Kisspeptin
Kisspeptin is a natural brain hormone that switches on the reproductive hormone cascade; kisspeptin-10 and kisspeptin-54 are unapproved research peptides.
US regulatory status
Compounding restricted
Kisspeptin is not approved by the FDA for any use. Kisspeptin-10 has been in Category 2 of the FDA’s 503A compounding policy since September 29, 2023, because of possible immune reactions, impurities and limited safety data, and it remained there in the FDA’s May 14, 2026 update. It is not among the substances on the agenda of the FDA’s next compounding advisory committee meeting.
At a glance
- Also known as
- Kisspeptin-10, Kisspeptin-54, KP-10, KP-54, Metastin
- Supplied as
- Freeze-dried powder, mixed before use
- Research
- Limited human evidence
- US status
- US status: Restrictedchecked
What the research shows
Evidence grade
Limited human evidence
Some studies in people, but they are small, short, early-phase or uncontrolled.
Small human studies show that kisspeptin switches on the reproductive hormone axis. In six men, an intravenous infusion of kisspeptin-54 raised LH, FSH and testosterone compared with saline, and its half-life in the blood was about 27.6 minutes. In an IVF study of 53 women, a single injection of kisspeptin-54 under the skin triggered egg maturation at every dose tested; the biochemical pregnancy rate was 40% and the clinical pregnancy rate 23%. In a 2026 study of 15 healthy men, daily 8-hour infusions of kisspeptin-10 under the skin kept LH and FSH raised for 12 days, but with round-the-clock exposure LH and FSH fell back to placebo levels within 5 days, while testosterone stayed raised. Two crossover trials in people with hypoactive sexual desire disorder (HSDD), 32 men and 32 women who completed them, found that a single 75-minute intravenous infusion of kisspeptin-54 changed activity in brain areas that process sexual cues. These were one-visit brain-imaging studies under medical supervision, not treatment trials, and no kisspeptin treatment is approved.
How we grade evidence
Strong human evidence
Consistent results from large randomized controlled trials in people.
Limited human evidence · this page
Some studies in people, but they are small, short, early-phase or uncontrolled.
Mixed evidence
Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.
Animal or lab studies only
Studied in cells or animals, not properly in people. Animal results may not apply to humans.
The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.
Side effects and safety
Human data come from short, supervised research studies, and long-term safety has not been established. In the trial in women with HSDD, kisspeptin was well tolerated with no reported adverse effects. The FDA put kisspeptin-10 in compounding Category 2 because compounded versions may cause immune reactions and may have problems with peptide-related impurities and with confirming what the active ingredient is. In the FDA’s words, it has “no, or only limited, safety-related information” for the proposed routes, so it “lacks sufficient information to know whether the drug would cause harm when administered to humans.” Kisspeptin also acts on reproductive hormones: in research, continuous exposure stopped raising LH and FSH within 5 days. No FDA label sets a dose, a water volume or storage for any kisspeptin vial.
Vial math
Pre-filled calculators turn your vial, water and prescribed dose into syringe units.
Pre-filled for your vial size
This is arithmetic, not medical advice. Confirm with your prescriber or pharmacist.
Questions people ask
What is kisspeptin?
Kisspeptin is a hormone made in the brain that controls the release of gonadotropin-releasing hormone (GnRH), which in turn drives LH, FSH, testosterone and estrogen. People born without working kisspeptin signaling do not go through normal puberty. Synthetic kisspeptin-10 and kisspeptin-54 are used in research studies; neither is an approved medicine.
What is the difference between kisspeptin-10 and kisspeptin-54?
They are different lengths of the same hormone, 10 and 54 amino acids, sharing the same 10-amino-acid active end. In mice, kisspeptin-54 lasted about 32 minutes in the blood and kisspeptin-10 about 4 minutes, and only kisspeptin-54 kept LH raised for long; it also appeared able to cross the blood-brain barrier. In men, kisspeptin-54 had a half-life of about 27.6 minutes. The early hormone, IVF and sexual-desire studies in people used kisspeptin-54. The FDA’s Category 2 compounding entry is for kisspeptin-10, so check which form a label names.
Sources
- PLoS One, 2017: Mechanistic insights into the more potent effect of KP-54 compared to KP-10 in vivo (opens in a new tab)
- J Clin Endocrinol Metab, 2005: Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (opens in a new tab)
Is kisspeptin FDA-approved?
No. No kisspeptin product is approved for any use in the US. The FDA lists kisspeptin-10 in Category 2 of its 503A compounding policy, meaning it has “identified significant safety risks” and does not extend the policy that lets compounders use Category 1 substances. It has been there since September 29, 2023, and was still listed in the May 14, 2026 update. The next FDA compounding advisory committee meeting, planned before the end of February 2027, does not include kisspeptin on its agenda.
