Is Thymosin Alpha-1 FDA-approved?

Not in the US. Italy's medicines agency authorizes Zadaxin (thymalfasin), but Drugs@FDA lists no application with thymalfasin as an active ingredient, and other products don't share that authorization.

Checked 25 Oct 2026. The sources are below, with the non-US regulator in More sources.

Thymosin Alpha-1

Also: thymalfasin, Tα1, Zadaxin

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
SubcutaneousIntramuscular
Updated
25 Oct 2026

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with thymalfasin (thymosin alpha-1) as an active ingredient.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add Thymosin Alpha-1 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 “Approved outside the US”. In Italy, the medicines agency AIFA lists Zadaxin (thymalfasin) as an authorized prescription medicine. That authorization doesn’t apply in the US, and other thymosin alpha-1 products don’t share it.

  • Routes: subcutaneous or intramuscular. Choose the one that matches each 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 thymosin alpha-1 or any other compound.

More sources

  • AIFA (Italian Medicines Agency), medicines database, checked 25 Oct 2026: Zadaxin (timosina alfa 1), marketing authorization 028364, listed as authorized since 1996, prescription only, for subcutaneous or intramuscular use.
  • FDA, Global Substance Registration System, Thymalfasin, checked 25 Oct 2026: its sequence of 28 amino acids with an acetylated first serine, and the names thymalfasin and Zadaxin.

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