Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)
Can you apply?
This grant is for academic researchers, research institutions, and NIH-eligible organizations seeking to fund early-stage translational research on neurotherapeutic agents. Applicants must propose research that characterizes novel neurotherapeutic compounds and evaluates their in vivo efficacy in animal models or non-clinical systems. The program is open to public and private institutions, including universities, hospitals, research organizations, and small businesses that can conduct rigorous preclinical research. Geographic scope is nationwide. Clinical trials are not supported under this mechanism. The IGNITE program prioritizes innovative approaches that bridge basic science discoveries and clinical development, with emphasis on rigorous methodology and reproducibility of findings.
This grant is for academic researchers, research institutions, and NIH-eligible organizations seeking to fund early-stage translational research on neurotherapeutic agents. Applicants must propose research that characterizes novel neurotherapeutic compounds and evaluates their in vivo efficacy in animal models or non-clinical systems. The program is open to public and private institutions, including universities, hospitals, research organizations, and small businesses that can conduct rigorous preclinical research. Geographic scope is nationwide. Clinical trials are not supported under this mechanism. The IGNITE program prioritizes innovative approaches that bridge basic science discoveries and clinical development, with emphasis on rigorous methodology and reproducibility of findings.
Program description
Reissue PAR-21-122. This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for academic researchers, research institutions, and NIH-eligible organizations seeking to fund early-stage translational research on neurotherapeutic agents. Applicants must propose research that characterizes novel neurotherapeutic compounds and evaluates their in vivo efficacy in animal models or non-clinical systems. The program is open to public and private institutions, including universities, hospitals, research organizations, and small businesses that can conduct rigorous preclinical research. Geographic scope is nationwide. Clinical trials are not supported under this mechanism. The IGNITE program prioritizes innovative approaches that bridge basic science discoveries and clinical development, with emphasis on rigorous methodology and reproducibility of findings.
How to apply
Application links
Required documents
- NIH Form SF-424 (Application for Federal Assistance)
- Research/Project Narrative (typically 6-12 pages for R61 phase)
- Specific Aims (1 page)
- Research Strategy section including Background, Significance, Innovation, and Approach
- Budget and Budget Justification
- Curriculum Vitae of key personnel (typically 5 pages each)
- Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval or justification for animal studies
- Letters of Support from collaborators (if applicable)
- Resource Sharing Plan (data management and sharing)
- Facilities and Administrative Cost proposal
- Biographical sketches of all key personnel
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$82,511,281
-
$67,362,785
-
$62,646,087
-
$56,144,651
-
$45,268,737
-
$40,959,789
-
$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
Top States by Funding
- MA 6 awards $186.5M
- CA 4 awards $129.9M
- OH 4 awards $112.5M
- FL 3 awards $100.3M
- MN 2 awards $99.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who is eligible to apply for IGNITE neurotherapeutic research funding?
Eligible applicants include academic institutions, research organizations, hospitals, and small businesses with NIH-eligible status. Individual researchers must be affiliated with an eligible institution. Both for-profit and non-profit entities can apply.
Can I conduct clinical trials under this grant mechanism?
No. This R61/R33 mechanism specifically excludes clinical trials. Research must focus on preclinical characterization and in vivo efficacy studies in animal models or non-clinical systems only.
What types of neurotherapeutic agents can I propose to study?
Research should focus on novel neurotherapeutic compounds with potential therapeutic value for neurological or neuropsychiatric conditions. Examples may include small molecules, biologics, or other agent types at early translational stages, but must exclude human clinical trials.
What is the typical funding range and project duration?
R61/R33 awards typically provide funding for 2-4 year projects with a total project period of up to 4 years. Funding amounts vary by institution type and research scope; contact the NIH program officer for specific budget guidance.
How competitive is this funding mechanism?
This is a moderately competitive program targeting high-quality translational research. Success typically requires a clear innovation story, rigorous methodology, preliminary data demonstrating feasibility, and a pathway to clinical development. Review emphasis is on scientific merit and innovation in neurotherapeutic characterization.
💡 Tips for applicants
- Develop a compelling innovation narrative: Clearly articulate how your neurotherapeutic agent represents a novel approach and addresses an unmet clinical need. Reviewers want to see why this compound is worth advancing toward clinical development.
- Present robust preliminary data: Include strong preliminary data demonstrating the rationale for your proposed studies, agent characterization, and evidence of in vivo efficacy in your chosen model system. This significantly strengthens competitiveness.
- Design rigorous and reproducible protocols: Emphasize reproducibility, proper statistical design, controls, and methodology. NIH emphasizes rigor; include power calculations, randomization, and blinding where applicable.
- Clarify the translational pathway: Explain the logical progression from your proposed preclinical studies toward future clinical development. Reviewers want confidence that successful outcomes will lead to viable clinical applications.
- Engage with the NIH program officer early: Contact the relevant NINDS or NIMH program officer before submission to ensure your research aligns with program priorities and to clarify any questions about scope or eligibility.
⚠️ Common mistakes
Many applications fail due to insufficient preliminary data or unconvincing rationale for the proposed neurotherapeutic agent. Reviewers want evidence that the compound has genuine potential; vague or overly ambitious claims without supporting data are common rejection reasons. Additionally, applications that blur the line between preclinical research and clinical development, or that propose clinical trial components, are automatically ineligible; ensure your application clearly focuses on in vivo efficacy studies in non-human systems. Finally, inadequate detail on methodology, statistical design, or reproducibility protocols is a frequent weakness.
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