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TB-500 is a synthetic fraction of the protein Thymosin Beta-4, a protein naturally ubiquitous in both animal and human cells

the FDA has stated it lacks sufficient information to know whether the substance would cause harm when administered to humans Evidence snapshot: The evidence base is almost entirely preclinical, decades of animal (largely rat) studies, mostly from one Croatian research group (Sikiric et al., University of Zagreb), with a single small human trial under the brand name "Bepecin" (around 2015) that did not lead to any FDA-approved use

It is sterile at the moment of manufacture and remains sterile until the seal is broken

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It was designed to confirm the Phase 2b results and advance AOD 9604 toward regulatory approval