What is it?
Growth hormone-releasing factor analog
Peptide Library · checked July 17, 2026
Tesamorelin
Tesamorelin has stronger human evidence than most peptides promoted online and a real FDA-approved product. The boundary is the point: approval is for reducing excess abdominal fat in adults with HIV and lipodystrophy—not general weight loss, bodybuilding, or anti-aging.
EstablishedReplicated relevant human evidence, or approved labeling for the exact use.How labels work →
TL;DR
The lowdown
Four answers first. The source record follows.
What do humans show?
Randomized trials in adults with HIV and excess abdominal fat
Where does FDA stand?
Approved for one defined population and use; not indicated for weight-loss management
What is known—and not?
FDA labeling includes contraindications and warnings concerning active malignancy, disruption of the hypothalamic-pituitary axis, pregnancy, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, and injection-site reactions. Those considerations require individual medical assessment.
U.S. status · July 17, 2026
Approval, compounding, product, sport.
- FDA approval
- FDA-approved in specific EGRIFTA formulations for a narrow indication; not approved for general weight loss
- U.S. federal record
- FDA-approved in specific EGRIFTA formulations for a narrow indication; not approved for general weight loss
- Product identity
- Reviewed named-product record: EGRIFTA SV and EGRIFTA WR.
- Sport
- No WADA status recorded in the reviewed source.
This reports the dated federal and sport record. It does not determine whether a particular product or transaction complies with state or federal law, and it is not legal advice.
01
What it is
Tesamorelin is a synthetic analog of growth hormone-releasing factor. FDA-approved EGRIFTA products stimulate pituitary growth hormone release and are indicated to reduce excess abdominal fat in adults with HIV and lipodystrophy.
The indication is unusually important here. The product is not approved simply because someone has abdominal fat, wants to lose weight, or is interested in changing body composition.
02
What humans actually show
- Pivotal population: A 12-month randomized study enrolled 404 adults with HIV and excess abdominal fat. At six months, visceral adipose tissue decreased by 10.9% in the tesamorelin group and 0.6% in the placebo group.
- What happened after stopping: In the extension phase, the visceral-fat improvement was rapidly lost in participants switched from tesamorelin to placebo.
- Liver-fat research: A separate 12-month randomized trial in 61 people with HIV and fatty liver disease reported a greater reduction in liver fat with tesamorelin than placebo. That study was research beyond the current FDA-approved indication, not a blanket liver-disease approval.
- What the evidence does not show: These trials do not establish tesamorelin as general weight-loss treatment, an anti-aging therapy, or a muscle-building shortcut in otherwise healthy adults.
03
FDA and U.S. status
FDA labeling states that EGRIFTA WR is indicated for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The same label says long-term cardiovascular safety has not been established and that the product is not indicated for weight-loss management.
Evidence and labeling belong to the identified drug product and studied formulation. They do not automatically establish the identity or performance of an unrelated product sold under the ingredient name.
04
Risks and warning limits
FDA labeling includes contraindications and warnings concerning active malignancy, disruption of the hypothalamic-pituitary axis, pregnancy, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, and injection-site reactions. Those considerations require individual medical assessment.
PepCurrent does not provide dosing, sourcing, switching, or personalized treatment advice.
05
What would change this answer
- Any new FDA labeling or formulation changes
- Long-term cardiovascular and metabolic outcomes
- Research on liver fat and fibrosis in people with HIV
- Marketing that silently widens a narrow approval into general weight loss or anti-aging
06
Sources and records
- FDA-approved EGRIFTA WR prescribing information, 2025
- Falutz et al., 2010 — 404-person randomized trial
- Stanley et al., 2019 — randomized liver-fat trial
Educational journalism only; not medical advice. We do not evaluate individual products or link vendors.
What changed
Added the source-verified Claim Check to the structured claim/source/change registry.
What would change our answer
A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.
Version history · 1 entry
- v1 · 2026-07-17Initial structured record created from the reviewed Claim Check.Source ↗
Boundary: PepCurrent explains public evidence and regulatory records. We do not evaluate individual products, recommend use, name vendors, or provide protocols.