Early-Stage T1 Translational Aging Research (Bench to Bedside) for the Development of Novel Therapeutics (R21/R33 Clinical Trial Optional) | PAR 19 305

Opportunity Information: Apply for PAR 19 305

The NIH funding opportunity "Early-Stage T1 Translational Aging Research (Bench to Bedside) for the Development of Novel Therapeutics (R21/R33 Clinical Trial Optional)" (PAR-19-305; CFDA 93.866) supports projects that move promising aging biology discoveries out of the lab and toward practical therapies for older adults. The focus is early-stage T1 translation, meaning the work should connect preclinical findings and mechanistic insights to clear development steps that position an intervention for eventual testing in humans. The goal is to accelerate the creation of interventions that can prevent, delay, or treat conditions tied to aging and/or the burden of multiple chronic diseases that commonly occur together in later life.

The FOA is built around the Exploratory/Developmental Phased Innovation grant mechanism (R21/R33). In practice, this structure is meant for projects that still need an early exploratory push (R21 phase) but are intended to progress into a more advanced, milestone-driven development stage (R33 phase) if the initial work succeeds. Applicants are generally expected to define measurable go/no-go milestones that demonstrate readiness to transition from the exploratory stage into more rigorous development activities. Because it is labeled "Clinical Trial Optional," the program can accommodate applications that either stay in the preclinical-to-translational lane or include a clinical trial component when appropriate, as long as the proposed work fits the early translational intent and is justified by the maturity of the therapeutic candidate.

Scientifically, the program targets therapeutics relevant to aging-related conditions and geriatric syndromes, including examples such as sarcopenia, heart failure with preserved ejection fraction (HFpEF), immunosenescence, metabolic syndrome, and chronic kidney disease. A key theme is addressing the biology of aging in a way that could improve health outcomes across multiple conditions, particularly in older people who often experience multimorbidity. Projects are expected to be more than basic discovery; they should articulate a credible path toward a therapeutic product or intervention with defined development steps.

A wide range of therapeutic modalities are explicitly encouraged. This includes development of new classes of compounds and strategies such as senolytics, anti-inflammatory agents, and modulators of proteostasis and autophagy. It also includes natural products and their derivatives (including mimics and synthetic equivalents), biologics, stem/progenitor cell-based therapies, and repurposing of existing FDA-approved drugs for aging-related indications. In other words, the FOA is not limited to one therapeutic approach; it is structured to support whichever modality has the strongest rationale and the most workable translational plan for an aging-relevant clinical need.

Eligibility is broad and spans many U.S.-based organization types. Eligible applicants include state, county, and city/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; 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; small businesses; and other entities. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, faith-based or community-based organizations, tribally controlled colleges and universities, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, foreign participation is explicitly restricted. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by NIH policy) are not allowed. This means the work and the organizational presence tied to the application must be structured to remain within NIH rules for domestic eligibility.

The opportunity is administered by the National Institutes of Health as a discretionary grant program. The source information lists an original closing date of 2022-07-16 and notes that award ceiling and expected awards were not specified in the provided excerpt. Overall, the program is best suited for teams that already have a credible aging-related therapeutic concept and need NIH support to complete the early translational steps (and defined milestones) that bridge a strong preclinical foundation to a product-oriented development path with eventual clinical relevance.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Early-Stage T1 Translational Aging Research (Bench to Bedside) for the Development of Novel Therapeutics (R21/R33 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2019-06-25.
• Applicants must submit their applications by 2022-07-16. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 19 305

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