Not approved anywhereThe FDA: "There is no approved product in any country containing kisspeptin-10 at this time."[3] No application exists for kisspeptin-54 either.[1] This page does arithmetic and reports the record; it does not suggest amounts.
What is kisspeptin?
Kisspeptin is a family of peptides cut from the KISS1 protein; they all end in the same 10 amino acids, and that ending on its own is kisspeptin-10.[21] In human physiology studies it raised LH, FSH and testosterone in men.[8][9]
- Kisspeptin-10
- YNWNSFGLRF-NH2, C63H83N17O14, 1,302.4 g/mol[22]; our engine: C63H83N17O14, 1,302.46 g/mol
- Kisspeptin-54 (metastin)
- KISS1 residues 68–121 with an amidated end[21]; PubChem: C258H401N79O78, 5,857 g/mol[23]
- Which kisspeptin-54?
- PubChem's formula is the common variant with arginine at KISS1 position 81. The reference sequence, with proline there, comes to C257H396N76O78, 5,798.4 g/mol. Our engine reproduces both, so state which one a number refers to.
- Peptide or protein?
- Kisspeptin-54 has more than 40 amino acids, the line above which U.S. drug law calls a molecule a protein[20]
Check either sequence in the peptide molecular weight calculator with "C-terminal amide" ticked. The what are peptides page explains the 40-amino-acid line.
Kisspeptin-10 vs kisspeptin-54
Kisspeptin-54 carries most of the human trial record, while kisspeptin-10 is the form that was nominated for compounding and placed on the FDA's safety list.[3][6]
| Kisspeptin-10 | Kisspeptin-54 | |
|---|---|---|
| Length | 10 amino acids | 54 amino acids |
| Molecular weight | 1,302.4 g/mol | 5,857 g/mol (Arg-81 form) |
| Nanomoles in 1 mg | 767.8 | 170.7 |
| Main human research | Short hormone-response studies | IVF egg-maturation trials, hypothalamic amenorrhea, sexual desire |
| FDA compounding lists | 503A Category 2[6] | Not on any list |
| WADA 2026 | S2.2.1 (males) | S2.2.1 (males) |
Because kisspeptin-54 is about 4.5 times heavier, the same weight of kisspeptin-10 holds about 4.5 times as many molecules. That is why the research literature counts kisspeptin in nanomoles rather than micrograms, and why the dosage calculator shows nanomoles alongside units.
FDA status and the 2024 committee vote
No kisspeptin product is approved, and kisspeptin-10 is one of only six substances left on the FDA's 503A Category 2 list as of May 14, 2026, because its nomination was never withdrawn.[6]
| Date | What happened |
|---|---|
| Sept 29, 2023 | Placed in 503A Category 2, substances that "raise significant safety risks"[6] |
| Oct 29, 2024 | FDA proposes not adding it to the 503A bulks list; the committee votes 0 yes, 11 no, 0 abstain[3][4] |
| May 14, 2026 | Still in Category 2, one of six substances remaining there[6] |
| Oct 30, 2026 | Not covered by the HHS enforcement-discretion policy[7] |
- What was nominated. An injectable product for male hypogonadism and for preserving sperm production during testosterone therapy.[3]
- FDA's reasons. Not well characterized; possible immune reactions; "no clinical studies that administered kisspeptin-10 to humans via the IM" route; loss of response with repeated exposure in animals; "pro-atherosclerotic effects" in nonclinical models whose clinical relevance "remains unclear"; and approved treatments already exist.[3]
- Human exposure. About 300 people in total, mostly intravenous, and "no published clinical trials" testing kisspeptin-10 on a fixed schedule for more than one day.[3]
- Adverse event reports. One U.S. report: a 17-year-old with hypogonadotropic hypogonadism given a compounded kisspeptin-10 product for six weeks had weight gain and raised estrone, with causality unclear.[3]
- Safety page. The FDA says it "lacks sufficient information to know whether the drug would cause harm when administered to humans".[5]
What Category 2 means for a pharmacy is set out on are peptides legal?
What the kisspeptin research found
Kisspeptin's best-tested use is as an egg-maturation trigger in IVF, where kisspeptin-54 worked in phase 2 trials of 53 to 62 women; none of this research has produced an approved product.[12][13][14]
| Study | Design and people | Form | Reported |
|---|---|---|---|
| Dhillo 2005[8] | Placebo crossover, 6 healthy men | Kisspeptin-54, intravenous | LH, FSH and testosterone rose; plasma half-life 27.6 minutes |
| George 2011[9] | Dose-response, healthy men | Kisspeptin-10, intravenous | LH rose, then responded less at the highest amount tested |
| Jayasena 2011[10] | Healthy men and women, 4–5 per group | Kisspeptin-10 | Response in men and in pre-ovulatory women, none in the follicular phase |
| Jayasena 2009[11] | Randomized, 10 women with hypothalamic amenorrhea | Kisspeptin-54, two weeks | Strong LH rise on day 1, almost none by day 14 |
| Jayasena 2014[12] | 53 women undergoing IVF | Kisspeptin-54, single injection | Eggs matured at every amount tested; clinical pregnancy 23% |
| Abbara 2015[13] | Phase 2, 60 women at high risk of OHSS | Kisspeptin-54, single injection | Egg maturation in 95%; no moderate, severe or critical OHSS |
| Abbara 2017[14] | Placebo-controlled phase 2, 62 women | Kisspeptin-54, with or without a second injection | Good egg yield in 71% vs 45% (p = 0.042) |
| Thurston 2022[15] | Placebo crossover, 32 women with low sexual desire | Kisspeptin-54, intravenous | Changed brain responses on fMRI; "no reported adverse effects" |
| Mills 2023[16] | Placebo crossover, 32 men with low sexual desire | Kisspeptin-54, intravenous | Changed brain activity; more penile tumescence than placebo |
| Yeung 2026[17] | Randomized, 15 healthy men plus 12 controls | Kisspeptin-10, continuous vs 8 hours a day | Continuous: effect gone by day 5. Eight hours a day: LH stayed raised for 12 days |
The recurring finding is tachyphylaxis: given continuously, kisspeptin stops working within days, and the body's own release is pulsed rather than constant.[11][17] All of this is research under medical supervision, not a treatment anyone can buy.
