What is the evidence grade for TESAMORELIN?

TESAMORELIN carries an evidence grade of Strong (score 8.6). Strong human RCT or meta-analysis

What is the risk band for TESAMORELIN?

TESAMORELIN is rated Low risk. Well-characterized, minor reported AEs

What is the regulatory status of TESAMORELIN?

TESAMORELIN has a status of FDA-approved based on Peptides Pub's classification of clinical stage and approval data.

What research goals is TESAMORELIN studied for?

TESAMORELIN is studied in relation to the following research goals: Metabolic health.

PEP-0076FDA-approved

TESAMORELIN

Also known as

TESAMORELIN is catalogued in the Peptides Pub research index, with coverage focused on Metabolic health.

Evidence

Strong· 8.6

Strong human RCT or meta-analysis

Risk band

Low

Well-characterized, minor reported AEs

Research goals

Metabolic health

Summary

Tesamorelin is a synthetic growth hormone-releasing hormone (GHRH) analogue, approved by the FDA in November 2010 for the reduction of excess abdominal (visceral) fat in HIV-infected patients with lipodystrophy ^[3,1]. It is administered subcutaneously and exerts major effects on glucose and lipid metabolism without being linked to clinically apparent liver injury ^[1]. In a more recent randomized controlled trial in people with HIV on integrase-inhibitor regimens, tesamorelin produced beneficial effects on body composition without worsening glycemic control ^[2]. The combination of randomized controlled trial data and established regulatory approval supports strong clinical evidence for its approved indication, with metabolic monitoring as a relevant caveat ^[1,2].

Sources

1. Tesamorelin (LiverTox) LiverTox: Clinical and Research Information on Drug-Induced Liver Injury, 2012.
2. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors AIDS (London, England), 2024.
3. Tesamorelin Nature reviews. Drug discovery, 2011.

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