HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
About
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.
The HEAL Initiative: Non-addictive Analgesic Therapeutics Development grant supports researchers and organizations developing innovative small molecule and biologic therapeutics to treat pain without addiction risks. This program is designed for entrepreneurs, biotech companies, and research institutions with promising early-stage therapeutic candidates ready for optimization and clinical advancement. The initiative funds preclinical optimization, lead development, IND-enabling studies, biomarker development, and Phase I clinical testing. Applicants must demonstrate a strong biological rationale, established optimization assays, and a viable lead candidate. This is ideal for organizations seeking to accelerate non-addictive pain treatment solutions through a structured, milestone-driven cooperative agreement with active NIH oversight. The program addresses a critical public health need by advancing safer alternatives to opioid-based pain management, making it particularly valuable for biotech entrepreneurs focused on therapeutic innovation and clinical development.
Funding Facts
● Applications openDeadline
February 20, 2029
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by funding cycle
Deadline
2029-02-20
Grant Type
federal
Application Cycle
Annual (Next deadline: February 20, 2029)
Best For
Biotech companies, research institutions, and entrepreneurs developing non-addictive pain therapeutics
Eligibility
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.
Frequently Asked Questions
Who is eligible for HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)?
U.S.-based organizations are eligible to apply. Non-domestic (non-U.S.) entities and foreign components are not eligible. Applicants must have a promising small molecule or biologic lead candidate for optimization, strong biological rationale, and established assays to guide development. For complete eligibility requirements, refer to Section III of the Notice of Funding Opportunity (NOFO) on the official NIH website.
How much funding does HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) provide?
Specific funding amounts vary and are not listed in the current summary. Visit the official NIH HEAL Initiative website or the full NOFO document for detailed funding ranges, which may vary by funding cycle and project scope.
How do I apply for HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)?
Applications are submitted through the NIH grants system. The next deadline is February 20, 2029. Applicants should review the complete NOFO on the official NIH website for submission requirements, application components, and specific instructions. Contact the NIH program officer listed in the NOFO for guidance on your specific project.
What can HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) funding be used for?
Funding supports lead optimization, early-stage development activities, IND-enabling studies, pharmacodynamic and/or target engagement biomarker development, IND application preparation and submission, and Phase I clinical testing. This is a milestone-driven program with phased cooperative agreements and active NIH program staff participation.
Last updated: July 5, 2026