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.
Response Date	Feb 20, 2029 12:00:00 AM EST
Posting Date	Jun 16, 2026 12:00:00 AM EDT
Archive Date	Apr 21, 2029 12:00:00 AM EDT
Award Ceiling	N/a
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info on 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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	N/a
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

• 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