1. What It Is (Mechanism of Action)
Tesamorelin is a synthetic 44-amino-acid peptide consisting of the complete human GHRH sequence attached to a trans-3-hexenoyl fatty acid moiety at the N-terminus, which confers enhanced enzymatic resistance to DPP-4 cleavage.
2. Clinical Indications Under Study
FDA-approved for the reduction of excess abdominal visceral adipose tissue in HIV-infected patients with lipodystrophy. Under active clinical investigation for MASH and non-alcoholic fatty liver disease.
3. FDA Approval & Regulatory Status
FDA-Approved Prescription Drug (Egrifta)
4. Human Clinical Evidence Summary
5. Known Risks, Side Effects & Boxed Warnings
Arthralgia, peripheral edema, myalgia, injection site reactions, glucose intolerance (elevated fasting blood glucose and HbA1c), and hypersensitivity reactions. IGF-1 levels must be monitored periodically.
6. Legal, Prescription & Compounding Status
Prescription medication (Rx only). Subject to tight FDA compounding oversight.
7. Why Gray-Market "Research Chemical" Versions Are Risky
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8. Questions to Ask a Licensed Clinician
If you are discussing this compound with your doctor or healthcare provider, consider bringing these evidence-based questions:
- Q1: What are the specific clinical criteria for prescribing FDA-approved tesamorelin?
- Q2: How frequently should IGF-1 and fasting glucose levels be monitored during therapy?
9. Primary Peer-Reviewed Sources & Citations
- [1] Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2359-2370. PubMed / Source →
- [2] U.S. FDA Approval Information: EGRIFTA (tesamorelin for injection). PubMed / Source →