U.S. regulatory status

Kisspeptin-10

Also known as Metastin 45-54, Kisspeptin 112-121, KP10

RestrictedFDA 503A Category 2 (significant safety risks) since Sep 29, 2023; advisory committee voted 0-11 against listing

Is Kisspeptin-10 legal right now?

Kisspeptin-10 is a ten-amino-acid fragment of the hormone kisspeptin, also known as metastin 45-54.

It is not FDA-approved, and the FDA’s 2024 review found no approved kisspeptin-10 product in any country. On September 29, 2023 the FDA placed it in Category 2 of its interim 503A policy, the group of nominated bulk substances that raise significant safety risks, citing possible immunogenicity, complexities with peptide-related impurities and characterization, and little or no safety information for the proposed routes.

Category 2 substances fall outside the FDA’s enforcement discretion for compounders: the agency says it would consider taking action against a pharmacy that compounds with one. On October 29, 2024 the FDA’s Pharmacy Compounding Advisory Committee voted 0-11 against adding kisspeptin-10 to the 503A bulks list.

The FDA has not yet published a rule finalizing that outcome, and kisspeptin-10 was not on the July 2026 committee agenda. The FDA has not posted a warning letter that names kisspeptin.

For pharmacies to compound it, the FDA would have to take it out of Category 2 and add it to the 503A list.

Restricted: Prescription-only, banned, controlled, or under active FDA enforcement.

Verified Oct 15, 2026 (ET) · status held since Sep 29, 2023

Primary source: FDA All 10 sources FDA category lists

The committee vote

October 29, 2024

The question put to the FDA Pharmacy Compounding Advisory Committee (PCAC) “Should Kisspeptin-10 be placed on the list?”

Not recommended by the committee

0 in favour
11 against
0 abstained

11 votes recorded.

What this means: the vote is advice to the FDA, not a decision. Kisspeptin-10 was not on the 503A Bulk Drug Substances List before the vote and is not on it now. Only a completed FDA rulemaking can change that.

Where it sits in the process

Nominated (stalled here - not advancing)
Under review (not reached)
Rulemaking (not reached)
Compounding-legal (not reached)

Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

Kisspeptin-10: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Restricted	503A Category 2 since Sep 29, 2023 - FDA would consider taking action against a pharmacy that compounds with it. PCAC voted 0-11 against adding it to the 503A bulks list (Oct 29, 2024); no final rule yet. No FDA-approved kisspeptin product.
Australia (TGA)	Unscheduled	Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides.
United Kingdom (MHRA)	Restricted	No UK marketing authorisation; the MHRA products database holds no kisspeptin product (its only matches are other medicines’ documents that mention kisspeptin).
European Union (EMA)	Restricted	No EU marketing authorisation and no EU orphan designation; absent from the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement at member-state level.
Canada (Health Canada)	Restricted	Not in the Drug Product Database; Health Canada has listed kisspeptin products among unauthorized products seized in Calgary (Apr 2025), from Canada Peptide (Aug 2025) and at Rize Fitness (Dec 2025).
Sport / anti-doping (WADA)	Restricted	Named in S2.2.1: “kisspeptin and its agonist analogues” are testosterone-stimulating peptides prohibited at all times in males (2026 and 2027 Lists).

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

FDA warning letters

No FDA warning letter mentions Kisspeptin-10. We search the FDA’s warning-letter index for it and its other names; last searched Oct 15, 2026 (ET).

A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound

Sources & transparency

Sources for this entry

FDA - Safety risks associated with certain bulk drug substances (Category 2) FDA · primaryKisspeptin-10, 503A, added September 29, 2023, with FDA’s stated safety concerns (page current as of Apr 22, 2026).
FDA - Bulk drug substances used in compounding under section 503A FDA · primaryDefines Category 2: FDA would consider taking action against a compounder using these substances.
FDA - 503A bulk drug substances: Category 1, 2 and 3 lists (updated May 14, 2026) FDA · primaryKisspeptin-10 is listed under 503A Category 2.
FDA - Final summary minutes, Pharmacy Compounding Advisory Committee, Oct 29, 2024 FDA · primaryVote on whether kisspeptin-10 should be placed on the 503A bulks list: Yes 0, No 11, Abstain 0.
FDA - Briefing document, Pharmacy Compounding Advisory Committee, Oct 29, 2024 FDA · primaryFDA evaluation: no approved product in any country contains kisspeptin-10; evaluation criteria weigh against listing.
TGA - Responsibilities when importing, compounding and supplying unapproved peptide products (Apr 13, 2026) TGA · primaryBasis for the Australia (TGA) row: unapproved peptide products are goods not included in the ARTG.
MHRA Products database - search: kisspeptin UK gov · primaryBasis for the United Kingdom (MHRA) row: matches are only elinzanetant and fezolinetant documents.
Union Register of medicinal products (European Commission) EU · primaryBasis for the European Union (EMA) row: no kisspeptin entry (register updated Oct 15, 2026).
Health Canada - Unauthorized injectable peptide drugs seized from Optimum Wellness Centre, Calgary (Apr 2, 2025) Health Canada · primaryBasis for the Canada (Health Canada) row: Kisspeptin-10 listed among seized unauthorized products.
WADA - 2027 Prohibited List (in force Jan 1, 2027) WADA · primaryS2.2.1 testosterone-stimulating peptides in males includes kisspeptin and its agonist analogues; prohibited at all times.

Last verified by a human: Oct 15, 2026 (ET) · how we verify
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