Legal status · United States
Is ER-100 legal in the United States?
No. ER-100 is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. Human evidence to date: Preliminary.
ER-100 in the United States at a glance
| Classification | Investigational, not approved |
|---|---|
| FDA approval status | Investigational; Phase 1 |
| Evidence level | Preliminary (research strength: Preliminary) |
| Reviewed | Sep 2026 |
Classification and note come from the ER-100 profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
ER-100 is being studied in registered clinical trials but has not received FDA marketing approval in the United States.
- 02
Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.
- 03
Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.
What ER-100 is
The first partial cellular reprogramming therapy in humans: Life Biosciences dosed the first patient in June 2026, delivering three Yamanaka factors to retinal cells to reverse epigenetic age in glaucoma and optic neuropathy.
ER-100 uses a gene therapy to express OCT4, SOX2 and KLF4 in retinal ganglion cells, switched on by a course of oral doxycycline, with the goal of resetting the cells' epigenetic age without erasing their identity. The FDA cleared the IND in January 2026 and the Phase 1 in glaucoma and non-arteritic anterior ischemic optic neuropathy began dosing in June.
Mechanism: Transient, inducible expression of three reprogramming factors (OSK) to restore youthful epigenetic patterns in aged cells.
Regulatory history: Investigational; Phase 1
How FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for ER-100 at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
ER-100 in other countries
Frequently asked questions
Is ER-100 legal in the United States?
No. ER-100 is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. Human evidence to date: Preliminary.
Can I buy ER-100 in the United States?
No approved product exists to buy. In the United States ER-100 is classified as "Investigational, not approved", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors.
Is ER-100 FDA approved?
No. FDA status: Investigational; Phase 1. Current US classification: "Investigational, not approved". Evidence level: Preliminary.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for ER-100 live on its compound profile.
ER-100 profileThis page is general information about the regulatory status of ER-100 in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.