(Polysulfated Glycosaminoglycan): Treats Arthritis, Not Just Symptoms Adequan i.m
C., Caffo, B., & Pekar, J
**BPC-157, a synthetic gastric pentadecapeptide studied primarily in animal models for tissue repair, gut healing, and anti-inflammatory effects, remains unapproved by the FDA as a finished drug with only limited small-scale human data available.** It was placed in Category 2 in 2023 due to concerns over immunogenicity, peptide impurities, and insufficient safety information for compounding under Section 503A
What would move this position is: a randomised, placebo-controlled trial in a defined population with an objective primary endpoint, a pre-registered protocol, and pharmacovigilance over a clinically meaningful duration
The weight loss seen in the Phase IIB trial was approximately double that produced by medications that had been approved (as of 2008) by the US Food and Drug Administration (FDA) for the treatment of obesity