HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
National Institutes of Health · Research and Training in Complementary and Integrative Health (93.213)
Posted 16 Jun 2026 · About 29 months left
Summary
The purpose of this Notice of Funding Opportunity (NOFO) is to support the preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics for the treatment of pain. The goal of the program is to accelerate the advancement of promising early-stage therapeutic candidates and facilitate their readiness for Phase II clinical trials. Applicants must have a promising small molecule or biologic lead candidate for optimization, a strong biological rationale for the proposed approach, and established assays to guide the optimization process. The scope of the program includes lead optimization, early-stage development activities, IND-enabling studies, development of pharmacodynamic and/or target engagement biomarkers, preparation and submission of an Investigational New Drug (IND) application, and Phase I clinical testing. This is a milestone-driven, phased cooperative agreement program that involves active participation by NIH program staff in project planning and ongoing monitoring of research progress.
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Eligibility and conditions
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Applicant types: Public and State controlled institutions of higher education; Native American tribal governments (Federally recognized); For profit organizations other than small businesses; City or township governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Independent school districts; Special district governments; Public housing authorities/Indian housing authorities; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Others (see text field entitled "Additional Information on Eligibility" for clarification); County governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; State governments
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.