Sexual & reproductive Reproductive peptide
Kisspeptin-10
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- On the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Kisspeptin-10 is a fragment of a natural reproductive hormone, sold on the "research peptide" market and not FDA-approved. The one human trial of kisspeptin-10 itself was small. In a 2013 proof-of-concept study by George and colleagues, five men with type 2 diabetes and low testosterone took part. An 11-hour infusion in four of them raised luteinizing hormone (LH) from 3.9 to 20.7 IU/L (p = 0.03) and testosterone from 8.5 to 11.4 nmol/L (p = 0.002) against their own baseline, with no placebo group. Much other human work used the longer kisspeptin-54, and the peptide remains investigational.
At a glance
- FDA status
- Non-FDA-approved peptide; remains investigational
- What it is
- Fragment of kisspeptin, which triggers the reproductive hormone axis
- Research
- Real, peer-reviewed human investigational studies, though small and often using a longer form (kisspeptin-54)
- Approval status
- No approved product exists for any use
- Evidence strength
- Moderate research
Summary
Kisspeptin-10 is a fragment of a reproductive hormone studied in small human trials. It remains investigational and has no FDA-approved product.
What is kisspeptin-10?
Kisspeptin-10 is a ten-amino acid fragment of kisspeptin, a natural hormone that acts as a master switch for the reproductive system. It is studied for reproductive and sexual function and sold through "research peptide" channels. A closely related longer natural form, kisspeptin-54, is used in much of the human research. It is not an approved medicine.
How does it work?
Kisspeptin acts on receptors on the brain's GnRH neurons, stimulating the release of GnRH, which in turn drives the pituitary hormones LH and FSH that regulate the gonads. This reproductive-axis role is well established in humans and animals. Additional effects on brain regions involved in sexual and emotional processing are an emerging, investigational area. This describes the mechanism, separate from any approved treatment use.
Is it FDA-approved?
Safety note
Status: Non-FDA-approved peptide; remains investigational
Category: Wellness and performance · Primary body area: Sexual & reproductive
No. There is no FDA-approved kisspeptin product for any indication, and it remains investigational. It was not among the peptides reviewed favorably at the 2026 FDA compounding advisory meetings.
The WADA 2026 Prohibited List bans kisspeptin and its agonist analogues in male athletes.
What does the research show?
Editor’s note
Evidence strength: Moderate research
There is real, peer-reviewed, placebo-controlled human investigational data with a well-characterized reproductive-axis mechanism, but the trials are small, use surrogate endpoints, often used a longer form of the peptide, and no approved efficacy exists.
There is genuine, peer-reviewed human investigational data, with limits. According to PubMed, controlled studies from academic groups have reported that kisspeptin modulates brain processing of sexual and emotional cues in healthy men (here and here) and in women with low sexual desire (here), alongside its well-characterized stimulation of reproductive hormones (review). These studies have limits:
- They are small, early-phase studies.
- They often use brain-imaging rather than clinical endpoints.
- Much of the sexual-behavior work used the longer kisspeptin-54.
The work is investigational and does not amount to an approved, proven treatment.
The only trial of kisspeptin-10 itself was small. In 2013, George and colleagues found that a single intravenous dose raised LH in five men with type 2 diabetes and low testosterone, plus seven healthy men. In four of the men with diabetes, an 11-hour infusion raised LH and testosterone.
| Hormone | Before infusion | After infusion | p-value |
|---|---|---|---|
| LH | 3.9 IU/L | 20.7 IU/L | 0.03 |
| Testosterone | 8.5 nmol/L | 11.4 nmol/L | 0.002 |
The trial had no placebo arm, so it shows feasibility rather than benefit.
The women's trial enrolled 32 premenopausal women with hypoactive sexual desire disorder in a crossover design using kisspeptin-54. Brain scans showed deactivation of the left inferior frontal gyrus, an imaging finding rather than a clinical outcome.
Sources: randomized human studies of kisspeptin and sexual/emotional brain processing (Comninos et al., Journal of Clinical Investigation, 2017, DOI: 10.1172/JCI89519; JCI Insight, 2018, DOI: 10.1172/jci.insight.121958; Thurston et al., JAMA Network Open, 2022, DOI: 10.1001/jamanetworkopen.2022.36131) and a review (Patel et al., Endocrine Reviews, 2024, DOI: 10.1210/endrev/bnad023), all indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
Compare every peptide’s status in the peptide regulatory status database
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