A fragment of the hormone that triggers the reproductive hormone cascade. FDA lists it in 503A Category 2.
Key takeaway
Kisspeptin-10 is the active ten-amino-acid end of kisspeptin, a hormone that signals the hypothalamus to release GnRH and, in turn, reproductive hormones.
At a glance
| FDA status | Not FDA-approved |
|---|---|
| 503A compounding | 503A Category 2: FDA identified significant safety risks |
| Body areas | Sexual & reproductive health, Hormones & pituitary |
| Through ScriptMates | Information only |
| Open questions | 1 noted below |
What is kisspeptin-10?
Kisspeptin-10 is the active ten-amino-acid end of kisspeptin, a hormone that signals the hypothalamus to release GnRH and, in turn, reproductive hormones.
FDA placed it in 503A Category 2, citing immunogenicity risk, impurity concerns, and little safety information. It cannot be compounded under the interim policy.
Dosage forms
No FDA-approved dosage form. A standardized dosage form for human use was not confirmed from the sources below.
Is kisspeptin-10 FDA-approved?
Not FDA-approved. In 503A Category 2 (significant safety risks) since September 29, 2023.
Can it be prescribed through ScriptMates?
503A Category 2: FDA identified significant safety risks. A partner pharmacy lists it, but it has no lawful 503A pathway today (503A Category 2: FDA identified significant safety risks).
What we could not confirm
- One partner catalog also lists “Kisspeptin-11” and “Kisspeptin-12”. We treat these as data-entry variants of kisspeptin-10.
Sources
- FDA: Bulk substances that may present significant safety risks (Category 2 and withdrawn nominations)
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.