Dr. Pep

Peptides · Hypothalamic neuropeptide (kisspeptin-10, -54)

Kisspeptin: what the studies show

Every line below comes from a study, label or regulator record, checked by two models, with the source linked. Information, not medical advice. For adults 18+.

What it is

  • Kisspeptin is a brain hormone that tells the brain to release GnRH, which in turn drives LH, FSH and the sex hormones. It exists in forms of different length, such as kisspeptin-54 and the shorter kisspeptin-10, and is made by the body.[1][2]
  • Kisspeptin is an endogenous hormone. Studies that only measure the body's own kisspeptin (for example in miscarriage, placenta previa or puberty) do not show that giving it works.[3][4]
  • Kisspeptin itself is a research drug. Analogues such as MVT-602 and TAK-448 are different molecules, and their results are not kisspeptin's own.[5][6]

Bottom line

  • In small, short human trials, injected kisspeptin reliably raises LH, FSH and testosterone or estrogen, and kisspeptin-54 helped trigger egg maturation in IVF patients at risk of overstimulation. Repeated dosing can wear off in some regimens. No kisspeptin product is approved, and FDA lists kisspeptin-10 as a compounding substance with safety concerns.[2][7][8][9]

What the human studies found

  • Healthy men: in a placebo-controlled study of 15 men, subcutaneous kisspeptin-10 infusions raised LH, FSH and testosterone dose-dependently over 8 hours. Continuous infusion for 5 days lost its gonadotropin effect, but daily 8-hour infusions for 12 days sustained gonadotropin rises (mean LH increase day 1 +1.68, day 12 +1.14 versus -0.16 on vehicle).[2]
  • Intranasal kisspeptin-54 (12.8 nmol/kg) rapidly raised LH versus placebo in healthy men (+3.1 IU/L difference), healthy women (+1.0) and women with hypothalamic amenorrhoea (+4.3). No adverse events were reported. The study also tested stability and mouse effects.[10]
  • Hypothalamic amenorrhoea (absent periods), randomised double-blind trial, 5 women per group: twice-daily kisspeptin-54 injections (6.4 nmol/kg) for 2 weeks first raised LH and FSH strongly, but the response fell sharply by day 14 (LH rise 24.0 to 2.5 IU/L), meaning tolerance developed.[8]
  • Hypothalamic amenorrhoea, randomised trial: twice-weekly kisspeptin-54 injections for 8 weeks gave only partial tolerance and kept reproductive hormones elevated versus saline, with no adverse effects reported. The dose and group size are not in the abstract.[11]
  • IVF, phase 2 randomised open-label trial of 60 women at high risk of ovarian hyperstimulation syndrome (OHSS): a single kisspeptin-54 injection triggered oocyte maturation in 95%, with the best yield at 12.8 nmol/kg. No woman developed moderate, severe or critical OHSS.[7]
  • IVF, randomised trial of 62 women aged 18 to 34 at high risk of OHSS: all got kisspeptin-54 9.6 nmol/kg; a second dose 10 hours later raised the share with a good oocyte yield (71% vs 45%, p=0.042).[12]

Known risks and side effects

  • Trials reported few adverse events: none with intranasal kisspeptin-54 and none in the 8-week amenorrhoea study. Studies are small (5 to 75 per group) and short, so rare or long-term harms are unknown.[10][11]
  • FDA flagged immunogenicity concerns (from aggregation and peptide impurities) for compounded kisspeptin-10 and said it lacked sufficient information on harm for the proposed routes.[9]
  • Because kisspeptin raises sex hormones and can desensitise the system, effects on fertility with repeated use have only been studied in small trials (for example, twice-daily injections did not abolish menstrual cycles in 5 healthy women).[13][8]

Legal status

  • As of the FDA category 2 page (content current 2026-04-22), kisspeptin-10 is listed under 503A category 2 (added 2023-09-29) as a substance that may pose significant safety risks for compounding, because of potential immunogenicity and peptide-related impurities and limited safety information.[9]

Sources

  1. [1] Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males.
  2. [2] Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men.
  3. [3] Kisspeptin as a predictor of miscarriage: a systematic review.
  4. [4] Kisspeptin expression levels in patients with placenta previa: A randomized trial.
  5. [5] Endocrine profile of the kisspeptin receptor agonist MVT-602 in healthy premenopausal women with and without ovarian stimulation: results from 2 randomized, placebo-controlled clinical tricals.
  6. [6] Sustained exposure to the investigational Kisspeptin analog, TAK-448, down-regulates testosterone into the castration range in healthy males and in patients with prostate cancer: results from two phase 1 studies.
  7. [7] Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy.
  8. [8] Subcutaneous injection of kisspeptin-54 acutely stimulates gonadotropin secretion in women with hypothalamic amenorrhea, but chronic administration causes tachyphylaxis.
  9. [9] FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (503A/503B category 2)
  10. [10] Intranasal kisspeptin administration rapidly stimulates gonadotropin release in humans.
  11. [11] Twice-weekly administration of kisspeptin-54 for 8 weeks stimulates release of reproductive hormones in women with hypothalamic amenorrhea.
  12. [12] A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial.
  13. [13] Twice-daily subcutaneous injection of kisspeptin-54 does not abolish menstrual cyclicity in healthy female volunteers.