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

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

A major public meeting co-hosted by the Reagan-Udall Foundation, ARPA-H, and XPRIZE tackled the biggest obstacle in longevity medicine: getting anti-aging therapies through FDA approval. The summit moved past the tired debate over whether aging is a disease and instead focused on practical frameworks. Researchers are now rallying around measurable health metrics — like gait speed, grip strength, and cognitive tests — organized under an 'Intrinsic Capacity' framework. A Delphi survey found 87% of investigators cite the lack of a validated surrogate endpoint as the field's top barrier. Drugs like metformin and SGLT2 inhibitors, originally developed for diabetes, are showing broad mortality benefits that suggest they may be targeting aging itself, strengthening the case for pragmatic 'stepping stone' regulatory strategies.

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