U.S. Food and Drug Administration (FDA)
Is Kisspeptin legal in United States?
Not approvedNo FDA approval; kisspeptin-10 is in FDA's 503A Category 2 because of immunogenicity and missing safety data
Not approved as a medicine here.
Kisspeptin is not approved for any use. FDA added kisspeptin-10 to the 503A Category 2 list on 29 September 2023, saying compounded versions may pose immunogenicity risk for some routes and that FDA has little or no safety information for the proposed routes. Category 2 means FDA does not extend its Category 1 policy and could consider action against compounders under its general enforcement policies. It remains on the 503A Category 2 list as of the 14 May 2026 update.
Last verified 2026-09-29 · how we verify
Kisspeptin elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)U.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29
- 03Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29