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Breaking developments across peptide therapeutics: trial launches, regulatory actions, and industry moves, reported with primary sourcing.
The Pharmacy Compounding Advisory Committee is scheduled to review seven peptides for the Section 503A bulk drug substances list on July 23-24, part of a broader reconsideration of substances the agency flagged in 2023.
Topline results from TRIUMPH-1, the first pivotal trial of the investigational triple-hormone agonist, showed average weight reductions of roughly 19% to 28% across three doses over 80 weeks.
The company submitted a New Drug Application on December 18, 2025 for the once-weekly injection combining semaglutide and the amylin analogue cagrilintide for chronic weight management.
The August 15, 2025 decision made semaglutide 2.4 mg the first GLP-1 receptor agonist cleared to treat noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis.
A TGA decision added the experimental peptide BPC-157 to Schedule 4 of the Poisons Standard effective June 1, 2024, amid warnings about a growing market for unapproved peptide products.
Career reviewers at the agency posted documents finding little human evidence for BPC-157, TB-500 and five other peptides, setting up a clash with Health Secretary Robert F. Kennedy Jr., who has pushed to widen access before the July 23-24 advisory meeting.