Kisspeptin-10: What Human Studies Show and Its Legal Status

Kisspeptin-10 is the shortest fragment of kisspeptin that still activates the kisspeptin receptor. In small human studies it raises luteinizing hormone (LH) within minutes. We found no approved kisspeptin product, and the FDA lists kisspeptin-10 as a compounding substance with significant safety questions [19][20].

Key points

• Kisspeptin-10 acts on the hypothalamic pathway that controls GnRH, the signal behind LH and FSH. In studies of 4 to 15 people it raised LH, FSH and, in men, testosterone for hours [3][7].
• The best-known human trials (IVF egg maturation, hypoactive sexual desire, brain imaging) used the longer kisspeptin-54 given by intravenous infusion or clinic injection, not kisspeptin-10 [8][9][11][12].
• Takeda’s kisspeptin analogue TAK-448 missed its primary endpoint in two small testosterone trials, both terminated [15][16].
• On 2024-10-29 an FDA advisory committee voted 0 to 11 against adding kisspeptin-10 to the 503A bulks list; it sits in Category 2 [19][21]. Kisspeptin is on the 2026 WADA list [22].
• The “very cope” tier-list placement is partly supported: no benefit is shown for healthy adults, but the LH effect is real.

What kisspeptin-10 is

Kisspeptins are products of the KISS1 gene. Kisspeptin-54 is the major circulating form in humans [8]; kisspeptin-10 is the minimal sequence with full activity [3]. A 2014 systematic review calls kisspeptin a principal regulator of gonadotrophin secretion, critical for puberty and adult fertility. It acts upstream of GnRH neurones, with neurokinin B and dynorphin (the “KNDy” signals), to control pulsatile GnRH release [1]. The receptor is called GPR54 or KISS1R, and kisspeptin is its endogenous agonist [2].

Kisspeptin-10 clears fast: FDA cites a half-life of about 4 minutes in healthy volunteers, against 27.6 minutes for kisspeptin-54 in men [20][2].

What the human studies show

Study	Peptide	Who and how many	Design and control	Result
Dhillo 2005 [2]	kisspeptin-54	6 healthy men	double-blind, placebo-controlled crossover	LH, FSH and testosterone rose versus saline
George 2011 [3]	kisspeptin-10	healthy men, 4 to 6 per condition	IV bolus versus vehicle; infusions of up to 22.5 h	Dose-dependent LH rise (a higher dose gave less); infusion raised LH pulse frequency and testosterone
George 2013 [4]	kisspeptin-10	5 men with type 2 diabetes and low testosterone, 7 healthy men	open proof of concept	LH rose in both; infusion raised testosterone in 4 diabetic men
George 2012 [5]	kisspeptin-10	women: early follicular phase, 6 postmenopausal, 8 on contraceptives	acute IV bolus, compared across groups	LH rose except in women on the combined pill
Jayasena 2009 [6]	kisspeptin-54	10 women with hypothalamic amenorrhea	randomized, double-blind, saline control, 2 weeks	First injection raised LH strongly; by day 14 the response had largely gone
Yeung 2026 [7]	kisspeptin-10	15 healthy men (Imperial)	randomized, single-blind, placebo-controlled	Subcutaneous infusion raised LH, FSH and testosterone; continuous infusion for 5 days lost the gonadotropin effect, an intermittent daily pattern kept it for 12 days

The acute LH effect is consistent across studies. The response fades with continuous exposure (“tachyphylaxis”), as seen in women with amenorrhea [6] and in the 2026 men’s study [7]. Funding was public: MRC and NIHR for the 2026 study [7], MRC for the George studies [3][4][5].

