Epitalon

FDA status

Not FDA-approved. It was on FDA's compounding safety-risk list until the nomination was withdrawn. FDA advisers voted in July 2026 to recommend adding it to the pharmacy list for insomnia. On October 30, 2026 HHS published a draft policy: it does not intend to act against pharmacies and doctors that compound epitalon, as injections only, given in intermittent courses, under set conditions while that list is worked out. That is not an approval. FDA safety-risk list ↗FDA advisers ↗McDermott ↗Federal Register ↗HHS ↗

FDA advisers, July 2026

The FDA's compounding advisory committee recommended adding it to the substances pharmacies may use, for insomnia (7 in favor; reports differ on the votes against). The FDA hasn't decided. What's changing →

What's changing

A draft HHS policy, published October 30, 2026: no action against pharmacies that compound it under set conditions while the pharmacy list is worked out. Comments are open for two weeks. See what's changing →

In people so far

• A 2026 review: human evidence is limited to small studies of body measurements and an older study in an inherited eye disease; no adequately powered trial has shown it works. PubMed ↗
• A 2003 report from the same Russian group followed 266 older people for 6 to 8 years and reported fewer deaths among those given the thymus and pineal extracts Thymalin and Epithalamin than in a control group. Epithalamin is an extract, not lab-made epitalon. PubMed ↗

Safety

• The FDA says it has found no safety information for the proposed use and that epitalon may cause immune reactions. A 2026 review calls the dose and long-term safety data inadequate. FDA safety-risk list ↗PubMed ↗

In sport

Not named on the World Anti-Doping Agency's 2026 Prohibited List. WADA's class S0 also bans unnamed substances that no health authority has approved for use in people. WADA ↗

One of the peptides we follow. We don't give doses or say where to buy. Talk to your doctor before trying any of them.