Should Aging Be Treated as a Disease? Scientists, Clinics and Regulators Rethink Growing Older

What if the next major target for medicine isn't a single illness but the shared biology that makes many diseases more likely as we get older?

Researchers, clinics and regulators are taking that question seriously. Instead of waiting for diabetes, heart disease or cancer to appear and treating each condition separately, some scientists propose targeting the slow biological processes that underlie many age-related illnesses. The hoped-for result: more years lived in good health — a longer healthspan — and potentially longer lives.

Why the Debate Matters

The idea sounds philosophical until you consider the practical consequences. Would aging need to be officially labeled a disease before treatments aimed at it can be developed, tested and regulated? Different stakeholders — from academics and biotech firms to national regulators — are approaching the question from different directions.

"Aging has biology. This biology drives diseases," said Nir Barzilai, director of the Institute for Aging Research at Albert Einstein College of Medicine.

If Barzilai is right, therapies that slow or alter those biological processes could reduce the risk of multiple age-related diseases at once rather than addressing each one after it appears.

Laboratory Progress vs. Human Evidence

In animal studies — from roundworms to mice — scientists have demonstrated that genetic, dietary and pharmaceutical interventions can alter aging biology and extend lifespan. Interventions such as exercise and calorie restriction also modulate cellular markers linked to aging.

But translating those findings to humans remains challenging. Columbia epidemiologist Daniel Belsky notes that "for humans, we do not yet have clinical trial evidence that intervention on this biology to extend health span is possible." Large, definitive trials could need to follow people who start interventions at age 40–50 for two or three decades to measure whether chronic disease is delayed — an impractically long timeline for many studies.

Searching for Shortcuts: Biomarkers and Surrogate Endpoints

Because of that timeline problem, researchers are searching for biomarkers that reliably reflect biological aging and that could serve as surrogate endpoints in shorter trials. Projects like Belsky's FAST study collect proteins, metabolites and epigenetic marks from blood to find signals that respond to interventions.

To date, no biomarker of aging has been clinically validated. A December 2025 review of biomarker data from longevity trials concluded that none have met clinical validation standards. An August analysis in Nature Medicine of 51 intervention studies also highlighted a major unresolved issue: researchers have not agreed on how large a change in an epigenetic ‘‘clock’’ must be to be considered clinically meaningful.

Clinics, Licensing and Regulation Arrive Ahead of Definitive Proof

Despite scientific uncertainty, longevity medicine is already entering clinical practice. The Mayo Clinic opened a Healthy Longevity Clinic in 2023, and Singapore's National University Health System has a comparable program combining thorough assessments with personalized lifestyle or medical recommendations. Some experts warn the field needs clearer standards to protect patients and ensure treatments are evidence-based.

In October 2024, Abu Dhabi's Department of Health introduced a licensing framework for "Healthy Longevity Medicine Centers," which its proponents described as a global first. Licensing establishes operational standards but does not validate particular therapies.

How Regulators Are Responding

The FDA has not approved any therapy with an anti-aging indication. However, agency officials have begun discussing what credible evidence of an aging intervention would look like. Agency leaders say aging and longevity topics will be included in the FDA's updated Focus Areas of Regulatory Science report expected in fiscal year 2027.

FDA scientists have sketched two possible regulatory approaches for future therapies: (1) show that a single mechanism benefits multiple age-related diseases (suggesting it targets aging biology), or (2) run controlled trials demonstrating that treated participants lose less function than controls in domains such as cognition, frailty, hearing and vision.

Separately, one company has received FDA clearance to test an approach in human eyes, providing an early human trial of concepts that have largely lived in animal research.

Open Questions Remain

Two practical questions dominate the debate: (1) Who defines aging as a disease (if anyone), and (2) what counts as convincing evidence that a therapy modifies the biology of aging rather than merely altering a lab measurement? As UCLA's Steve Horvath has observed, answering those questions will likely require robust molecular biomarkers in addition to measures of function.

For most people today, the best-supported actions to increase healthy years remain familiar: prioritize sleep, maintain regular exercise, nurture social connections, and follow a balanced diet.

What to Watch Next

• The FDA's updated Focus Areas of Regulatory Science report (expected FY2027), which will signal how regulators weigh aging and longevity priorities.
• Results from the FDA-cleared human eye trial, which will be one of the first human tests of longevity-focused techniques translated from animal studies.

The broader debate — whether a lower biological-age score is as persuasive as prolonged mobility and independence — will shape how research, regulation and clinical care evolve over the coming years.