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Peptide profile

Kisspeptin: FDA Status, Research and Uses

By Living+. Updated October 25, 2026.

Key takeaway

Kisspeptin is a family of natural peptides from the KiSS-1 gene that bind the GPR54 receptor and switch on reproductive hormones. It is not FDA approved for any use. FDA places kisspeptin-10 in 503A Category 2 over safety concerns. Kisspeptin has been studied for triggering egg maturation in IVF and for low sexual desire [1, 2, 6, 11, 13].

At a glance

Where it stands

Checked

  • FDA approvedNoNo approved product
  • Pharmacy compounding (503A)Category 2Kisspeptin-10 added September 29, 2023; still Category 2 on the FDA list updated May 14, 2026. PCAC voted 0 to 11 against the 503A bulks list on October 29, 2024.
  • Outsourcing facilities (503B)Not nominatedNot on the FDA 503B nominated substances list (updated March 21, 2025).
  • WADA (sport)ProhibitedS2.2.1 Testosterone-stimulating peptides in males (kisspeptin and its agonist analogues)
Same data as the Status Tracker. Checked against 8 sources

Key facts

Class
Neuropeptide; agonist of the kisspeptin receptor (GPR54) [6]
Length
54, 14, 13 or 10 amino acids, depending on the form [6, 10]
Half-life
27.6 minutes for kisspeptin-54 in plasma (one small study in men) [9]
Route in studies
Intravenous infusion or bolus, and subcutaneous injection, in studies [9, 10, 11]
First studied
1996 (KiSS-1 gene described); peptides named in 2001 [5, 6]

How it works

The KiSS-1 gene was first described in 1996 as a gene that held back the spread of melanoma cells. Its role in hormones came later [5].

In 2001, researchers found that the gene's product is cut into peptides of 54, 14 and 13 amino acids. They named them kisspeptins. These peptides bind a receptor called GPR54, which is found in the placenta, pituitary, pancreas and spinal cord [6]. Another group named the 54-amino-acid form metastin [7]. Kisspeptin-10 is the shortest form with full activity [10].

The key link to reproduction came in 2003. People with faulty GPR54 genes did not go through puberty, and mice without the gene had the same problem. This showed the receptor is needed for normal release of gonadotropin-releasing hormone (GnRH) [8].

Kisspeptin acts upstream of GnRH. When it binds GPR54, the brain releases more GnRH, and the pituitary then releases luteinizing hormone (LH) and follicle-stimulating hormone (FSH). In men, kisspeptin infusions raised LH, FSH and testosterone [9, 10].

In women, LH drives the final maturation of eggs before ovulation. That is why kisspeptin-54 was tested as a trigger for egg maturation during IVF [11].

What the research shows

6 human trials1 lab study

  1. 2023Human trial

    Kisspeptin in men with HSDD (Mills et al.)

    Studied for low sexual desire

    37 men with hypoactive sexual desire disorder randomized Double-blind, placebo-controlled, 2-way crossover, single intravenous infusion

    Kisspeptin changed brain activity during sexual videos and increased penile tumescence versus placebo [14].

    Read the study
  2. 2022Human trial

    Kisspeptin in women with HSDD (Thurston et al.)

    Studied for low sexual desire

    40 premenopausal women with hypoactive sexual desire disorder randomized Double-masked, placebo-controlled, 2-way crossover, single intravenous infusion

    Kisspeptin changed brain responses to erotic and attraction cues. No adverse effects were reported [13].

    Read the study
  3. 2015Human trial

    Kisspeptin-54 in women at high risk of OHSS (Abbara et al.)

    Studied as an IVF trigger

    60 women at high risk of ovarian hyperstimulation syndrome Phase 2, multi-dose, open-label, randomized trial

    Egg maturation occurred in 95% of women. No woman developed moderate, severe or critical OHSS [12].

    Read the study
  4. 2014Human trial

    Kisspeptin-54 trigger in IVF (Jayasena et al.)

    Studied for triggering egg maturation

    53 women undergoing IVF Single subcutaneous injection at four dose levels after ovarian stimulation

    Egg maturation was seen at each dose. Clinical pregnancy rate was 23% (12 of 53) [11].

    Read the study
  5. 2011Human trial

    Kisspeptin-10 in healthy men (George et al.)

    Healthy men Intravenous bolus dose-response and infusions up to 22.5 hours versus vehicle

    Kisspeptin-10 raised LH in a dose-dependent way and increased LH pulse frequency and testosterone [10].

    Read the study
  6. 2005Human trial

    First kisspeptin-54 infusion in men (Dhillo et al.)

    6 male volunteers Double-blind, placebo-controlled crossover, 90-minute intravenous infusion

    Kisspeptin-54 raised LH, FSH and testosterone versus saline. Plasma half-life was 27.6 minutes [9].

