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

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The National Institutes of Health, through twelve participating institutes and the HEAL Initiative, is soliciting applications under solicitation RFA-NS-27-007 for the discovery and development of non-addictive small molecule and biologic analgesic therapeutics to treat pain. This milestone-driven, phased cooperative agreement utilizes the UG3/UH3 activity code and focuses on accelerating the optimization of early therapeutic molecules to ensure readiness for Phase II clinical studies. The program scope covers activities from early optimization through Phase I development, including lead optimization, IND-enabling studies, biomarker development, and IND submission. It specifically excludes basic research, therapeutic device development, and clinical studies beyond Phase I. The initiative encourages collaborations between investigators with expertise in pain biology, drug development, clinical testing, and statistical design, and allows for the use of NIH-funded consultants and contract research organizations. Projects are expected to enter first-in-human studies by the end of the grant period. The solicitation was posted on May 28, 2025, with an open date of August 21, 2026, and multiple application deadlines extending through February 20, 2029. This effort is part of a broader national strategy to provide scientific solutions to the opioid public health crisis.

General Info

NIH funding for developing non-addictive analgesic therapeutics from early optimization to Phase I.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
Contacts
Mohamed Hachicha PhD National Institute of Neurological Disorders and Stroke
contact@example.gov
+1 (555) 000-0000

Full Description

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Twelve NIH Institutes, including NINDS, NEI, NHLBI, NIA, NIAAA, NIAMS, NICHD, NIDCR, NIDDK, NIDA, NCCIH and NCI intend to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research focused on the discovery and development of small molecule and biologic non-addictive analgesic therapeutics to treat pain. This study is part of the NIH Helping to End Addiction Long -term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The goal of the program is to accelerate the optimization and development of promising early therapeutic molecules and to facilitate readiness for Phase II clinical studies. Through this NOFO, the NIH offers researchers funding for drug discovery and development activities that can be conducted in their own laboratories. Researchers also have the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) that specialize in critical areas associated with therapeutics development. The scope of this program spans early optimization through Phase I development activities. It is expected that all projects will be entering first in human studies at the end of the grant period either through NIH contracts or funds requested in the grant application. This is a milestone-driven, phased, cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress. The scope of this program excludes basic research, therapeutic device development and clinical studies beyond Phase I studies. Applications are not being solicited at this time. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will use the UG3/UH3 activity code. Investigators with expertise and insights into pain therapeutics development are encouraged to consider applying for this revised NOFO. In addition, applications from collaborating investigators combining expertise in pain biology, drug development, clinical testing and statistical design will be encouraged to consider applying for this funding opportunity.

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