Kisspeptin-10

Not FDA-approved Evidence grade C — small or uncontrolled human studies / case series Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: KP-10, kisspeptin 10, metastin 45-54, Kisspeptin-10 acetate.

Regulatory status

Not FDA-approved. FDA placed kisspeptin-10 in 503A category 2 (substances raising significant safety risks) on 29 Sep 2023, citing possible immunogenicity and little or no safety information for the proposed routes, so compounding pharmacies may not use it; still in category 2 on the 14 May 2026 list [1][2]. It was not among the seven peptides reviewed at the July 2026 PCAC meeting [3].

What it is

Endogenous hypothalamic neuropeptide (10-amino-acid fragment of kisspeptin; KISS1R / GPR54 agonist).

The shortest fully active fragment of kisspeptin, the brain peptide that switches on the reproductive hormone axis. It has been given to small groups of healthy volunteers in physiology studies; it is not an approved drug anywhere.

What the published research shows

Small human physiology studies only (4–6 healthy volunteers per dose group) measuring hormone responses; no therapeutic trials of kisspeptin-10. Most clinical work uses the longer kisspeptin-54.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

LH stimulation in healthy men (George et al., J Clin Endocrinol Metab 2011): IV bolus 0.01–3.0 µg/kg: maximal LH rise at 1 µg/kg (4.1 to 12.4 IU/L at 30 min, n = 6), smaller response at 3 µg/kg. IV infusion 4 µg/kg/h for 22.5 h raised testosterone from 16.6 to 24.0 nmol/L (n = 4); 1.5 µg/kg/h increased LH pulse frequency.
Men vs women (Jayasena et al., J Clin Endocrinol Metab 2011): IV bolus raised LH and FSH in men from 0.3 and 1.0 nmol/kg; in women in the follicular phase there was no response even at 10 nmol/kg IV, 32 nmol/kg SC or 720 pmol/kg/min infusion; women in the pre-ovulatory phase did respond to 10 nmol/kg IV (n = 4–5 per group).

Mechanism, as reported

Activates the kisspeptin receptor on GnRH neurons, which releases GnRH and in turn LH and FSH from the pituitary, raising testosterone in men.

Practical record

Elimination half-life: 0.065 h (confidence: high). Plasma half-life about 4 minutes after IV infusion in healthy volunteers (3.8 min men, 4.1 min women), measured as kisspeptin immunoreactivity. The app uses 4 min.
Studied routes: intravenous, subcutaneous.
Typical supply: No licensed product. Sold as lyophilised vials on the research-chemical market (unregulated).

Safety signals on record

Reported adverse events: No adverse effects were reported in the small volunteer studies, which were not designed to assess safety. FDA flags a possible immune (anti-drug antibody) response.
Contraindications: None established (no label).
Interactions: None documented. Its effect depends on an intact pituitary-gonadal axis, so drugs that suppress that axis (e.g. GnRH analogues, testosterone) would be expected to blunt it.
Notes: WADA prohibits kisspeptin and its agonist analogues at all times in males (S2.2.1, testosterone-stimulating peptides) [6]. Response differs sharply by sex and menstrual-cycle phase. The very short half-life means a single injection acts for minutes, not hours.

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

← All compounds