David Sinclair: First Human De-Aging Trial Gets FDA Green Light

Harvard Medical School geneticist David Sinclair is back in the headlines with the most significant milestone yet for his “Information Theory of Aging.” Life Biosciences, the biotech he co-founded, has secured FDA approval for a Phase 1 clinical trial — the first human test of partial epigenetic reprogramming.

What the trial does

The trial aims to restore vision in people with optic-nerve conditions such as glaucoma and non-arteritic anterior ischemic optic neuropathy (NAION). Rather than treating symptoms, the therapy attempts to reset the epigenetic “software” of aged cells to a younger state — the same partial-reprogramming approach Sinclair’s lab pioneered in animal models.

The science behind it

Sinclair’s core thesis is that aging is driven by a gradual loss of epigenetic information — the molecular tagging patterns that tell cells which genes to express. His lab reports new data directly linking sirtuins to epigenetic reprogramming and is preparing a paper for submission to Nature.

His current protocol

At the 2026 Abundance Summit, Sinclair reviewed his personal regimen with Peter Diamandis: a largely plant-based diet, daily intermittent fasting with a 14–16 hour window, and a supplement stack built around his aging research. As always, he emphasizes that lifestyle basics do most of the work.

Note: Sinclair has faced criticism from peers over “age reversal” claims in animal studies, which led him to step down as president of the Academy for Health and Lifespan Research in 2024. The FDA clearance marks a shift from lab claims toward regulated human evidence.