Is TB-500 FDA-approved?

No. TB-500 isn't FDA-approved: Drugs@FDA lists no application with TB-500 as an active ingredient.

Checked 23 Oct 2026. The sources are below.

TB-500

Also: Thymosin Beta-4 Fragment (Ac-LKKTETQ), TB500, N-acetyl-Leu-Lys-Lys-Thr-Glu-Thr-Gln

Status label in the Peptimes Library
Not FDA-Approved
Routes in Peptimes
SubcutaneousIntramuscular
Updated
25 Oct 2026

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with TB-500 as an active ingredient.

    Source: Drugs@FDA, checked 23 Oct 2026

How to track it in Peptimes

The Library has two entries for TB-500, and both show the status label “Not FDA-Approved”. “TB-500” can be logged as subcutaneous or intramuscular. “TB4 Fragment (17-23)” is a separate entry, and it is subcutaneous only. Thymosin beta-4 itself has separate entries. Add the entry that matches your own records 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.

  • Logging: the amount you took, the route and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • 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 TB-500 or any other compound.

More sources

  • FDA, Global Substance Registration System, TB-500, checked 23 Oct 2026: its sequence of seven amino acids, and the names TB500 and N-acetyl-Leu-Lys-Lys-Thr-Glu-Thr-Gln. “Thymosin Beta-4 Fragment (Ac-LKKTETQ)” is the name the Peptimes Library gives it.

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