TB-500
/ Naturally occurring 43-amino-acid peptide (Tβ4); TB-500 often used commercially as a synonym though technically refers to a synthetic fragmentALIAS · Thymosin Beta-4 · Tβ4
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Phase I intravenous safety (Ruff 2010) and Phase II ophthalmic efficacy (Sosne 2010) in humans, but no systemic musculoskeletal human trial data exists. Nomenclature confusion between full-length Tβ4 and fragment TB-500 is widespread.
Thymosin Beta-4 is a naturally occurring 43-amino-acid peptide. TB-500 is often used commercially as a synonym, though technically it refers to a synthetic fragment. Tβ4 sequesters G-actin monomers, regulating cytoskeletal dynamics and cell migration. Reported mechanisms include promotion of angiogenesis via VEGF upregulation, anti-inflammatory effects through reduced NF-κB activation, and support for epithelial and endothelial migration during wound healing.
More substantial than BPC-157. Completed Phase I intravenous safety trials (RegeneRx programs) and a Phase II ophthalmic trial (dry eye, Sosne 2010). No Phase III approvals. Systemic injectable use for musculoskeletal indications has no rigorous human trial evidence.
Phase I intravenous study (Ruff 2010) reported no serious adverse events across tested doses in 40 healthy volunteers. Ophthalmic trials report mild transient irritation. Long-term systemic safety unknown. WADA-banned for competitive athletes (S2 class).
Regulatory status
- FDA status:
- Not FDA-approved
- Compounding:
- 503A Category 2 — do-not-compound pending review
Nomenclature confusion between endogenous Tβ4 (studied in legitimate pharmaceutical development) and "TB-500" sold online (often unverified purity; fragment vs. full-length unclear). Tendon and ligament healing claims rest on rodent data; no human RCT exists for systemic musculoskeletal use.