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Sourcing Guide

Tesamorelin in the US: The GHRH Analog With Approved-Drug Data

The only compound in the GH-axis catalog with completed phase 3 trials, and why that does not transfer to a research vial

·Compiled by Eppix Labs

Tesamorelin is the only compound on the GH-axis shelf with completed phase 3 trials and a marketing authorization behind it, which makes it both the best-evidenced item in the category and the one most likely to have its evidence misapplied. The trials were run on an approved product, in a specific patient population, for a specific indication. A research vial inherits the molecule and none of that.

This guide covers the molecule, the trial record and the verification checks. Research-grade tesamorelin is supplied for laboratory research use only.

Chemical Identity

Name
Tesamorelin (trans-3-hexenoyl-GHRH(1-44) amide)
Also known as
Tesamorelin, TH9507, Egrifta (approved product)
Molecular formula
C₂₂₁H₃₆₆N₇₂O₆₇S
Molecular weight
5135.9 g/mol
CAS number
218949-48-5
Salt forms
Acetate

What tesamorelin is

Tesamorelin is a synthetic analog of human growth-hormone-releasing hormone, the full 44-residue GHRH(1-44) sequence with a trans-3-hexenoyl group attached at the N-terminal tyrosine. That single acyl modification is the whole design: it blocks dipeptidyl peptidase-4 cleavage at the N-terminus, which is the degradation route that gives native GHRH a half-life of a few minutes.

It acts at the GHRH receptor on pituitary somatotrophs, stimulating endogenous GH release rather than supplying exogenous GH. That distinction is the basis of the whole GHRH-analog class: the pituitary's own feedback loops remain in the circuit.

Research Material
General Image
Tesamorelin lyophilized research material as supplied by Eppix Labs. Labelled and measured content are stated on the certificate below.

Sequence and structure

Forty-four residues, around 5136 Da, N-terminally acylated. This is one of the longest peptides in the catalog and correspondingly one of the harder syntheses, with deletion sequences as the dominant impurity class. It is also the compound where an incomplete acylation is most consequential, because the acyl group is the entire reason the analog exists.

Amino Acid Sequence
Amino Acid Sequence diagram
Amino-acid sequence of tesamorelin.
Chemical Structure
Chemical Structure diagram
Chemical structure of tesamorelin.

What the published trials reported

Stated as findings from named, published, randomized trials conducted with pharmaceutical-grade material:

  • ·Phase 3, HIV-associated lipodystrophy. Falutz et al., New England Journal of Medicine 2007: a 26-week randomized, double-blind, placebo-controlled trial in patients with HIV and excess abdominal fat, reporting reduction in visceral adipose tissue against placebo.[1]
  • ·Pooled phase 3 analysis. Falutz et al. (2010) reported the pooled results of the tesamorelin phase 3 program, including the extension period and the effect of withdrawal.[2]
  • ·Hepatic fat. Stanley et al., Lancet HIV 2019: a randomized, double-blind, multicenter trial reporting reduction in hepatic fat fraction and effects on fibrosis progression in people with HIV and non-alcoholic fatty liver disease.[3]

The limit of the evidence

The tesamorelin trial program was conducted in people with HIV, on an approved GMP product, for indications defined in that population. It is not a general characterization of the molecule, and it is not evidence about a research vial. the FDA authorization, where it exists for a tesamorelin product, attaches to that product through the pharmacy channel, not to research material.

Research-grade tesamorelin is a laboratory material with no human-use authorization. The existence of an approved sibling product makes this distinction more important here, not less.

Verifying a tesamorelin lot

Identity by mass spectrometry against the expected mass near 5136 Da, HPLC purity, and measured content against the labeled amount. At 44 residues, purity is the figure that carries the most information about synthesis quality, because deletion sequences accumulate with chain length and a genuinely high purity number on a peptide this long is a meaningful signal.

Every Eppix tesamorelin lot is tested by Janoshik Analytical, published before sale and verifiable on the laboratory's own database. Multiple strengths are stocked; use the buttons under the certificate to switch.

Published Certificate
Certificate of analysis for Tesamorelin 10mg, batch TESA-CA-26A-01, 98.763% purity, 11.68 mg measured content

Select strength

Batch
TESA-CA-26A-01
Purity (HPLC)
98.763%
Measured content
11.68 mglabeled 10 mg
Laboratory
Janoshik
Published certificates for the current tesamorelin lots, by strength, read live from the batch record.

Frequently Asked

Is tesamorelin an approved drug?

An approved tesamorelin product exists for a specific indication in people with HIV, dispensed through the pharmacy channel. Research-grade tesamorelin is a separate supply chain, is not that product, and carries no human-use authorization.

How does tesamorelin differ from sermorelin?

Both are GHRH analogs. Sermorelin is the unmodified GHRH(1-29) fragment with a half-life of minutes. Tesamorelin is the full GHRH(1-44) sequence with an N-terminal acyl group that blocks DPP-4 cleavage, giving a longer duration of action and a completed phase 3 program.

Is tesamorelin legal to buy in the US as a research material?

Research-grade tesamorelin may be sold and held for laboratory use, and is not authorized for human or veterinary use in that form. This is not legal advice.

What should a tesamorelin certificate show?

Batch number matching the vial, the named testing laboratory with an independent verification path, MS identity against the expected mass near 5136 Da, HPLC purity, and measured content against the labeled amount.

Why does purity matter more for a 44-residue peptide?

Deletion and truncation sequences accumulate with chain length in solid-phase synthesis. A high purity figure on a very long peptide is a stronger statement about manufacturing quality than the same figure on a tripeptide.

How is tesamorelin stored?

Lyophilized: cool, dry, dark, at -20 °C for long-term storage. Reconstituted: refrigerated, used within the window your protocol defines.

References

  1. Falutz, J. et al. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med 357(23):2359-2370. PMID 18057338
  2. Falutz, J. et al. (2010). Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab 95(9):4291-4304. PMID 20554713
  3. Stanley, T.L. et al. (2019). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV 6(12):e821-e830. PMID 31611038

Research Use Only

This article summarizes published preclinical research literature. Compounds referenced are supplied by Eppix Labs strictly as research materials for laboratory investigation within the United States. They are not approved by the FDA for human or veterinary use, and nothing on this page should be interpreted as medical advice or guidance on human or animal administration.