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What the Research Does NOT Yet Support - There are currently no published randomised controlled trials (RCTs) in humans for BPC-157 - Human pharmacokinetic data (how it is absorbed, distributed, metabolised, and excreted) is limited - Optimal dosing, route of administration, and treatment duration have not been established clinically - Long-term safety data in humans is absent - Regulatory approval from the TGA, FDA, or EMA has not been granted for any therapeutic indication TB-500: Evidence Overview What the Research Supports TB-500 / Thymosin Beta-4 has somewhat more human-facing research, though still predominantly preclinical: Phase I and II clinical trials have investigated Thymosin Beta-4 (the native peptide) in cardiac repair following myocardial infarction, with promising safety profiles Wound healing applications have been explored in clinical settings, particularly for chronic non-healing wounds and dry eye disease Robust animal evidence supports its role in reducing inflammation, supporting angiogenesis, and promoting tissue regeneration The native peptide (TΞ²4) has demonstrated cardioprotective effects in animal models of heart failure and ischaemia What the Research Does NOT Yet Support TB-500 is a synthetic fragment of TΞ²4 β it is not identical to the native peptide, and extrapolating human clinical data from TΞ²4 studies directly to TB-500 may not be valid No approved therapeutic indications exist for TB-500 specifically Comparative efficacy versus established treatments has not been studied The long-term effects of exogenous peptide administration on endogenous thymosin beta-4 regulation are unknown Potential Benefits: A Summary Based on the available (predominantly preclinical) literature, the following potential benefits have been identified: Risks & Safety Considerations Known & Reported Side Effects Because large-scale human trials are lacking, our understanding of the side effect profile is limited
