Life Biosciences ER-100 IND cleared; Phase 1 in optic neuropathies (NCT07290244)
On 28 Jan 2026, Life Biosciences (co-founded by Sinclair) announced FDA clearance of its IND for ER-100 — the first cellular-rejuvenation therapy using partial epigenetic reprogramming (OSK) ever cleared for human testing. The Phase 1 first-in-human study enrolls open-angle glaucoma and NAION patients via intravitreal injection, following non-human-primate studies showing controlled OSK expression, methylation restoration, and improved visual function.
This is the anchor card for HKG's longevity arm. Life Biosciences — a company co-founded by David Sinclair — announced that the FDA had cleared its Investigational New Drug (IND) application for ER-100, moving partial epigenetic reprogramming (the OSK approach validated in mice, see the vision- loss card) into human testing for the first time. The Phase 1 trial enrolls patients with open-angle glaucoma (OAG) and non-arteritic anterior ischemic optic neuropathy (NAION, sometimes called "stroke of the eye"), delivered by intravitreal injection. Non-human-primate studies preceding the filing showed controlled OSK expression, restoration of youthful methylation patterns, and improved visual function without evidence of runaway cell dedifferentiation or tumor formation.
Why it matters (spine): this is the genuine clinical inflection point for the entire longevity field — the first time reprogramming-based rejuvenation biology has been judged safe enough by a regulator to test in people. It converts a mouse-model hypothesis into a tracked, dated, NCT-numbered human trial. It is exactly the kind of verified milestone HKG exists to surface clearly, separated from the noise around it.
Live status / Provenance: Life Biosciences, Inc. press release, 28 Jan 2026 (company primary source — a filing-adjacent regulatory announcement, not third-party reporting). Trial registered as NCT07290244, Phase 1, first-in-human, intravitreal ER-100 in OAG and NAION. Co-founded by David A. Sinclair (Harvard Medical School); status as of this card is enrollment-stage with no efficacy readout yet.
So we should hold this as the single most important verified fact in the sweep — genuinely a milestone — while explicitly correcting the natural overreach: this is a Phase 1 safety trial in a specific eye disease, not evidence of whole-body age reversal in humans. Track NCT07290244 for enrollment status and, eventually, safety and preliminary-efficacy readouts, and re-verify this card each time the trial status changes.
Mark this as a real regulatory milestone for the whole field — but frame it honestly to HKG: it is a Phase 1 SAFETY trial in an eye disease, not "full-body age reversal." Track the readout.
domains: longevity · epigenetics · aging · clinical-trials · regulatory