Sources
- U.S. Food and Drug Administration, 2026: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (updated May 14, 2026) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Meeting of the Pharmacy Compounding Advisory Committee (to be held before the end of February 2027) (opens in a new tab)
Is kisspeptin used for men?
Only in research so far. In healthy men, kisspeptin raises LH, FSH and testosterone, and a 2026 study of 15 men kept LH and FSH raised for 12 days with daily 8-hour infusions under the skin. With round-the-clock infusion, though, LH and FSH fell back to placebo levels within 5 days. It is not an approved treatment for low testosterone or infertility. If you compete in sport, the World Anti-Doping Agency’s 2026 Prohibited List bans kisspeptin and its analogues in men at all times, as testosterone-stimulating peptides.
Sources
- Eur J Endocrinol, 2026: Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men (opens in a new tab)
- J Clin Endocrinol Metab, 2005: Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males (opens in a new tab)
- World Anti-Doping Agency, 2026: The 2026 Prohibited List (opens in a new tab)
Does kisspeptin affect sexual desire?
It changed how the brain responds to sexual cues in two small trials, but it is not a treatment. In 32 men with hypoactive sexual desire disorder (HSDD), a 75-minute intravenous infusion of kisspeptin-54 changed activity in the brain’s sexual-processing network and increased penile tumescence to sexual stimuli by up to 56% more than placebo; the men also reported more happiness about sex. In 32 premenopausal women with HSDD, it changed brain processing of sexual and facial attraction. Each was a single supervised visit with brain scans. A 2025 review, by an author with a related patent application, says delivery methods and other hurdles remain. For acquired, generalized HSDD in premenopausal women, the FDA has approved bremelanotide (Vyleesi), a different drug that acts on melanocortin receptors.
Sources
- JAMA Netw Open, 2023: Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial (opens in a new tab)
- JAMA Netw Open, 2022: Effects of Kisspeptin Administration in Women With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial (opens in a new tab)
- Trends Endocrinol Metab, 2025: Can kisspeptin be a new treatment for sexual dysfunction? (opens in a new tab)
- DailyMed, U.S. National Library of Medicine, 2024: VYLEESI (bremelanotide) injection, prescribing information (opens in a new tab)
How much bacteriostatic water do I mix with 5 mg or 10 mg of kisspeptin-10?
There is no single correct amount. The water only sets the concentration: mg in the vial ÷ mL of water = mg per mL. For example (numbers for illustration only, not a dose), 5 mg of kisspeptin-10 in 1 mL makes 5 mg/mL, so each unit on a U-100 insulin syringe holds 0.05 mg (50 mcg). The same vial in 2 mL makes 2.5 mg/mL, or 0.025 mg (25 mcg) per unit. More water means each unit holds less; less water means each unit holds more. The reconstitution calculator does this arithmetic for your vial. A 10 mg vial in the same volume is twice as concentrated. Because this product is not FDA-approved, no official label sets a water volume, and the contents of unapproved vials are not verified. Talk to a licensed prescriber or pharmacist before using any unapproved product.
Sources
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (updated May 14, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Meeting of the Pharmacy Compounding Advisory Committee (to be held before the end of February 2027)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human malesJ Clin Endocrinol Metab, 2005 · Accessed Oct 16, 2026 (opens in a new tab)
- Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilizationJ Clin Invest, 2014 · Accessed Oct 16, 2026 (opens in a new tab)
- Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy menEur J Endocrinol, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder: A Randomized Clinical TrialJAMA Netw Open, 2023 · Accessed Oct 16, 2026 (opens in a new tab)
- Effects of Kisspeptin Administration in Women With Hypoactive Sexual Desire Disorder: A Randomized Clinical TrialJAMA Netw Open, 2022 · Accessed Oct 16, 2026 (opens in a new tab)
- The Emerging Therapeutic Potential of Kisspeptin and Neurokinin BEndocr Rev, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
- Mechanistic insights into the more potent effect of KP-54 compared to KP-10 in vivoPLoS One, 2017 · Accessed Oct 16, 2026 (opens in a new tab)
- The 2026 Prohibited ListWorld Anti-Doping Agency, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Can kisspeptin be a new treatment for sexual dysfunction?Trends Endocrinol Metab, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
- VYLEESI (bremelanotide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
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Guides
Every medical and regulatory statement on this page links to a checkable source, listed above. Peptinote does arithmetic and education, not medical advice, and never sells or links to sellers of peptides.