Where the claims come from
The reproductive endocrinology is genuine: kisspeptin reliably stimulates luteinising hormone, and academic groups at Massachusetts General Hospital and Imperial College have studied it in fertility settings. Marketing extends that to testosterone and libido in healthy men, which the trials were not designed to address.
What evidence exists outside the registry
The registered trials are mostly small Phase 1 and Phase 2 physiology studies rather than treatment trials. Two are labelled Phase 3 but are small academic studies using a laboratory reagent, so the phase label overstates them considerably. A caution on naming: bare "kisspeptin" also returns trials of kisspeptin-54, a longer fragment and a different molecule.
- NCT01667406 — kisspeptin 112-121 in reproductive endocrinology — Representative of the academic trials that use the KP-10 fragment.
- FDA — bulk drug substances that may present significant safety risks — Kisspeptin-10 is on the ACTIVE Category 2 list under 503A, added 29 September 2023.
Approved for, studied for, sold for
Three separate lists, kept by three separate processes: a regulator decides the first, researchers the second, and whoever is selling it the third. They are often not the same list, and the differences are the most useful thing on this page.
Not approved by the FDA for any use. Nothing has been reviewed for safety, effectiveness or manufacturing quality.
- Hypogonadotropic Hypogonadism
- Reproductive Disorder
- GnRH Deficiency
- Hyperprolactinemia
- Hypothalamic Amenorrhea
- Kallmann Syndrome
- PCOS
- Agonadism
- Testosterone support
- Fertility
- Libido
Is it studied for what it's sold for?
Each claim below is matched against the condition and title fields of every registered trial. Not listed means no trial names it as a studied condition — not that it has been disproven, and not that no trial touches it indirectly.
Every trial on record
Every registered human study we can find for Kisspeptin-10. Click any ID to read the original record — we would rather you checked us than trusted us.
| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| NCT07224490 | Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease | Reproductive Disorder, Neurodegeneration | Phase 1 | Recruiting now | 40 |
| NCT07224438 | Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea | Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism | Phase 2 | Recruiting now | 20 |
| NCT05896293 | Kisspeptin Administration Subcutaneously to Patients With IHH | Hypogonadotropic Hypogonadism | Phase 2 | Recruiting now | 36 |
| NCT00914823 | Kisspeptin Administration in the Adult | Hypogonadotropic Hypogonadism, Kallmann Syndrome | Phase 1 | Completed | 256 |
| NCT03771326 | KP-10 and Insulin Secretion in Men | Kisspeptin Action on Insulin in Healthy Normal Men, Kisspeptin Action on Insulin in Obese Diabetic Men | Phase 3 | Completed | 14 |
| NCT03315325 | Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men | Sterility, Reproductive | Phase 3 | Completed | 15 |
| NCT02956447 | Administration of Kisspeptin in Patients With Hyperprolactinemia | Hyperprolactinemia, Hypogonadism | Phase 2 | Completed | 36 |
| NCT03286517 | Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys. | Reproductive Physiological Phenomena | Phase 3 | Completed | 30 |
| NCT01952782 | Neuropeptides in Human Reproduction | Hypogonadotropic Hypogonadism | Phase 1 | Completed | 61 |
| NCT05971849 | Dampening the Reproductive Axis With Continuous Kisspeptin | Reproductive Disorder, PCOS | Phase 1 | Completed | 8 |
| NCT05633966 | Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders | Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism | Phase 1 | Completed | 13 |
| NCT04648969 | Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism | Hypogonadotropic Hypogonadism | Phase 2 | Completed | 18 |
| NCT01438073 | Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling | Hypogonadotropic Hypogonadism, Healthy Postmenopausal Women | Phase 1 | Completed | 96 |
| NCT01438034 | Kisspeptin in the Evaluation of Delayed Puberty | Delayed Puberty, Kallmann Syndrome | Phase 1 | Completed | 24 |
| NCT05901467 | Recall by Genotype: Neuropeptide Stimulation | Reproductive Disorder | Phase 1 | Stopped early | 16 |
| NCT04532801 | Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance | Insulin, Glucose | Phase 1 | Withdrawn before enrolling | 0 — nobody enrolled |
| NCT05456854 | Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp | Metabolic Disease | Phase 1 | Withdrawn before enrolling | 0 — nobody enrolled |
What regulators have said
Compounded drugs containing Kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has no, or only limited, safety-related information.
This is a statement about compounding Kisspeptin-10 into medicines — FDA is saying a pharmacy or outsourcing facility should not use it as a bulk ingredient. It is not a criminal prohibition, and it is a judgment about manufacturing and safety rather than about whether the compound has any effect.
Why sources disagree on this number
Different sites publish different counts for Kisspeptin-10 because they are answering different questions. Here is every way of counting the same set of studies, so you can see which rule produces which number.
Sources that count only completed studies get 11. We count registered trials at any status, because a trial that is recruiting is still a real trial and is the thing most likely to change this page. Neither number is wrong; they answer different questions.
For "how much human evidence exists", 17 is the honest answer, with the caveat that 11 have actually finished. Every trial is listed on this page with its ID — if you disagree with how we count, you can recount it yourself in about a minute.
Common questions about Kisspeptin-10
How many human trials does Kisspeptin-10 have?
17. That is the number of registered interventional human studies we can find, each listed on this page with a link to its original record.
Is Kisspeptin-10 FDA approved?
No. Kisspeptin-10 is not approved by the FDA for any indication. Compounded or "research use only" preparations are not FDA-approved and receive no premarket review for safety, effectiveness, or manufacturing quality.
What is Kisspeptin-10 actually being tested for?
Registered studies cover: reproductive disorder, neurodegeneration, sars-cov 2. Compare that to what it is marketed for — the two lists are often different, which is the whole point of this page.
Where does this data come from?
ClinicalTrials.gov, the US public registry of clinical studies. We count interventional human studies only — observational studies are not evidence of effect. Every trial on this page links to its original record so you can check us rather than trust us.
More on Kisspeptin-10: how many human trials it has · is it FDA approved · has it been studied for safety · what it is studied for
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