Tesamorelin
FDA-approved GHRH analog with durable Phase 3 fat-loss data.
- Primary research area
- GH / fat redistribution
- FDA status
- FDA approved 2010 (HIV-lipodystrophy)
- Last updated
- Apr 21, 2026
- Reviewed by
- Peptide Examiner editorial team
What it is
Tesamorelin is a synthetic analog of growth-hormone-releasing hormone (GHRH), FDA approved in 2010 under the brand Egrifta for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It is one of a small number of FDA-approved peptide therapeutics and the only GHRH analog with a durable body-composition indication. It is administered as a daily subcutaneous injection.
Mechanism of action
Tesamorelin is a stabilized analog of the 44-amino-acid GHRH peptide with structural modifications that resist enzymatic degradation. It binds GHRH receptors in the anterior pituitary, stimulating endogenous pulsatile release of growth hormone, which in turn elevates circulating IGF-1 and drives reductions in visceral adipose tissue (VAT). The effect is mechanistically distinct from exogenous recombinant growth hormone (somatropin), which supplies GH directly rather than stimulating native pulsatile secretion.
Research history
Pivotal Phase 3 trials in HIV-associated lipodystrophy reported ~15-18% reductions in visceral adipose tissue at 26 weeks with sustained effect at 52 weeks. Subsequent research has examined tesamorelin in NAFLD/MASH (hepatic steatosis reduction demonstrated in multiple trials), cognitive function in aging adults (mixed results), and in endocrine disorders. The MASH program has been the most active non-HIV expansion area.
Current trial status
FDA approved for HIV-associated lipodystrophy. Off-label use in metabolic and body-composition contexts is common. Phase 2/3 trials in NAFLD/MASH have produced positive but mixed data; no broader approval has followed as of April 2026.
Regulatory status
FDA approved (November 2010). Marketed as Egrifta and Egrifta SV (a reformulation). Compounded versions of tesamorelin are available through certain pharmacies. Not on FDA Category 2 list. Full regulatory timeline →
Controversies and open questions
Cost is the dominant issue: list price exceeds $3,000-$4,000 per month, limiting access. IGF-1 elevation with chronic GH axis stimulation raises theoretical cancer-risk concerns (breast, prostate, colorectal), though these have not been clinically confirmed in approved-indication populations. The off-label use for general body composition in healthy adults sits well outside the evidence base supporting FDA approval.
Further reading
Frequently asked
Is tesamorelin FDA approved?
Yes — approved November 2010 as Egrifta for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It's one of a small number of FDA-approved peptide drugs.
Can it be used off-label for general anti-aging?
Physicians can prescribe off-label, but insurance almost exclusively covers the HIV lipodystrophy indication. Out-of-pocket cost at list ($3,000-4,000/month) is prohibitive for most off-label use cases.
How is it different from sermorelin?
Both are GHRH analogs. Tesamorelin is a stabilized modified GHRH with protease resistance and Phase 3 evidence for a specific body-composition indication. Sermorelin is a simpler GHRH 1-29 fragment with pediatric historical approval and widespread compounded off-label adult use.
Does it actually reduce visceral fat?
Yes, in HIV lipodystrophy populations. Phase 3 trials reported ~15-18% reductions in visceral adipose tissue at 26 weeks, sustained at 52 weeks. Non-HIV populations haven't been studied at the same rigor.