NeuroNEXT Small Business Innovation in Clinical Trials (U44) | Apply Online

Opportunity Summary:

The NeuroNEXT Small Business Innovation in Clinical Trials (U44) opportunity (Funding Opportunity Number PAR 11-345) is an NIH SBIR funding announcement designed specifically for small business concerns that are ready to generate clinical evidence in neurological disorders. It targets projects that move beyond basic research into human studies by supporting either biomarker validation trials or exploratory clinical trials involving therapeutics and interventions such as drugs, biologics, surgical approaches, or medical devices. The central idea is to help small companies produce the kind of early clinical data that can justify and properly design a later, definitive efficacy trial, typically a Phase III study, for a neurologic disease indication.

A key feature of this FOA is the use of the cooperative agreement mechanism (U44), which generally means NIH expects to have substantial scientific and/or programmatic involvement during the project rather than serving only as a passive funder. In practice, this kind of structure is commonly used when the sponsor wants projects managed in a milestone-driven way, with clear, pre-specified benchmarks that guide decision-making as the study progresses. The announcement explicitly emphasizes milestone-driven projects, reflecting a translational focus on measurable progress, accountability, and readiness for the next stage of clinical development.

The funding instrument is categorized as discretionary and falls under the Health activity area, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost sharing or matching requirement, which lowers financial barriers for small businesses and is consistent with typical SBIR expectations. Eligibility is limited to small businesses, aligning the program with the SBIR mission of supporting innovation and commercialization potential in the U.S. small business sector, particularly where high-risk clinical development can be difficult to fund through private investment alone at early stages.

From an applicant standpoint, the projects that fit best are those positioned to answer concrete clinical development questions: whether a biomarker is valid and useful in a real clinical context, or whether an intervention shows enough signal of activity, feasibility, and safety in an exploratory clinical setting to warrant a larger, confirmatory trial. The FOA is oriented toward producing actionable results that can inform the design of a future Phase III trial, such as effect size estimates, endpoint selection, biomarker performance characteristics, feasibility metrics, and other data needed to reduce uncertainty before a major efficacy study.

Administrative details in the archived record show it was posted on September 21, 2011, with later record creation on March 12, 2014. The original closing date was August 1, 2014, and the current closing date listed was December 2, 2014, with an archive date of January 2, 2015. The sponsoring agency is the National Institutes of Health. The full announcement was made available via the NIH grants guide at http://grants.nih.gov/grants/guide/pa-files/PAR-11-345.html (spacing in the source text appears to be formatting-related), and assistance for access or linking issues was directed to the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

Overall, this FOA can be understood as a targeted NIH pathway for small businesses to run well-structured, milestone-based clinical studies in neurology that are intended to de-risk and enable the next step: a rigorously powered Phase III clinical trial aimed at confirming efficacy.

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Next opportunity: NeuroNEXT Infrastructure Resource Access (X01)

Previous opportunity: NeuroNEXT Clinical Trials (U01)

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