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.

Program Details

National Institutes of Health is a federal agency that offers the HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) grant program to support eligible programs and projects. This funding opportunity is available nationally and is administered by National Institutes of Health through Grants.gov. Organizations seeking funding for eligible programs and projects should review the details below and confirm their eligibility before preparing an application.

Eligibility

Eligible applicants include government agencies and municipalities, educational institutions, tribal governments and Native American organizations, and nonprofit organizations. Organizations that meet the eligibility criteria are encouraged to apply and to review the full program guidelines before submission. Because eligibility rules and funding priorities can change between cycles, applicants should always confirm the current requirements with National Institutes of Health or on Grants.gov before investing time in an application.

Funding and Timeline

The application deadline is February 20, 2029 (938 days remaining). Applicants should allow sufficient time to gather required documentation, including organizational information, project descriptions, budgets, and supporting materials as specified in the program guidelines. Submitting a complete application well ahead of the deadline reduces the risk of disqualification on technical or administrative grounds.

Program Focus

This grant supports eligible programs and projects. This grant is associated with NAICS industry classifications: 541714, 621111, 621112, 622. Organizations operating in these sectors are encouraged to review eligibility. Funded projects are expected to demonstrate measurable outcomes aligned with the program's stated objectives. Grant recipients may be required to submit progress reports and final evaluations as a condition of the award, and to retain records for audit and compliance purposes.

How to Apply

Eligible organizations can apply through Grants.gov. Create a free organization profile on GrantRegister to see whether this grant matches your organization's NAICS code, entity type, location, and focus area, and to receive a weekly digest of every open grant you qualify for.

GrantRegister maintains a complete, authoritative registry of US federal, state, and foundation grant opportunities — matched automatically to your organization profile and delivered every Monday.

Eligibility

• Funded by NIH

Award details

Applications close on February 20, 2029 (938 days remaining).

Categories

Not categorized