The HEAL Initiative's funding opportunity, titled "Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain" (RFA-NS-24-019), is aimed at advancing the development of new, safe, and non-addictive pain treatments. The initiative, reissuing RFA-NS-20-010, seeks to accelerate the preclinical optimization and early development of small molecule and biologic therapies with the potential to address pain management effectively without reliance on addictive substances. The funding will support research that progresses promising compounds through the stages of preclinical optimization, IND-enabling studies, and preparation for Investigational New Drug (IND) applications. The program is structured as a phased, milestone-driven cooperative agreement (UG3/UH3), where NIH program staff actively participate in shaping the project plan and monitoring progress.

Eligible applicants include a wide range of entities such as private and public higher education institutions, non-profit organizations, small businesses, state and local governments, tribal organizations, and specific minority-serving institutions. This diverse eligibility criteria aim to encourage participation from various sectors and leverage a broad spectrum of research expertise. Notably, foreign entities cannot apply, though foreign components within U.S.-based organizations are permitted under the NIH policy guidelines.

The program does not specify a minimum or maximum award amount, allowing flexibility in project scope and funding requests. Importantly, no cost-sharing or matching funds are required from applicants, making it more accessible for entities that may not have substantial financial resources to contribute. While the announcement does not state a specific number of awards or total program funding, the phased cooperative agreement structure underscores a commitment to guiding projects through early development stages towards clinical readiness.

The primary objective is to foster the discovery and development of non-addictive analgesics that have a strong biological rationale and a clear path for clinical application. This includes identifying promising therapeutic candidates, optimizing their efficacy and safety profiles, and conducting studies necessary to meet regulatory requirements for IND filing. The program encourages innovative approaches in pain treatment that could ultimately provide safer alternatives to traditional opioids, addressing a critical public health need.

Applications are due by January 7, 2027, providing ample time for interested parties to prepare and submit comprehensive proposals. The program’s phased approach allows for an initial UG3 phase focused on preclinical development, followed by a UH3 phase contingent on meeting predetermined milestones, which will focus on advancing the project towards clinical trials.