The FDA cited the lack of human studies on the peptide and concerns about safety as its rationale
Inflammopharmacology (2022) 30(3):77588
By activating FXRs in both the intestine and the liver, OCA is hypothesized to lessen liver exposure to toxic bile acids, leading to anti-inflammatory and anti-fibrotic effects [99,100]
4), consistent with reduced activities of key phase I enzymes, including CYP1A2, 2C8, 2C9, 2C19, and 3A4, in patient organoids (Fig
47 SavranM.OzmenO.ErzurumluY.SavasH
In summary, arginine depletion may be a feasible approach for cancer treatment because of the anti-cancer effects reported in pre-clinical studies, the low adverse reactions and the treatment-achieved stable disease in clinical trials of advanced stage cancers