Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed) | PAR 18 761

Opportunity Information: Apply for PAR 18 761

The Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33, Clinical Trial Not Allowed) funding opportunity, listed as PAR-18-761, is a National Institutes of Health (NIH) grant program aimed at helping researchers generate the key preclinical evidence needed to move potential neurotherapeutics closer to full translational development. It focuses on neurological disorders that fall under the mission of the National Institute of Neurological Disorders and Stroke (NINDS), and it is designed specifically for projects that are beyond basic discovery but not yet ready for larger, more advanced development pipelines. The central purpose is to support rigorous pharmacokinetic (PK), pharmacodynamic (PD), and in vivo efficacy studies that can show a proposed therapeutic agent has meaningful biological activity and enough promise to justify continued investment.

This opportunity supports therapeutic agents across multiple modalities, including small molecules, biologics, and biotechnology-derived products, among others. In practical terms, applicants are expected to use the award to characterize how a candidate agent behaves in the body (PK), how it engages its target and produces measurable biological effects (PD), and whether it produces beneficial outcomes in relevant animal or other in vivo models of neurological disease. The goal is to produce decision-quality data that helps determine whether the agent is worth advancing toward the next stage of development, rather than simply exploring early hypotheses. Importantly, the notice specifies that clinical trials are not allowed under this mechanism, signaling that the work should remain in the preclinical translational space.

The program uses the R61/R33 phased award structure. While the detailed milestone language is not included in the excerpt you provided, the intent of an R61/R33 mechanism is generally to support an initial, time-limited exploratory or milestone-driven phase (R61) that transitions to a second phase (R33) if predefined objectives are met. For applicants, that typically means the proposed research plan should be framed around clear, measurable go/no-go criteria such as achieving adequate exposure levels, demonstrating target engagement, showing dose-response relationships, establishing an acceptable PK profile for the intended use, and producing reproducible efficacy signals in appropriate in vivo models. The emphasis is on generating the kind of package that would convince experienced translational reviewers that the candidate is truly ready to be handed off to larger programs.

IGNITE, as a suite, is meant to act as an on-ramp to more resource-intensive NINDS translational efforts. This particular FOA is positioned to push projects to the point where they can meet entry criteria for programs such as the NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics (CREATE Bio) for biologics and biotechnology products, the Blueprint Neurotherapeutics Network for small molecules, or other translational development programs. In other words, the award is intended to help applicants bridge a common gap in therapeutic development: having a promising agent but lacking the rigorous in vivo efficacy and PK/PD evidence needed to attract the next level of structured development support.

From an administrative standpoint, this is a discretionary grant in the health funding category, associated with CFDA number 93.853, and administered by NIH. The source data lists an award ceiling of $499,000. The original closing date shown is 2021-03-12, and the opportunity record indicates a creation date of 2018-04-19. Because many NIH funding opportunity announcements operate on cycles and may be reissued, anyone interested would normally confirm the current status and active due dates on NIH/Grants.gov or NINDS program pages rather than relying only on the original closing date in the excerpt.

Eligibility is broad and includes many types of U.S. organizations and several categories of non-U.S. entities. Eligible applicants listed include state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education as well as private institutions of higher education; Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; 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 FOA also explicitly highlights additional eligible applicant types 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, non-domestic (non-U.S.) entities (foreign organizations), Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions. This wide eligibility reflects an intent to encourage diverse institutional participation in translational neuroscience research.

Overall, the opportunity is best understood as targeted preclinical translational support for neurotherapeutic candidates: it pays for the practical, evidence-building studies (PK, PD, and in vivo efficacy) that help determine whether a therapeutic agent is ready to move into more formalized development programs. It is not meant for clinical testing, and it is not simply a basic science discovery mechanism; it is aimed at creating a credible, data-driven foundation for the next step in neurotherapeutic translation under NINDS-aligned pipelines.

• 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 2018-04-19.
• Applicants must submit their applications by 2021-03-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $499,000.00 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.

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