IVF and ovulation

In 2014, Imperial College reported 53 women undergoing IVF who received a single injection of kisspeptin-54 to trigger egg maturation. It was a dose-finding study with no control group. Eggs matured at every dose, 49 of 53 women had embryos transferred, and 12 (23%) had a clinical pregnancy [8]. In 2017 a randomized, blinded trial of 62 women at high risk of ovarian hyperstimulation syndrome (OHSS) compared one kisspeptin-54 dose with two. An oocyte yield of at least 60% was reached by 14 of 31 (45%) on one dose and 21 of 31 (71%) on two (P = 0.042). Moderate OHSS occurred in 1 of 31 and 0 of 31. The authors declared no competing interests and called for a head-to-head comparison with other triggers [9].

Sexual desire and brain imaging

These were acute studies of infused kisspeptin with brain activity (fMRI) as the main outcome.

• Comninos 2017: 29 healthy men, kisspeptin versus vehicle. Limbic activity to sexual and couple-bonding images rose and negative mood fell. The abstract does not name the isoform [10].
• Thurston 2022: 40 premenopausal women with hypoactive sexual desire disorder (HSDD) were randomized and 32 completed a double-masked placebo crossover of kisspeptin-54. Brain responses to erotic and attractive-face stimuli changed in several regions; no adverse effects were reported [11].
• Mills 2023: 37 men with HSDD were randomized and 32 completed a similar kisspeptin-54 crossover. Whole-brain activity changed (Cohen d 0.81, P = .003). Secondary outcomes: penile tumescence up to 56% above placebo, and “happiness about sex” up 0.63 points [12].

None tested a treatment over weeks, and none used kisspeptin-10. PubMed lists MRC, NIHR, Department of Health or Wellcome funding [10][11][12]; we did not open the conflict statements.

Trials by companies

Takeda’s TAK-448 is a kisspeptin analogue. In a phase 2a trial (NCT02381288) in 17 men with low testosterone, randomized and single-blind, six weeks of injections did not separate from placebo: mean change in average testosterone was +14.3% on placebo and +7.1%, +10.6% and +15.8% across three TAK-448 groups of 2 to 5 men. The sponsor ended it for missing the primary endpoint [15]. A second, open-label trial (NCT02369796) in 15 men with hypogonadotropic hypogonadism was also terminated for missing its primary objective [16]. A prostate-cancer depot study (NCT01132404, 9 men) was stopped for a new formulation [17]. A 2024 paper reported two randomized trials (24 and 75 healthy women) of a kisspeptin agonist, MVT-602. It produced an LH rise like a mid-cycle surge; ovulation within 5 days occurred in 75 to 100% of women across four doses versus 60% on placebo (5 women), and the authors called it “safe and well tolerated” [14]. Several authors worked for Myovant Sciences; we did not open the funding statement. Secondary sources say MVT-602 is TAK-448; we could not confirm that, or MVT-602’s current development status, from a primary source.

Of 45 ClinicalTrials.gov records returned for “kisspeptin” on 2026-11-08, the only industry-sponsored analogue trials were the three TAK-448 studies [18].

Regulatory status

• United States (FDA). FDA says kisspeptin-10 is in no approved drug and in no approved product in any country (October 2024 briefing) [20]. FDA’s page on bulk substances that may present significant safety risks, current as of 2026-04-22, lists it in Category 2 under the 503A interim policy (added 2023-09-29), citing possible immunogenicity and impurity and characterisation problems [19]. The page shows no removal. FDA’s briefing proposed against the 503A bulks list, and the advisory committee voted 0 yes, 11 no on 2024-10-29, citing a lack of convincing safety and efficacy data [20][21]. FDA found no USP or European Pharmacopoeia monograph for it [20]. We could not verify any FDA action after that date.
• WADA. The 2026 Prohibited List (effective 2026-01-01), as published in the Dutch Tractatenblad on 2026-03-27, lists “kisspeptin and its agonist analogues” under S2.2.1, testosterone-stimulating peptides in males [22]. A German anti-doping laboratory says kisspeptin-10 is covered and dates the listing to 2024 [23]. WADA’s own site blocked us.
• EU, UK, Germany. The EMA, MHRA and BfArM registers were not checked. FDA reports no European Pharmacopoeia monograph [20].
• “Research use only.” A seller’s label saying a product is for laboratory work, not people. It does not mean a regulator assessed identity, purity or safety, and kisspeptin-10 has no pharmacopoeial standard to test against [20].

