Advancing Geroscience Research - A Scoping Review of Regulatory Environments for Gerotherapeutics

Globally, older adults are living longer but often in poorer health with multiple chronic conditions straining healthcare systems. Gerotherapeutics, which target the biological mechanisms of aging, could reduce this burden by extending healthspan. However, before therapies can be adopted, they must undergo rigorous study and regulatory approval; existing regulatory frameworks and the barriers to their development are unknown.

We conducted a scoping review of geroscience regulatory frameworks and identified barriers to their development.

A comprehensive government, academic, and grey literature search in the United States, Europe, Canada, and other regions including Medline and EMBASE (via OVID), Google Scholar, CINAHL, and CADTH Grey Matters was conducted. For inclusion of only recent literature, searches were limited to English-language publications from 2014 to 2024.

In 3,780 publications screened for inclusion, no regulatory frameworks for gerotherapeutics were found. In the 34 included publications, 4 major barriers were identified: 1) lack of recognition of the biological processes of aging as targets for medical intervention; 2) absence of clear regulatory pathways to evaluate aging-focused therapies; 3) economic uncertainties, including high development costs and limited incentives due to unclear regulatory environments; and 4) insufficient public and policy engagement.

We did not identify any geroscience specific regulatory frameworks but identified barriers to their development. For biological aging to advance as a therapeutic target, stakeholders must develop comprehensive regulatory guidelines, incentivize research and conduct public education. Global collaboration is crucial to harmonize regulatory efforts and ensure equitable adoption of therapies, ultimately enhancing healthspan worldwide.