Research information only, not medical advice. Kisspeptin is a naturally occurring neuropeptide that activates the KISS1 receptor (GPR54), acting upstream of GnRH to regulate the hypothalamic-pituitary-gonadal axis. It is not approved by the FDA for any indication. It has been used extensively in academic clinical research (notably in the UK and US) for reproductive endocrinology, and is available through compounding pharmacies by prescription, representing the prescribing provider's independent clinical judgment rather than an approved use.
Kisspeptin at a glance
Kisspeptin's evidence base comes from academic clinical research rather than approval trials. A 2024 systematic review covering 29 clinical trials describes applications relevant to secondary amenorrhoea, regulation of puberty onset, ovarian function, trophoblast invasion, fertility regulation, parturition and lactation, reflecting its role upstream of GnRH in the hypothalamic-pituitary-gonadal axis. It remains investigational, with no FDA-approved product or labelling.
See how we grade evidence for the methodology behind this page.
Evidence profile
129 studies- Human RCT 1 · 1%
- Human trial 17 · 13%
- Review 29 · 22%
- Animal 45 · 35%
- In-vitro 31 · 24%
- Unknown 6 · 5%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
Clinical trials
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Kisspeptin Administration in the Adult
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Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448
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Kisspeptin in the Evaluation of Delayed Puberty
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Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
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The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
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Neuropeptides in Human Reproduction
- NCT01956851 COMPLETED
Association of Kisspeptin Levels With Insulin Secretion in Diabetes Mellitus
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Reproductive Hormones During Sustained Administration of Kisspeptin
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A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism
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Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone
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Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells
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Administration of Kisspeptin in Patients With Hyperprolactinemia
- NCT03018314 COMPLETED
Serum Kisspeptin Levels in Infertile Women
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Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.
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Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men
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KP-10 and Insulin Secretion in Men
- NCT03877939 COMPLETED
Detection of Kisspeptins and miRNAs in Patients With Non-viable Pregnancy
- NCT03940495 COMPLETED
Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
- NCT04012632 COMPLETED
Kisspeptin/GPR54 Pathway and Early Puberty
- NCT04371991 COMPLETED
Kisspeptin Levels in Early Pregnancy
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Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
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Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
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Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
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Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
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Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
- NCT05835089 UNKNOWN
Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases
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Kisspeptin Administration Subcutaneously to Patients With IHH
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Recall by Genotype: Neuropeptide Stimulation
- NCT05971836 COMPLETED
The Molecular Basis of Inherited Reproductive Disorders
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Dampening the Reproductive Axis With Continuous Kisspeptin
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Kissing as a Protective Factor Against Acidic pH in Saliva
- NCT06545994 RECRUITING
A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
- NCT06775990 COMPLETED
Molecules Associated with Pediatric Obesity
- NCT06793098 RECRUITING
Functional Proteins in Polycystic Ovary Syndrome
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Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
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Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
Indexed research
Sorted by evidence level, strongest first.
- Human RCT 2025OR14-07 Gonadotropin Response Following Intranasal Kisspeptin Administration Is Augmented in Women With Hypothalamic Amenorrhoea Compared To Healthy Women
Intranasal kisspeptin-54 administration resulted in greater gonadotropin release in women with hypothalamic amenorrhea compared to healthy women in a randomized placebo-controlled crossover trial.
- Human trial 2026Kisspeptin-10/basal LH ratio improves differentiation of central precocious puberty and premature thelarche
This study evaluated the diagnostic performance of the kisspeptin-10/basal LH ratio in distinguishing central precocious puberty from premature thelarche in girls aged 6-9 years.
- Human trial 2026Dynamic modulation of LH secretion by continuous kisspeptin infusion in healthy men
This study examined the effects of continuous kisspeptin infusion on LH secretion in three healthy men.
- Human trial 2025Kisspeptin as a marker for male infertility: a comparative study of serum and seminal plasma kisspeptin between fertile and infertile men
This comparative study investigated serum and seminal plasma kisspeptin levels in fertile and infertile men, finding significantly lower serum kisspeptin in fertile men compared to infertile men regardless of semen parameters, while seminal plasma kisspeptin showed no significant difference.
- Human trial 2025Serum Kisspeptin levels in patients undergoing maintenance hemodialysis: a case-control study protocol
This study protocol aims to compare serum Kisspeptin levels between maintenance hemodialysis patients and healthy controls to investigate the role of Kisspeptin in uremic hypogonadism.
- Human trial 2026Dynamic Modulation of LH Secretion by Continuous Kisspeptin Infusion in Healthy Men
This study examined the effects of continuous kisspeptin infusion on LH secretion in three healthy men, finding an initial increase in LH levels followed by a decline.
- Human trial 2026Serum Kisspeptin in Iraqi Men with Beta-Thalassemia Major: A Cross Sectional Study
A cross-sectional study found elevated kisspeptin levels and suppressed gonadotropins and testosterone in Iraqi men with beta-thalassemia major, suggesting hypothalamic-pituitary-gonadal axis disruption due to iron overload.
- Human trial 2026Serum Spexin, Kisspeptin-1, Substance P, and Neurokinin-1 Receptor Levels in Hyperemesis Gravidarum: A Prospective Paired Follow-Up Study
This prospective paired follow-up study found no significant differences in serum levels of spexin, kisspeptin-1, substance P, and neurokinin-1 receptor between acute hyperemesis gravidarum and symptom-resolved periods.
- Human trial 2025The association between 1st trimester serum kisspeptin level and antenatal complications
The study investigated the association between first trimester serum kisspeptin levels and antenatal complications, suggesting a potential role for kisspeptin as a biomarker for fetal growth retardation.
- Human trial 2026Investigation of Plasma Metastin Levels in Reproductive-Age Women with Polycystic Ovary Syndrome Diagnosed with Adnexal Masses
This prospective case-control study investigated plasma metastin levels in reproductive-age women with polycystic ovary syndrome and adnexal masses, finding no significant difference in metastin levels between those with and without masses, nor a correlation with tumor markers.
+ 119 more studies indexed for Kisspeptin.
Frequently asked questions
- Is Kisspeptin approved for human use?
- Kisspeptin is a naturally occurring neuropeptide that activates the KISS1 receptor (GPR54), acting upstream of GnRH to regulate the hypothalamic-pituitary-gonadal axis. It is not approved by the FDA for any indication. It has been used extensively in academic clinical research (notably in the UK and US) for reproductive endocrinology, and is available through compounding pharmacies by prescription, representing the prescribing provider's independent clinical judgment rather than an approved use.
- What does the research on Kisspeptin show?
- Kisspeptin's evidence base comes from academic clinical research rather than approval trials. A 2024 systematic review covering 29 clinical trials describes applications relevant to secondary amenorrhoea, regulation of puberty onset, ovarian function, trophoblast invasion, fertility regulation, parturition and lactation, reflecting its role upstream of GnRH in the hypothalamic-pituitary-gonadal axis. It remains investigational, with no FDA-approved product or labelling.