# Kisspeptin-10

Kisspeptin-10 has 17 registered human trials. It is marketed for 3 different uses.

**In short**

- 17 registered human trials exist for Kisspeptin-10.
- Kisspeptin-10 is not FDA-approved for any use.
- What has actually been studied: reproductive disorder, neurodegeneration, sars-cov 2.
- Last checked against ClinicalTrials.gov on 2026-07-30.

## What it is

Kisspeptin-10 is a ten-amino-acid fragment of kisspeptin, the protein made by the KISS1 gene, and is also called metastin 45-54. It acts on the KISS1R receptor to trigger the release of gonadotropin-releasing hormone, which sits at the top of the chain controlling puberty and reproduction.

## 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.

**Sources for the above**

- [NCT01667406 — kisspeptin 112-121 in reproductive endocrinology](https://clinicaltrials.gov/study/NCT01667406) — Representative of the academic trials that use the KP-10 fragment.
- [FDA — bulk drug substances that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) — Kisspeptin-10 is on the ACTIVE Category 2 list under 503A, added 29 September 2023.

## Approved for

Not approved by the FDA for any use. Nothing has been reviewed for safety, effectiveness or manufacturing quality.

## Studied for

- Reproductive Disorder
- Neurodegeneration
- SARS-CoV 2
- Long COVID
- Hypogonadotropic Hypogonadism
- Kallmann Syndrome
- GnRH Deficiency
- PCOS
- Polycystic Ovarian Syndrome
- Hyperprolactinemia
- Kisspeptin Action on Insulin in Healthy Normal Men
- Kisspeptin Action on Insulin in Obese Diabetic Men
- Sterility, Reproductive
- Hypogonadism
- Reproductive Physiological Phenomena
- Hypothalamic Amenorrhea
- Polycystic Ovary Syndrome
- Healthy Postmenopausal Women
- Agonadism
- Delayed Puberty
- Insulin
- Glucose
- Healthy Volunteers
- Women
- Pregnancy
- Metabolic Disease

## Marketed for

- Testosterone support
- Fertility
- Libido

## What regulators have said

Kisspeptin-10 is on FDA's list of bulk drug substances that may present significant safety risks when used in compounding (503A), listed September 29, 2023.

FDA's own words: "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."

Source: US Food and Drug Administration — https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Checked 2026-07-30. This list changes.

This is a judgment about compounding and manufacturing, not a finding about whether Kisspeptin-10 has any effect.


## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT07224490](https://clinicaltrials.gov/study/NCT07224490) | Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease | Reproductive Disorder, Neurodegeneration | Phase 1 | RECRUITING | 40 |
| [NCT00914823](https://clinicaltrials.gov/study/NCT00914823) | Kisspeptin Administration in the Adult | Hypogonadotropic Hypogonadism, Kallmann Syndrome | Phase 1 | COMPLETED | 256 |
| [NCT03771326](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/NCT03315325) | Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men | Sterility, Reproductive | Phase 3 | COMPLETED | 15 |
| [NCT02956447](https://clinicaltrials.gov/study/NCT02956447) | Administration of Kisspeptin in Patients With Hyperprolactinemia | Hyperprolactinemia, Hypogonadism | Phase 2 | COMPLETED | 36 |
| [NCT03286517](https://clinicaltrials.gov/study/NCT03286517) | Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys. | Reproductive Physiological Phenomena | Phase 3 | COMPLETED | 30 |
| [NCT01952782](https://clinicaltrials.gov/study/NCT01952782) | Neuropeptides in Human Reproduction | Hypogonadotropic Hypogonadism | Phase 1 | COMPLETED | 61 |
| [NCT07224438](https://clinicaltrials.gov/study/NCT07224438) | Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea | Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism | Phase 2 | RECRUITING | 20 |
| [NCT05901467](https://clinicaltrials.gov/study/NCT05901467) | Recall by Genotype: Neuropeptide Stimulation | Reproductive Disorder | Phase 1 | TERMINATED | 16 |
| [NCT05971849](https://clinicaltrials.gov/study/NCT05971849) | Dampening the Reproductive Axis With Continuous Kisspeptin | Reproductive Disorder, PCOS | Phase 1 | COMPLETED | 8 |
| [NCT05633966](https://clinicaltrials.gov/study/NCT05633966) | Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders | Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism | Phase 1 | COMPLETED | 13 |
| [NCT04648969](https://clinicaltrials.gov/study/NCT04648969) | Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism | Hypogonadotropic Hypogonadism | Phase 2 | COMPLETED | 18 |
| [NCT05896293](https://clinicaltrials.gov/study/NCT05896293) | Kisspeptin Administration Subcutaneously to Patients With IHH | Hypogonadotropic Hypogonadism | Phase 2 | RECRUITING | 36 |
| [NCT01438073](https://clinicaltrials.gov/study/NCT01438073) | Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling | Hypogonadotropic Hypogonadism, Healthy Postmenopausal Women | Phase 1 | COMPLETED | 96 |
| [NCT01438034](https://clinicaltrials.gov/study/NCT01438034) | Kisspeptin in the Evaluation of Delayed Puberty | Delayed Puberty, Kallmann Syndrome | Phase 1 | COMPLETED | 24 |
| [NCT04532801](https://clinicaltrials.gov/study/NCT04532801) | Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance | Insulin, Glucose | Phase 1 | WITHDRAWN | 0 |
| [NCT05456854](https://clinicaltrials.gov/study/NCT05456854) | Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp | Metabolic Disease | Phase 1 | WITHDRAWN | 0 |

## Common questions

**How many human trials does Kisspeptin-10 have?**
17, each listed above with a link to its original record.

**Is Kisspeptin-10 FDA approved?**
No. It is not approved by the FDA for any indication.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

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*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/kisspeptin-10*