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Kisspeptin-10 regulatory status

Current status of Kisspeptin-10 in the United States: Not eligible for compounding. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Kisspeptin-10?

Regulatory: Not eligible for compoundingWADA: WADA prohibitedVerified: Verified Sep 22, 2026
FDA and compounding
FDA placed kisspeptin-10 on the 503A Category 2 list (substances that may present significant safety risks) on September 29, 2023, citing immunogenicity risk, peptide impurities, and no or limited safety information. As of the FDA page current to April 22, 2026, kisspeptin-10 remains in Category 2 and was not among the peptides withdrawn in April 2026 or taken up by the Pharmacy Compounding Advisory Committee in July 2026. It is not an FDA approved drug and a 503A pharmacy may not compound it.
WADA
WADA prohibited
Access path
  1. Not legally available for human use in the United States outside a clinical trial.
  2. Not an FDA approved drug; on the FDA 503A Category 2 list.
  3. Products labeled research use only are not lawful for human use and are not verified for purity.

Full Kisspeptin-10 page: evidence, dosing in the literature, and sources

How has the status of Kisspeptin-10 changed over time?

  1. WADA

    WADA publishes the 2027 Prohibited List

    WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.

    Source: WADA 2027 Prohibited List
  2. WADA

    WADA 2026 Prohibited List takes effect

    The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.

    Source: WADA Prohibited List
  3. WADA

    WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times

    The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.

    Source: WADA Prohibited List
  4. FDA

    FDA places a batch of nominated peptides in 503A Category 2

    In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.

    Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Kisspeptin-10 and the source of each dated event.

  1. [1]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
  2. [2]FDA: Compounding and the FDA, questions and answersFDA, 2026
  3. [3]WADA Prohibited List, sections S0 and S2WADA, 2026
  4. [4]WADA 2027 Prohibited ListWADA, 2026