Bottom line
Kisspeptin-10 (KP-10) is a 10-amino-acid C-terminal fragment of the KISS1 gene product (kisspeptin). It is an An entry with substantial scientific visibility or identity value. Biological rationale and non-human evidence do not establish patient benefit. Источник определения: Scope and selection methodology · Глоссарий agonist of the kisspeptin receptor (KISS1R, GPR54), a key regulator of GnRH secretion and reproductive function. KP-10 is A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Источник определения: Scope and selection methodology · Глоссарий only — no FDA- or EMA-approved product was identified — with ongoing phase 1/2 trials exploring its use in hypothalamic amenorrhea, hypogonadotropic hypogonadism, and as a diagnostic tool for GnRH neuronal function.
Identity and composition
| Field | Verified information |
|---|---|
| Preferred name | Kisspeptin-10 |
| Key aliases | KP-10; metastin (45-54); KISS1 (112-121); kisspeptin decapeptide |
| Molecular/sequence identity | Y-N-W-N-S-F-G-L-R-F-NH2 (Tyr-Asn-Trp-Asn-Ser-Phe-Gly-Leu-Arg-Phe-NH2) |
| Modifications/form | C-terminal amidation (essential for activity); minimal bioactive kisspeptin fragment |
| Stable identifiers | The record number of a compound in PubChem, the atlas's primary structure-asset source. A registry record or depiction does not authenticate a commercial sample. Источник определения: Identity and structure assets methodology · Глоссарий 25240297; UniProt Q8NG95 (KISS1 precursor) |
| Identity caveats | Longer kisspeptins (KP-54, KP-14, KP-13) share the same C-terminal 10-mer; KP-10 is the shortest fully active fragment. Not to be confused with kisspeptin-54, which has a longer plasma The time for the amount of a substance in the body to fall by half. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий |
Development and approval status
| Jurisdiction | Status and indication | Product/source | As of |
|---|---|---|---|
| No jurisdiction | A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Источник определения: Scope and selection methodology · Глоссарий; phase 1/2 clinical trials only | Research-grade peptide | 2026 |
Registered trials include NCT05633966 (KASPR, phase 1, completed 2025), NCT05896293 (phase 2, recruiting), NCT04648969 (phase 2, completed 2025), all investigating Administered into the tissue layer under the skin. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий or Administered into a vein. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий pulsatile KP-10 in HH and HA.
- UNITED STATES
- No UNITED STATES row is present in the source status table
- EU/EEA
- No EU/EEA row is present in the source status table
- UNITED KINGDOM
- No UNITED KINGDOM row is present in the source status table
- OTHER DOCUMENTED
- No jurisdiction: Investigational; phase 1/2 clinical trials only
Sport status: WADA: The 2026 List explicitly names kisspeptin and its agonist analogues under S2.2.1 as testosterone-stimulating peptides prohibited at all times in males. Kisspeptin stimulates endogenous GnRH release but is not itself a GnRH analogue.
Mechanism and pharmacology
An entry with substantial scientific visibility or identity value. Biological rationale and non-human evidence do not establish patient benefit. Источник определения: Scope and selection methodology · Глоссарий agonist at KISS1R (GPR54) on hypothalamic GnRH neurons. KP-10 binding stimulates GnRH release, which in turn triggers LH and FSH secretion from the anterior pituitary. The effect is dose-dependent and modulated by baseline sex-steroid levels. In direct human comparison, Administered into a vein. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий KP-10 stimulates LH less potently than exogenous GnRH but is thought to produce a more physiological pattern of gonadotropin release. The time for the amount of a substance in the body to fall by half. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий is very short (~4 min), limiting chronic use without pulsatile pump delivery.
