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Evidence tier for each claimed use · ← established · unknown →
Use	E1	E2	E3	E4	E5	E6	E7	E8
E4 Low testosterone / secondary hypogonadism in men				E4

Class C · Gray market

Kisspeptin-10

YNWNSFGLRF

C-terminal arginyl-phenylalanine amide (RF-NH2); the ten C-terminal residues of the kisspeptin precursor encoded by KISS1.

Also: Metastin 45-54, Kisspeptin 112-121 · Codes: KP-10

A ten-amino-acid peptide corresponding to the shortest naturally occurring active fragment of kisspeptin, a hypothalamic signal that drives release of gonadotropin-releasing hormone. It is used as a research tool in human reproductive-physiology studies. It is not approved as a medicine in any jurisdiction checked, and it is sold on the gray market with claims of raising testosterone and libido. The US FDA lists it among bulk substances raising significant safety risks for pharmacy compounding.

US C gray market
EU ? not verified
UK ? not verified
CA ? not verified
AU ? not verified
JP ? not verified
CN ? not verified

01Regulatory status, by jurisdiction

Standing notice. This compound is not approved as a medicine in any jurisdiction tracked here and has no active sponsor seeking approval. Material sold under this name, typically labelled “research chemical, not for human consumption”, is of unverified identity and purity and is not manufactured to pharmaceutical standards.

Jurisdiction	Status	Detail and primary source
US	FDA 503A Category 2	Not approved: no FDA application exists. FDA's 503A bulk drug substances list (updated 14 May 2026) places Kisspeptin-10 in Category 2, bulk substances raising significant safety risks, added 29 September 2023. At the 29 October 2024 Pharmacy Compounding Advisory Committee meeting, reviewing use for secondary hypogonadism in men, the committee voted 0 yes, 11 no on adding it to the 503A bulks list. “503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks” Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (Updated May 14, 2026) · retrieved 2026-10-10
EU UK CA AU JP CN	Not yet verified from a primary source. No status is shown rather than an unsourced one.

Sport (WADA): Prohibited · class S2.2.1. “S2.2.1 TESTOSTERONE-STIMULATING PEPTIDES IN MALES INCLUDING, BUT NOT LIMITED TO: chorionic gonadotrophin (CG) luteinizing hormone (LH) gonadotrophin- releasing hormone (GnRH, gonadorelin) and its agonist analogues (e.g. buserelin, deslorelin, goserelin, histrelin, leuprorelin, nafarelin and triptorelin) kisspeptin and its agonist analogues” WADA source

02What the human evidence shows

Low testosterone / secondary hypogonadism in men

n/cpublished human RCTs

3published human trials

5registered studies

0with posted results

n/c: not counted here; see the cited review.

Small, short physiology studies in healthy men and in men with type 2 diabetes and low testosterone found that intravenous kisspeptin-10 acutely raised luteinising hormone and, during infusion, testosterone. These studies measured hormone levels over hours; none tested symptoms, sexual function, body composition or any clinical outcome, and none lasted weeks or months. Whether any of the designs were randomised was not verified, so the RCT count is left blank. No trial of repeated self-administered kisspeptin-10 in hypogonadism was identified.

[1] Intravenous kisspeptin-10 acutely raised LH and increased LH pulse frequency in healthy men
[2] Kisspeptin-10 infusion raised LH and serum testosterone over hours in men with type 2 diabetes and mildly low testosterone
[3] A single intravenous kisspeptin-10 bolus reset the timing of endogenous GnRH-driven LH pulses in healthy men

Registered-study counts: ClinicalTrials.gov intervention search “kisspeptin-10”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.

Key registered trials

NCT	Title (as registered)	Phase	Status
NCT00914823	Kisspeptin Administration in the Adult	1	Completed
NCT03315325	Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men	3	Completed

03Safety signals

S4Minimal human exposure data

There are no adequate human safety data. The absence of reported harm is not evidence of safety.

04What is unknown

No human data on repeated or long-term kisspeptin-10 exposure; published human studies are acute, lasting hours
No human pharmacokinetic or safety data for subcutaneous or intramuscular self-administration of gray-market material; FDA states it has no, or only limited, safety information for the proposed routes
Immunogenicity is unassessed: FDA's compounding risk summary states injectable kisspeptin-10 may pose a risk of immunogenicity and raises peptide-impurity and characterisation concerns
No kisspeptin-10 study of sexual desire or sexual function in humans was identified; the human brain-imaging and tumescence studies of kisspeptin and sexual processing used kisspeptin-54, a different peptide
Whether continued exposure stimulates or instead suppresses the reproductive axis in men over time is not established for kisspeptin-10
Regulatory status outside the US was not verified from regulator sources for this record

05Product quality

No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.

06Citations

Kisspeptin-10 Is a Potent Stimulator of LH and Increases Pulse Frequency in Men (2011). doi:10.1210/jc.2011-0089
Exploring the pathophysiology of hypogonadism in men with type 2 diabetes: Kisspeptin‐10 stimulates serum testosterone and LH secretion in men with type 2 diabetes and mild biochemical hypogonadism (2013). doi:10.1111/cen.12103
Kisspeptin Resets the Hypothalamic GnRH Clock in Men (2011). doi:10.1210/jc.2010-3046

Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.

07Mechanism

Kisspeptin-10 is an agonist of the kisspeptin receptor (KISS1R, formerly GPR54) on hypothalamic GnRH neurons; in human studies intravenous kisspeptin-10 acutely increased luteinising hormone secretion.

Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.

Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.