19 stories
Epitalon (Glu-Asp-Gly-Lys, also spelled Epithalon or Epithalamin) is a four-amino-acid peptide originally isolated from the bovine pineal gland by the late Vladimir Khavinson at the St. Petersburg Institute of Bioregulation and Gerontology. The molecule was studied for decades in Russian-language gerontology literature as a senescent-cell modulator, telomerase activator, and circadian-rhythm regulator. Western clinical evidence remains thin.
On July 24, 2026 the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 7-4 to recommend adding Epitalon to the Section 503A Bulks List for adult insomnia. The vote overrode FDA career-staff briefing documents (released June 29-30) that concluded there was not enough effectiveness evidence to support Epitalon's use for insomnia. The recommendation is advisory only; FDA rulemaking to actually add Epitalon to the bulks list typically takes 6-18 months from the date the agency decides to act.
Epitalon was reviewed on Day 2 of the July 23-24 peptide session alongside Emideltide/DSIP (rejected) and Semax (recommended 8-5). Before the vote, epitalon sat in a regulatory gray zone: removed from FDA Category 2 effective April 23, 2026 but not on the 503A Bulks List. If the FDA follows the PCAC vote and completes rulemaking, epitalon becomes legal to compound under 503A for the first time since the 2023 effective ban.
Stories here cover the PCAC review timeline, the underlying Khavinson research literature, the compounding-pharmacy economy preparing for the regulatory outcome, and any clinical-grade research that emerges in the indication. See [[pcac]], [[503a-bulks-list]], and [[tetrapeptide]] for adjacent threads.
Effective April 22, BPC-157, TB-500, Semax, Epitalon, MOTS-c and seven other peptides were formally removed from the FDA's 503A Category 2 significant-safety-concerns list after original nominators withdrew submissions. The FDA Pharmacy Compounding Advisory Committee will meet July 23-24 to decide whether to add these peptides to the 503A bulks list, which would restore legal compounding under prescription.