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.
In 2026, epitalon sits in a regulatory gray zone in the US — removed from the FDA's Category 2 ('Bulk Drug Substances that Raise Significant Safety Concerns') effective April 23 after nominations were withdrawn, but not yet on the 503A Bulks List that would formally permit compounding-pharmacy production. The Pharmacy Compounding Advisory Committee (PCAC) will review epitalon on Day 2 of its July 23-24, 2026 meeting alongside Emideltide/DSIP and Semax. A favorable PCAC recommendation followed by an FDA final determination would put epitalon back on the legal-compounding shelf for the first time since 2023.
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-compounding, and #tetrapeptide for adjacent threads.
The FDA's Pharmacy Compounding Advisory Committee meeting on July 23-24, 2026 at the agency's White Oak campus (Silver Spring, Maryland) reaches its first procedural cutoff next Tuesday: June 30, 2026 is the deadline to register for oral testimony in the public-comment portion of the meeting. Written comments to docket FDA-2025-N-6895 at regulations.gov must arrive by 11:59 PM ET July 22, 2026 (one day before the meeting opens). The Committee will discuss BPC-157, KPV, TB-500, and MOTS-C on Day 1 (July 23) and Emideltide/DSIP, Semax, and Epitalon on Day 2 (July 24). All seven peptides came off FDA Category 2 effective April 23, 2026. PCAC recommendations are advisory: the agency makes the final 503A bulks list decision, and the Hims & Hers (HIMS) stock breakout above $30 reflected market consensus that the July vote will tilt toward eligibility. Lengea Law and PeptideClarity have both published prescriber-facing trackers ahead of the meeting.
With EASL and ASCO dominating the clinical-data cycle, the FDA peptide-compounding regulatory track continues moving toward the July 23-24, 2026 Pharmacy Compounding Advisory Committee (PCAC) meeting. Twelve peptides came off the FDA Category 2 'significant safety risk' bulks list effective April 23, 2026; seven of those (BPC-157, TB-500, KPV, MOTs-C on Day 1; Emideltide/DSIP, Semax, Epitalon on Day 2) advance to the July PCAC for affirmative 503A bulks-list inclusion. A second PCAC before end of February 2027 reviews five more (GHK-Cu injectable, Melanotan II, Cathelicidin LL-37, Dihexa, PEG-MGF). Removal from Category 2 does not yet permit compounding — that requires the affirmative PCAC recommendation plus FDA final determination (6-12 month timeline). The parallel 503B bulks-list proposal excluding semaglutide, tirzepatide, and liraglutide closes public comments June 29. The compounded-semaglutide shipment volume is down 90% year-over-year per the BSR Intelligence briefing as the regulatory vise tightens on the gray-market segment.
Umbrella Labs announced Monday May 25 a documentation and traceability update for its Epitalon peptide reference material, provided strictly for laboratory developmental research use. The update is part of the company's standardization initiative focused on identity-field consistency, record continuity, and reproducibility — the same template Umbrella applied to Dihexa on May 19. Epitalon (Glu-Asp-Gly-Lys) is a four-amino-acid peptide originally derived from the bovine pineal gland by Vladimir Khavinson and studied as a senescent-cell modulator and telomerase activator. The peptide is on the FDA's PCAC review docket for July 23-24, 2026 — Day 2 alongside Emideltide/DSIP and Semax — for potential 503A bulks-list inclusion. Reference-material standardization across the research-peptide supply chain is the soft regulatory signal that compounding pharmacies and supply networks are preparing for the PCAC review window.
The FDA's PCAC public docket FDA-2025-N-6895 is now accepting written comments on the proposed addition of seven peptides to the Section 503A bulk drug substances list ahead of the July 23–24 advisory committee meeting at White Oak. Day 1 will cover BPC-157, KPV, TB-500, and MOTs-C; Day 2 will cover Emideltide (DSIP), Semax, and Epitalon. Comments received by July 9 are guaranteed to be presented to the committee, and the docket closes July 22. The window gives compounders, prescribers, and patient advocates roughly twelve weeks to formally submit clinical evidence, pharmacovigilance data, and access arguments.
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.