FDA and ARPA-H Chart a Real Regulatory Path for Anti-Aging Drugs

The longevity field reached a regulatory inflection point at a May 2026 summit convened by the Reagan-Udall Foundation for the FDA, co-sponsored by ARPA-H's PROSPR program and the XPRIZE Foundation. The central goal was solving the field's most persistent problem: how to get therapies that target biological aging through an approval system built around specific diseases.

The morning session focused on defining 'Intrinsic Capacity' — a multi-domain framework borrowed from geroscience that tracks locomotion, cognition, and vitality using tools like gait speed, grip strength, the MoCA cognitive test, and the Short Physical Performance Battery. Crucially, the group decided to score each domain separately rather than collapsing them into a single composite score, preserving the ability to identify which intervention actually moved which needle.

A Delphi survey presented by Dr. Jamie Justice added statistical weight to the urgency. Among participating investigators, 90% rejected an aging-as-disease framing, and 87% identified the absence of a validated surrogate endpoint — not funding or trial design — as the single greatest barrier to progress. This reframes the problem clearly: the science is advancing, but the measurement infrastructure has not kept up.

Nir Barzilai made the case for repurposed drugs as proof of concept. SGLT2 inhibitors cut renal, cardiovascular, and all-cause mortality by roughly 40% in a largely non-diabetic trial population. Metformin halved hospitalization and death rates in COVID-era data with no connection to blood sugar management. Barzilai argues these results suggest both drugs were inadvertently treating aging across multiple hallmarks simultaneously.

The practical takeaway is a 'stepping stone' strategy: seek approval for specific, measurable conditions first — muscle loss, cognitive decline — while building the evidence base for broader aging indications. Regulators remain appropriately skeptical and will require proof that benefits are patient-noticeable, not just biomarker-detectable. The field is maturing from theory into regulatory engineering.