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

National Institutes of Health

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-st

Funding
Estimated total program funding: $11,000,000
Deadline
February 21, 2029
Status
OPEN
Category
Health & Medical
Opens
June 16, 2026
Directory link check
October 27, 2026

About this opportunity

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 recorded

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.

Applicant types

Focus areas

Health

Recorded notice evidence

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

Applicant evidence

  • Applicant type: State governments
  • Applicant type: County governments
  • Applicant type: City or township governments
  • Applicant type: Special district governments
  • Applicant type: Independent school districts
  • Applicant type: Public and state-controlled institutions of higher education
  • Applicant type: Federally recognized tribal governments
  • Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

  • Recorded funding: Estimated total program funding: $11,000,000
  • Recorded deadline: February 21, 2029; confirm the closing time.
  • Recorded focus: Health
Connect every eligibility claim, registration, attachment and deadline to the current notice. Open the specific official notice →

Application checklist

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

Use this record for discovery, then connect every requirement and date to the current official notice and its amendments.

Recorded applicant fit

State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and state-controlled institutions of higher education

Recorded geography

No structured geographic scope is recorded.

Recorded deadline

February 21, 2029 — confirm the closing time.

Eligibility summary: 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.

Recorded focus: Health

1Confirm fitMatch entity type, location, project scope, exclusions and cost share.
2Read the noticeCollect amendments, budget rules, attachments and portal instructions.
3Plan timingRecord the funder’s time zone, registrations and internal review dates.
4Submit officiallyUse the funder’s route and save the submission confirmation.

Official sources

Directory link check: October 27, 2026. Always recheck the live notice before relying on it.

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