Early-Phase Clinical Trials of Novel Interventions to Prevent, Delay, or Treat Aging-Related Conditions by Targeting Aging-Related Mechanisms (U01 Clinical Trial Required) | RFA AG 22 011

Opportunity Information: Apply for RFA AG 22 011

The National Institute on Aging (NIA), part of the National Institutes of Health (NIH), is seeking applications for early-stage human clinical trials that test promising interventions aimed at preventing, delaying, or treating aging-related diseases and conditions by going after the underlying biological mechanisms of aging. This funding opportunity, RFA-AG-22-011, supports Phase 1, Phase 2a, and Phase 2b clinical trials under a U01 cooperative agreement mechanism, meaning the work is funded through an NIH award where NIA staff are expected to have an active, collaborative role in the project as it moves forward. The overall emphasis is on exploratory and translational testing in humans rather than large, definitive studies.

The core purpose of the opportunity is to evaluate new compounds or repurposed existing drugs, biologics (with a clear exclusion of stem cell products), and supplements that may improve health in later life by modulating fundamental aging processes. In practical terms, the FOA is designed for interventions that either (1) could plausibly affect multiple chronic conditions at once by targeting shared aging-related pathways, or (2) could meaningfully impact specific diseases and conditions that disproportionately affect older adults. The intent is to encourage work that links mechanistic aging biology to clinical outcomes, with early-phase trials that can establish feasibility, dosing, safety/tolerability, signals of biological activity, and initial evidence suggesting potential clinical benefit.

This announcement is not meant to pay for definitive efficacy and safety trials. In other words, it is not aimed at large Phase 3-style studies that would be expected to settle whether an intervention works conclusively or to fully characterize rare adverse events. Instead, it supports the kind of rigorously designed early clinical testing needed to decide whether an intervention is ready to move into larger confirmatory trials and to clarify the best endpoints, target populations, and trial procedures for subsequent studies.

The eligible applicant pool is broad and includes many types of U.S.-based organizations: state, county, and local governments; special districts; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The FOA also highlights additional 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, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions are not eligible to apply as the primary applicant, but non-U.S. components of U.S. organizations can participate, and foreign components are allowed as defined by NIH policy, which permits certain international collaborations when they are justified and appropriately structured.

Administratively, the opportunity is categorized as discretionary funding, uses the cooperative agreement funding instrument (U01), and falls under the health funding activity category with CFDA number 93.866. The original closing date listed for the opportunity was June 17, 2021, and the posting indicates it was created on February 3, 2021. The listing does not specify an award ceiling or the expected number of awards in the provided summary fields, so those details would need to be confirmed in the full FOA or related NIH documentation.

In short, this grant opportunity is geared toward well-justified, early-phase clinical trials that test interventions tied to aging biology, with an eye toward improving late-life health by addressing mechanisms that drive vulnerability to multiple chronic diseases, while stopping short of funding large, definitive trials intended to prove efficacy for regulatory or practice-changing purposes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Early-Phase Clinical Trials of Novel Interventions to Prevent, Delay, or Treat Aging-Related Conditions by Targeting Aging-Related Mechanisms (U01 Clinical Trial Required)" 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 2021-02-03.
• Applicants must submit their applications by 2021-06-17. (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 RFA AG 22 011

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