Is Kisspeptin-10 Legal? FDA, Compounding and WADA Status
Kisspeptin-10's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.
- FDA status
- Not approved
- research chemical
- PCAC vote
- Not reviewed
- not on the Jul 2026 PCAC agenda
- WADA
- Prohibited (S2.2.1)
- In and out of competition
Current status
Not FDA approved · research chemicalNo. Kisspeptin-10 is not FDA approved for any use.
| Country | Status | Source |
|---|---|---|
| United States | No approved product foundNo FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "Kisspeptin-10" returned no matches on 2 Oct 2026. | api.fda.govchecked 2 Oct 2026 |
Timeline
Compounding and research-use sellers
- Category 2 is the FDA's list of bulk substances it flagged as raising significant safety concerns. Compounding pharmacies are not expected to compound from them while they are on it.
- The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on which substances belong on the 503A bulks list that pharmacies may compound from. Its votes are advice; the FDA decides.
- "Research use only" products are sold outside these rules and are not checked by the FDA for identity, purity or dose.
FDA compounding record: Kisspeptin-10 is in FDA's 503A category 2 (significant safety risks), added 29 September 2023. · fda.gov, checked 2 Oct 2026
Sport and drug testing
Prohibited by WADA (S2.2.1)Kisspeptin and its agonist analogues are named in S2.2.1 (testosterone-stimulating peptides in males).
Outside the US
Rules differ by country. What each regulator's own records show, with the date we checked:
| Country | Status | Source |
|---|---|---|
| United Kingdom | No approved product foundNo approved product found in an emc (UK SmPC compendium) search for "Kisspeptin-10" on 2 Oct 2026. | medicines.org.ukchecked 2 Oct 2026 |
| Canada | No approved product foundNo product found in a Health Canada Drug Product Database search for ingredient "Kisspeptin-10" on 2 Oct 2026. | health-products.canada.cachecked 2 Oct 2026 |
| Australia | No approved product foundNo approved product found in an ARTG search for "kisspeptin" on 2 Oct 2026. | tga.gov.auchecked 2 Oct 2026 |
| European Union | No centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026 | ema.europa.euchecked 2 Oct 2026 |
Where FDA places kisspeptin-10 for compounding
FDA's safety-risk table lists kisspeptin-10 for 503A compounding, dated September 29, 2023, with a note on immunogenicity risk for certain routes.[3]
The same entry says the agency lacks sufficient information to know whether the drug would cause harm in humans.[3]
An archived copy of the FDA list still names kisspeptin-10.[8]
Sports rule
The WADA 2026 Prohibited List names kisspeptin and its agonist analogues among testosterone-stimulating peptides in males, section S2.2.1.[1]
Searches of other regulators
The Health Canada database returned zero active-ingredient records for kisspeptin.[5]
The Australian ARTG search for kisspeptin found no matching results.[6]
The cached EMA medicines export search found no matching rows.[7]
The Drugs@FDA lookup returned an error response for the ingredient kisspeptin, so there is no labelled dosage schedule to cite.[2]
Common questions
Is Kisspeptin-10 FDA approved?
No. Kisspeptin-10 is not FDA approved for any use.
Is Kisspeptin-10 legal to buy?
It is not an approved drug. Online sellers label it "for research use only, not for human use"; the FDA sent warning letters to five such sellers on 24 Aug 2026. Whether a pharmacy may compound it depends on its FDA bulk-substance status. Rules differ by country.
Is Kisspeptin-10 banned by WADA?
Yes. Prohibited by WADA (S2.2.1), in and out of competition.
Is kisspeptin FDA approved?
The Drugs@FDA ingredient search returned a not-found code.[2]
Is there a kisspeptin dosage schedule?
There is none on a label; the Drugs@FDA lookup for the ingredient says no matches.[2]
More on Kisspeptin-10
Sources
- 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
- 2United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "Kisspeptin-10" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 3US compounding: Kisspeptin-10 is in FDA's 503A category 2 (significant safety risks), added 29 September 2023.U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
- 4United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "Kisspeptin-10" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
- 5Canada: No product found in a Health Canada Drug Product Database search for ingredient "Kisspeptin-10" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
- 6Australia: No approved product found in an ARTG search for "kisspeptin" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
- 7EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
- 8Official web pageOfficial web page · web page
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