Over two days, the committee recommended six families for inclusion on the 503A Bulks List: BPC-157 Favorable recommendation KPV Favorable recommendation TB-500 Favorable recommendation MOTS-c Favorable recommendation Epitalon Favorable recommendation Semax Favorable recommendation Emideltide/DSIP Not recommended Reported topline votes included an 86 favorable vote for BPC-157, a 74 favorable vote for Epitalon, an 85 favorable vote for Semax, and a 67 vote against Emideltide, with abstentions reported in those deliberations
Regulatory Status International Approvals EMA (EU): Approved as Ozempic (2018), Rybelsus (2020), Wegovy (2022) MHRA (UK): Approved for all three indications TGA (Australia): Approved for T2D and weight management Health Canada: Approved for T2D and chronic weight management PMDA (Japan): Approved as Ozempic for T2D Research / Compounding Access Updated 2026-04-23 Important regulatory update: The FDA declared the semaglutide drug shortage resolved on February 21, 2025
First few dosages are offered at lesser strength
These data are useful not as therapeutic endpoints, but as a way of examining how tri-agonist signaling may affect tissue-level energy partitioning under experimental conditions [2][3][5]
Low food intake can be a problem, especially in debilitated patients or those who have been hospitalized for long periods
B12 has been shown to promote recovery of nerve tissue after traumatic brain injury (TBI) , and to stabilize and reduce the rate of nerve cell death