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Reproductive & sexual health

Kisspeptin-10

A fragment of the body's own reproductive signalling peptide, studied in human physiology research but not an approved therapy.

L3Early humanExperimental / researchUnclearLow confidenceLast reviewed 2026-08-23
Other

Also known as: Kisspeptin, KP-10, metastin fragment

Evidence passport

Last reviewed 2026-08-23

Evidence level
L3Early human
Confidence
Low confidence
Human efficacy
35/100
Human safety
35/100
Regulatory status
Experimental / research
Development
Unclear
Routes
Other
Evidence base
Includes human data
Furthest stage
Not established
Source curation
Sources fully curated
Clinical maturity
Human physiology research only; no approved product

Overview

Human evidence35/100
Preclinical evidence55/100
Human safety evidence35/100

Clinical maturity: Human physiology research only; no approved product

Routes & formulations

Studied / approved routes

Other

Human physiology studies have used parenteral administration (infusion or injection) under research conditions. The curated record does not establish a consumer route, and none should be inferred from what is marketed.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

UnclearFurthest stage not established in our curated record

Active academic endocrine research, but no established pharmaceutical development programme in the curated record.

What it is

Kisspeptin is an endogenous peptide that sits near the top of the reproductive hormone cascade, triggering GnRH release. Kisspeptin-10 is the shortest active fragment used in research.

What people claim

  • Restores reproductive hormone signalling in hypogonadism
  • Investigational fertility applications

What the evidence actually says

Real human endocrine studies exist — this is legitimate physiology research, not folklore. But demonstrating that a hormone axis responds in a research study is not the same as establishing a therapy, and the FDA's advisory committee found the evidence insufficient for compounding use.

Human evidence

  • Controlled human studies demonstrating effects on LH/FSH and reproductive hormone release in research settings.
  • No randomised trials establishing clinical benefit for any marketed use.

Preclinical evidence

  • Extensive animal work establishing the kisspeptin-GnRH axis in reproduction.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Activates KISS1R (GPR54) on GnRH neurons, driving pulsatile GnRH and downstream LH/FSH release.

Safety and unknowns

  • Short-term research administration has been tolerated in studies, but there is no systematic long-term human safety dataset.
  • The FDA PCAC weighed evidence against 503A bulks-list inclusion in 2024.

Cancer relevance

Theoretical / mechanistic concern only

Kisspeptin signalling has context-dependent roles in cancer biology, including metastasis-suppression research. This is mechanistic context, not a demonstrated risk or benefit of administration.

Regulatory status

Not an FDA-approved therapy. The FDA's Pharmacy Compounding Advisory Committee concluded in October 2024 that the evidence and safety data were insufficient for the proposed compounding use (secondary hypogonadism) and weighed against including kisspeptin on the 503A bulk substances list.

Evidence grade

L3Early humanLow confidence

Small, short or uncontrolled human studies. Suggestive, not conclusive.

What would change our rating?

  • Randomised controlled trials in a defined clinical population.
  • A published long-term safety dataset.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.