Simpler Grants.gov #RFA-NS-27-007

NIH Solicitation for Non-addictive Analgesic Therapeutics Development (HEAL Initiative)

This opportunity is issued by the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), under the HEAL Initiative for pain therapeutics development. - Government Buyer: - National Institutes of Health (NIH) - National Institute of Neurological Disorders and Stroke (NINDS) - Products/Services Requested: - Preclinical optimization and development of non-addictive small molecule and biologic therapeutics for pain - Activities include: - Lead optimization - Early-stage development - IND-enabling studies - Biomarker development - IND application preparation - Phase I clinical testing - OEMs and Vendors: - No specific OEMs or commercial vendors are named; the focus is on research and development of novel therapeutics - Notable Requirements: - Applicants must have a promising small molecule or biologic lead candidate with a strong biological rationale - Established assays for optimization are required - Foreign organizations and components are not eligible - Funding is milestone-driven with active NIH program staff involvement - The goal is to accelerate candidates toward Phase II clinical trials

Description

This Notice of Funding Opportunity (NOFO) supports the preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics for pain treatment. The program aims to accelerate early-stage therapeutic candidates to readiness for Phase II clinical trials. Activities include lead optimization, IND-enabling studies, biomarker development, IND application preparation, and Phase I clinical testing. It is a milestone-driven, phased cooperative agreement with active NIH program staff involvement in project planning and monitoring.

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