HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

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.

Estimated Total Program Funding

$11,000,000

Expected Number of Awards

3

This opportunity from National Institutes of Health is open to eligible applicants nationwide. Organizations working in Healthcare are especially encouraged to review the requirements.

Federal grant opportunities like this one are typically open to a range of applicant types. Common eligible organizations include:

• Nonprofits and 501(c)(3) organizations
• Small businesses and startups (especially for SBIR/STTR programs)
• State, local, and tribal governments
• Colleges, universities, and research institutions
• Individuals (for select programs in education, arts, and research)

Eligibility requirements vary by opportunity. Always review the official listing before investing time in an application.