FDA Approved Human Trial of Cellular Rejuvenation Therapy.
In late January 2026, the U.S. Food and Drug Administration (FDA) cleared Life Biosciences’ Investigational New Drug (IND) application for ER-100, authorizing the first human trial of a cellular rejuvenation therapy using partial epigenetic reprogramming.
The experimental therapy, ER-100, builds on groundbreaking research from Harvard geneticist Dr. David Sinclair, whose work reshaped how scientists think about aging. His studies demonstrated that age is, in part, a reversible process of “epigenetic noise” — chemical changes that accumulate on DNA over time and interfere with gene expression.
Partial epigenetic reprogramming uses a select combination of Yamanaka factors, proteins that can reset these epigenetic marks, effectively turning back the biological clock of cells without stripping them of their identity. Instead of reverting cells to a pluripotent state (which can be risky), ER-100 aims to restore youthful function specifically in retinal ganglion cells, the neurons responsible for transmitting visual information from the eye to the brain.
ER-100’s first clinical target is age-related optic neuropathies, including glaucoma and non-arteritic anterior ischemic optic neuropathy (NAION). Both conditions involve damage to the optic nerve leading to gradual and often irreversible vision loss. Existing treatments primarily manage symptoms or slow progression, but they do not restore lost vision.
Preclinical studies in animals showed remarkable results — damaged retinal tissues regenerated, and previously blind mice regained sight after treatment with similar reprogramming factors. Now, for the first time, these promising lab results will be tested in human patients.
If successful, ER-100 could establish a blueprint for using controlled epigenetic reprogramming to rejuvenate other tissues — potentially addressing conditions linked to aging throughout the body.
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