Tesamorelin

Tesamorelin Acetate (GHRH Analogue)

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Established

At a Glance

An FDA-approved GHRH analogue used to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. It stimulates the body’s own growth hormone and IGF-1 pathways and remains under investigation for other metabolic and neurological questions.

Plain English

Tesamorelin stimulates the pituitary to release the body’s own growth hormone rather than supplying growth hormone directly. Its established clinical use is reducing excess visceral abdominal fat in adults with HIV-associated lipodystrophy. Researchers are also interested in how the GHRH/GH/IGF-1 pathway may affect metabolism and brain function, but those broader uses remain investigational.

Overview

Tesamorelin is a synthetic 44-amino-acid analogue of growth hormone-releasing hormone (GHRH). EGRIFTA WR and EGRIFTA SV are FDA-labeled for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy and are not substitutable. Neurocognitive and other metabolic research remains investigational and does not broaden the approved indication.

Research Summary

Tesamorelin has strong Phase III human evidence for reduction of visceral abdominal fat in HIV-infected adults with lipodystrophy. Pooled randomized trials showed significant reductions in visceral adipose tissue that were maintained with continued treatment, along with improvements in body-image measures and some lipid parameters. Tesamorelin has also been investigated in metabolic and neurocognitive research, including studies in people with HIV, but evidence does not currently support describing it as an established treatment for mild cognitive impairment or Alzheimer’s disease prevention.

Research Areas

  • Visceral adipose reduction
  • HIV lipodystrophy
  • Neurocognitive & brain-aging research
  • Metabolic syndrome
  • IGF-1 axis research

Safety & Risks

Serious Risks

  • Tesamorelin increases IGF-1 concentrations; IGF-1 levels should be monitored during treatment and persistent elevations may require discontinuation
  • Tesamorelin is contraindicated in patients with active malignancy; treatment should be discontinued if recurrent malignancy is identified
  • Tesamorelin can cause glucose intolerance or diabetes; glucose status should be evaluated before and during treatment
  • Fluid retention can occur and may cause edema, arthralgia, or carpal tunnel syndrome
  • Serious hypersensitivity reactions can occur
  • Tesamorelin is contraindicated in patients with disruption of the hypothalamic-pituitary axis due to conditions such as pituitary tumor, hypopituitarism, head irradiation, or pituitary surgery
  • Increased mortality in patients with acute critical illness has been reported with pharmacologic growth hormone; current EGRIFTA labeling advises considering discontinuation in critically ill patients because tesamorelin stimulates endogenous growth hormone production. This is a label warning, not a finding from tesamorelin clinical trials.

Reported Side Effects

  • Injection site reactions
  • Arthralgia
  • Myalgia
  • Peripheral edema
  • Paresthesia
  • Nausea
United States
FDA-approved as EGRIFTA WR and EGRIFTA SV for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy; the formulations are not substitutable.
United Kingdom
Current authorization status not established in this record
Australia
Current authorization status not established in this record
Canada
Current authorization status not established in this record

Citations & Sources