Is Thymosin Beta-4 FDA-approved?

No. Thymosin beta-4 is investigational: it's being studied in clinical trials and isn't FDA-approved for any use, by injection, by mouth or by any other route.

Checked 1 Nov 2026. The sources are below.

Thymosin Beta-4

Also: Tβ4, TB4, thymosin β4, timbetasin, RGN-352, NL005

Status label in the Peptimes Library
Phase 2 Trials
Routes in Peptimes
SubcutaneousOtherOral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application with thymosin beta-4 or timbetasin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, 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

    A randomized, double-blind, placebo-controlled trial in 96 people with a type of heart attack (STEMI) after PCI to reopen the artery. Heart damage at 90 days did not differ significantly between recombinant thymosin beta-4 and placebo overall; it was smaller in a subgroup of 43. Some authors work for the maker.

    Source: PMID 41229390, checked 1 Nov 2026

How to track it in Peptimes

The Library has two thymosin beta-4 entries. “Thymosin Beta-4 (injectable, full length)” shows the status label “Phase 2 Trials”, which describes its investigational status. It isn’t an approval. “Thymosin Beta-4 Oral” shows “Not FDA-Approved”. 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.

  • Routes by entry: “Thymosin Beta-4 (injectable, full length)” can be logged as subcutaneous or Other; “Thymosin Beta-4 Oral” is oral.
  • TB-500 is a different substance, a fragment of thymosin beta-4, with its own entries and its own page.
  • 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. Oral doses and doses logged as Other 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 thymosin beta-4 or any other compound.

More sources

  • NIH, ClinicalTrials.gov, studies of thymosin beta-4, checked 1 Nov 2026: registered studies of it as an injection, as eye drops and as a skin gel, including NCT07586865, a Phase 2 study of a recombinant injection that is not yet recruiting. None gives it by mouth.
  • FDA, Global Substance Registration System, Thymosin beta-4 and Timbetasin, checked 1 Nov 2026: the sequence of 43 amino acids, and the names thymosin β4 and timbetasin.
  • FDA, Global Substance Registration System, TB-500, checked 1 Nov 2026: the “N-terminal acetylated 17-23 fragment of thymosin beta 4”.

Coming soon to the App Store

Coming soon to Google Play

See planned pricing