Tesamorelin

FDA-approved (prescription) Evidence grade A — regulator-approved with pivotal randomised trials Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: Egrifta, Egrifta SV, Egrifta WR.

Regulatory status

FDA-approved (initial US approval 2010) for reducing excess abdominal fat in HIV-infected adults with lipodystrophy; current formulations Egrifta WR (11.6 mg vial) and Egrifta SV (2 mg vial), not interchangeable [1][2]. Not indicated for weight loss; long-term CV safety not established. Prescription only.

What it is

Growth hormone-releasing factor (GHRH) analogue (44-amino-acid human GRF with a C6 hexenoyl group on the N-terminal tyrosine).

A daily injected synthetic GHRH analogue that raises the body's own growth hormone and IGF-1. Approved in the US only to reduce excess abdominal (visceral) fat in adults with HIV-associated lipodystrophy; not for weight loss.

What the published research shows

Two 26-week phase 3 RCTs (412 and 404 HIV patients with abdominal fat) with 26-week extensions; visceral fat fell about 15-18 % versus a small rise with placebo.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

HIV-associated abdominal fat (Egrifta WR label): Label: 1.28 mg (0.16 mL of 8 mg/mL solution) subcutaneously into the abdomen once daily, rotating sites.
HIV-associated abdominal fat (Egrifta SV label): Label: 1.4 mg (0.35 mL of reconstituted 2 mg vial) subcutaneously once daily.
Visceral fat in HIV (phase 3 trial, Falutz 2007): 412 patients, 2 mg SC daily (original 1 mg/vial formulation) for 26 weeks: visceral adipose tissue fell 15.2 % versus a 5.0 % rise with placebo; triglycerides and cholesterol ratio improved; IGF-1 rose 81 %.

Mechanism, as reported

Binds pituitary GHRH receptors with potency similar to the natural hormone, stimulating pulsatile growth hormone release; growth hormone, partly through IGF-1, is lipolytic and anabolic. Other pituitary hormones were not meaningfully changed in trials.

Practical record

Elimination half-life: 0.18 h (confidence: high). Current labels: mean elimination half-life 11 min in healthy subjects after a single 1.28 mg SC dose of Egrifta WR (8 min for Egrifta SV 1.4 mg); Tmax 0.15 h; SC bioavailability under 4 % (2 mg); apparent Vd 4.8 ± 1.9 L/kg. The 2010 label reported 26 min (healthy) and 38 min (HIV-infected) after 14 consecutive days of dosing, which is where the app's earlier 32 min came from.
Studied routes: subcutaneous.
Typical supply: Lyophilised powder: Egrifta WR 11.6 mg vial (7 daily doses per vial) with bacteriostatic water; Egrifta SV 2 mg single-dose vial with sterile water (Rx).
Reconstitution: Egrifta WR: 1.3 mL of the supplied bacteriostatic water (8 mg/mL), swirl, do not shake; keep at 20-25 °C, discard 7 days after mixing, do not refrigerate or freeze. Egrifta SV: 0.5 mL of sterile water, roll gently 30 s; inject immediately and discard the rest.
Storage: Unmixed vials at 20-25 °C (excursions 15-30 °C) in the original box, protected from light; do not freeze.

Safety signals on record

Reported adverse events: Injection-site reactions (17 % vs 6 % placebo), joint pain, limb pain, muscle pain, peripheral oedema, tingling or numbness, rash; higher risk of developing diabetes (HbA1c ≥6.5 %: 5 % vs 1 %); hypersensitivity reactions.
Contraindications: Disrupted hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumour or surgery, head irradiation or trauma); active malignancy; hypersensitivity to tesamorelin or excipients (e.g. mannitol); pregnancy.
Interactions: Growth hormone may alter clearance of CYP450-metabolised drugs (e.g. corticosteroids, sex steroids, anticonvulsants, cyclosporine), so monitor; patients on glucocorticoid replacement may need higher doses. No significant effect on simvastatin.
Notes: Raises IGF-1: the label advises monitoring IGF-1 and considering stopping with persistent elevation; fluid retention and carpal tunnel can occur; consider stopping in acute critical illness. Anti-tesamorelin antibodies were found in 50 % of patients after 26 weeks, without a change in average effect.

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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