Washington, DC, USA - The U.S. Food and Drug Administration has cleared a first-in-human clinical trial for a gene therapy designed to reverse certain aspects of cellular aging, marking a significant milestone in longevity research—while also prompting confusion over what has actually been approved.
The therapy, known as ER-100, has been developed by Life Biosciences and uses a technique called partial epigenetic reprogramming. Rather than altering DNA itself, the approach works by resetting how genes are switched on and off inside cells, nudging older or damaged cells toward a more youthful state.
Importantly, the FDA has not approved an age-reversal treatment for general use. The agency has cleared an Investigational New Drug (IND) application, allowing the company to begin a Phase 1 clinical trial focused primarily on safety.
The initial trial will not target aging broadly. Instead, it will study patients with specific optic nerve disorders, including open-angle glaucoma and non-arteritic anterior ischemic optic neuropathy. The eye was chosen as a controlled and localized testing ground, rather than attempting whole-body effects at this early stage.
The Phase 1 study will evaluate safety, immune response, and early biological signals related to vision. Any evidence of functional improvement would be considered preliminary and exploratory.
The excitement surrounding the announcement stems from years of animal research suggesting that partial epigenetic reprogramming can restore youthful gene expression patterns without causing cells to lose their identity. However, translating those findings into humans remains a major scientific and regulatory challenge.
For now, the development represents a cautious but historic first step: the FDA has allowed human testing of a therapy explicitly designed to rejuvenate cells at the molecular level. Whether this approach can safely deliver meaningful benefits—and whether it can ever be expanded beyond localized diseases—remains to be seen.
