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The key regulatory facts as of early 2026: FDA classification: BPC-157 has been classified as a Category 2 compound under the FDAs revised peptide framework

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However, the core downstream target genes mediating Nrf2-regulated DR iron metabolism and lipid peroxidation lack in-depth validation, and the optimal activation strategy, long-term safety of Nrf2 pathway and its crosstalk with other ferroptosis regulatory pathways remain insufficiently studied, warranting further investigation

J., Anderson, R