The only FDA-approved GHRH analog — specifically approved for HIV-associated lipodystrophy.
Tesamorelin is a synthetic analog of GHRH — specifically, a trans-3-hexenoic acid-conjugated GHRH (1-44) peptide. It was developed by Theratechnologies specifically to treat HIV-associated lipodystrophy, a condition where antiretroviral therapy causes abnormal fat accumulation in the abdomen (visceral adiposity) and face (lipoatrophy).
Unlike sermorelin (which mimics only the first 29 amino acids of GHRH), tesamorelin includes the full 44-amino acid GHRH sequence with a chemical modification that stabilizes it from degradation and extends its biological activity. It is administered as a daily subcutaneous injection.
Tesamorelin makes it to a rare category of compounded substances that have FDA approval for specific indications. While often prescribed off-label for body composition in non-HIV patients, the on-label indication and robust clinical trial data make it one of the more medically credible GHRH analogs.
PIVOT trials demonstrated significant reduction of visceral adipose tissue (VAT) by approximately 18% compared to placebo in HIV patients. Triglycerides were also significantly reduced. IGF-1 levels increased consistently. These Phase 3 results supported FDA approval in 2010.
Off-label research in non-HIV populations shows similar body composition effects: reduction in visceral fat, improvement in lean mass, and favorable lipid changes. A growing body of evidence also suggests cognitive benefits — tesamorelin is being studied for Alzheimer's prevention in older adults with mild cognitive impairment.
📚 Key Reference: PMID: 20697942 (Egrifta Phase 3), PMID: 23867123 (PIVOT extension)
Side effects include injection site reactions, fluid retention, arthralgias (joint pain), and peripheral neuropathy. IGF-1 levels should be monitored — excessive elevation can indicate over-treatment. Contraindicated in active malignancy. Use caution in patients with diabetes as it can impair glucose tolerance. Pregnancy and breastfeeding: avoid. Consult your provider.
FDA-approved as Egrifta (Theratechnologies, 2010) and updated as Egrifta SV (2019) for HIV-associated lipodystrophy. Off-label prescribing for body composition is common. Compounded tesamorelin is available but the approved brand product is preferred where accessible.