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

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.

Eligibility

• Private Institutions of Higher Education
• Native American Tribal Governments Federally Recognized
• Other
• Public and Indian Housing Authorities
• Nonprofits Having A 501(c)(3) Status With the Irs Other Than Institutions of Higher Education
• Special District Governments
• State Governments
• County Governments
• Nonprofits Non Higher Education Without 501c3
• Native American Tribal Organizations Other Than Federally Recognized Tribal Governments
• For Profit Organizations Other Than Small Businesses
• Small Businesses
• City Or Township Governments
• Public and State Institutions of Higher Education
• Independent School Districts

Funding categories

• Health