    Read the study
  7. 2001Lab study

    Kisspeptins identified as GPR54 ligands (Kotani et al.)

    Cell culture Peptide isolation from human placenta and receptor binding studies in cells

    Identified 54-, 14- and 13-amino-acid kisspeptins that bind GPR54 [6].

    Read the study

Doses used in studies

The first study in men used a 90-minute intravenous infusion of kisspeptin-54 at 4 pmol/kg per minute [9]. A kisspeptin-10 study gave intravenous bolus doses of 0.01 to 3.0 μg/kg, and infusions of 1.5 and 4 μg/kg per hour [10].

IVF studies gave a single subcutaneous injection of kisspeptin-54 at 1.6 to 12.8 nmol/kg [11] and 3.2 to 12.8 nmol/kg [12]. The sexual desire trials in men and women used a 75-minute intravenous infusion of kisspeptin-54 at 1 nmol/kg per hour [13, 14]. No dose is FDA approved.

Dosing is set by a licensed provider.

Side effects and safety

There is no FDA-approved kisspeptin product, so there is no FDA label with tested side effect rates [1].

FDA placed kisspeptin-10 in 503A Category 2 on September 29, 2023. FDA said compounded kisspeptin-10 may pose a risk of immune reactions for some routes, may have problems with peptide impurities, and that it has no or only limited safety information for the proposed routes. FDA said it lacks enough information to know whether the drug would cause harm in humans [1].

In 2024, FDA's compounding advisory committee voted 0 to 11 against adding kisspeptin-10 to the 503A bulks list, citing a lack of convincing safety and efficacy data [3].

Published human studies were small and short, mostly single doses. In one trial in women, kisspeptin was well tolerated with no reported adverse effects [13]. In an IVF trial in women at high risk of ovarian hyperstimulation syndrome, no woman developed moderate, severe or critical OHSS [12]. These trials used a single injection or short infusions, so they do not show long-term safety [9, 11, 13].

Common questions

Is kisspeptin FDA approved?

No. No kisspeptin product is FDA approved. FDA lists kisspeptin-10 in 503A Category 2, substances that raise significant safety risks [1, 2].

Can a compounding pharmacy make kisspeptin?

Kisspeptin-10 is in 503A Category 2, and FDA advisers voted 0 to 11 in 2024 against adding it to the 503A bulks list [2, 3]. It does not appear on the FDA 503B nominated list [16].

Is kisspeptin banned in sports?

Yes. The WADA 2026 Prohibited List names kisspeptin and its agonist analogs under S2.2.1, testosterone-stimulating peptides in males, prohibited at all times [4].

Does kisspeptin raise testosterone?

In small studies of men, kisspeptin-54 and kisspeptin-10 infusions raised LH and testosterone [9, 10]. This was studied for research, not as an approved use.

What is kisspeptin studied for?

It was studied for triggering egg maturation in IVF [11, 12] and for low sexual desire in men and women [13, 14].

What is the difference between kisspeptin-10 and kisspeptin-54?

Kisspeptin-54 is the major circulating form in humans [11]. Kisspeptin-10 is the shortest form with full activity [10]. FDA's Category 2 listing names kisspeptin-10 [1].

Is kisspeptin a treatment for low libido?

No kisspeptin product is approved for this. Two small single-dose trials studied it for hypoactive sexual desire disorder and measured brain responses [13, 14].

What are the side effects of kisspeptin?

There is no FDA label. FDA says it has no or only limited safety information for the proposed routes [1]. One small trial reported no adverse effects [13].

Sources

  1. FDA: Certain bulk drug substances that may present significant safety risks
  2. FDA: 503A nominated bulk drug substances categories (updated May 14, 2026)
  3. FDA: PCAC final summary minutes, Oct 29, 2024
  4. WADA: 2026 Prohibited List
  5. Lee et al. 1996, J Natl Cancer Inst (PubMed)
  6. Kotani et al. 2001, J Biol Chem (PubMed)
  7. Ohtaki et al. 2001, Nature (PubMed)
  8. Seminara et al. 2003, N Engl J Med (PubMed)
  9. Dhillo et al. 2005, J Clin Endocrinol Metab (PubMed)
  10. George et al. 2011, J Clin Endocrinol Metab (PubMed)
  11. Jayasena et al. 2014, J Clin Invest (PubMed)
  12. Abbara et al. 2015, J Clin Endocrinol Metab (PubMed)
  13. Thurston et al. 2022, JAMA Netw Open (PubMed)
  14. Mills et al. 2023, JAMA Netw Open (PubMed)
  15. FDA: Bulk drug substances used in compounding under section 503A
  16. FDA: 503B nominated bulk drug substances list (March 21, 2025)

Updated October 25, 2026. Educational information, not medical advice.