Peptide reference
Tesamorelin
Egrifta ·Egrifta SV ·Egrifta WR ·TH9507 ·trans-3-hexenoyl-GRF(1-44)
What cited sources report about Tesamorelin
Tesamorelin is a synthetic 44-amino-acid analog of human growth hormone-releasing hormone (GRF 1-44) bearing an N-terminal trans-3-hexenoyl modification that confers metabolic stability. The U.S. Food and Drug Administration approved tesamorelin (Egrifta) in 2010 and subsequent reformulations (Egrifta SV in 2019, Egrifta WR in 2024) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Despite this narrow approved indication, tesamorelin is widely promoted off-label for general body-composition use in research-peptide and direct-to-consumer markets. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
Dhillon (2011) — Drugs
A 2011 evaluative review by Dhillon in Drugs covered the pivotal Phase III trials that supported the original FDA approval of tesamorelin. The review reported that two 26-week placebo-controlled studies in HIV-infected adults with lipodystrophy observed reductions in visceral adipose tissue measured by CT relative to placebo, alongside improvements in patient-reported body-image outcomes.
Tesamorelin reduced visceral adipose tissue and improved patient-reported outcomes related to body image.
Mendias and Awan (2026) — Sports Medicine
A 2026 narrative review from the Performance Medicine Institute placed tesamorelin among the FDA-approved peptide therapies but noted that off-label marketing for general body composition has expanded substantially in the direct-to-patient peptide market. The authors observed that prescribing outside the approved HIV-lipodystrophy indication is not supported by adequate clinical-trial evidence in the general population.
Tesamorelin (Egrifta) has FDA approval for HIV-associated lipodystrophy, but it is also marketed off-label for general body composition changes.
FDA NDA 022505 — Egrifta SV Prescribing Information
The FDA-approved label specifies the indication, dosage (2 mg subcutaneous daily), and contraindications, which include disruption of the hypothalamic-pituitary axis, active malignancy, and pregnancy. The label also describes warnings around glucose intolerance, fluid retention, and hypersensitivity reactions, and reports the IGF-1 elevation observed in clinical trials.
EGRIFTA SV is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Theratechnologies M01-94186 — ClinicalTrials.gov NCT00123253
The pivotal Phase III multicenter randomized placebo-controlled trial sponsored by Theratechnologies enrolled 412 HIV-infected adults with excess abdominal fat. The protocol assessed change in visceral adipose tissue at 26 weeks as primary endpoint. Results posted on ClinicalTrials.gov informed the original FDA approval package and the subsequent label.