Kisspeptin
Regulatory
Legal Status in 2026
Compounding restricted under the FDA 503A bulk-substance list.
Federal law restricts compounding of this compound. For compounds whose FDA-declared shortage has resolved, Section 503B bulk compounding rights have ended; Section 503A compounding remains possible only with a documented patient-specific clinical justification (a verified allergy to an inactive ingredient, or a strength the manufacturer does not make, not cost or convenience). For compounds affirmatively excluded by the FDA's Pharmacy Compounding Advisory Committee, compounding is not permitted under the bulk-substance list. The FDA-approved product (where one exists) is the appropriate default.
About
About Kisspeptin
Kisspeptin is an endogenous neuropeptide produced in the hypothalamus that acts as the master regulator of the reproductive axis by directly stimulating GnRH neurons. It is being studied for hypogonadism, sexual dysfunction, and fertility applications where upstream HPG axis stimulation is desired. In men, kisspeptin-10 injections produce significant LH and testosterone surges. It represents a more upstream intervention than HCG or gonadorelin.
Science
Mechanism of Action
Binds KISS1R (GPR54) receptors on hypothalamic GnRH neurons to trigger GnRH pulse release, initiating a cascade of LH and FSH secretion from the pituitary and downstream gonadal sex hormone production.
Dosing
Typical Protocol
0.3–10 nmol/kg subcutaneous injection; research doses in human studies. Not standardized for clinical use.
⚠ Protocol information is for educational purposes only. Dosing must be determined by a licensed physician based on individual health status and goals.
Evidence
Evidence Tier
Evidence primarily from animal studies, cell cultures, or small pilot human trials. Results are promising but have not yet been confirmed in large-scale human RCTs. Effects in humans may differ from animal models.
Availability
Provider availability
Compounded Kisspeptin is restricted. Pharmacies can't legally make it under the FDA's compounding rules. If an FDA-approved version exists, that is the legal channel. We don't list sellers here because we can't verify which ones stay inside those rules.
This page evaluates compliance signals, not clinical outcomes. Consult a licensed physician before starting any therapy, medication, or treatment. Vial does not provide medical advice.