Is Tesamorelin FDA Approved? | DrugStatusIndex.com

Is Tesamorelin FDA Approved?

DrugStatusIndex provides a clear, data-driven view of the regulatory status of medications, compounds, and related products. This page explains whether Tesamorelin is FDA approved and how it is commonly categorized.

Overview

Tesamorelin is a synthetic growth hormone releasing factor (GHRF) analog used to stimulate endogenous growth hormone production. It is most commonly known under the brand name Egrifta.

FDA Status Details

Tesamorelin is classified as FDA Approved for a specific medical indication. It received FDA approval for reducing excess abdominal fat in HIV-infected patients with lipodystrophy under the prescription brand Egrifta.

Rx

Approved Use

Tesamorelin is approved specifically for HIV-associated lipodystrophy and not for general anti-aging, bodybuilding, fat loss, or hormone optimization therapy in the general population.

Peptide Clinic Confusion

Tesamorelin is often marketed by peptide clinics for off-label wellness and body composition purposes, but these uses are separate from its FDA-approved indication and should not be confused with standard approved medical treatment.

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