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

Description

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.

Official source

Eligible beneficiaries

• Independent school districts
• Special district governments
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• County governments
• For profit organizations other than small businesses
• City or township governments
• Private institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Public housing authorities/Indian housing authorities
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized tribal governments)
• Public and State controlled institutions of higher education
• Small businesses
• State governments