Peptide dossier, updated Nov 1, 2026

Kisspeptin-10

Kisspeptin-10, the shortest fragment of kisspeptin that keeps full activity, a ten-amino-acid peptide. A naturally occurring signalling peptide that switches on the brain’s reproductive hormone system. It has no FDA-approved use. Human studies are small research studies, mostly from academic centers. FDA lists it as a compounding substance with no or limited safety information for the routes proposed. This page lays out what each source actually says.

See all 12 verified records for Kisspeptin-10 on the Records page

In plain terms

Approved for: Nothing from FDA. It is not an approved drug. It is listed in FDA’s category 2 for 503A compounding.

What it is: A short version of kisspeptin, a hormone-like signal from the brain that tells the pituitary to release the hormones that drive the testes and ovaries.

What it is said to do, and by whom:

Researchers, 2011: a single injection raised luteinizing hormone in healthy men, with the biggest rise at 1 microgram/kg and a smaller rise at 3 micrograms/kg.
Researchers, 2026: daily subcutaneous infusions for 12 days kept gonadotropin and testosterone levels raised in 15 healthy men across three small studies.
FDA: says it has no, or only limited, safety information for the routes proposed, so cannot tell whether it would cause harm.
We did not collect sellers’ claims for this compound.

How strong the evidence is: Small human research studies in healthy volunteers and some patients, mostly short, showing a hormone effect. We found no trial of a clinical outcome such as fertility or testosterone-related symptoms.

FDA safety-risk page

Listed (503A)

FDA says compounded kisspeptin-10 may pose immunogenicity risk and peptide-impurity complexities, and that it has no, or only limited, safety information for the proposed routes, so it lacks enough information to know whether the drug would cause harm. Added Sep 29, 2023.

HHS enforcement, Oct 30

Not covered

The draft policy’s covered list names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Kisspeptin-10 is not one of them. Draft policy. Not binding.

FDA advisory panel, July

Not reviewed

FDA’s Federal Register notice for the July 23–24 meeting lists seven peptides. Kisspeptin-10 is not among them.

WADA prohibited list

Kisspeptin named

The 2026 list names “kisspeptin and its agonist analogues” in section S2.2.1, testosterone-stimulating peptides in males. We read WADA’s own file through a text extraction and cross-checked a copy hosted by an athletics federation.

Human evidence

Small academic studies

ClinicalTrials.gov returns 36 studies, many of them academic phase 1 and 2 work and some that only measure kisspeptin levels. One phase 2 study in hypogonadotropic hypogonadism has posted results.

FDA review

FDA’s safety-risk page (content current Apr 22, 2026) is the one FDA document on kisspeptin-10 that we read.

What the page says

It lists “Kisspeptin-10” in category 2 under the 503A interim policy, added Sep 29, 2023.
It says compounded drugs containing kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with peptide-related impurities and API characterization.
It says FDA has no, or only limited, safety-related information for the proposed routes of administration, and so lacks sufficient information to know whether the drug would cause harm when administered to humans.

What we did not find

The page does not describe any adverse event reports. This is a statement about missing information, not about a known harm.
We found no FDA briefing document, advisory committee review or press release specific to kisspeptin-10.

Sources: FDA: bulk substances that may present significant safety risks

Published research

PubMed returns 318 results for kisspeptin-10 in the title or abstract as of Nov 1, 2026. Most concern reproductive biology, puberty or cancer. We read abstracts of the human studies below.

What the papers show

Healthy men, 2011. Intravenous kisspeptin-10 raised luteinizing hormone dose-dependently, peaking at 1 microgram/kg, with a smaller response at 3 micrograms/kg. A 22.5-hour infusion raised LH and testosterone. J Clin Endocrinol Metab PubMed
Healthy men, 2026. 15 men in three small randomized studies. Subcutaneous infusions raised LH, FSH and testosterone. Continuous infusion over 5 days did not sustain the gonadotropin rise, while 8-hour daily infusions over 12 days did (LH rise p = .003 versus vehicle). Eur J Endocrinol PubMed
Healthy men, kisspeptin-54, 2005. A longer kisspeptin form. Six men received a 90-minute infusion and a saline control in random order; LH, FSH and testosterone were higher with kisspeptin-54. J Clin Endocrinol Metab PubMed
Age and kisspeptin-10, 2019. A single 1 microgram/kg bolus in adult, middle-aged and older men. LH rose in all groups; testosterone rose significantly only in the younger adult group. Andrologia PubMed
Review, 2006. GPR54 and kisspeptin in reproduction. Hum Reprod Update PubMed

Read with care

These are short physiology studies. They show that a hormone rises; they do not show a clinical benefit.
Sample sizes are small, from 4 to 7 men per sub-study in the 2026 paper.
We read abstracts only, not full text, funding or disclosures.

Registered trials

ClinicalTrials.gov returns 36 studies for kisspeptin as of Nov 1, 2026. Several only measure kisspeptin levels. We list four that give the drug. Registry entries are written by sponsors and are not reviewed for scientific merit.

Registry	Study	Status	What the record says
NCT04648969	Phase 2, prolonged pulsatile kisspeptin in hypogonadotropic hypogonadism (Seminara)	Completed, Aug 2025	Results are posted on the registry. We did not read them.
NCT00914823	Phase 1, kisspeptin administration in adults (Massachusetts General Hospital)	Completed, Oct 2021	No results posted.
NCT01438034	Phase 1, kisspeptin in the evaluation of delayed puberty (MGH)	Completed, Sep 2021	No results posted.
NCT07224490	Phase 1, kisspeptin to quantify GnRH neuron function in health and disease (Seminara)	Recruiting; est. completion May 2030	No results.

We did not open each record or check each study’s dose, form (kisspeptin-10 or -54) or sponsor.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; Kisspeptin-10 is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
Federal Register Docket HHS policy appendix BakerHostetler summary
July 23–24, 2026Regulatory
FDA advisory committee meets on seven peptides; Kisspeptin-10 is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list Kisspeptin-10.
Federal Register notice Holland & Knight summary
Apr 22, 2026Regulatory
FDA’s safety-risk page lists Kisspeptin-10
FDA lists kisspeptin-10 and says it lacks sufficient information to know whether the drug would cause harm for the proposed routes.
FDA page
2026Literature
Twelve-day subcutaneous kisspeptin-10 study in healthy men reports sustained LH rises
15 men. Published in Eur J Endocrinol.
PubMed
Jan 1, 2026Anti-doping
WADA’s 2026 Prohibited List names “kisspeptin and its agonist analogues” in S2.2.1
The list names it among testosterone-stimulating peptides in males. We read WADA’s own file through a text extraction.
WADA 2026 list (PDF)
Sep 29, 2023Regulatory
FDA places kisspeptin-10 in category 2 under the 503A interim policy
Date added, per FDA’s safety-risk page.
FDA page
2011Literature
First study of kisspeptin-10 in men reports dose-dependent LH rises
Healthy men. Published in J Clin Endocrinol Metab.
PubMed

Still not covered

Left off rather than guessed:

HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not kisspeptin-10.
FDA review: we found no FDA briefing document or advisory committee evaluation for kisspeptin-10. FDA’s notice for the July meeting does not name it.
WADA wording: the list names “kisspeptin and its agonist analogues” under testosterone-stimulating peptides in males, and does not name kisspeptin-10 separately. We take it to include kisspeptin-10; WADA does not say so in the text we read.
Warning letters: we found none that name kisspeptin-10. Absence is not proven.
Patents and SEC filings: not researched for this dossier.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.