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US Peptide Guide

Last reviewed May 22, 2026·Editorial Board

Tesamorelin (Egrifta)

Also known as TH9507, Egrifta, Egrifta SV, Egrifta WR

Tesamorelin is a stabilized synthetic analog of growth hormone-releasing hormone (GHRH 1-44) with an N-terminal hexenoyl modification that resists enzymatic cleavage. It is the only GHRH-class peptide with current FDA approval as a finished drug product, indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.[1]

Tier 1 — FDA-ApprovedFDA-Approved(2010-11-10)
Class
GHRH analog (1-44)
Modification
N-terminal hexenoyl
Half-life
~26 min subcutaneous
Approved indication
HIV lipodystrophy
Pivotal RCT n
~800 (Falutz 2007/2010)
WADA status
Prohibited

What tesamorelin is

Tesamorelin (developmental code TH9507) is a 44-amino-acid GHRH analog with a hexenoyl group attached to the N-terminus. Native GHRH is rapidly degraded by dipeptidyl peptidase-IV (DPP-IV); the hexenoyl modification blocks this cleavage and extends the functional half-life of the molecule, while preserving binding to the pituitary GHRH receptor.[2]

The result is a peptide that produces a more sustained GH-releasing signal than native GHRH or sermorelin (~26 minute plasma half-life vs. ~11 minutes for sermorelin), while still acting upstream through the pituitary's own secretory machinery. As with sermorelin, GH release remains under normal feedback regulation — IGF-1 elevation suppresses further GH secretion — which differentiates this class from exogenous somatropin.

Tesamorelin holds the distinction of being the only GHRH-class peptide that completed pivotal trials and received FDA approval that remains active in 2026. It was approved in November 2010 under the brand name Egrifta. A more concentrated formulation, Egrifta SV (F4), was subsequently approved. A further reformulation, Egrifta WR (F8 — 8× concentrated, weekly reconstitution instead of daily), was approved March 25, 2025.[3]

Mechanism of action

Tesamorelin binds the GHRH receptor on anterior pituitary somatotrophs (a Gs-coupled GPCR), elevating intracellular cAMP and triggering pulsatile growth hormone release. Released GH acts at the liver and peripheral tissues to drive IGF-1 production and engage GH-dependent metabolic pathways including lipolysis in visceral adipose depots.[2]

The HIV-lipodystrophy use case rests on two mechanistic observations: (1) HIV-associated lipodystrophy involves disproportionate accumulation of visceral adipose tissue (VAT), and (2) GH preferentially mobilizes visceral fat. Restoring physiologic GH pulse amplitude via GHRH stimulation reduces VAT without the supraphysiologic GH exposures associated with direct somatropin administration.

Human evidence

Tesamorelin has the strongest human dataset of any peptide in this database. The Phase 3 program enrolled ~800 patients across two multicenter trials with safety extension data, supporting the 2010 FDA approval. Subsequent investigator-initiated work has examined NAFLD (non-alcoholic fatty liver disease) in HIV.

Pivotal Phase 3 — HIV-associated abdominal fat accumulation
412 patients, 26 weeks

Falutz et al. (NEJM 2007) randomized 412 HIV-infected patients with excess abdominal fat to subcutaneous tesamorelin 2 mg daily or placebo for 26 weeks. Visceral adipose tissue decreased 15.2% in the tesamorelin arm vs. 5.0% increase in placebo. Triglycerides decreased and IGF-1 rose into the upper-normal range. Glucose homeostasis was not adversely affected.

Sources:2
Pooled Phase 3 analysis with safety extension
~800 patients across two multicenter trials

Falutz et al. (JCEM 2010) pooled two multicenter, double-blind, placebo-controlled Phase 3 trials of tesamorelin with safety extension data. The pooled dataset confirmed the visceral fat reduction signal and characterized the safety profile (injection-site reactions, mild glucose tolerance changes, IGF-1 elevation generally within normal range). The pooled evidence supported the 2010 FDA approval of Egrifta.

