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.
Growth hormone-releasing hormone (GHRH) analog: FDA-approved (Egrifta)
Tesamorelin
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.
Regulatory watch
Last reviewed Jul 1, 2026
Next review Jul 29, 2026
Evidence snapshot
Tesamorelin (Egrifta) received FDA approval in 2010 for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. It is 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.
Research record
What the evidence record says
- Evidence grade
- Not Graded
- Regulatory status
- Tesamorelin regulatory status has not been fully reviewed by Peptide Report editorial team. See company profiles and regulatory watch for current status.
Evidence records
Studies, registries, reviews, and regulatory records
Evidence review pending
- Detailed evidence review for Tesamorelin is pending editorial assessment. Current summary reflects available public records.
Records: Egrifta (tesamorelin): FDA Drug Label, Tesamorelin, a Growth Hormone-Releasing Hormone Analog, Reduces HIV Visceral Adiposity, Tesamorelin Clinical Trial Registry Entries: ClinicalTrials.gov
Evidence timeline
What changed, and when
Peptide Report last reviewed Tesamorelin on 2026-07-01.
Direct answers
Frequently asked questions
What is Tesamorelin?
Tesamorelin is a growth hormone-releasing hormone (ghrh) analog: fda-approved (egrifta) tracked by Peptide Report. See the full profile for current editorial assessment.
Open research questions
What is still unknown
- What is the complete human evidence base for Tesamorelin?
- What are the long-term safety considerations for Tesamorelin?
Tracked claims
Tesamorelin is FDA-approved for HIV-associated lipodystrophy.
Evidence level: Primary regulatory
Sources: Egrifta (tesamorelin): FDA Drug Label, Tesamorelin, a Growth Hormone-Releasing Hormone Analog, Reduces HIV Visceral Adiposity
How to read this: 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.
Phase 3 trial data showed significant reduction in visceral adipose tissue.
Evidence level: Peer reviewed
Sources: Tesamorelin, a Growth Hormone-Releasing Hormone Analog, Reduces HIV Visceral Adiposity
How to read this: Cite the Falutz et al. (2010) NEJM publication directly. The trial population was HIV patients with lipodystrophy. Do not extrapolate to non-HIV populations.
Online communities discuss tesamorelin for off-label fat loss in non-HIV populations.
Evidence level: Community discussion
Sources: Warning Letter: Gram Peptides
How to read this: 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.
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Sources on this page
Each source record is linked to the claim or evidence note it supports.
Egrifta (tesamorelin): FDA Drug Label
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.
9 linked pagesOpen original ·
fda-egrifta-labelTesamorelin, a Growth Hormone-Releasing Hormone Analog, Reduces HIV Visceral Adiposity
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.
7 linked pagesOpen original ·
nejm-tesamorelin-phase3-2010Tesamorelin Clinical Trial Registry Entries: ClinicalTrials.gov
ClinicalTrials.gov registry entries for tesamorelin clinical trials, including the pivotal Phase 3 trials for HIV-associated lipodystrophy that supported FDA approval of Egrifta.
5 linked pagesOpen original ·
clinicaltrials-gov-tesamorelinWarning Letter: Gram Peptides
FDA warning letter discussing peptide products marketed online and the limits of research-use-only positioning.
35 linked pagesOpen original ·
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