Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed) | PAR 25 058

Opportunity Information: Apply for PAR 25 058

The Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program announcement PAR 25 058 is a National Institutes of Health (NIH) discretionary grant opportunity focused on early, practical translational work for potential neurotherapeutics. It is a reissue of PAR-21-122 and is administered within NIH, aligned with the National Institute of Neurological Disorders and Stroke (NINDS) mission area. The core purpose is to fund the kinds of preclinical studies that help determine whether a proposed therapeutic agent has enough real biological activity and supporting evidence to justify moving forward into more advanced development stages for neurological or neuromuscular disorders.

This specific IGNITE notice is centered on neurotherapeutic agent characterization and in vivo efficacy studies, using the R61/R33 phased award structure, and it explicitly does not allow clinical trials. In practical terms, the funding is meant to support key experiments that reduce early development risk, especially pharmacokinetic (PK) and pharmacodynamic (PD) work and efficacy testing in living systems. PK studies typically address what the body does to the agent (for example, absorption, distribution, metabolism, and elimination, including exposure in relevant tissues such as the brain, spinal cord, peripheral nerves, or muscle). PD studies focus on what the agent does to the body (for example, target engagement, pathway modulation, and downstream biological effects). In vivo efficacy studies then tie these properties to functional outcomes in appropriate animal or other in vivo models, helping establish whether the agent produces meaningful benefit in a disease-relevant context. Collectively, these data are intended to demonstrate sufficient biological activity and a plausible therapeutic signal, rather than simply generating basic discovery findings.

The opportunity supports a range of therapeutic modalities, including small molecules, biologics, and other biotechnology-derived products. That breadth means applicants could propose, for example, a novel chemical entity, a repurposed compound with a new neurological indication, an antibody or protein therapeutic, or other engineered biologic approaches, as long as the work plan is focused on rigorous characterization and in vivo proof-of-concept aligned with NINDS-relevant disorders. The larger program intent is to push projects forward to a point where they can meet entry criteria for later-stage translational pipelines, particularly the Blueprint Neurotherapeutics Network (BPN) or similar development programs. In other words, this FOA is meant to bridge the gap between an interesting therapeutic concept and the more demanding evidence package needed to justify deeper investment in development.

From an eligibility standpoint, the applicant pool is intentionally broad. Eligible applicants include many types of U.S. governmental entities (state, county, city or township, and special district governments), independent school districts, and public housing authorities/Indian housing authorities. Higher education institutions are eligible across the spectrum, including public and state-controlled institutions of higher education and private institutions of higher education. The FOA also welcomes nonprofit organizations both with and without 501(c)(3) status (when they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses. In addition, the notice calls out several categories as other eligible applicants, including 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), eligible federal agencies, faith-based or community-based organizations, Indian/Native American tribal governments that are not federally recognized, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities. This wide eligibility suggests NIH is aiming to attract strong translational proposals from a diverse set of organizations, including those that may be positioned to address unmet needs in neurological and neuromuscular disease.

Administratively, the funding instrument is a grant under the health activity category, associated with CFDA number 93.853. The source information lists an award ceiling of $750,000, and the opportunity’s original closing date is noted as 2024-11-03, with a creation date of 2024-10-22. While the expected awards field is not specified in the provided source data, the structure and ceiling indicate the program is designed to support well-scoped, milestone-driven preclinical packages rather than large, open-ended research programs. Overall, this NOFO is best understood as targeted translational funding for teams that have a candidate neurotherapeutic agent in hand and now need disciplined PK/PD and in vivo efficacy evidence to justify the next development step, while staying firmly on the preclinical side (no clinical trials) and within the NINDS mission space.

• 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 2024-10-22.
• Applicants must submit their applications by 2024-11-03. (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 $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 25 058

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