NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
National Institutes of Health (NIH)
Total funding support for Phase I awards typically does not exceed $295,924 and for Phase II awards, it does not exceed $1,972,828.
Project durations can be up to 2 years for Phase I and up to 3 years for Phase II.
To provide funding for small business concerns conducting exploratory clinical trials related to neurological disorders.
Focus on advancing diagnostics and treatments for neurological diseases.
Small Business Concerns (SBCs)
Patients with neurological disorders
Healthcare providers and researchers in the field of neurology
Only United States small business concerns (SBCs) are eligible to apply.
SBCs must be organized for profit and primarily operate within the United States.
SBCs must be more than 50% owned and controlled by U.S. citizens or permanent resident aliens.
Only U.S.-based organizations are eligible; non-domestic entities are not eligible to apply.
Projects must focus on exploratory clinical trials related to neurological disorders.
Applications must demonstrate readiness for clinical trials, including FDA approval if applicable.
Funding amounts for Phase I and Phase II are capped at $295,924 and $1,972,828 respectively.
No cost-sharing is required.
Applications are due by 5:00 PM local time of the applicant organization.
Key deadlines include application due dates on January 5, April 5, and September 5 of each year until 2026.
Applicants must not have submitted identical or overlapping applications to other HHS funding opportunities.
Applicants must follow the SBIR/STTR Application Guide for required documentation.
A regulatory plan must be included to describe the regulatory pathway for the proposed study.
Applications will be evaluated based on scientific merit, innovation, approach, and potential impact.
Applications undergo peer review and are evaluated for scientific and technical merit.
Priority is given to projects that address significant unmet needs in neurological disorders.
The grant supports only exploratory clinical trials and not definitive efficacy trials.
Applicants must demonstrate the feasibility of recruitment and retention of study participants.
Encouragement to establish partnerships with third-party investors to support commercialization.
SBCs with prior experience in clinical trials may have a competitive advantage.
Strong scientific rationale and preliminary data supporting the proposed trial.
Submitting overlapping applications to multiple funding opportunities.
Engage with NINDS staff early in the application process for guidance.
Highlight unique aspects of the proposed intervention and its potential impact on patient care.