Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed) | PAR 25 225

Opportunity Information: Apply for PAR 25 225

The NIH funding opportunity PAR-25-225, titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)," supports early-stage translational research aimed at strengthening the evidence that a proposed therapeutic agent is ready for more advanced development. This announcement is a reissue of PAR-21-122 and is designed for projects focused on neurological or neuromuscular disorders that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). The core idea is to fund the key preclinical studies that help move a candidate therapy from a promising concept toward a development path that is credible, data-driven, and competitive for larger translational programs.

The work supported by this program centers on three main study areas: pharmacodynamics (PD), pharmacokinetics (PK), and in vivo efficacy. In practical terms, applicants are expected to generate data showing how the therapeutic agent engages biology (PD), how it behaves in an organism over time (PK, such as absorption, distribution, metabolism, and elimination), and whether it produces meaningful beneficial effects in living models relevant to the intended neurological or neuromuscular indication (in vivo efficacy). The purpose of these studies is not simply to explore interesting biology, but to demonstrate sufficient biological activity and a clear, evidence-based rationale that the agent is worth pushing into the next stages of development.

Therapeutic modalities covered by the opportunity are broad and include small molecules, biologics, and biotechnology-derived products. That range is important because it signals that NINDS is open to multiple technology approaches, as long as the proposal is grounded in rigorous experimental design and addresses the translational questions needed to de-risk further development. While the opportunity supports translational research, it explicitly does not allow clinical trials, meaning the funded activities should remain on the preclinical side rather than involving human participants or clinical endpoints.

This NOFO sits within the broader IGNITE program suite, which is structured to help investigators advance projects to a point where they can meet entry criteria for larger, milestone-driven translational pipelines such as the Blueprint Neurotherapeutics Network or comparable programs. In other words, it is meant to function as a bridge: applicants use these funds to generate the kinds of PK/PD and in vivo efficacy datasets that reviewers and downstream development programs typically require before committing to more resource-intensive development activities.

The mechanism is an R61/R33, which generally reflects a phased structure often used to support an initial stage of work followed by a subsequent stage, with progression typically dependent on meeting predefined goals. While the detailed milestone requirements would be spelled out in the full NOFO text, the presence of the R61/R33 format signals an emphasis on clear deliverables, measurable progress, and a development-oriented plan rather than open-ended discovery research.

Eligibility is broad and includes a wide array of organization types across government, academia, nonprofit, and industry. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private 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 with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); eligible federal agencies; faith-based or community-based organizations; Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American tribal governments (other than federally recognized); non-U.S. entities (foreign organizations); regional organizations; Tribally Controlled Colleges and Universities (TCCUs); and U.S. territories or possessions. This breadth indicates a deliberate effort to support participation from diverse institutional settings, including organizations with strong community or regional ties and international entities when appropriate.

From an administrative standpoint, the opportunity is categorized as a discretionary grant under NIH, within the health activity category, and is associated with CFDA number 93.853. The posting shows a creation date of November 4, 2024, with an original closing date of October 20, 2027, giving a long runway for prospective applicants to plan submissions around NIH receipt cycles. The listing does not specify an award ceiling or expected number of awards in the provided source data, so applicants would need to consult the full NOFO for budget expectations, project period limits, and any institute-specific funding considerations.

Overall, this grant is best understood as targeted funding for preclinical translational package-building: generating credible PK/PD characterization and in vivo efficacy evidence for a neurotherapeutic candidate so that it is positioned for the next stage of development in a larger translational or product-focused program, while keeping all supported work firmly outside the clinical trial realm.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (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 2024-11-04.
• Applicants must submit their applications by 2027-10-20.
• 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 25 225

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