Risks and unknowns

FDA reviewed the kisspeptin-10 studies and found no serious adverse events, but they were small, short and often did not report adverse events; the longest earlier exposure was a 24-hour infusion; the 2026 trial reached 12 days [20][7]. FDA’s adverse-event database held one report for a compounded kisspeptin-10 injectable and FDA drew no conclusion from it [20].

Animal data raise questions. A 14-day dog study found no drug-related toxicity, but a mouse study FDA describes found kisspeptin-10 accelerated aortic atherosclerosis in ApoE-deficient mice; FDA called the human relevance unclear. FDA found no carcinogenicity or formal immunogenicity studies and noted antibodies could cross-react with the body’s own kisspeptin [20].

Effects depend on hormonal state: the response was absent in women on the combined pill and larger after menopause [5]. We found no data in pregnancy or older adults, and no long-term studies. A 2023 Imperial study examined kisspeptin and food intake in women with overweight or obesity; we could not open its results, so we report none [24].

What the source post claims and how it holds up

On 2026-10-15 the account @Hoostethics posted a tier-list image, “ranking the most cope supplements” (about 289,000 views), with kisspeptin-10 in the second-worst tier, “very cope”, beside CLA, MOTS-c, pregabalin, Ritalin and berberine [25]. It defines neither “cope” nor an outcome. See our full list check.

Verdict: partly supported. If “cope” means no demonstrated benefit for a healthy adult, the evidence fits: we found no controlled study showing a benefit on an outcome people seek from it, and FDA found too little data even for its nominated use [20]. If “cope” means inert, it does not fit, because kisspeptin-10 reliably raises LH in lab studies [3][7]. The tier also mixes a supplement, research peptides and prescription drugs, so it does not track evidence.

What research supports and what sellers imply

FDA reported that clinic websites mostly promote kisspeptin products for weight loss and fertility [20]. We found no trial of kisspeptin-10 for weight loss. The fertility evidence is kisspeptin-54 injected in IVF clinics [8][9]. The desire data are brain-imaging studies of infused kisspeptin-54 [11][12]. The testosterone evidence is acute, and the one company analogue trial in low-testosterone men did not beat placebo [15]. Peptilyze’s kisspeptin compound page is a price comparison, not evidence of efficacy.

Frequently asked questions

Is kisspeptin-10 approved by the FDA? No. FDA says it is not part of any approved drug, with no approved product in any country as of October 2024 [20]. It is in FDA’s Category 2, and an advisory committee voted 0 to 11 against the 503A bulks list [19][21].

Is kisspeptin-10 the same as kisspeptin-54? No. Kisspeptin-10 is the ten-amino-acid active end of the 54-amino-acid peptide. The IVF and brain-imaging trials used kisspeptin-54, which stays in the blood far longer [2][8][11][20].

Is kisspeptin banned in sport? The 2026 WADA list names “kisspeptin and its agonist analogues” under testosterone-stimulating peptides in males [22].

Does kisspeptin-10 raise testosterone? In men it did during infusions in lab studies [3][7]. Continuous exposure lost its gonadotropin effect, and a company analogue did not beat placebo over six weeks in 17 men [7][15].

