Kisspeptin: FDA Status and Evidence
A reproductive-hormone peptide that FDA lists in Category 2 for 503A compounding. It is not FDA-approved, and the human research belongs mainly to reproductive endocrinology.
Medically reviewed by Charles Kamen, MD, board-certified neurologist · ·
What the research shows
Kisspeptin signals the brain to release GnRH, which drives LH and testosterone or estrogen production. Human research sits in reproductive endocrinology, including fertility treatment studies run in specialist research settings. There is no approved product and no outcome evidence for libido or wellness use.
Frequently Asked Questions
Is kisspeptin FDA-approved?
No. No kisspeptin product is FDA-approved.
Can a pharmacy compound kisspeptin?
FDA lists kisspeptin-10 in Category 2 for 503A compounding. Check the live FDA lists, which change.
What are FDA-approved options for low testosterone?
Diagnosed hypogonadism is treated with FDA-approved testosterone products after confirmed lab testing and a physician evaluation.
Selected Research
Peer-reviewed sources on Kisspeptin. Research does not constitute a treatment recommendation; appropriateness is determined only after a medical evaluation.