OSK trials seem to be starting next month!
Prof David:
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Brave gave this simple summary. Exciting.
Life Biosciences has received FDA clearance for the world’s first human trial of an epigenetic reprogramming therapy using the OSK factors (Oct4, Sox2, Klf4). The trial, known as the ER-100 study, is a first-in-human clinical trial focused on safety and tolerability. It targets age-related eye conditions such as glaucoma and non-arteritic anterior ischemic optic neuropathy (NAION) , leveraging partial epigenetic reprogramming to reverse cellular aging without altering cell identity.
The therapy uses adeno-associated viruses (AAVs) to deliver transient OSK expression, avoiding the oncogenic risks associated with the full Yamanaka factor set (OSKM) by excluding c-Myc. Preclinical studies in mice and non-human primates demonstrated significant reversal of epigenetic age , improved visual function, and enhanced tissue regeneration—without tumor formation.
While David Sinclair’s team at Harvard and Rejuvenate Bio have shown that OSK gene therapy extends lifespan by 109% in aged mice and reverses aging markers in human cells, no human trials have yet begun for those programs. However, Bill Faloon’s team , funding OSK therapy development, aims for human trials in 2026 , pending primate results.
As of March 2026 , the only confirmed human trial is Life Biosciences’ ER-100 study, expected to begin within the year. This marks a pivotal step toward clinical applications of OSK-based longevity therapies.