NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required) | PAR 24 044

Opportunity Information: Apply for PAR 24 044

The NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required), funding opportunity number PAR-24-044, is an NIH grant program designed specifically to help small businesses move promising neurological technologies into early-stage, investigator-initiated clinical testing. It is a reissue of PAR-18-617 and is run by the National Institute of Neurological Disorders and Stroke (NINDS), which means applications need to clearly align with NINDS mission priorities and the burden of neurological disorders. The central aim is to give Small Business Concerns a clear, dedicated route to support exploratory clinical trials that generate real human data and de-risk a product enough to justify larger pivotal trials or follow-on investment.

The program is structured under the Small Business Technology Transfer (STTR) mechanism, using the R41/R42 activity codes, and it is explicitly a clinical trial required announcement. In practical terms, that means the proposed work must include a clinical trial as NIH defines it, and the application should be written with the full set of clinical-trial expectations in mind, including protocol-level planning, operational readiness, and credible human-subjects protections. The research is intended to be exploratory in nature, typically focusing on early clinical evaluation rather than confirmatory, registration-oriented trials, although applicants still need to show rigorous design and clear decision points.

NINDS is open to a wide range of product types as long as the product fits neurological indications and advances NINDS goals. The FOA allows evaluation of drugs and biologics, medical devices, and diagnostics, and it also includes non-pharmacologic interventions such as surgical approaches, behavioral therapies, and rehabilitation strategies. The unifying theme is that there is a defined product or intervention to be tested in humans, with a plan to collect meaningful clinical data that informs safety, feasibility, dosing or use parameters, potential signals of activity, and next development steps.

Only STTR Phase II and Fast-Track applications are supported under this opportunity. A standalone Phase I STTR application is not accepted here; Phase I is only permitted if it is part of a Fast-Track submission that proposes both Phase I and Phase II in a single, linked application. This structure signals that NINDS is targeting projects that are already relatively mature, or that can credibly progress from early feasibility to more advanced exploratory testing through the Fast-Track pathway. Applicants should be prepared to show a solid technical foundation, a realistic clinical operations plan, and a well-justified path to the next stage of development beyond the funded work.

Eligibility is restricted to small businesses, consistent with STTR rules, and the FOA is clear about limits on foreign participation. Non-domestic (non-U.S.) entities (foreign institutions) cannot apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, may be allowed in some circumstances, which typically means narrowly justified portions of work done outside the U.S. that are essential to the project and are appropriately documented. Even with that allowance, the applicant organization itself must be eligible as a U.S. small business, and the overall project should be planned primarily within eligible domestic settings.

Administratively, this is a discretionary grant program under the NIH, categorized under Health, with CFDA number 93.853. The sponsoring agency is the National Institutes of Health, specifically NINDS. The listing indicates an original closing date of 2026-09-05, so the program is positioned as an ongoing opportunity over multiple receipt cycles up to that date, subject to NIH submission schedules and any updates in the full FOA. The notice does not provide an award ceiling or expected number of awards in the provided excerpt, which usually means applicants should consult the full FOA text and NINDS budget guidance to understand typical funding ranges, project periods, and any institute-specific expectations around trial size and scope.

Overall, PAR-24-044 is best understood as a translation-focused clinical trial funding pathway for small businesses that have a neurological therapeutic, device, diagnostic, or intervention ready for an exploratory human study. The FOA emphasizes real-world clinical evaluation, a strong fit to NINDS priorities, and a development-minded plan that uses clinical trial outcomes to make clear go/no-go decisions and position the product for the next milestone in commercialization or later-stage clinical development.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2023-11-27.
• Applicants must submit their applications by 2026-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 24 044

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: