Kisspeptin-10

Definition

Kisspeptin-10 is the shortest active fragment of kisspeptin, the hypothalamic peptide that gates release of gonadotropin-releasing hormone and therefore the entire reproductive axis. Administered to a person, it produces a measurable rise in luteinizing hormone; that response is the reason it is studied and the reason it is sold.

Its regulatory position is unlike anything else in this index. Every other unapproved molecule here sits on no list. This one is named, by FDA, on a list that prohibits it.

Evidence

The human literature is real, specific, and almost entirely physiological. Across four name variants PubMed returns 324 indexed records, of which 119 carry the Humans subject heading, 9 the clinical-trial publication type, and 5 the randomized-controlled-trial type ^[1].

All nine trial-type records were opened and read, and three of them do not belong to this molecule in people: one studies kisspeptin-54, a different fragment; one is conducted in rhesus monkeys; one in female goats ^[1]. Counting nine would have overstated the record by a third, and the two animal studies carry the clinical-trial publication type regardless.

The six that remain are human endocrine-probe studies. They establish that kisspeptin-10 is a potent stimulator of luteinizing hormone and increases pulse frequency in men ^[2], and the most recent shows that continuous subcutaneous administration sustains gonadotropin secretion over twelve days in healthy men rather than desensitizing the axis ^[3]. What none of them reports is a clinical outcome: no fertility endpoint, no symptom scale, no hypogonadism trial. The record establishes that the compound does something measurable to a hormone, which is a different claim from establishing that it treats anything.

Lawful access

There is no lawful United States supply route, and this molecule's position is stronger than that: compounding it is affirmatively barred. FDA placed Kisspeptin-10 in Category 2 of the interim section 503A bulks list with a date added of September 29, 2023, on the stated grounds that compounded drugs containing it may pose a risk for immunogenicity for certain routes of administration, may have complexities with regard to peptide-related impurities and characterization of the active ingredient, and that the agency has no or only limited safety-related information for the proposed routes ^[4].

On October 29, 2024 the Pharmacy Compounding Advisory Committee voted 0 in favor, 11 against, and 0 abstaining on whether Kisspeptin-10 should be placed on the 503A bulks list. The minutes record that the committee unanimously agreed it should not be included, for lack of convincing safety and efficacy data. The use FDA evaluated was treatment of secondary hypogonadism in men ^[5].

It remains in Category 2 on the list FDA published on May 14, 2026, where that category contains six substances in total: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration ^[6]. Kisspeptin-10 is the only peptide among them. Every other peptide this index tracks has left that category or was never in it; this one is still there, and placement in it bars a licensed pharmacy from compounding the substance. The research-only page covers what an absent route means for a buyer.

Related molecules

Kisspeptin-10 is filed with the neuropeptides, where Semax and DSIP show what the same committee did with dossiers it took further. The nomination tracker is the page that files this molecule correctly — under the category it is in, not the category others left — and what removal does not mean explains why the difference matters.

Elsewhere in this index