Funder: National Institutes of Health
Due Dates: June 18, 2025 | October 20, 2025 | February 18, 2026 | June 18, 2026 | October 20, 2026 | February 18, 2027 | June 18, 2027 | October 20, 2027 (New, Renewal, Resubmission, Revision)
Funding Amounts: Up to $499,000 direct costs per year; total direct costs for the 3-year project period may not exceed $750,000.
Summary: Supports pharmacodynamic, pharmacokinetic, and in vivo efficacy studies of neurotherapeutic agents to advance them toward further development for neurological or neuromuscular disorders.
Key Information: Clinical trials are not allowed; R61/R33 phased award mechanism; clear, quantitative milestones required for transition between phases.
Description
This funding opportunity supports translational research to characterize and evaluate the in vivo efficacy of potential neurotherapeutic agents—such as small molecules, biologics, or biotechnology-derived products—for neurological or neuromuscular disorders within the mission of the National Institute of Neurological Disorders and Stroke (NINDS). The goal is to generate robust preclinical data (pharmacodynamic, pharmacokinetic, and efficacy) to justify further development of these agents, potentially enabling entry into later-stage translational programs like the NIH Blueprint Neurotherapeutics Network.
The grant uses the R61/R33 phased innovation mechanism:
- R61 phase: Focuses on preparatory activities, including agent characterization and pharmacokinetic studies.
- R33 phase: Supports pharmacodynamic and in vivo efficacy studies, contingent on successful completion of R61 milestones.
Optimization of agents (e.g., medicinal chemistry or iterative design) and clinical trials are not supported under this opportunity.
Due Dates
- Upcoming application deadlines:
- June 18, 2025
- October 20, 2025
- February 18, 2026
- June 18, 2026
- October 20, 2026
- February 18, 2027
- June 18, 2027
- October 20, 2027
- All applications are due by 5:00 PM local time of the applicant organization.
- No letter of intent is required.
Funding Amount
- Direct costs: Up to $499,000 per year.
- Total direct costs: Not to exceed $750,000 for the entire project (up to 3 years).
- Project period: Maximum of 3 years (no more than 2 years for R61 and no more than 2 years for R33; phases cannot overlap).
Eligibility
Eligible applicants include:
- Public and private institutions of higher education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Native American tribal governments and organizations (federally recognized and other)
- Public housing authorities/Indian housing authorities
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
- Non-domestic (non-U.S.) entities and components
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to apply.
Application Process
- Mechanism: R61/R33 Exploratory/Developmental Phased Award (no clinical trials).
- Submission: Applications must be submitted electronically via NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace.
- Required attachments:
- 1-page quantitative milestones document (for R61 to R33 transition)
- 1-page intellectual property (IP) strategy
- Research Plan: Must clearly delineate R61 and R33 activities; phases cannot overlap.
- Registrations: Applicant organizations must have active registrations in SAM.gov, eRA Commons, and Grants.gov.
- Review: Applications are peer-reviewed for scientific and technical merit, with emphasis on significance, innovation, rigor, feasibility, and expertise.
Additional Information
- Scope: Supports studies to characterize and test pre-defined neurotherapeutic agents, not agent optimization or clinical trials.
- Milestones: Transition from R61 to R33 is contingent on meeting pre-specified, quantitative milestones.
- Collaboration: Multidisciplinary teams (including industry, clinical, and technical experts) are encouraged.
- Non-responsive applications: Proposals focused on agent optimization, clinical trials, basic disease mechanism, or device development are not eligible.
- Small businesses: SBIR/STTR applicants are encouraged to use the appropriate SBIR/STTR funding opportunities.
External Links
Contact Information