FDA compounding status
Kisspeptin-10
Also listed as Kisspeptin, KP-10.
Kisspeptin-10 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. It remains in FDA's 503A Category 2 for substances that may present significant safety risks. FDA's Pharmacy Compounding Advisory Committee voted against placing it on the 503A bulks list on October 29, 2024.
This record covers kisspeptin-10. Kisspeptin-54 is a different form and is not covered by this record.
Checked against the primary sources on .
The record
- FDA status
- No compounding pathway today.
- Compounding basis
- No compounding pathwayNo facility type may compound this substance today.
- FDA advisory committee
- Voted against, Oct 29, 2024
- Sport (WADA 2026)
- Prohibited at all times in males under WADA class S2.2.1 (testosterone-stimulating peptides).
- Offered by PEPLUX
- Yes, as Kisspeptin Injection
- Checked on
Offered by PEPLUX
Kisspeptin Injection
PEPLUX offers Kisspeptin-10 as Kisspeptin Injection. The product page covers what it is, its risks, and how prescribing and pricing work.
Basis
What this status traces to.
FDA's current 503A categories document lists kisspeptin-10 in Category 2. Its October 2024 evaluation states that there is no applicable USP or NF drug-substance monograph and it is not a component of an FDA-approved drug. It is not on the 503A or 503B bulks list. The advisory committee's final minutes record a vote against its inclusion. FDA identifies potential immune reactions, peptide impurities and limited safety information as concerns.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA advisory committeeOctober 29, 2024 Pharmacy Compounding Advisory Committee: FDA evaluation of kisspeptin-10Document dated . Checked .
- FDA advisory committee minutesPharmacy Compounding Advisory Committee, October 29, 2024: final minutesDocument dated . Checked .
- FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee voted against it at its meeting of October 29, 2024, according to the final minutes.
Pharmacy Compounding Advisory Committee, October 29, 2024: final minutes (dated )
If you are subject to anti-doping rules
Prohibited at all times in males under WADA class S2.2.1 (testosterone-stimulating peptides).
The 2026 list names kisspeptin and its agonist analogues under testosterone-stimulating peptides in males.
Common questions
Kisspeptin-10, answered plainly.
- What is the FDA compounding status of Kisspeptin-10?
- Kisspeptin-10 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. It remains in FDA's 503A Category 2 for substances that may present significant safety risks. FDA's Pharmacy Compounding Advisory Committee voted against placing it on the 503A bulks list on October 29, 2024.
- What does the status of Kisspeptin-10 trace to?
- FDA's current 503A categories document lists kisspeptin-10 in Category 2. Its October 2024 evaluation states that there is no applicable USP or NF drug-substance monograph and it is not a component of an FDA-approved drug. It is not on the 503A or 503B bulks list. The advisory committee's final minutes record a vote against its inclusion. FDA identifies potential immune reactions, peptide impurities and limited safety information as concerns. Checked against the primary sources on October 14, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of Kisspeptin-10?
- Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
- Does PEPLUX offer Kisspeptin-10?
- PEPLUX offers Kisspeptin-10 as Kisspeptin Injection. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Kisspeptin-10 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Is Kisspeptin-10 prohibited in sport?
- Prohibited at all times in males under WADA class S2.2.1 (testosterone-stimulating peptides). The 2026 list names kisspeptin and its agonist analogues under testosterone-stimulating peptides in males.