Tesamorelin

Brand: Egrifta, Egrifta SV, Egrifta WRAlso known as: TH9507

FDA-approved

The one growth-hormone-axis peptide in this group with a genuine FDA approval — proven in large trials to reduce excess visceral abdominal fat in people with HIV-associated lipodystrophy.

FDA-approved in 2010 as Egrifta for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. It remains marketed (Egrifta SV; the reformulated Egrifta WR was approved in 2025). Approval is specific to HIV-associated lipodystrophy — any other use (general fat loss, anti-aging, bodybuilding) is off-label and not supported by its approved evidence.

What it is

Tesamorelin is a stabilized analog of growth-hormone-releasing hormone (GHRH). Like sermorelin and CJC-1295 it stimulates the pituitary to release the body’s own growth hormone, but structural modifications make it more resistant to breakdown. Unlike the other peptides in this group, tesamorelin was developed as a conventional pharmaceutical, tested in large trials, and brought to market.

What it’s approved or studied for

Tesamorelin is FDA-approved (2010) as Egrifta for one specific indication: reducing excess visceral abdominal fat in people with HIV-associated lipodystrophy — a condition in which fat accumulates around the abdominal organs. It is the only medication approved in the U.S. for that purpose, and it remains marketed (Egrifta SV, and the 2025 reformulation Egrifta WR). Everything outside that indication — general weight loss, “anti-aging,” bodybuilding — is off-label.

What human evidence exists

For its approved use the evidence is strong. Two large phase-3, randomized, placebo-controlled trials showed roughly a 15% reduction in visceral adipose tissue over 26 weeks versus placebo, with accompanying lipid improvements (Grade A for VAT reduction, Grade B for triglycerides). Later randomized work in people with HIV also suggests liver-fat reduction (Grade C, not approved). Critically, this evidence is HIV-specific: there is no adequate trial showing it helps people without HIV-associated lipodystrophy (Grade U).

The major unknowns

The main open question is generalizability — the approved benefit was measured in a particular patient population, and it should not be assumed to transfer to healthy adults seeking fat loss or anti-aging effects. Long-term safety beyond the trial periods, and the significance of the IGF-1 rise it produces, continue to be monitored.

Most important safety considerations

Tesamorelin raises IGF-1 and can worsen glucose control and cause fluid retention; joint pain and injection-site reactions are common. It is contraindicated in active malignancy, in pregnancy, and with disruption of the hypothalamic-pituitary axis. It is prohibited in sport under WADA’s S2 category. Even though it is FDA-approved, it is approved for a narrow indication and should be used only under medical supervision — this page is a research summary, not medical advice.

Evidence by outcome

Each outcome is graded on its own evidence — a compound can be strong for one use and unproven for another. See how we grade.

Visceral adipose tissue reduction (HIV lipodystrophy)
AEstablished

FDA-approved and proven in large randomized trials. — Two phase-3, randomized, placebo-controlled trials (pooled ~800+ patients) showed roughly a 15% reduction in visceral adipose tissue over 26 weeks vs. placebo (Falutz 2007). This is the approved indication and the reason for its Grade A.

Triglyceride / lipid improvement (HIV lipodystrophy)
BSupported

Consistent secondary-endpoint benefit in the pivotal trials. — VAT reduction was accompanied by improvements in fasting triglycerides and other lipid measures in the phase-3 program.

Liver fat / NAFLD reduction
CPreliminary

Promising randomized data in HIV, not an approved indication. — Later randomized studies in people with HIV reported reductions in liver fat, but this remains off-label and needs confirmation outside that population.

Fat loss / body composition in non-HIV or general anti-aging use
UUnknown

Unknown — the evidence base is HIV-specific and does not transfer. — There is no adequate trial evidence that tesamorelin produces useful fat loss or anti-aging effects in people without HIV-associated lipodystrophy.

Safety

Common adverse effects

  • Injection-site reactions
  • Arthralgia (joint pain)
  • Peripheral edema
  • Myalgia
  • Flushing
  • Hypersensitivity reactions

Serious risks

  • Increased IGF-1 levels
  • Glucose intolerance / impaired glucose control
  • Fluid retention
  • Potential to accelerate growth of existing malignancy
  • Serious hypersensitivity reactions

Contraindications

  • Active malignancy
  • Pregnancy
  • Disruption of the hypothalamic-pituitary axis (hypophysectomy
  • hypopituitarism
  • pituitary tumor/surgery
  • head irradiation/trauma)
  • Known hypersensitivity to tesamorelin or mannitol

References

  1. FDA Prescribing Information — Egrifta SV (tesamorelin for injection)
  2. Falutz J et al. Metabolic Effects of a Growth Hormone–Releasing Factor in Patients with HIV. NEJM 2007