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 Do not publish dosing, sourcing, or off-label treatment instructions.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.
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.
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