PCAC July 24, 2026: Three peptides under review (preview)

Background

The U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee (PCAC) will convene a second public meeting on July 24, 2026, the day after the July 23 session. The two-day format is consistent with previous PCAC convenings in which a larger slate of nominated bulk drug substances was distributed across consecutive sessions to allow each substance adequate presentation time.

The July 24 agenda includes three peptides: delta-sleep-inducing peptide (DSIP), also referenced under the name Emideltide; Semax; and epitalon (also spelled epithalon). None of the three currently has an FDA-approved drug application in the United States. Two — Semax and epitalon — were originally developed and registered in the Russian Federation, where each carries a national marketing authorization for specific neurological or geroprotective indications.

What’s on the agenda

The FDA’s evaluation criteria are described in the agency’s 2018 guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (FDA Guidance, 2018). The agency weighs physicochemical characterization, safety signals raised by use in compounding, evidence of effectiveness or lack thereof, and historical use of the substance in compounded products.

The committee’s advisory function is summarized on the FDA’s PCAC landing page (FDA PCAC):

The Committee provides advice on scientific, technical, and medical issues concerning drug compounding by licensed pharmacists in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.

Briefly, here is what cited literature reports about each substance on the July 24 agenda:

DSIP / Emideltide

Delta-sleep-inducing peptide (DSIP) is a nine-amino-acid peptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu) originally isolated from rabbit cerebral venous blood by Schoenenberger and Monnier in the 1970s. The foundational review by Graf and Kastin in Neuroscience & Biobehavioral Reviews in 1984 catalogued the peptide’s chemistry, central and peripheral distribution, and the heterogeneous body of reports on its physiological effects (PMID:9926346). The name “Emideltide” appears in some nomination materials and refers to the same nine-residue sequence.

Semax

Semax (Met-Glu-His-Phe-Pro-Gly-Pro) is a synthetic seven-residue analogue of fragment 4-10 of adrenocorticotropic hormone (ACTH) that was developed at the Institute of Molecular Genetics of the Russian Academy of Sciences. The peptide is registered as a medicinal product in the Russian Federation. A 2018 review by Koroleva and Myasoedov in Biology Bulletin summarized the preclinical and clinical literature on its reported neuroprotective and nootropic activities (PMID:30607450). Semax has no marketing authorization in the United States or in the European Union.

Epitalon

Epitalon (Ala-Glu-Asp-Gly), also rendered “epithalon” in some literature, is a synthetic tetrapeptide developed at the St. Petersburg Institute of Bioregulation and Gerontology. The PubChem record for the compound (CID 219042) aggregates the chemical and literature data (PubChem CID 219042). Epitalon has no FDA-approved indication.

Why it matters

PCAC’s recommendation on each substance is advisory; the FDA’s listing decision follows the meeting and may be issued months or years later. The agency’s reference page catalogues the four evaluation categories used to organize the bulks list (FDA bulks page).

For substances with an existing foreign marketing authorization, the foreign approval does not, by itself, satisfy the 503A criteria — those criteria reference USP/NF monographs, FDA-approved drug components, or appearance on the agency’s bulks list. A peptide registered in another jurisdiction can still be declined for 503A use, and several peptides in this category have previously been declined when the available U.S.-relevant evidence base was judged insufficient by the FDA.

The July 24 meeting will be open to the public and will accept written and oral comments in the docket the FDA opens for each substance. Briefing materials are usually posted by the agency about two weeks ahead of the meeting; pepi.ninja will summarize the briefing documents for each substance as they are published. This preview reports what is publicly known about the agenda and the framework, and does not predict committee recommendations or final agency action.