HIV-associated lipodystrophy / excess abdominal fat
Established
This is the FDA-labeled use. Pooled phase 3 analyses reported visceral fat reductions versus placebo in studied populations.
Also known as Egrifta, Egrifta SV, Egrifta WR, TH9507
Growth hormone–releasing factor analog approved to reduce excess abdominal fat in HIV-infected adults with lipodystrophy — not a general weight-loss medicine.
Tesamorelin is a synthetic analog of growth hormone-releasing factor (GHRH/GHRF). It is FDA-approved for a narrow indication: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Labeling states it is not indicated for weight-loss management and that long-term cardiovascular safety has not been established.
Tesamorelin mimics growth hormone-releasing hormone, which can stimulate the pituitary to release growth hormone.
It is an approved prescription medicine for a specific HIV-associated fat-distribution problem, not a general 'GH peptide' for fitness use.
Multiple vial strengths and brand presentations exist (including Egrifta WR). They are not automatically substitutable.
Tesamorelin signals the pituitary like growth hormone-releasing hormone. That can raise growth hormone, which then affects IGF-1 and fat-tissue biology. In the approved setting, the clinical goal described in labeling is reducing excess abdominal fat in adults with HIV and lipodystrophy — not general weight loss.
Tesamorelin is a GHRF analog that binds pituitary GHRH receptors, stimulating endogenous GH pulsatility and downstream IGF-1. Labeling emphasizes visceral adipose tissue reduction in HIV lipodystrophy and lists limitations including unknown long-term cardiovascular safety and lack of data that the drug improves antiretroviral adherence.
Step 1
Peptide
Tesamorelin (GHRF analog)
Step 2
Target
Pituitary GHRH receptor
Step 3
Pathway
GH secretion → IGF-1 and metabolic effects on adipose tissue
Step 4
Labeled research effect
Reduction of excess abdominal fat in indicated HIV lipodystrophy populations
This is the FDA-labeled use. Pooled phase 3 analyses reported visceral fat reductions versus placebo in studied populations.
A 2019 randomized trial reported reductions in hepatic fat with tesamorelin versus placebo in a selected HIV NAFLD population. That research question is not the same as the labeled lipodystrophy indication.
Phase 3 trials in HIV-associated abdominal fat accumulation support the approved indication. Additional research (for example hepatic fat in HIV) exists but may be off-label relative to current labeling.
As a GHRH analog, pharmacologic effects on GH/IGF-1 are expected. Product-specific nonclinical details are in labeling.
2010 · Human clinical trial
Population: HIV-infected adults with excess abdominal fat / lipodystrophy in phase 3 programs
Objective: Summarize visceral adipose tissue and safety findings from two multicenter, double-blind, placebo-controlled phase 3 trials.
Main finding: Pooled analysis reported reductions in visceral adipose tissue with tesamorelin versus placebo in the studied HIV lipodystrophy population.
Limitations: Indication is specific. Long-term cardiovascular safety is described as not established in labeling. Results do not support use for general weight loss.
2019 · Human clinical trial
Population: People with HIV and hepatic steatosis meeting trial criteria
Objective: Assess effects of tesamorelin on liver fat and related measures versus placebo.
Main finding: The randomized trial reported reductions in hepatic fat with tesamorelin compared with placebo in the studied population. This is not an FDA indication summary; see labeling for approved use.
Limitations: Sample size and selected NAFLD population limit generalization. Safety monitoring in the paper should be read in full.
Safety information may be incomplete, especially for experimental peptides.
Safety information may be incomplete, especially for experimental peptides. Consult a qualified healthcare professional for personal medical advice. Tesamorelin labeling includes malignancy, glucose, and injection-site concerns among others.
Long-term safety: Labeling explicitly states long-term cardiovascular safety is unknown. Treatment duration decisions belong with a clinician.
Evidence limitations: Approval is narrow. Using tesamorelin as a general fat-loss or 'GH optimization' agent is not an established, labeled use.
Administration practices vary by compound and clinical context. Follow approved prescribing information or guidance from a qualified healthcare professional. This page does not provide injection technique, mixing, or personalized dosing instructions.
Approved prescribing information
Dose, reconstitution, and storage differ by Egrifta presentation (WR vs SV vs older vials) and are not interchangeable. See DailyMed. This site does not provide mixing instructions.
Discovery
complete
Synthetic GHRH analog (TH9507).
Preclinical research
complete
GH-axis pharmacology.
Human studies
complete
HIV lipodystrophy development program.
Clinical trials
complete · 2010
Phase 3 visceral-fat trials; 2010 U.S. approval.
Regulatory status
complete · 2010–2025
Approved 2010; later formulation updates including Egrifta WR.
A GHRH analog approved to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.
Labeling says it is not indicated for weight-loss management. The approved use is specific.
It stimulates pituitary GH release via GHRH receptors, with downstream metabolic effects on visceral fat in the studied indication.
Malignancy-related warnings, glucose effects, injection-site reactions, and unknown long-term cardiovascular safety are among labeled issues.
Growth Hormone Research
GHRH (1-29) analog that was previously marketed in the U.S. Current routine availability and approved status should not be assumed from historical branding.
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Growth Hormone Research
Long-acting GHRH analog studied in healthy adults for prolonged GH and IGF-I secretion. Not an approved therapy for general use.
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