Growth hormone-releasing hormone (GHRH) analog — FDA-approved (Egrifta)
Tesamorelin (brand name Egrifta) is an FDA-approved growth hormone-releasing hormone (GHRH) analog indicated for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. It is the only GHS/GHRH-class peptide with current FDA approval. Its efficacy was established in a Phase 3 trial published in the New England Journal of Medicine.
Track regulatory status and approved indication. Do not publish dosing, sourcing, or off-label treatment instructions. Maintain the FDA-approved indication as the primary framing; flag any off-label use claims.
Tesamorelin (Egrifta) received FDA approval in 2010 for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy — the only GHRH/GHS-class peptide with FDA approval.
The pivotal Phase 3 trial was published in the New England Journal of Medicine (Falutz et al., 2010; PMID 20879920), showing significant reduction in visceral adipose tissue (VAT) over 26 weeks in HIV patients with lipodystrophy.
The FDA drug label (Egrifta) is available on accessdata.fda.gov; the approved administration route is subcutaneous injection.
Tesamorelin is a stabilized GHRH analog; its mechanism involves stimulating endogenous GH release, which in turn increases lipolysis and reduces visceral fat accumulation.
Evidence level: Primary regulatory
Sources: U.S. Food and Drug Administration, New England Journal of Medicine
Cite the FDA drug label directly. This is the only GHS/GHRH-class peptide with FDA approval. The indication is specific to HIV-associated lipodystrophy — not general obesity or cosmetic fat loss.
Evidence level: Peer reviewed
Sources: New England Journal of Medicine
Cite the Falutz et al. (2010) NEJM publication directly. The trial population was HIV patients with lipodystrophy — do not extrapolate to non-HIV populations.
Evidence level: Community discussion
Sources: U.S. Food and Drug Administration
Track off-label use discussions without endorsing them. The FDA-approved indication is specific to HIV-associated lipodystrophy. Flag any claims about general fat loss as off-label.
Free report
Use the same checklist Peptide Report uses to separate Tesamorelin claims, source records, supplier documentation, and media signals.
V1 collects email, role, and topic interest only. No medication, health-condition, dosing, or current-use data is collected in this form.
Source records are stored in the repo and linked from each claim.
FDA-approved drug label for Egrifta (tesamorelin for injection), indicated for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The only GHRH/GHS-class peptide with FDA approval.
Pivotal Phase 3 randomized trial (Falutz et al., 2010; PMID 20879920) showing tesamorelin significantly reduced visceral adipose tissue (VAT) over 26 weeks in HIV-infected patients with lipodystrophy. This trial supported FDA approval of Egrifta.
ClinicalTrials.gov registry entries for tesamorelin clinical trials, including the pivotal Phase 3 trials for HIV-associated lipodystrophy that supported FDA approval of Egrifta.
FDA warning letter discussing peptide products marketed online and the limits of research-use-only positioning.
CJC-1295 is a synthetic growth hormone-releasing hormone (GHRH) analog developed by ConjuChem with drug affinity complex...
Evidence reviewIpamorelin is a synthetic pentapeptide growth hormone secretagogue (GHS) that stimulates GH release via ghrelin receptor...
Evidence reviewMK-677 (ibutamoren) is a non-peptide, orally active growth hormone secretagogue developed by Merck that mimics ghrelin t...
Evidence reviewSermorelin is a synthetic N-terminal fragment (1-29) of growth hormone-releasing hormone (GHRH) that was formerly FDA-ap...
Evidence reviewStay informed