Egrifta WR (tesamorelin for injection)
FDA-approved for reducing excess abdominal fat in HIV-infected adults with lipodystrophy; not indicated for weight-loss management, and long-term cardiovascular safety has not been established.
Current sourceTesamorelin
A narrow FDA-approved use, human trial evidence, and important boundaries
Tesamorelin is a growth hormone-releasing factor analog. FDA-approved Egrifta products have a narrow indication: reducing excess abdominal fat in adults with HIV and lipodystrophy. The current label says the product is not indicated for weight-loss management, and its formulation-specific instructions are not interchangeable. Research or compounded products called tesamorelin are not automatically equivalent to an approved Egrifta product.
Editorial status
This page aggregates regulatory documents and published human research. Its claims, citations, populations, and limitations received an independent editorial evidence check. Last editorial audit: .
It has not been medically reviewed by a clinician. It provides general education, not diagnosis, treatment, dosing instructions, or advice for an individual. Use the product-specific official information and consult a qualified clinician or pharmacist for personal decisions.
Product and regulatory distinctions
A compound name is not one interchangeable set of instructions. Product, formulation, indication, labeling, and jurisdiction matter.
Egrifta SV (tesamorelin for injection)
An FDA-approved tesamorelin formulation with product-specific instructions. The current Egrifta WR label states that WR and SV differ and are not substitutable.
Current sourceCompounded or research products described as tesamorelin
The ingredient name alone does not establish FDA approval, approved-product equivalence, identity, purity, sterility, potency, or the labeled indication.
Current sourceClaim-by-claim evidence map
Each finding is tied to the population and product actually studied. Trial results are not personal predictions.
Tesamorelin reduced visceral adipose tissue in phase 3 studies of adults with HIV and excess abdominal fat.
- Population
- 806 antiretroviral-treated adults with HIV and excess abdominal fat pooled from two multicenter phase 3 studies.
- Finding
- At 26 weeks, the placebo-adjusted treatment effect for visceral adipose tissue was -15.4%; reductions were maintained among continuing participants through 52 weeks.
- Limits
- This evidence applies to the studied HIV-associated abdominal-fat population and trial product. It does not establish general weight-loss, bodybuilding, anti-aging, or non-HIV use.
The FDA-approved indication is reduction of excess abdominal fat in adults with HIV and lipodystrophy—not general weight management.
- Population
- Adults meeting the indication in current U.S. prescribing information.
- Finding
- The Egrifta WR label expressly identifies the HIV-lipodystrophy indication and states that it is not indicated for weight-loss management because it has a weight-neutral effect.
- Limits
- An approved indication does not mean the product is appropriate for every person with HIV or abdominal fat; the complete label contains contraindications, warnings, and monitoring requirements.
A small randomized trial found reductions in visceral and liver fat over six months.
- Population
- 50 antiretroviral-treated adults with HIV and abdominal fat accumulation in a double-blind, placebo-controlled trial.
- Finding
- The treatment effect was -42 cm² for visceral adipose tissue and -2.9 percentage points for liver-fat measurement versus placebo over six months.
- Limits
- This preliminary, single-center study was small and used imaging outcomes. It did not establish fewer liver events, cardiovascular events, or benefit outside the studied population.
A later randomized trial studied tesamorelin for liver fat in people with HIV and hepatic steatosis.
- Population
- 61 adults with HIV and hepatic fat accumulation enrolled in a 12-month randomized, double-blind, multicenter trial.
- Finding
- The absolute treatment effect for hepatic fat fraction was -4.1 percentage points versus placebo at 12 months.
- Limits
- This was a modest-sized research study; hepatic-fat change is a surrogate outcome and tesamorelin is not FDA-approved as a general treatment for fatty liver disease.
What this evidence does not answer
- Long-term cardiovascular safety has not been established, as the FDA label explicitly notes.
- Evidence is insufficient to transfer the HIV-lipodystrophy indication to general fat loss, athletic performance, anti-aging, or stacking claims.
- The clinical importance and long-term outcome effect of liver-fat changes remain uncertain.
- Approved-product trials do not validate the identity, sterility, purity, potency, stability, or equivalence of compounded or research-market tesamorelin.
- The effects of prolonged IGF-1 elevation and outcomes in populations excluded from trials require product-label and clinician review.
Useful information to organize between visits
- The exact product and formulation name, because Egrifta WR and Egrifta SV are not substitutable
- The labeled indication and the prescriber's treatment objective
- Clinician-requested visceral-fat, glucose, IGF-1, and other measurements with dates and original units
- Symptoms such as swelling, joint symptoms, sensory changes, injection-site reactions, or glucose-related changes
- All cancer history, pituitary history, pregnancy status, medicines, and supplements disclosed to the treating clinician
Questions to bring to a clinician or pharmacist
- 1.Does the FDA-approved HIV-lipodystrophy indication apply to me, and how will response be assessed?
- 2.Which Egrifta formulation is prescribed, and which product-specific instructions should I follow?
- 3.How will IGF-1, glucose, fluid retention, malignancy history, and other label risks be monitored?
- 4.What findings would lead to stopping or reconsidering treatment?
Primary sources
- Egrifta WR prescribing informationU.S. Food and Drug Administration · Published 2025 · Accessed July 12, 2026
- Effects of tesamorelin in HIV-infected patients with excess abdominal fat: pooled phase 3 analysisThe Journal of Clinical Endocrinology & Metabolism via PubMed · Published 2010 · Accessed July 12, 2026
- Effect of tesamorelin on visceral fat and liver fat in HIV-infected patientsJAMA via PubMed · Published 2014 · Accessed July 12, 2026
- Effects of tesamorelin on non-alcoholic fatty liver disease in HIVThe Lancet HIV via PubMed · Published 2019 · Accessed July 12, 2026
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