Tesamorelin
/ Stabilized human growth hormone-releasing hormone (1-44) analogALIAS · Egrifta · Egrifta SV
Terms in this page you can click for a plain-English popup: , , , , , , , .
Only FDA-approved peptide in the growth-hormone-secretagogue class with a human efficacy indication. Approved 2010 for HIV-associated lipodystrophy.
Tesamorelin is synthetic human GHRH(1-44) with an N-terminal trans-3-hexenoic acid modification that increases stability against DPP-4 cleavage. Full GHRH receptor agonist producing pulsatile growth hormone and downstream IGF-1 elevation. Clinically distinct among GH secretagogues for demonstrated selective visceral adipose tissue (VAT) reduction in HIV patients with lipodystrophy.
Phase 3 pivotal trials established efficacy for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Additional randomized controlled trial evidence supports hepatic fat reduction in HIV-NAFLD.
Factual reporting of what cited studies used — not a recommendation.
- Falutz 2007 phase-3 pivotal HIV lipodystrophy trial — Adult humans with HIV-associated lipodystrophy — 2 mg Subcutaneous dailyREFFalutz 2007 (Tesamorelin)
Labeling adverse events include arthralgia, injection-site reactions, extremity pain, peripheral edema, myalgia, flushing. Glucose intolerance: modest fasting-glucose increase with new-onset diabetes in approximately 4-5% vs 2-3% placebo. Contraindications include disrupted hypothalamic-pituitary axis, active malignancy, and pregnancy.
Regulatory status
- FDA status:
- FDA-approved
- Compounding:
- Not eligible for compounding (approved, not in shortage)
Efficacy outside the HIV-lipodystrophy population is supported only by smaller studies. Robust non-HIV MASLD phase-3 data do not yet exist.