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Category 2 is the problem bucket: substances the FDA says may present significant safety risks citing issues such as immunogenicity (the body forming antibodies against an injected peptide), impurities from synthesis, and thin human data

Archives of toxicology 2014, 88, 455-473, doi:10.1007/s00204-013-1120-7

Inflammatory cells, which are locally activated in the renal microenvironment or migrate from hematopoietic organs, further produce ROS

No Phase III data is not the same as no data Many of the specific compounded versions of peptides lack the standardized Phase III trial data the FDA requires for approval

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These studies are intended to describe the compounds biochemical behavior and its role in redox-associated mechanisms