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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Twelve NIH Institutes, including prominent entities such as NINDS, NEI, and NCI, plan to issue a Notice of Funding Opportunity aimed at advancing research on small molecule and biologic non-addictive analgesic therapeutics for pain treatment. This initiative is part of the broader NIH Helping to End Addiction Long-term (HEAL) Initiative, designed to expedite the development of novel therapeutic solutions in response to the opioid crisis. The program focuses on accelerating early-stage therapeutic molecule optimization through Phase I clinical development, with an emphasis on projects that will transition into first-in-human studies by the grant's conclusion. Researchers funded through this program will conduct investigations in their own laboratories, with access to NIH-supported consultants and contract research organizations to support critical aspects of drug development. This cooperative agreement uses a phased, milestone-driven framework involving NIH program staff closely collaborating on project plans and monitoring progress. The scope is intentionally limited to drug discovery and development activities, excluding basic research, therapeutic devices, and clinical trials beyond Phase I. Although applications are not currently being solicited, this advance notice provides investigators an opportunity to form strategic collaborations. The funding opportunity will follow the UG3/UH3 activity code and encourages proposals from investigators with expertise spanning pain biology, drug development, clinical testing, and statistical design to foster multidisciplinary approaches to developing non-addictive pain therapeutics.
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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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