TB-500: What It Is and Its U.S. Regulatory Status

What is TB-500?

TB-500 is a synthetic peptide based on a short active region of thymosin beta-4, a naturally occurring protein made of 43 amino acids. Thymosin beta-4 is found in most human cells, where it binds to actin, a protein that forms part of the cell’s internal skeleton and helps cells move.

TB-500 is a trade-style name rather than a formal drug name. Products sold under it may contain different peptide sequences, and they are not the same as full-length thymosin beta-4.

What does research say?

Most published research related to TB-500 has been done in laboratory and animal models of tissue injury. Separately, full-length thymosin beta-4 has been studied in clinical trials in eye drop form, including for dry eye. Those trials involved a different product and do not apply to TB-500.

U.S. regulatory status

Current status: Not FDA-approved.

This means the FDA has not approved TB-500 as safe and effective for any medical use. No product containing it is an approved medicine in the United States.

Thymosin beta-4 and its derivatives, including TB-500, are also prohibited in competitive sport under the World Anti-Doping Code.

Because TB-500 is not an approved drug, the FDA has not reviewed the contents, purity or quality of products sold under that name.

Why Peptide Labs does not sell TB-500

Peptide Labs does not sell this compound. This page is general information, not medical advice. Our Peptide Guide exists to explain what these compounds are and how they are regulated, not to supply them.

Anyone with questions about TB-500 should speak with a licensed healthcare provider, who can explain the current evidence and the legal status in plain terms.

Related reading

See the full list of compound profiles in the Peptide Guide.