E

Tier

TB-500

TB-500

TB-500

Synthetic actin-binding fragment of thymosin beta-4 used for systemic recovery.

Recovery & Healing

Peptide fragment of a larger protein

WADA Status:

Prohibited at all times (S2.3)

Human Trial Scoreboard

Completed human RCTs

0
0
0

None completed

Largest Human Study

0
0
0

No human studies

Longest exposure

0
0
0

None studied

Most Recent Trial

0
0
0

No completed trial

Description

TB-500 is a synthetic fragment of thymosin beta-4, a naturally occurring protein involved in cell movement and tissue repair. The fragment corresponds to the region of the parent molecule that binds actin, the protein that forms part of a cell's internal scaffolding. The reasoning behind it is that if this small section does the useful work, you can synthesise just that section. Whether that reasoning holds has never been tested in people. Every study cited in marketing was performed on the full-length protein, which is a different molecule with a different development history and its own separate trial record. TB-500 itself has no completed human trials of any design. The distinction between the fragment and the parent is the single most important thing to understand about it, and it is the distinction almost every vendor page collapses.

What Are The Claims

Claims made for this compound: May support soft-tissue and muscle repair via cell migration (animal); Proposed to reduce adhesions and improve flexibility (preclinical); Promotes angiogenesis around injured tissue (animal); Claimed systemic recovery effect is inferred, not shown

Evidence

The central confusion is chemical, and it is load-bearing for the entire marketing case. TB-500 is a synthetic fragment corresponding to the actin-binding domain of thymosin beta-4. The human clinical work that vendors cite belongs to full-length thymosin beta-4, a 43-amino-acid protein that has been through registered trials in cardiac and ophthalmic indications. These are different molecules. There is no human trial of the fragment. This is not a technicality. Borrowing a different molecule's trial pedigree is the specific mechanism by which an untested compound acquires the appearance of an evidence base.

Evidence Strength

Animal/preclinical only

Caveats

TB-500 is a synthetic fragment, not the full-length Tb4 studied in trials; no human data; WADA-prohibited.

Safety
Alternative Measures
Legal Status

US

Not approved; removed from restricted compounding category April 2026 without approval

UK

Not approved

EU

Not approved

AU

Not approved

WADA

Prohibited at all times (S2.3)

Not approved anywhere. WADA-prohibited. Placed in FDA Category 2 in September 2023 and removed in April 2026 without promotion to Category 1, leaving it unapproved and uncompoundable. Scheduled for Pharmacy Compounding Advisory Committee review in July 2026.

Citations

No human trial of the TB-500 fragment exists. | Human clinical data pertains to full-length thymosin beta-4 (RegeneRx clinical programs), a distinct molecule. | FDA 503A Category 2, September 2023; removed April 2026. | WADA Prohibited List.

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