Sources:41
HIV-associated NAFLD — randomized double-blind
61 patients, 12 months

Stanley et al. (Lancet HIV 2019) randomized 61 HIV-positive patients with hepatic fat fraction >5% to tesamorelin 2 mg daily or placebo for 12 months. Hepatic fat fraction decreased 32% on tesamorelin vs. increased 5% on placebo (absolute effect size −4.1%, p=0.02). 35% of tesamorelin patients returned to liver fat below 5%, vs. 4% on placebo. Progression of liver fibrosis was reduced.

Sources:5

Marketed claims vs. published evidence

Marketed claims
  • General fat loss in healthy adults
    no data
  • Anti-aging benefits
    anecdotal
  • Muscle building in athletes
    no data
  • Universal NAFLD treatment
    no data
Published evidence
  • Reduces visceral adipose tissue in HIV lipodystrophy[2]
    human RCT
  • Reduces hepatic fat fraction in HIV-associated NAFLD[5]
    human RCT
  • Reduces triglycerides in HIV lipodystrophy[4]
    human RCT
  • Raises IGF-1 into upper-normal range[2]
    human RCT

The published evidence base for tesamorelin is narrow but strong: it works in HIV-associated lipodystrophy (FDA-approved indication) and shows real signal in HIV-associated NAFLD (off-label). The dataset does not extend to general-population fat loss, anti-aging applications, or NAFLD outside HIV.

Regulatory status

Tesamorelin is the only growth-hormone-axis peptide on this site with active FDA approval as a finished drug product:

  • Egrifta — approved November 10, 2010 for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.[1]
  • Egrifta SV — F4 reformulation approved earlier than Egrifta WR; reduced injection volume.
  • Egrifta WR — F8 reformulation (8× more concentrated, weekly reconstitution) approved March 25, 2025.[3]

Because a finished FDA-approved product is commercially available, the compounding question is largely moot for tesamorelin. Off-label use should be of the approved branded product rather than a compounded version; this is both a quality and a liability question.

Tesamorelin is on the WADA Prohibited List (S2) as a GH secretagogue.[6]

Safety considerations

The Phase 3 safety profile included injection-site reactions, mild glucose tolerance changes (HbA1c effects generally small but present), occasional fluid retention/arthralgia consistent with GH-axis activation, and IGF-1 elevation typically remaining within the normal range.[4]

The most clinically relevant ongoing safety question is long-term cancer risk from sustained IGF-1 elevation. The Phase 3 trials were not powered for malignancy endpoints. Tesamorelin is contraindicated in patients with active malignancy, and the prescribing information instructs discontinuation if pituitary disease or active neoplasia develop.

Dosing is not addressed on this page. Dosing decisions belong with a licensed prescriber working from the FDA prescribing information for the specific formulation (Egrifta, Egrifta SV, or Egrifta WR).

Frequently asked questions

Sermorelin (GHRH 1-29)peptideCJC-1295peptideGH secretagogueshub

Citations

  1. U.S. Food and Drug Administration. EGRIFTA (tesamorelin for injection) — Approval for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. FDA Drug Approval Package, NDA 022505. 2010. ↗ Source fda
  2. Falutz J, Allas S, Blot K, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine. 2007. PMID 18057338
  3. Theratechnologies / U.S. Food and Drug Administration. EGRIFTA WR (tesamorelin F8 formulation) — supplemental BLA approval, increased concentration, weekly reconstitution. Theratechnologies press release / FDA action. 2025. ↗ Source fda
  4. Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. Journal of Clinical Endocrinology and Metabolism. 2010. PMID 20554713
  5. Stanley TL, Fourman LT, Feldpausch MN, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet HIV. 2019. ↗ Source DOI: 10.1016/S2352-3018(19)30338-8
  6. World Anti-Doping Agency. The 2026 Prohibited List — S2 Peptide Hormones, Growth Factors, Related Substances and Mimetics. wada-ama.org. 2026. ↗ Source wada
Revision history
  • 2026-05-22Initial page. Pivotal Phase 3 (NEJM 2007), pooled analysis (JCEM 2010), HIV-NAFLD (Lancet HIV 2019), 2010 FDA approval, and March 2025 Egrifta WR F8 reformulation noted.