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

Open Posted

Opportunity number
RFA-NS-27-007
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Category
  • Health
Eligible applicants
  • Higher Education Inst. (Private)
  • Tribal Governments (Federally Recognized)
  • Other
  • Public or Indian Housing Auth.
  • 501(c)(3) Nonprofits
  • Special District Governments
  • State Governments
  • County Governments
  • Non-501(c)(3) Nonprofits
  • Tribal Organizations (Not Federally Recognized)
  • For Profit Organizations
  • Small Businesses
  • City/Township Governments
  • Higher Education Inst. (Public)
  • Independent School Districts
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

Twelve NIH Institutes, including NINDS, NEI, NHLBI, NIA, NIAAA, NIAMS, NICHD, NIDCR, NIDDK, NIDA, NCCIH and NCI, are soliciting applications for research focused on discovery and development of small molecule and biologic non-addictive analgesic therapeutics to treat pain, with applications due February 20, 2029. This is a milestone-driven, phased cooperative agreement program (UG3/UH3 activity code) supporting the NIH Helping to End Addiction Long-term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis.

Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, state and local governments, tribal governments and organizations, and other specified entity types. Foreign organizations and non-domestic components of U.S. organizations are not eligible.

The program provides $11 million in estimated funding for 3 awards in FY 2027. The two-phase structure comprises a UG3 preparatory phase (1–2 years) and a UH3 execution phase (up to 4 years), with total project period not exceeding 5 years. Applicants must propose activities spanning lead optimization through Phase I clinical testing, including IND-enabling studies, biomarker development, IND application assembly, and Phase I clinical trial initiation. The program excludes basic research, animal model development, diagnostics, therapeutic devices, and Phase II/III clinical studies.

Applicants must demonstrate a promising small molecule or biologic lead candidate, strong biological rationale, and established assays for optimization. The PD/PI must commit at least 20 percent effort. Recipients must establish a Lead Development Team co-chaired by the PD/PI and an NIH subject-matter expert and meet annual go/no-go milestones with quantitative success criteria. The NIH provides substantial programmatic involvement and no-cost contract resources for medicinal chemistry, pharmacokinetics, toxicology, manufacturing, formulation, and clinical studies. Applications must include a Target Product Profile table, intellectual property strategy document (2 pages), activities for both UG3 and UH3 phases, annual milestones, and a Data Management and Sharing Plan compliant with HEAL Initiative requirements. Recipients must participate in mandatory HEAL Investigators Meetings and comply with HEAL data sharing and intellectual property development expectations.

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

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.

Files

File Type Posted
PKG00293332.pdf PDF
RFA-NS-27-007-Full-Announcement.html HTML file

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