Kisspeptin

What has kisspeptin been studied for?

In a placebo-controlled crossover trial, 40 women with hypoactive sexual desire disorder (HSDD) were randomized to a 75-minute IV infusion of kisspeptin-54 or placebo; 32 completed the trial, and kisspeptin modulated brain activity linked to sexual and romantic processing on fMRI [1]. A similarly designed crossover trial in 37 men with HSDD, of whom 32 completed it, used the same kisspeptin-54 infusion and measured brain activity, penile tumescence, and behavioral outcomes [2]. Both are single-dose, mechanistic studies of brain and physiological response, not trials assessing kisspeptin as an ongoing therapy.

Is kisspeptin FDA-approved or regulated as a peptide?

No form of kisspeptin is FDA-approved as a drug. FDA's Category 2 safety page lists "Kisspeptin-10" as an active Category 2 substance under section 503A, and FDA states that compounded drugs containing it "may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization" [3]. That listing covers kisspeptin-10, a different fragment from the kisspeptin-54 used in the HSDD studies above. Kisspeptin and its agonist analogues are also prohibited at all times under the 2026 WADA list for male athletes [4].