Peptide research

Tesamorelin peptide: what an FDA label does and does not tell you about a vial

Tesamorelin peptide is unusual among research compounds because a finished prescription drug made from it has an FDA label. Three documents get mixed up here: the label for the finished product, a supplier's listing for a vial, and a lot report for one lot. Each one records its own statements.

The tesamorelin peptide identity and research record collects the sources. This post explains how to read the three documents side by side.

What the label records

The label for Egrifta WR, revised March 2025, describes tesamorelin as a GRF analog produced synthetically. It names a 44 amino acid sequence with a hexenoyl group at the N-terminal tyrosine, gives a formula for the acetate salt and states a free-base weight of 5135.9 Da. It also records the finished product's inactive ingredients and its indication. All of that describes the approved product. Sources: FDA label for Egrifta WR, revised March 2025 and PubChem tesamorelin record, CID 16137828.

What the approval records add

Drugs@FDA ties the label to BLA 022505 and to the applicant, Theratechnologies. The approval letter of November 10, 2010 and the supplement letter of March 25, 2025 show when each Egrifta change took effect. These records concern the Egrifta products, and the tesamorelin FDA approval records page lists them in order. Sources: Drugs@FDA record for BLA 022505 and FDA supplement approval letter, March 25, 2025.

What a lot report adds

Curo's testing page lists the fields on a report: identity by FTIR or LC-MS, purity by HPLC, fill, and endotoxin and sterility where available. An LC-MS result is a measured mass, which a reader can compare with the reference mass on the label. The label answers what the compound is. The report answers what one lot measured.

Where the three documents stop

The label says nothing about the contents of a particular research vial. A lot report says nothing about FDA approval. A listing's label amount stays the supplier's statement until a report measures the fill. Matching a vial to its report starts with the lot number: enter it in Curo's lot-certificate library and compare the compound and fill with the vial label.

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