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None of the peptides currently being considered for compounding are FDA approved drugs, said Edgar Asebey, a life science attorney and partner at the Frier Levitt law firm who heads the FDA Practice Group

The molecule was first identified and studied by the Sikiric research group in Croatia starting in the early 1990s, and the bulk of the preclinical evidence base comes from more than three decades of rat and rodent studies showing consistent tissue-repair, anti-inflammatory, and gastroprotective effects