Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed) | PAR 25 059

Opportunity Information: Apply for PAR 25 059

The Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed) opportunity, Funding Opportunity Number PAR 25 059, is a National Institutes of Health (NIH) discretionary grant program in the health area (CFDA 93.853). Its main purpose is to help research teams build and validate practical laboratory assays and then use those assays in iterative screening campaigns to find and characterize candidate therapeutic agents aimed at neurological or neuromuscular disorders. The emphasis is on early translational work that bridges basic discovery and more advanced preclinical development, with the specific intent of moving projects far enough along that they can meet entry expectations for larger, later-stage translational efforts such as the Blueprint Neurotherapeutics Network (BPN) or similar programs.

At its core, the FOA supports projects that create or refine in vitro and/or ex vivo assay systems and then apply those systems in repeated cycles of screening and follow-up testing. In practice, that usually means developing an assay that is robust, reproducible, and relevant to disease biology, then using it to evaluate panels or libraries of compounds, biologics, or other agents, and progressively narrowing down to the most promising candidates. The word "iterative" matters because the program is oriented around learning-and-improving cycles: initial hits are identified, characterized, and then re-tested or optimized using improved assay conditions or secondary assays to build confidence that a candidate is real, meaningful, and worth advancing. The end goal is not a clinical study, but rather a credible, assay-driven package of evidence that a therapeutic direction is viable and ready for the next translational step.

The activity uses an R61/R33 structure and explicitly does not allow clinical trials. That pairing typically reflects a phased approach where an early stage supports establishing feasibility and generating key proof data, and a later stage supports expanded development once predefined milestones are met. In this context, the structure signals that applicants should be thinking in terms of concrete, measurable progress points: for example, assay performance characteristics, hit identification criteria, confirmation in orthogonal assays, and preliminary characterization steps that collectively de-risk the program and position it for entry into more advanced translational pipelines.

Eligibility is broad and includes many types of domestic applicants such as state, county, and local 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 governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories that expand reach and participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, Indian/Native American tribal governments other than federally recognized, and non-domestic (non-U.S.) entities (foreign organizations). This range of eligible organizations is consistent with translational assay and screening work, which can be done in academic, nonprofit, government, or industry settings, and often benefits from collaborations across sectors.

From a funding perspective, the listed award ceiling is $750,000. The opportunity was created on 2024-10-22, and the original closing date is 2027-10-20, indicating a multi-year window for submission opportunities under this announcement. The announcement does not specify an expected number of awards in the provided text, but the central theme is clear: NIH is seeking projects that will generate well-founded, assay-supported candidate therapeutics for neurological and neuromuscular diseases, with deliverables strong enough to justify entry into larger translational development programs, while keeping the scope firmly in the preclinical, non-clinical-trial domain.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (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 25 059

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: