Class

Neuropeptides

By Peptide America · Publisher · Reviewed September 2026

The neuropeptides in this index are compounds marketed for cognition, mood, stress, and sleep — the claims that are hardest to measure and easiest to assert. What makes the class worth reading as a group is that its members have been treated very differently by the same agency, on evidence that is not obviously different in kind.

One was recommended for listing by an advisory committee and one was refused by the same panel on the same days. One was never placed on any agenda at all. One is the single peptide FDA still names in the category that prohibits compounding outright. The difference in each case was the state of the dossier rather than the pharmacology.

Molecules in this class

MoleculeClassUS statusPosition
SemaxNeuropeptidesPCAC-recommended · pendingRemoved from Category 2 in April 2026; PCAC recommended 503A listing in July 2026 on a reported tally; no FDA final rule. Verified August 2026.
DSIPDelta sleep-inducing peptide; emideltideNeuropeptidesNo lawful routeRemoved from Category 2 in April 2026; the only peptide PCAC declined to recommend at the July 2026 meeting; no lawful route. Verified August 2026.
DihexaDihexa acetate; PNB-0408NeuropeptidesNo lawful routeNomination withdrawn in 2026; on no list. FDA states it has identified no human exposure data for this substance by any route. Verified August 2026.
CerebrolysinPeptide fraction derived from porcine brain protein; FPF-1070NeuropeptidesNo lawful routeLicensed in Austria, never approved in the US; FDA stated in 2020 and 2021 warning letters that it had not been nominated for the 503A bulks list, and no list names it.
Kisspeptin-10KP-10; metastin(45–54)NeuropeptidesNo lawful routeThe only peptide FDA still lists in Category 2 of the 503A bulks list; placed there September 2023, and the advisory committee voted 0–11 against listing it in October 2024. Verified August 2026.
SelankSelank acetate; TP-7NeuropeptidesNomination withdrawnNomination withdrawn; on no list, and never placed on an advisory-committee agenda — the disposition with the least record behind it. Verified August 2026.

The recommended member's record is at Semax and the refused one at DSIP; the committee's only rejection sets out what the panel was reading. Selank shares Semax's origin and never reached a committee, dihexa has no human record at all, Cerebrolysin is licensed abroad with a large trial record and was never nominated at all, and kisspeptin-10 remains prohibited by name. The vote ledger carries the July tallies and the human trial record carries the measurements.

The class on the other records

The advisory committee voted on two members in July 2026, as reported in secondary accounts (FDA has published no vote record): Semax 8–5 with 1 abstaining and DSIP 6–7 with 1 abstaining.

The 2026 WADA Prohibited List names Kisspeptin-10 (section S2.2.1). It does not name Semax, DSIP, Dihexa, Cerebrolysin and Selank, and that is not the same as permitted: the relevant sections are expressly non-exhaustive, and section S0 covers any substance with no current approval for human therapeutic use.

The vote ledger and the WADA table carry the sources.

Elsewhere in this index

Evidence reviews

Reference tables

Definitions