Moreover, mice lacking the cytosolic Cu/Zn superoxide dismutase 1 (Sod1) and the Fanconi Anaemia DNA repair pathway gene FancC develop hematopoietic failure and liver steatosis 52
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Several factors explain the lack of approval: insufficient clinical trials (no completed Phase 3 trials for most indications), safety concerns (FDA has identified specific adverse events), commercial considerations (patent status affects development investment), regulatory pathway (approval requires specific, rigorous documentation), and competition (Tesamorelin already approved for related indication)
Allergic or hypersensitivity reactions (rare) May occur in response to peptide compounds or formulation preservatives
The angiogenesis promotion that makes BPC-157 potentially valuable for cardiovascular applications also raises theoretical questions