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.
- How settled this rating is:
- low confidence in the current evidence rating
- Routes studied:
- Other route
- Also known as:
- Kisspeptin, KP-10, metastin fragment
- Last reviewed:
- 2026-08-23
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Evidence passport
Kisspeptin-10
A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.
- Evidence level
- L3Early human studies
- Confidence
- Low confidence in rating
- Regulatory status
- Research / unapproved supply
- Development status
- Unclear
Evidence strength
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.
- Evidence base
- Includes human studies
- Furthest established stage
- Not established
- Human research maturity
- Human physiology research only; no approved product
- Source curation
- Sources fully curated
Routes recorded
Overview
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
How to read these scores
Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.
- Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
- Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
- Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
- Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
- Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.
None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.
How far human research has progressed: Human physiology research only; no approved product
Routes & formulations
Studied / approved routes
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
Discovery
Preclinical
Phase I
Phase II
Phase III
Approved
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.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Nafarelin evidence profile
A GnRH agonist that has been an approved nasal-spray medicine for decades — the standing rebuttal to 'nasal peptide means research chemical'.
- Compare
Compare Kisspeptin-10 vs Nafarelin evidence
Same questions, same fields, side by side — including how much human evidence exists.
- Context
Safety Centre
What approved, investigational and unapproved actually mean for documented human safety.
- Context
Research Desk
How to read animal, early-phase and controlled human studies without over-reading them.
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
This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.
Theoretical / mechanistic concern only
Regulatory status
Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.
Check the regulatory note and linked primary sources for jurisdiction-specific details.
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
Preliminary human outcome research, including small or observational studies. Descriptive exposure studies alone do not demonstrate therapeutic benefit.
What would change our rating?
- Randomised controlled trials in a defined clinical population.
- A published long-term safety dataset.
References and sources
Source transparency
A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.
- Last editorial review
- 2026-08-23
- Recently reviewed · 54 days ago
- Linked curated sources
- 3
- Sources still pending
- 0
- External specialist reviews
- 0
- None recorded for this profile
Review provenance
Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.
Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.
- Regulatory / labelFDA — October 29, 2024 meeting of the Pharmacy Compounding Advisory Committee
- Regulatory / labelFDA — Kisspeptin briefing material (PCAC 2024)
- Regulatory / labelFDA GSRS substance record — Kisspeptin (FS1N52VS3S)
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
These entries record changes to our assessment of the published evidence — not changes to the compound itself.
No recorded changes yet. Baseline position set on 2026-08-23.