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

Background
The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. This program 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 NIH HEAL Initiative bolsters research across the NIH to improve treatment for opioid misuse and addiction and enhance pain management.

Grant Details
The scope of this program includes optimization and early development activities, IND-enabling studies, development of a pharmacodynamic/target engagement biomarker, assembly and filing of an Investigational New Drug (IND) application, and Phase I clinical testing. 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.

Eligibility Requirements
Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The program encourages diversity in team development plans and meaningful engagement of people with lived experience and other collaborators in the research process.

Period of Performance
The period of performance extends from January 24, 2024, to January 23, 2027.
The UG3 phase must not exceed 2 years.

Grant Value
The total value of the grant is not specified in the provided text.