Industry/Regulatory Developments
Approved peptide medicines are defined by their labels
Tesamorelin, bremelanotide, semaglutide, and tirzepatide each became a specific product with an indication. A related research listing is not that product.
Some peptides really did become drugs. That fact is used, constantly, to launder peptides that did not. The distinction is the label.
Four labels worth opening
Tesamorelin was approved as Egrifta to reduce excess abdominal fat in HIV-associated lipodystrophy. Bremelanotide was approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women, after a dose-finding program that includes the trial published under PMID 27181790. The research nickname PT-141 is not the label name, and a 10 mg research vial is not Vyleesi’s autoinjector. Semaglutide 2.4 mg weekly was approved as Wegovy for chronic weight management. Tirzepatide was approved as Zepbound for the same broad therapeutic area, with its own titration. Each PDF states warnings the abstracts do not.
Approval is not contagious
Approval of one formulation does not approve a compounded copy of uncertain composition, and it does not approve a different peptide that happens to sit in the same catalog. Melanotan I is not the approved afamelanotide implant, either, unless a specific licensed product says so. When this journal discusses an approved medicine, the label link is part of the citation. When it discusses a research peptide, the absence of a label is part of the citation too.