10.3390/biomedicines9081029 41 KnezevicM.GojkovicS.KrezicI.ZizekH.MalekinusicD.VrdoljakB.et al (2021b)
A negative vote typically results in the FDA issuing a final determination against listing, leaving the gray market as the only practical source though rejected substances can be re-nominated in future cycles or challenged in federal court
Clinical Indications Musculoskeletal Applications Both BPC-157 and TB-500 have demonstrated significant therapeutic potential in addressing various musculoskeletal pathologies, representing some of the most promising clinical applications for these peptide therapeutics
The peptide BPC-157 has not been evaluated for safety as part of the drug review process of the United States Food and Drug Administration (FDA), nor has it been formally evaluated for safety by any international regulatory counterpart of the FDA
BPC-157 demonstrates a favorable safety profile in research studies, with minimal adverse effects reported across hundreds of animal studies
While this application requires further clinical investigation, some studies have shown the peptide stimulating cartilage cell proliferation and demonstrating potential benefits for osteoarthritis treatment