Overview
Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH/GRF) that stimulates endogenous growth hormone release. It is FDA-approved (Egrifta, 2010) to reduce excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The approved product is distinct from generic research-grade tesamorelin, which is not an approved pharmaceutical.
Biological Target / Mechanism
Tesamorelin binds and activates the pituitary GHRH receptor (Gs/cAMP), stimulating pulsatile endogenous GH secretion and downstream IGF-1, distinct from ghrelin-receptor secretagogues (GHRPs).
Research Areas
HIV-associated lipodystrophy (visceral adipose tissue reduction) and GH-axis physiology. Evidence includes two phase 3 randomized placebo-controlled trials supporting approval.
Evidence Overview
Two multicenter phase 3 trials in 816 HIV-positive adults with lipodystrophy demonstrated significant reductions in visceral adipose tissue and waist circumference versus placebo at 26 weeks. Labeling notes long-term cardiovascular benefit is not established and that IGF-1 and glucose monitoring are required.
Regulatory / Development Context
Tesamorelin (Egrifta) was FDA-approved on November 10, 2010, for HIV-associated lipodystrophy; a concentrated formulation (Egrifta WR) was later approved. The approved product is distinct from research-grade material; Peptide Underground does not represent or offer an approved pharmaceutical.
Analytical / Research Considerations
Research-grade tesamorelin is handled under appropriate laboratory storage and documentation. Research-grade material is handled under appropriate laboratory storage and documentation. No purity, identity, stability, sterility, batch, or COA claims are made here for any Peptide Underground material.
Limitations
Approved-product evidence applies to the specific HIV-lipodystrophy indication only. Effects on long-term cardiovascular outcomes are not established.
References
- FDA. EGRIFTA (tesamorelin) prescribing information (BLA 022505, 2010). https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf
- FDA Clinical Outcome Assessment Compendium (tesamorelin approval, Nov 10 2010). https://www.fda.gov/media/130138/download
- Tesamorelin: a review of its use in HIV-associated lipodystrophy (review). https://pubmed.ncbi.nlm.nih.gov/21668043/
- FDA Approves Tesamorelin for HIV Lipodystrophy (Medscape, 2010). https://www.medscape.com/viewarticle/732450