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There is one open-label intravenous safety pilot in two healthy adults, who received single doses of 10 mg and 20 mg with no comparator, no blinding, and short-term observation limited to vital signs, self reported symptoms and labs across two days [4]

C., Adams, M

BPC-157 falls under the S0 Unapproved Substances category, a blanket ban covering any pharmacological substance not currently approved by any governmental regulatory health authority for human therapeutic use