Kisspeptin-10: where it stands with the FDA, and what it costs
No FDA-approved drug contains it.
Go to clinicLowest per monthKisspeptin-10 injection
BRAVO1 Wellness · $155/mo
Go to clinicLowest at a clinic we link toKisspeptin-10 injection (5ml)
Pepti · $229/mo (≈ $245 per 30 days with its fees)
Where Kisspeptin-10 stands today
No FDA-approved drug contains kisspeptin-10. It is in FDA's 503A Category 2 (significant safety risks) since September 29, 2023, which means FDA would consider taking action against a compounder using it. On October 29, 2024 the advisory committee voted 0-11 against listing it. It is not on the 503A or 503B bulks list and not in HHS's October 2026 interim policy.
For pharmacies compounding one patient's prescription (section 503A)
Category 2 (Bulk Drug Substances that Raise Significant Safety Risks), since September 29, 2023: FDA would consider enforcement action. The advisory committee voted 0-11 against listing it (Oct 29, 2024). Not in HHS's Oct 2026 interim policy.
“503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks ... Kisspeptin-10”
“Kisspeptin-10 503A September 29, 2023 Compounded drugs containing Kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization.”
What Category 2 means
“FDA would consider taking action against a compounder for compounding drug products with this bulk drug substance under its general enforcement policies.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The FDA's compounding advisory committee
29 October 2024: Should kisspeptin-10 be placed on the 503A bulks list? (use FDA reviewed: treatment of secondary hypogonadism in men). Vote: Yes 0, No 11, Abstain 0. Committee unanimously advised against listing; FDA has published no rule since
“VOTE: FDA is proposing that Kisspeptin-10 NOT be included on the 503A Bulks List. Should Kisspeptin-10 be placed on the list? Vote Result: Yes: 0 No: 11 Abstain: 0 Committee Discussion: The committee unanimously agreed that Kisspeptin-10 should not be included on the 503A Bulks List due to the lack of convincing safety and efficacy data.”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“kisspeptin and its agonist analogues”
Our reading
Kisspeptin-10 is the compound in this set FDA most clearly does not tolerate in compounding: a 503A pharmacy compounding it risks FDA action, and 503B facilities have no route.
Every source above was checked again on 14 November 2026.
What 8 clinics charge
- BRAVO1 WellnessKisspeptin-10 injection$155/mo
- PeptiKisspeptin-10 injection (5ml)$229/mo≈ $245 per 30 days with its fees
- Better Med SpaKisspeptin-10 injection (1mg/ml)$260for 30 days
- Nuvo Life HealthKisspeptin-10 injection (1mg/ml)$299for 30 days
What Kisspeptin-10 is
- What it is
- Hypothalamic peptide
- How it works
- A peptide that signals the hypothalamus to release GnRH, upstream of the reproductive hormones.
- How it is given
- Subcutaneous injection
- Also called
- kisspeptin
Kisspeptin-10 side by side
About Kisspeptin-10
Is Kisspeptin-10 FDA-approved?
No. No FDA-approved drug contains Kisspeptin-10. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Kisspeptin-10 legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains kisspeptin-10. It is in FDA's 503A Category 2 (significant safety risks) since September 29, 2023, which means FDA would consider taking action against a compounder using it. On October 29, 2024 the advisory committee voted 0-11 against listing it. It is not on the 503A or 503B bulks list and not in HHS's October 2026 interim policy.
How much does Kisspeptin-10 cost?
8 clinics publish a price. The lowest that compares per month is $155/mo at BRAVO1 Wellness, and the middle of 4 clinics' lowest monthly prices is about $253. What a month buys differs by clinic, so each price lists what it includes. every Kisspeptin-10 price