Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

The Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) is a funding initiative from the National Institutes of Health (NIH), specifically reissued under PAR-24-063. This program is designed to accelerate the development of small molecule drug candidates for disorders affecting the nervous system. It is administered in partnership with several NIH institutes and centers, including the National Institute of Neurological Disorders and Stroke (NINDS), National Eye Institute (NEI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), and the National Center for Complementary and Integrative Health (NCCIH). Co-funding may be provided by the Office of Behavioral and Social Sciences Research (OBSSR). The opportunity is open to U.S.-based small business concerns and offers a cooperative agreement mechanism (U44), which includes both Phase I and Phase II support. The goal of the BPN program is to enable academic researchers and small businesses to progress small molecule therapeutics from the exploratory stages through to early clinical testing. Projects may begin at either the Discovery or Development stage, depending on their level of advancement. Discovery phase objectives include the optimization of hit compounds through medicinal chemistry to establish structure-activity and structure-property relationships (SAR/SPR), while Development stage goals focus on advancing a single candidate compound through IND-enabling toxicology studies and potentially into Phase I clinical testing. Applicants retain intellectual property rights and gain rights from NIH contractors, enhancing commercial viability. Applicants receive funding for disease- or target-specific activities conducted in their own labs and may also utilize NIH-supported contract research organizations (CROs) for services such as medicinal chemistry, toxicology, pharmacokinetics, formulation, and GMP manufacturing. Projects are supported through a customized Lead Development Team (LDT) composed of the PI, NIH consultants, and CROs. The NIH sets go/no-go milestones that must be met to proceed from Phase I to Phase II and beyond. Funding is awarded based on these milestones, scientific merit, strategic alignment with NIH priorities, and budget availability. Application deadlines are recurring, with semi-annual due dates of January 15 and July 15 through 2026. A letter of intent is encouraged 30 days prior to each deadline. The grant opportunity opened on January 9, 2024, and is scheduled to expire on August 19, 2026. Applications are submitted through NIH ASSIST, Grants.gov Workspace, or institutional system-to-system platforms. Applicants must follow all NIH and SBIR-specific application instructions and use the correct submission methods to avoid delays or rejection. Eligible applicants include U.S.-based small business concerns that meet specific ownership and operational criteria defined by the Small Business Administration (SBA). NIH requires registration with several systems including SAM, eRA Commons, Grants.gov, and the SBA Company Registry. Phase I budgets typically should not exceed $500,000 total cost per year, and Phase II budgets should not exceed $1.5 million total cost per year. The total project period for both phases combined may not exceed five years. Matching funds are not required. Potential applicants are encouraged to discuss their proposals with NIH scientific and research staff before submission. Inquiries can be directed to Charles Cywin, Ph.D., via email at charles.cywin@nih.gov or phone at 301-496-1779. This funding opportunity is part of a broader effort by NIH to promote the translation of neuroscience research into viable therapeutic solutions and commercial products. It is important for applicants to carefully align their proposals with the missions and priorities of the participating NIH institutes and adhere to the program’s rigorous expectations for quality, reproducibility, and compliance.

Contact NIH staff early; follow milestone templates and rigor standards.