Supporting biologic-based drug discovery and development for nervous system disorders through preclinical research, Phase I trials, and collaboration with NIH consultants and CROs.
Funder: National Institutes of Health
Due Dates: July 15, 2025 | August 18, 2025 (AIDS) | January 15, 2026 | April 17, 2026 (AIDS) | July 15, 2026 | August 18, 2026 (AIDS) | January 15, 2027 | April 19, 2027 (AIDS) | July 15, 2027 | August 18, 2027 (AIDS)
Funding Amounts: No budget cap; up to 2 years for UG3 phase and up to 4 years for UH3 phase (max 5 years total). Budgets must reflect actual project needs.
Summary: Supports biologic-based drug discovery and development for nervous system disorders, from lead optimization through Phase I clinical trials, with NIH collaboration and access to contract research resources.
Key Information: Phased, milestone-driven cooperative agreement (UG3/UH3); limited submission; clinical trial optional; strong preclinical data required for entry.
This opportunity provides funding, resources, and expert support to accelerate the development of biologic-based therapeutics for nervous and neuromuscular system disorders. The program supports projects from lead optimization through first-in-human (Phase I) clinical trials, focusing on diverse biotherapeutic modalities such as antibodies, peptides, proteins, oligonucleotides, gene therapies, cell therapies, and other emerging approaches (e.g., microbiome-based therapies).
Awardees benefit from a collaborative, milestone-driven structure, including regular interaction with NIH program staff, access to NIH-funded consultants with industry and regulatory expertise, and optional use of NIH-supported contract research organizations (CROs) for manufacturing, nonclinical, and clinical activities. Intellectual property developed within the program is assigned to the recipient institution.