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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.
Read full storyThe Pharmacy Compounding Advisory Committee meets July 23-24 to consider whether peptides including BPC-157, TB-500, KPV and MOTS-c should be eligible for 503A compounding.
Topline TRIUMPH-1 results showed average weight reductions of roughly 19% to 28% across three doses over 80 weeks. Retatrutide remains investigational.
The December 2025 New Drug Application covers a once-weekly injection combining semaglutide and the amylin analogue cagrilintide for chronic weight management.
The August 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.
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In 17,604 adults with cardiovascular disease and overweight or obesity but without diabetes, semaglutide reduced major adverse cardiovascular events by 20% (hazard ratio 0.80).
A New England Journal of Medicine Phase 2 trial reported a 24.2% mean weight reduction at the highest dose over 48 weeks - a large but early, small-sample result.
The pivotal obesity trial for tirzepatide reported mean weight reductions of 15.0%, 19.5%, and 20.9% across doses over 72 weeks versus 3.1% for placebo.
A TGA decision added the experimental peptide to Schedule 4 of the Poisons Standard effective June 2024, amid warnings about a growing market for unapproved peptide products.
Data aggregated from primary regulatory and trial sources
Active and recruiting trials across GLP-1, tissue repair, anti-aging, and metabolic peptide categories.
FDA, EMA, TGA, and Health Canada regulatory status for peptide therapeutics and research compounds.
Aggregated adverse event reports from FAERS, EudraVigilance, and published case series for monitored peptides.
Study limitations: A secondary-prevention population (older adults with established cardiovascular disease, predominantly male and white); the results do not establish benefit in people without established heart disease. Not medical advice.
Body Protection Compound-157
Gastric peptide
Cytoprotective; promotes angiogenesis and tissue repair via VEGFR2 and EGR1 pathways.
TGA Schedule 4 (AU) · No FDA approval
LY3437943
GLP-1/GIP/glucagon triple agonist
Triple incretin receptor agonism; superior weight loss vs. dual agonists in early trials.
Phase 3 (US/EU) · NDA not yet submitted
Ozempic · Wegovy · Rybelsus
GLP-1 receptor agonist
GLP-1 receptor agonist; increases insulin secretion, reduces glucagon, slows gastric emptying.
FDA approved (T2D, obesity) · EMA approved
Mounjaro · Zepbound
GLP-1/GIP dual agonist
Dual GIP and GLP-1 receptor agonism with superior metabolic and adipose remodeling vs. GLP-1 alone.
FDA approved (T2D, obesity) · EMA approved
Thymosin Beta-4 fragment
Thymosin fragment
G-actin sequestration; promotes cell migration, wound healing, and cardiac regeneration.
No regulatory approval · Research use only
DAC:GRF
GHRH analogue
GHRH receptor agonist with extended half-life via drug-affinity complex (DAC) technology.
No regulatory approval · Compounded Rx in some jurisdictions
Epithalamin · Epitalon
Pineal tetrapeptide
Proposed telomerase activator and melatonin production modulator; limited human trial data.
No major regulatory classification · Scheduling review pending (WHO)
Copper peptide GHK
Copper-binding tripeptide
Copper chelation; upregulates wound-healing genes, antioxidant enzymes, and collagen synthesis.
No systemic regulatory approval · Topical only in cosmetics
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