Is Kisspeptin-10 FDA-approved?

No. Kisspeptin-10 isn't FDA-approved, and FDA lists it in category 2 for 503A compounding: substances that may present significant safety risks.

Checked 1 Nov 2026. The sources are below.

Kisspeptin-10

Also: KP-10, metastin 45-54, KISS1 fragment

Status label in the Peptimes Library
Compounding Restricted
Routes in Peptimes
SubcutaneousOther
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with kisspeptin-10 as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    FDA lists Kisspeptin-10 among the bulk drug substances in category 2 for 503A compounding, added 29 September 2023: substances that may present significant safety risks when used in compounding.

    Source: FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    In small groups of healthy volunteers (4 to 5 per group), kisspeptin-10 raised the reproductive hormones LH and FSH in men and in women just before ovulation, but not in women early in the menstrual cycle.

    Source: PMID 21976724, checked 1 Nov 2026

  • In humans

    In healthy men (5 per group), kisspeptin-10 and kisspeptin-54, each given on a separate study day, raised LH and FSH to broadly similar levels, and both less than GnRH did. The authors noted the small sample.

    Source: PMID 26089302, checked 1 Nov 2026

How to track it in Peptimes

Add kisspeptin-10 in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Compounding Restricted”, after FDA’s category 2 list for 503A compounding.

  • Routes: subcutaneous or Other. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Other doses skip this step.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell kisspeptin-10 or any other compound.

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