The National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. Department of Health and Human Services and administered through the National Institutes of Health (NIH), issued funding opportunity PAR-24-221 to support Small Business Innovation Research (SBIR) Phase IIB renewal awards for clinical trials and clinical research. This program was designed for small business concerns (SBCs) that previously received NIH SBIR or STTR Phase II awards and aimed to facilitate the advancement of therapeutic, diagnostic, or device-based innovations toward commercialization.
The opportunity was created to help address the funding gap many early-stage companies face, particularly when transitioning from development to commercialization. This “Valley of Death” stage is often too capital-intensive for traditional SBIR/STTR support alone. To mitigate this, the program promoted partnerships with third-party investors or strategic partners. Applications were required to include a commercialization plan and secure third-party funding equal to or exceeding the NINDS contribution—or at least one-third for projects focused on rare diseases or pediatric populations.
Funding was intended for a range of activities including exploratory Phase I and II clinical trials, feasibility studies for medical devices, and studies providing safety, dose-ranging, or pharmacokinetic data. Trials proposing to assess efficacy or involving more than three clinical sites were not eligible under this announcement. Applicants were required to submit a regulatory plan and include Community Engagement and Research Inclusion (CERI) strategies where applicable.
Although this opportunity was originally scheduled to accept applications through April 5, 2027, the current and final application deadline was November 17, 2025, and the program was officially archived on November 18, 2025. As of the most recent update, the funding announcement has been removed from active circulation, and applications are no longer being accepted. The NIH has also pulled specific funding figures from the announcement, indicating potential closure or redirection of this initiative.
Applicants are no longer able to apply through the NIH ASSIST or Grants.gov platforms for this opportunity. Interested parties should consult NIH staff or monitor the NIH Guide for Grants and Contracts for any future opportunities or similar reissuances. For reference or historical inquiry, Emily Caporello, Ph.D., is reachable at emily.caporello@nih.gov or 301-496-1778.
Secure third-party funding early; ensure rigor; match project scope to prior Phase II; consult NIH for network fit
