Is klotho FDA-approved?

No. Klotho isn't FDA-approved, and Drugs@FDA lists no application with it as an active ingredient.

Checked 1 Nov 2026. The sources are below.

Klotho

Also: alpha-klotho, α-klotho, soluble klotho

Status label in the Peptimes Library
Not FDA-Approved
Routes in Peptimes
SubcutaneousIntramuscularOralSublingualNasalTopicalOther
Updated
1 Nov 2026

US regulatory status

  • FDA status

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

    Source: Drugs@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 animals or the lab

    Mice with a defect in klotho gene expression developed a syndrome resembling human ageing, including a short lifespan, infertility, arteriosclerosis, skin atrophy, osteoporosis and emphysema.

    Source: PMID 9363890, checked 1 Nov 2026

  • In animals or the lab

    Mice genetically engineered to overproduce klotho lived longer than normal mice. Klotho acted as a circulating hormone that dampened insulin and IGF-1 signalling. No klotho was given in this study.

    Source: PMID 16123266, checked 1 Nov 2026

How to track it in Peptimes

Add klotho 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 “Not FDA-Approved”.

  • Routes: the app lets you record whichever route you used; none is established. Its routes are subcutaneous, intramuscular, oral, sublingual, nasal, topical and Other.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous and intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Other routes 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 klotho or any other compound.

More sources

  • FDA, Global Substance Registration System, Klotho secreted peptide, checked 1 Nov 2026: the protein sequence of the secreted form, and the name alpha-klotho.

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