Evidence by claim
| Claim/indication | Stage | Grade | Best human evidence | Main result | Important limitations |
|---|---|---|---|---|---|
| Stimulation of LH/FSH in healthy men and women | Phase 1/2 | B | Multiple controlled human studies | Dose-dependent LH/FSH increase after i.v., s.c., or i.n. administration | Short The time for the amount of a substance in the body to fall by half. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий; pulsatile delivery required; small n |
| Treatment of hypogonadotropic hypogonadism (HH) | Phase 1/2 | C | A study in which participants and investigators know what is administered. Источник определения: Neutral gloss; usage context: Evidence grading methodology · Глоссарий, single-group studies | Increased LH pulsatility; some ovarian follicle development | No An inactive comparator used in a controlled study. Источник определения: Neutral gloss; usage context: Evidence grading methodology · Глоссарий-controlled efficacy data; small n |
| Treatment of hypothalamic amenorrhea (HA) | Phase 1/2 | C | Open-label studies ongoing | Preliminary evidence of LH increase; follicular development signal | Data incomplete; trials recruiting |
- AУровень A: Установлен для конкретного зарегистрированного применения
- BУровень B: Умеренные данные на людях
- CУровень C: Предварительные данные на людях
- DУровень D: Только доклинические
- EУровень E: Анекдотическое/маркетинговое утверждение
- XУровень X: Данные противоречат утверждению или не подтверждают его
Text alternative for the claim-evidence diagram. Each grade is defined below:
- A — Established for a specific labeled use
- 0 claims
- B — Moderate human evidence
- 1 claim: Stimulation of LH/FSH in healthy men and women
- C — Preliminary human evidence
- 2 claims: Treatment of hypogonadotropic hypogonadism (HH); Treatment of hypothalamic amenorrhea (HA)
- D — Preclinical only
- 0 claims
- E — Anecdotal/marketing claim
- 0 claims
- X — Evidence contradicts or does not support the claim
- 0 claims
Key studies
| Study | Design/population | Exposure studied | Endpoints and result | Limitations |
|---|---|---|---|---|
| KP-10 vs KP-54 vs GnRH (Chan 2015) | Single-blind; healthy men (n=5 per dose) | i.v. infusion at 0.1-1.0 nmol/kg/h × 3 h | GnRH ~2-3× more potent than KP-10 in LH/FSH rise | Small n; acute exposure only; single-blind |
| KASPR (NCT05633966) | A study in which participants and investigators know what is administered. Источник определения: Neutral gloss; usage context: Evidence grading methodology · Глоссарий; women with HA (n=13) | Pulsatile s.c. KP-10 × 2 weeks | LH pulse increase; follicle development assessed | Completed 2025; results not fully published |
| Intranasal KP-54 (Lancet EBioMed 2025) | A study in which participants are assigned to the study material or a comparator by chance. Источник определения: Neutral gloss; usage context: Evidence grading methodology · Глоссарий crossover; healthy and HA patients | Intranasal KP-54 (includes KP-10 active core) | Significant LH rise with intranasal KP-54 | Not KP-10 specifically; included KP-54 data |
Dose and administration evidence
Approved labeled regimen
Not applicable — not approved.
Studied regimens (not recommendations)
Administered into a vein. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий bolus: 0.3-1.0 nmol/kg (single dose).
Administered into the tissue layer under the skin. Источник определения: Neutral gloss; usage context: Routes, devices, and absorption primer · Глоссарий pulsatile: ~0.24-1.8 nmol/kg per pulse every ~60-240 min via pump for up to 2 weeks.
Intranasal: Not studied with KP-10 specifically; KP-54 used at 3.2-25.6 nmol/kg as spray.
What is not established
No established or recommended human dose.
Safety
Human-study signals
Generally well-tolerated in acute studies.
No serious adverse events reported in phase 1/2 trials.
Theoretical risk of desensitisation with continuous exposure.
No long-term safety data.
Unknowns and product-quality risks
No chronic toxicity or carcinogenicity data.
Reproductive safety unknown.
Products sold online as "kisspeptin-10" are unregulated; purity and dose are not verified.
Interactions and special populations
Not studied in pregnancy, lactation, children, or elderly.
Effect may be modulated by baseline oestradiol in women.
Interactions with hormonal contraceptives or GnRH analogues unstudied.
Regulatory, compounding, and sport notes
Approval: No FDA-approved product or EMA-authorized medicine was identified; status elsewhere requires a current national-register check.
The World Anti-Doping Agency; its Prohibited List classifies many peptides as prohibited substances in sport. Источник определения: WADA and sport regulation brief · Глоссарий: The 2026 List explicitly names kisspeptin and its agonist analogues under S2.2.1 as testosterone-stimulating peptides prohibited at all times in males. Kisspeptin stimulates An entry with substantial scientific visibility or identity value. Biological rationale and non-human evidence do not establish patient benefit. Источник определения: Scope and selection methodology · Глоссарий GnRH release but is not itself a GnRH analogue.
Compounding: No general exemption or lawful-compounding conclusion follows from A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Источник определения: Scope and selection methodology · Глоссарий status; applicable rules are product-, jurisdiction-, and fact-specific.
Evidence gaps
Chronic safety and desensitisation risk.
Phase 2/3 efficacy for ovulation induction.
Optimal delivery route (pump vs. nasal vs. depot).
Comparison with conventional gonadotropin therapy.
Long-term reproductive outcomes.
Search notes
Databases and registries: PubMed, ClinicalTrials.gov, IUPHAR/BPS Guide to Pharmacology
Search terms: kisspeptin-10, KP-10, KISS1, metastin, GnRH neuron, hypothalamic amenorrhea
Last searched: 2026-08-06
Inclusion emphasis: Human clinical studies, registered trials
Sources
Chan YM, et al. Direct comparison of kisspeptin-10, kisspeptin-54 and GnRH. Hum Reprod. 2015;30(8):1849-56. PMID 26089302.
ClinicalTrials.gov NCT05633966 (KASPR), NCT05896293, NCT04648969.
Abbara A, et al. Intranasal kisspeptin-54 stimulates gonadotropin release. EBioMedicine. 2025. https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00133-1/fulltext
IUPHAR/BPS Guide to Pharmacology – kisspeptin receptor. https://www.guidetopharmacology.org/GRAC/FamilyIntroductionForward?familyId=34
Seminara SB, et al. Kisspeptin administration in humans. N Engl J Med. 2006;355(15):1615. Cited for foundational methodology.
PubChem CID 25074872 (kisspeptin-10).
WADA. 2026 Prohibited List. https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list
