Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required) | RFA AG 23 008

Opportunity Information: Apply for RFA AG 23 008

The grant opportunity titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required)" (Funding Opportunity Number RFA-AG-23-008) is a National Institutes of Health (NIH) call for clinical-trial-based research that focuses on how mTOR inhibitors behave in the body (pharmacokinetics, or PK) and what biological effects they produce (pharmacodynamics, or PD) in older adults. The central purpose is to generate rigorous, comparable PK/PD evidence for mTOR-modulating drugs in people who either have specific aging-related diseases or who are relatively healthy but at elevated risk for multiple aging-associated conditions. In practical terms, NIH is looking for studies that can clarify dosing, exposure, biological response, and mechanistic signals in relevant older populations, so that the field can better understand how mTOR inhibition might influence aging-related pathways and outcomes.

This FOA uses the U01 mechanism, which is a cooperative agreement. That matters because it signals substantial NIH program involvement beyond a typical research grant. Individual research teams would receive their own awards to run their PK/PD studies, but they would not operate in isolation. Instead, each funded project is expected to function as part of a coordinated network. The network structure is intended to promote active collaboration across studies, including sharing information and lessons learned in real time, working toward harmonized or aligned measurements where feasible, and pooling data across sites and projects. The overall aim of this network requirement is to support broader conclusions than any single study could provide, particularly around how mTOR modulation affects multiple aging-related outcomes and underlying mechanisms across different populations and conditions.

The scientific scope centers specifically on PK/PD studies of mTOR inhibitors, meaning proposals should be designed to measure drug exposure and time course (for example, concentration over time, distribution, metabolism, and clearance) alongside measurable biological responses that reflect target engagement or downstream pathway effects. Because the FOA emphasizes aging-related indications, the populations of interest include groups living with different age-associated diseases as well as relatively healthy older adults who are still at risk for developing a range of aging conditions. This framing encourages applications that can illuminate whether PK/PD profiles differ by disease state, age-related physiology, comorbidities, or other factors common in older populations, and whether PD readouts align with hypothesized mechanisms of mTOR-related aging biology.

Administratively, the opportunity is categorized as discretionary funding and sits in the health funding activity category, with CFDA number 93.866. The sponsoring agency is NIH, and the original closing date listed is 2022-06-15, with a creation date of 2022-01-05. The FOA title includes "Clinical Trial Required," indicating that the proposed work must include a clinical trial component rather than being purely observational or preclinical, and applicants should be prepared to meet NIH expectations for clinical trial design, conduct, and oversight consistent with a U01 cooperative agreement.

Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants listed include state, county, and city or 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; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; small businesses; and an "other" category. The FOA also explicitly highlights additional eligible applicant categories 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 government agencies, regional organizations, and U.S. territories or possessions, reinforcing an intent to include a wide range of institutions and communities in this research area.

At the same time, the FOA draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are stated as not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. In other words, the main applicant organization must be domestic and eligible, but collaborations that involve certain foreign components may still be permissible under NIH policy, provided the application structure follows those rules.

Overall, the opportunity is best understood as NIH support for coordinated, networked clinical PK/PD research on mTOR inhibitors aimed at aging-related conditions and risk states in older adults. The emphasis on collaboration, harmonization, and pooled analyses suggests NIH is trying to accelerate comparability and generalizability in this space, so that findings about dosing, exposure-response relationships, and mechanistic biomarkers can be interpreted across multiple studies rather than remaining siloed within individual trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (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 2022-01-05.
• Applicants must submit their applications by 2022-06-15. (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.

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