Sources

1. Skorupskaite K, George JT, Anderson RA, “The kisspeptin-GnRH pathway in human reproductive health and disease,” Human Reproduction Update (2014). https://pubmed.ncbi.nlm.nih.gov/24615662/
2. Dhillo WS et al., “Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males,” J Clin Endocrinol Metab (2005). https://pubmed.ncbi.nlm.nih.gov/16174713/
3. George JT et al., “Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men,” J Clin Endocrinol Metab (2011). https://pubmed.ncbi.nlm.nih.gov/21632807/
4. George JT et al., “Kisspeptin-10 stimulates serum testosterone and LH secretion in men with type 2 diabetes and mild biochemical hypogonadism,” Clin Endocrinol (2013). https://pubmed.ncbi.nlm.nih.gov/23153270/
5. George JT, Anderson RA, Millar RP, “Kisspeptin-10 stimulation of gonadotrophin secretion in women is modulated by sex steroid feedback,” Human Reproduction (2012). https://pubmed.ncbi.nlm.nih.gov/22956346/
6. Jayasena CN et al., “Subcutaneous injection of kisspeptin-54 acutely stimulates gonadotropin secretion in women with hypothalamic amenorrhea, but chronic administration causes tachyphylaxis,” J Clin Endocrinol Metab (2009). https://pubmed.ncbi.nlm.nih.gov/19820030/
7. Yeung AC et al., “Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men,” Eur J Endocrinol (2026-08-03). https://pubmed.ncbi.nlm.nih.gov/42549827/
8. Jayasena CN et al., “Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization,” J Clin Invest (2014). https://pubmed.ncbi.nlm.nih.gov/25036713/
9. Abbara A et al., “A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial,” Human Reproduction (2017). https://pubmed.ncbi.nlm.nih.gov/28854728/
10. Comninos AN et al., “Kisspeptin modulates sexual and emotional brain processing in humans,” J Clin Invest (2017). https://pubmed.ncbi.nlm.nih.gov/28112678/
11. Thurston L et al., “Effects of Kisspeptin Administration in Women With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial,” JAMA Netw Open (2022-10-03). https://pubmed.ncbi.nlm.nih.gov/36287566/
12. Mills EG et al., “Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial,” JAMA Netw Open (2023-02-01). https://pubmed.ncbi.nlm.nih.gov/36735255/
13. Abbara A et al., “Kisspeptin receptor agonist has therapeutic potential for female reproductive disorders,” J Clin Invest (2020-12-01). https://pubmed.ncbi.nlm.nih.gov/33196464/ (read for the MVT-602 context; abstract only)
14. Abbara A et al., “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 trials,” Fertil Steril (2024). https://pubmed.ncbi.nlm.nih.gov/37925096/ (abstract and author affiliations)
15. ClinicalTrials.gov, “Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone,” NCT02381288 (results posted 2017-04-07). https://clinicaltrials.gov/study/NCT02381288
16. ClinicalTrials.gov, “A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism,” NCT02369796. https://clinicaltrials.gov/study/NCT02369796
17. ClinicalTrials.gov, “Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448,” NCT01132404. https://clinicaltrials.gov/study/NCT01132404
18. ClinicalTrials.gov API search for “kisspeptin,” run 2026-11-08. https://clinicaltrials.gov/api/v2/studies?query.term=kisspeptin
19. U.S. FDA, “Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks” (content current as of 2026-04-22). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
20. U.S. FDA, “FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024” (kisspeptin-10 evaluation). https://www.fda.gov/media/182089/download
21. U.S. FDA, “Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024.” https://www.fda.gov/media/185412/download
22. Kingdom of the Netherlands, Tractatenblad 2026, 25, publishing the WADA Prohibited List 2026 (published 2026-03-27). https://zoek.officielebekendmakingen.nl/trb-2026-25.html (WADA’s own site blocked automated access)
23. German Sport University Cologne, Department of Biochemistry, “Kisspeptin - a testosterone-stimulating peptide,” doping glossary (last updated 2026-08-14). https://www.dshs-koeln.de/en/universitaet/organisation/institute-einrichtungen/department-of-biochemistry/doping-substances/doping-glossary/k/kisspeptin-a-testosterone-stimulating-peptide
24. Izzi-Engbeaya C et al., “The effects of kisspeptin on food intake in women with overweight or obesity,” Diabetes Obes Metab (2023). https://pubmed.ncbi.nlm.nih.gov/37039248/ (record only; results not read)
25. @Hoostethics, “ranking the most cope supplements” (2026-10-15). https://x.com/Hoostethics/status/2110728908735979632 (text and image read through the fxtwitter mirror, because X blocked direct access)

This article is information, not medical advice.