Evidence · Mostly animal and lab studies
Epitalon
Epithalon · AEDG peptide
What it is
A synthetic four-amino-acid peptide modelled on epithalamin, an extract of the pineal gland. It was developed by a research group in St Petersburg, Russia.
How it’s thought to work
Lab and animal studies report effects on telomerase activity in cell cultures and on melatonin rhythms in older animals.
What the research shows
- —Most of the literature is animal and cell work, plus small human studies from the group that developed it.
- —It has not been tested in rigorous, independently run trials. Read the literature as a signal, not proof.
Risks and side effects
- —Long-term safety in humans is unknown. FDA cites possible immune reactions and impurities.
- —Because it is described as growth-regulating, a history of cancer is a reason for caution.
- —No data in pregnancy or breastfeeding.
Regulatory status
- —Not approved by FDA for any use.
- —FDA put it in “category 2” of its compounding policy — substances that may present significant safety risks. The nomination was later withdrawn, and in April 2026 FDA moved it to the “nominated but withdrawn” list on the same page, which still sets out its safety concerns. Withdrawal does not make it approved, and it does not place it in category 1 (the substances FDA is still evaluating for compounding).
- —It was one of the peptides reviewed at FDA’s Pharmacy Compounding Advisory Committee in July 2026. The committee’s votes are recommendations only; as of 2 October 2026 FDA has not added it to the list of substances pharmacies may compound.
Sources