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Key Takeaways TB-500 is NOT FDA approved — No regulatory approval exists for TB-500 in any therapeutic indication Derived from Thymosin Beta-4: TB-500 is a synthetic fragment of the naturally occurring 43-amino-acid protein Thymosin Beta-4 (Tβ4) No active FDA clinical trials: There are no current IND applications or FDA-registered trials for TB-500 itself Published preclinical research exists: Thymosin Beta-4 has peer-reviewed studies on wound healing, actin regulation, and cardiac repair PCAC vote, July 23, 2026: The FDA's Pharmacy Compounding Advisory Committee voted 8-6 with one abstention to recommend TB-500 free base and TB-500 acetate for the 503A Bulks List — a compounding recommendation, not an approval WADA Prohibited List: TB-500 is classified under S2 (Peptide Hormones, Growth Factors) on the World Anti-Doping Agency banned substance list Research-grade availability: TB-500 is available for laboratory and investigational use only What Is TB-500

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J Babol Univ Med Sci