HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
Posted: Jun 16, 2026 12:00:00 AM EDT
Closes: 02/20/2029
Funding Information
Estimated Total Funding
$11,000,000
Expected Number of Awards
3
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.
Synopsis
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
Eligible Applicants:
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.
Funding Activity Categories
CFDA Numbers
- 93.213 - Research and Training in Complementary and Integrative Health
- 93.233 - National Center on Sleep Disorders Research
- 93.273 - Alcohol Research Programs
- 93.279 - Drug Use and Addiction Research Programs
- 93.395 - Cancer Treatment Research
- 93.837 - Cardiovascular Diseases Research
- 93.838 - Lung Diseases Research
- 93.839 - Blood Diseases and Resources Research
- 93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
- 93.846 - Arthritis, Musculoskeletal and Skin Diseases Research
- 93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders
- 93.865 - Child Health and Human Development Extramural Research
- 93.866 - Aging Research
- 93.867 - Vision Research
Contact Information
Agency: National Institutes of Health
Contact: National Institutes of Health
Email: PTDP@ninds.nih.gov
Phone: 301-402-2541
National Institute of Neurological Disorders and Stroke (NINDS)
PTDP@ninds.nih.gov
PTDP@ninds.nih.gov
Additional Information
Document Type: synopsis
Opportunity Category: Discretionary
Version: 1
Last Updated: Jun 16, 2026 11:41:53 AM EDT
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