PeptideAmerica

Reference table

Approved peptide drugs

Which peptides in this index are actually approved drugs?

The answer

Three, and their approvals are narrow: an approval belongs to a product in a stated indication, not to a molecule in every use a seller can imagine for it.

An FDA approval means a specific product completed clinical development — controlled trials in a named indication, a reviewed manufacturing process, and labeling that states what the evidence supports. It is the strongest position a molecule in this index can hold, and it is also the narrowest, because it attaches to a product and an indication rather than to a compound in general.

The consequence for supply is direct. Under section 503A a pharmacy may not compound what is essentially a copy of a commercially available drug unless a prescriber documents a clinical difference for an individual patient, and the FDA has rejected price as such a difference.

Denominator

The rows are the molecules this index files as approved. Where this index's ledger carries no dated approval entry for a product, the record column says so rather than supplying a year; the approved-product column states the products the ledger names.

Rows are read from MOLECULES[] where status is approved, MOLECULES[].approvedProduct, MOLECULES[].route, MOLECULES[].record[] entries stating an approval — the same dated ledger the molecule index renders. No cell on this page is typed by hand.

MoleculeApproved productRouteApproval record in this index
TesamorelinEGRIFTA WR (2025); EGRIFTA (2010)Subcutaneous injectionNovember 2010. FDA approves tesamorelin (EGRIFTA) for the reduction of excess abdominal fat in adults with HIV and lipodystrophy. March 2025. FDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV.
SemaglutideOzempic, Wegovy, RybelsusSubcutaneous injection; oral (Rybelsus)April 2026. FDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet.
TirzepatideMounjaro, ZepboundSubcutaneous injectionthis index's ledger carries no dated approval entry for this product

The approved page states where compounded copies of these products now stand, and the GLP-1 receptor agonists page covers the class where 2026's supply-side changes cut hardest.

Elsewhere in this index

Other tables

Monographs in this table