NINDS Competing Renewal Awards of STTR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (STTR R42) | Apply Online

Opportunity Summary:

The grant opportunity titled "NINDS Competing Renewal Awards of STTR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (STTR R42)" (Funding Opportunity Number PAR-12-074) is a National Institutes of Health (NIH) funding program run under the National Institute of Neurological Disorders and Stroke (NINDS). It is designed specifically for small business concerns that have already completed an NIH STTR Phase II award and now need additional support to take the next step toward commercialization by running an exploratory clinical trial. In practical terms, this is a Phase IIB competing renewal mechanism that helps a previous Phase II STTR project continue, but with a strong emphasis on generating clinical evidence that can move a technology closer to market readiness.

The core purpose of the FOA is to fund exploratory clinical trials for technologies that align with NINDS mission areas in neurology and neurological disorders. The program is intentionally broad in the types of interventions and products it can support, as long as they are relevant to neurological health and disease. Applicants may propose clinical evaluation of drugs and small molecules, biologics, medical devices, diagnostics, and also non-product interventions such as surgical approaches, behavioral therapies, or rehabilitation strategies. The common thread is that the work must involve a clinical trial component meant to test the intervention in humans in an exploratory manner, building the kind of early clinical data that is often required to attract partners, plan pivotal studies, and advance regulatory and commercial pathways.

A major rationale behind the funding is that clinical trials are expensive and can be difficult for small businesses to finance during the transition from research and development to commercialization. NINDS explicitly positions this award as a bridge across that funding gap. The FOA aims to help STTR-funded innovations reach a point where they are attractive for follow-on investment and partnership, and it encourages applicants to form or strengthen relationships with third-party investors and/or strategic partners. In other words, this opportunity is not only about paying for trial operations, but also about accelerating real-world translation by pushing awardees toward commercial planning, external validation, and market-facing development strategies.

From an administrative standpoint, this opportunity is a discretionary grant program (Funding Instrument Type: Grant) in the health research category, tied to CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It does not require cost sharing or matching. Eligibility is limited to small businesses, reflecting its STTR focus and the expectation that a small business applicant is working in partnership with a research institution consistent with STTR principles. The FOA was posted on January 11, 2012, with an original and final closing date of September 7, 2013, and it was archived on October 8, 2013, meaning it was a time-limited announcement rather than an open-ended standing program.

For applicants or reviewers, the main takeaway is that PAR-12-074 supported prior STTR Phase II projects that were ready to move into human testing but still needed targeted funding to demonstrate feasibility, preliminary efficacy, safety, usability, or other early clinical performance signals depending on the product type. It reflects NINDS interest in translational outcomes, especially projects that can credibly progress toward commercialization, regulatory milestones, and eventual patient impact in neurological disorders. The full announcement was hosted on the NIH Grants Guide website, and NIH provided standard support contacts through the NIH Office of Extramural Research (OER) for access or linking issues.

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