Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed) | PAR 25 060

Opportunity Information: Apply for PAR 25 060

The National Institutes of Health (NIH) is offering a discretionary grant opportunity under the IGNITE program titled "Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)," funding opportunity number PAR-25-060 (CFDA 93.853). The focus is on building and rigorously validating research models that better mirror real neurological or neuromuscular diseases, with the practical aim of making early-stage neurotherapeutic discovery more predictive and more useful for translation toward human treatment. Clinical trials are not permitted under this announcement, reinforcing that the work is meant to strengthen preclinical and ex vivo foundations rather than test interventions in human participants.

At the center of this FOA is the development and validation of animal models and human or animal tissue-based ex vivo systems that faithfully recapitulate the phenotypic and physiological characteristics of a clearly defined neurological or neuromuscular disorder. In plain terms, NIH is looking for model systems that do not just resemble a condition in superficial ways, but capture meaningful disease biology and measurable functional features that matter for therapy development. The intent is to address a common bottleneck in neuroscience translation: many existing models do not sufficiently predict whether a therapeutic strategy will show efficacy in humans. Projects supported here should therefore aim for a substantial improvement in translational relevance, not incremental tweaks, and should include convincing validation that the model behaves in ways that are consistent with the human disorder it is meant to represent.

A major theme of the opportunity is utility for therapeutic testing. NIH highlights the ideal that proposed models should enable feasible, meaningful assessments of efficacy following therapeutic intervention, with readouts that can make sense both in preclinical settings and in ways that align with clinical outcomes. This implies an emphasis on practical endpoints, reproducibility, and measurable phenotypes that could plausibly map to patient-relevant features of disease. While the FOA is not itself for clinical studies, it is structured to set up future therapeutic development by improving the quality and predictive power of the platforms used to evaluate candidate neurotherapeutics.

This FOA sits within the broader Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program, which is designed to support exploratory and early-stage drug discovery activities. Within that context, this particular announcement targets the enabling infrastructure of discovery: the model systems that researchers rely on to decide whether a therapeutic idea is worth advancing. By improving the models, NIH aims to reduce late-stage failures and speed up the path from basic insights to viable therapeutic approaches.

Funding is provided through the NIH grant mechanism and includes an award ceiling of $750,000. The original closing date listed is October 20, 2027. The opportunity is categorized under health and uses the R61/R33 structure, which generally signals a phased approach where earlier, milestone-driven work can transition into a subsequent stage if predefined objectives are met; applicants should expect an emphasis on clear validation plans, go/no-go criteria, and evidence that the proposed system will be broadly useful for translational neuroscience.

Eligibility is broad and includes many types of U.S. organizations and institutions: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly notes additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This broad eligibility signals NIH interest in drawing model-development innovation from a wide range of research environments and communities.

Overall, PAR-25-060 is best read as a targeted investment in better disease-relevant model systems for neurology and neuromuscular research, with strong expectations for validation and a clear line of sight to future therapeutic testing. The projects most aligned with the FOA are those that can demonstrate why the existing models fall short, how the proposed system more accurately captures disease biology and function, and how its endpoints can realistically support decisions in neurotherapeutic discovery and development without crossing into clinical trial activity.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2024-10-22.
• Applicants must submit their applications by 2027-10-20.
• Each selected applicant is eligible to receive up to $750,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 060

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