Kisspeptin and sport
Kisspeptin is banned for male athletes: the WADA 2026 list names it in S2.2.1, "testosterone-stimulating peptides in males including, but not limited to: … kisspeptin and its agonist analogues".[18]
- When. S2 substances are prohibited at all times, in and out of competition, and are non-Specified.[18]
- The heading matters. The S2.2.1 entry is written for males; WADA does not name kisspeptin elsewhere.[18]
- 2027. USADA says the 2027 list names "peptides" in general under S0; its advisory does not mention kisspeptin specifically.[19]
More quoted listings on are peptides banned in sports?
Kisspeptin weight math
At 1,302.4 g/mol, 1 mg of kisspeptin-10 is 767.8 nmol; at 5,857 g/mol, 1 mg of kisspeptin-54 is 170.7 nmol. The chart below shows what a vial of kisspeptin-10 holds once liquid is added.
| Vial + liquid | mg/mL | mcg per unit | nmol per unit | Units per 100 mcg |
|---|---|---|---|---|
| 2 mg + 1 mL | 2 | 20 | 15.36 | 5 |
| 2 mg + 2 mL | 1 | 10 | 7.68 | 10 |
| 5 mg + 1 mL | 5 | 50 | 38.39 | 2 |
| 5 mg + 2 mL | 2.5 | 25 | 19.2 | 4 |
| 10 mg + 1 mL | 10 | 100 | 76.78 | 1 |
| 10 mg + 2 mL | 5 | 50 | 38.39 | 2 |
The same arithmetic in general form is on the how to reconstitute peptides page.
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- EpitalonNot approved AEDG tetrapeptide. FDA flags a theoretical cancer risk.
- Thymosin alpha-1Approved in Italy Thymalfasin (Zadaxin). Not approved in the U.S.; 2025 sepsis trial negative.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
- TB-500Not approved A 7-amino-acid fragment of thymosin beta-4. No human trials of TB-500 itself.
- BPC-157 + TB-500 blendNot approved Two peptides in one vial: the arithmetic of a fixed ratio.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
Frequently asked questions
Is kisspeptin FDA-approved?
What does kisspeptin do?
What is the difference between kisspeptin-10 and kisspeptin-54?
Is kisspeptin banned in sport?
Yes for male athletes. WADA's 2026 list names "kisspeptin and its agonist analogues" under S2.2.1, testosterone-stimulating peptides in males, prohibited at all times.[18]
Sources
- openFDA Drugs@FDA searches for thymalfasin, thymosin, kisspeptin, emideltide, hexarelin, examorelin, GHRP, cathelicidin and Zadaxin (no match)
- Search orphan drug designations and approvals (thymalfasin: 4 designations; kisspeptin, hexarelin, emideltide, cathelicidin: none)
- FDA briefing document: kisspeptin-10
- Pharmacy Compounding Advisory Committee, October 29, 2024: transcript (ipamorelin and kisspeptin-10)
- Certain bulk drug substances for use in compounding that may present significant safety risks
- Bulk drug substances nominated for use in compounding under section 503A (category lists)
- Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (91 FR 68526)
- Dhillo WS et al. Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males (J Clin Endocrinol Metab 2005;90:6609–6615)
- George JT et al. Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men (J Clin Endocrinol Metab 2011;96:E1228–E1236)
- Jayasena CN et al. Kisspeptin-10 in healthy men and women across the menstrual cycle (J Clin Endocrinol Metab 2011;96:E1963–E1972)
- Jayasena CN et al. Twice-weekly vs twice-daily kisspeptin-54 in hypothalamic amenorrhea: tachyphylaxis (J Clin Endocrinol Metab 2009;94:4315–4323)
- Jayasena CN et al. Kisspeptin-54 triggers egg maturation in women undergoing IVF (J Clin Invest 2014;124:3667–3677)
- Abbara A et al. Kisspeptin-54 trigger in women at high risk of OHSS: phase 2 trial (J Clin Endocrinol Metab 2015;100:3322–3331)
- Abbara A et al. A second dose of kisspeptin-54 improves oocyte maturation: phase 2 RCT (Hum Reprod 2017;32:1915–1924)
- Thurston L et al. Kisspeptin and brain processing in women with hypoactive sexual desire disorder (JAMA Netw Open 2022;5:e2236131)
- Mills EG et al. Kisspeptin and sexual brain processing in men with HSDD (JAMA Netw Open 2023;6:e2254313)
- Yeung AC et al. Continuous vs intermittent subcutaneous kisspeptin-10 infusion in healthy men (Eur J Endocrinol 2026;195:206–216)
- World Anti-Doping Code: Prohibited List 2026
- Athlete advisory: what's new on the 2027 WADA Prohibited List
- 21 CFR 600.3(h)(6): definition of a protein
- UniProt Q15726: KiSS-1 (metastin 68–121, kisspeptin-10 112–121)
- PubChem CID 25240297: kisspeptin-10
- PubChem CID 71306396: kisspeptin (metastin, KISS-1 68-121)