driven, phased cooperative agreement (UG3/UH3), with substantial NIH involvement in project planning and monitoring. Projects must enter at the UG3 (preparatory) phase and, upon successful achievement of milestones, may transition to the UH3 (execution) phase. The ultimate goal is to assemble an IND application and initiate first-in-human studies.
