Semaglutide, tirzepatide, and retatrutide are larger, more complex molecules
Elevated IGF-1 levels raise concerns about potential proliferative effects on existing malignancies, making growth hormone therapy problematic for individuals with cancer history or elevated cancer risk
In the SURPASS-2 trial (published in The New England Journal of Medicine in 2021), tirzepatide at 5, 10, and 15 mg was compared with semaglutide 1 mg in 1,879 adults with type 2 diabetes on metformin over 40 weeks
For all four peptides on Thursday's agenda BPC-157, TB-500, KPV, and MOTS-C FDA staff reviewed the evidence under the agency's four-part balancing test and reached the same conclusion for each: do not add them to the 503A Bulk Drug Substances List, the only legal pathway for compounding pharmacies to dispense these compounds to patients