A growth hormone–releasing hormone analog approved to reduce excess abdominal fat in adults with HIV-associated lipodystrophy.
Key takeaway
Tesamorelin is a 44-amino-acid analog of growth hormone–releasing hormone (GHRH). It prompts the pituitary to release growth hormone.
At a glance
| FDA status | In an FDA-approved drug |
|---|---|
| 503A compounding | No 503A pathway: regulated as a licensed biological product |
| Body areas | Hormones & pituitary, Metabolism & weight |
| Through ScriptMates | Information only |
| Open questions | None noted |
What is tesamorelin?
Tesamorelin is a 44-amino-acid analog of growth hormone–releasing hormone (GHRH). It prompts the pituitary to release growth hormone.
Because it is longer than 40 amino acids, FDA now regulates it as a biological product. Licensed biologics are outside section 503A, so it has no compounding pathway.
Dosage forms
FDA-approved Egrifta SV and Egrifta WR are lyophilized powders for reconstitution as subcutaneous injections.
Is tesamorelin FDA-approved?
Active ingredient of Egrifta, which Drugs@FDA lists under a biologics license (BLA 022505) after the March 2020 transition of protein products.
Can it be prescribed through ScriptMates?
No 503A pathway: regulated as a licensed biological product. A partner pharmacy lists it, but it has no lawful 503A pathway today (regulated as a licensed biological product).
Sources
- Drugs@FDA: Egrifta (tesamorelin), BLA 022505
- FDA: Notice to compounders on the March 23, 2020 biologics transition
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.