Kisspeptin is a natural reproductive neuropeptide (the product of the KISS1 gene) that acts as a master activator of the hormonal axis controlling puberty and fertility. It is investigational: it is being studied in human reproductive medicine (for example, as a trigger for egg maturation in IVF and in disorders of reproduction) but is not approved as a medicine by any regulator.

Is Kisspeptin approved for medical use?

Kisspeptin is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved for any indication; investigational and studied only in clinical research. European Union (EMA): No EMA marketing authorisation; not an approved medicine in the EU. Australia (TGA): Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.

Is Kisspeptin legal in Australia?

Kisspeptin in Australia (TGA): Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.

Is Kisspeptin banned in sport?

Kisspeptin under the World Anti-Doping Agency (WADA) code: Prohibited in males under Section S2: WADA added kisspeptin to the 2024 Prohibited List as an example of a testosterone-stimulating peptide (a luteinising-hormone releasing factor); it is prohibited in males only, not in females.

Reproductive neuropeptide; KISS1 gene product and endogenous agonist of the kisspeptin receptor (KISS1R/GPR54); upstream stimulator of GnRH neurons

Kisspeptin

Investigationalaka Kisspeptin-54, Metastin, KP-54, KISS1

Kisspeptin, signalling through the KISS1R (GPR54) receptor, is a key upstream regulator of gonadotropin-releasing hormone (GnRH) neurons; loss-of-function mutations in its receptor cause absent puberty. Human experimental-medicine studies, notably kisspeptin-54 to trigger oocyte maturation in IVF and to probe reproductive disorders, have shown promising physiology, but kisspeptin remains investigational and unapproved.

Mechanism

In plain terms, kisspeptin is the switch that turns on the reproductive hormone system, prompting the brain to release the hormones that drive the ovaries and testes. Technically, kisspeptin binds KISS1R (GPR54), a Gq/11-coupled receptor on hypothalamic GnRH neurons, stimulating GnRH release; this in turn drives pituitary secretion of luteinising hormone (LH) and follicle-stimulating hormone (FSH). Its central role in initiating puberty and regulating fertility underlies its study as a more physiological trigger of the reproductive axis.

Regulatory Status by Region

United States (FDA)Not approved for any indication; investigational and studied only in clinical research.
Australia (TGA)Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.
European Union (EMA)No EMA marketing authorisation; not an approved medicine in the EU.
WADAProhibited in males under Section S2: WADA added kisspeptin to the 2024 Prohibited List as an example of a testosterone-stimulating peptide (a luteinising-hormone releasing factor); it is prohibited in males only, not in females.

See the full regulatory status matrix

Key Studies

The GPR54 gene as a regulator of puberty (loss-of-function mutations in the kisspeptin receptor cause absent puberty) (opens in a new tab) (Seminara SB, et al. N Engl J Med. 2003.)
Kisspeptin-54 stimulates the hypothalamic-pituitary-gonadal axis in human males (opens in a new tab) (Dhillo WS, et al. J Clin Endocrinol Metab. 2005.)
Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization (opens in a new tab) (Jayasena CN, et al. (Dhillo group). J Clin Invest. 2014.)

Related Clinical Trials

Latest research

Follicular kisspeptin-VEGF axis in polycystic ovary syndrome and ovarian hyperstimulation syndrome. (opens in a new tab)
Journal of assisted reproduction and genetics · Aug 28, 2026
Effect of High Intensity Sweeteners on the Reproductive System: From the Onset of Puberty to Menstrual Health: A Comprehensive Review of Human and Animal Evidence. (opens in a new tab)
International journal of women's health · Aug 21, 2026
Effects of Maternal Zinc Deficiency and Post-Weaning Zinc Status on Neuroendocrine Markers Associated with Pubertal Regulation in Female Rat Offspring. (opens in a new tab)
International journal of molecular sciences · Aug 21, 2026
Estrogen receptor expression in GnRH neurons: back to the future†. (opens in a new tab)
Biology of reproduction · Aug 18, 2026

See all recent Kisspeptin research

Common Questions

What is Kisspeptin?: Kisspeptin is a natural reproductive neuropeptide (the product of the KISS1 gene) that acts as a master activator of the hormonal axis controlling puberty and fertility. It is investigational: it is being studied in human reproductive medicine (for example, as a trigger for egg maturation in IVF and in disorders of reproduction) but is not approved as a medicine by any regulator.
Is Kisspeptin approved for medical use?: Kisspeptin is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved for any indication; investigational and studied only in clinical research. European Union (EMA): No EMA marketing authorisation; not an approved medicine in the EU. Australia (TGA): Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.
How does Kisspeptin work?: In plain terms, kisspeptin is the switch that turns on the reproductive hormone system, prompting the brain to release the hormones that drive the ovaries and testes. Technically, kisspeptin binds KISS1R (GPR54), a Gq/11-coupled receptor on hypothalamic GnRH neurons, stimulating GnRH release; this in turn drives pituitary secretion of luteinising hormone (LH) and follicle-stimulating hormone (FSH).
Is Kisspeptin legal in Australia?: Kisspeptin in Australia (TGA): Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.
Is Kisspeptin banned in sport?: Kisspeptin under the World Anti-Doping Agency (WADA) code: Prohibited in males under Section S2: WADA added kisspeptin to the 2024 Prohibited List as an example of a testosterone-stimulating peptide (a luteinising-hormone releasing factor); it is prohibited in males only, not in females.