Every drug on Geroevidence's index is approved for a specific disease, never for aging itself. This isn't an oversight — it reflects a real structural limitation in how the FDA's approval pathway is built, one the TAME trial was specifically designed around.
FDA drug approval requires demonstrating safety and efficacy against a specific, defined disease or condition with recognized diagnostic criteria and endpoints. Aging is not classified by the FDA — or by the ICD-10/11 diagnostic systems the FDA's framework relies on — as a disease with such criteria. This is the specific structural reason no drug can currently be approved "for aging" or "for longevity," regardless of how strong its evidence base is.
This is a genuinely different situation from a drug simply lacking sufficient evidence — it's the absence of an approval pathway to apply that evidence to at all, even in principle, without a regulatory reclassification of aging itself as an indication.
The proposed TAME (Targeting Aging with Metformin) trial is frequently discussed as a test of "whether metformin treats aging" — but its actual design works around the FDA's disease-based framework rather than against it. TAME is structured to test whether metformin delays the onset of any of several age-related diseases (cardiovascular disease, cancer, dementia, mortality) as a composite endpoint in non-diabetic older adults — a trial design built entirely from diseases the FDA does recognize, aggregated to approximate an "aging" effect without requiring aging itself to be a recognized indication.
This structural fact explains a pattern visible across Geroevidence's entire intervention index: every approved drug tracked (metformin, GLP-1 agonists, SGLT2 inhibitors, rapamycin, acarbose) is approved for a specific disease — diabetes, transplant rejection, heart failure — and its longevity-relevant use is, by definition, off-label. This isn't a sign these drugs lack promise; it's a direct consequence of there being no other route to approval currently available for a longevity indication.
No drug can currently be FDA-approved specifically "for aging," because aging is not a recognized disease indication — a structural fact, not a reflection of any drug's evidence quality. Trials like TAME work around this by using composite disease endpoints rather than waiting for a regulatory change that hasn't happened. Every approved drug used for longevity purposes today is, and will likely remain for the foreseeable future, an off-label use of a disease-indicated drug.
This information is provided for educational reference only and does not constitute medical advice or a treatment recommendation.