Kisspeptin-10

FDA has placed Kisspeptin-10 in ‘category 2’ of its interim compounding policy since September 29, 2023, a currently maintained designation for bulk substances that may present significant safety risks. FDA states it has no, or only limited, safety-related information for the proposed routes of administration and is concerned about immunogenicity and peptide-related-impurity complexities.^[3]

• A category-2 listing reflects an unresolved evidence gap identified by FDA, not a quantified adverse-event rate or a finding of harm.
• This category-2 designation is a currently maintained FDA action, distinct from the withdrawn-nomination rows recorded for several other compounds in this dataset.

Kisspeptin-10 increased LH secretion, and prolonged infusion increased testosterone, in small studies of healthy men. Those findings do not establish treatment of infertility or recovery from drug-induced endocrine suppression.^[1]

• The study population, route (intravenous) and physiological endpoints limit clinical application.
• See the separate 2026 record for a subcutaneous chronic-dosing study of this same compound.

A 2026 randomized, single-blinded, placebo-controlled study examined sustained subcutaneous kisspeptin-10 dosing in three sequential sub-studies of healthy men (15 treated, 12 vehicle controls). A single 8-hour infusion dose-dependently raised LH, FSH and testosterone. Five days of continuous infusion left gonadotropin (LH/FSH) concentrations similar to vehicle even though testosterone stayed elevated, but twelve days of once-daily 8-hour infusions sustained higher gonadotropins, and a further bolus after those twelve days still raised LH, indicating the kisspeptin receptor remained responsive.^[2]

• This describes a short research-infusion protocol in a small group of healthy men, not an established treatment regimen, fertility therapy, or recovery protocol from drug-induced suppression.
• Only the indexed abstract was inspected; full methods, tables and the acute dose-response curve were not reviewed.
• Findings are specific to men and to the subcutaneous route studied; they should not be extended to women, patients, or other formulations and should not be read as dosing guidance.