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The Regulatory Reality of 2026: What Actually Changed In late 2023, the FDA moved 19 peptides, including BPC-157, to what's known as "Category 2" status under its framework for bulk drug substances used in compounding, identifying them as substances that "may present significant safety risks." The concern, as stated in FDA guidance, centered on the limited large-scale human data and questions about immunogenicity

These peptides play a role in slowing down the aging process at the cellular level

In addition to the reduced glutathione (GSH)/GPX4 axis, ferroptosis is inhibited by the ferroptosis suppressor protein 1 (FSP1)/coenzyme Q10 (CoQ10), GTP cyclohydrolase 1 (GCH1)/tetrahydrobiopterin (BH4), and dihydroorotate dehydrogenase (DHODH)/CoQH2 pathways [162]

Taken together, these findings justified taking Sm-TSP-2 (made in Pichia pastoris ) forward in clinical trials