Tesamorelin

Synthetic growth hormone–releasing hormone analog approved in some regions for specific HIV-associated indications and studied more broadly in metabolic research.

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Educational only

This page is for general educational and informational purposes only. It is not medical advice and does not replace professional medical judgment. Always consult a qualified clinician before starting, stopping, or changing any medication or protocol.

Overview

Tesamorelin is a synthetic analog of growth hormone–releasing hormone (GHRH). In some regions it has regulatory approval for specific HIV-associated indications related to excess visceral adipose tissue.

Beyond labeled indications, tesamorelin appears in broader metabolic and body- composition discussions, though such uses may not be supported to the same evidentiary or regulatory standard.

Mechanism of action

Tesamorelin binds to GHRH receptors in the pituitary, stimulating endogenous growth hormone secretion and, downstream, influencing IGF-1 and metabolic pathways. Its effects on body composition and lipid metabolism are thought to be mediated through these GH/IGF-1–related mechanisms.

The pattern and magnitude of response can vary with dose, duration, and baseline GH-axis function, as well as with comorbid conditions such as HIV infection.

Indications and use context

In regions where tesamorelin is approved, labeled indications focus on specific HIV-associated changes in visceral adipose tissue. Use is typically guided by infectious disease and endocrine specialists.

Outside these indications, tesamorelin may be discussed in relation to general obesity, metabolic risk, or body composition. Such uses should be evaluated carefully against local regulations, available evidence, and the balance of potential risks and benefits.

Anti-doping status

WADA Classification

Status: Prohibited at all times, in and out of competition — S2.2.4, where the list names "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)"

Tesamorelin is named individually on the WADA Prohibited List, in the GHRH-analogue bullet of sub-section S2.2.4, "Growth hormone releasing factors," alongside CJC-1293, CJC-1295 and sermorelin. Class S2 substances are non-Specified Substances, which sets the default first-violation sanction at four years.

Approval does not create an exception — but it does open a route. Tesamorelin is the unusual case in this sub-section: unlike the research peptides listed beside it, it is an approved medicine in some jurisdictions, licensed for HIV-associated excess visceral abdominal fat. That distinction matters in one direction only. Being an approved drug does not remove a substance from the Prohibited Listsomatropin, testosterone and EPO are all licensed medicines and all prohibited. What approval does provide is a documented indication against which a therapeutic use exemption can be assessed. An athlete with the labelled HIV-associated indication has a real TUE pathway; an athlete using it for general body composition or visceral fat reduction does not, because a TUE requires that no reasonable permitted alternative exists and that the treatment produce no additional performance enhancement beyond a return to normal health (USADA, therapeutic use exemptions). Applications are made in advance, to the relevant anti-doping organization, not to a prescriber — USADA asks athletes "to submit a TUE 30 days in advance of their planned use of any prohibited medication or method." Tesamorelin is described in the NIH LiverTox monograph as "a synthetic 44 amino acid polypeptide analogue of growth hormone releasing hormone (GHRH)" whose "N terminal portion of the molecule has been modified to improve its stability and pharmacokinetics in comparison to native GHRH" (LiverTox, NIH) — that modification is precisely what makes it a distinguishable target for a laboratory.

Detection. Tesamorelin is an explicit target analyte in at least three validated doping-control methods: an immunoaffinity plasma assay with a "lower limit of detection (<50 pg/mL)" (Knoop et al., Anal Bioanal Chem 2016); an in vitro metabolism study that synthesised nineteen GHRH-analogue metabolites as reference materials and reached limits "generally 1 ng/ml (WADA required performance limit) or less" (Memdouh et al., Drug Test Anal 2021); and a WADA-validated nano-LC-Orbitrap urine method reporting "LODs (≤ 0.5 ng/mL)" (Uçaktürk and Nemutlu, J Pharm Biomed Anal 2026). The same 2021 review is candid that GHRH analogues "do not appear to have been found in anti-doping samples by WADA accredited laboratories" despite intelligence indicating use — a gap the subsequent method development was designed to close, and one that stored-sample re-analysis can reach backwards into.

Safety and side effects

High-level safety themes

Safety considerations for tesamorelin overlap with those of other GH-axis therapies and should always be interpreted using up-to-date labeling and clinical references.

Reported side effects include injection-site reactions, arthralgia, peripheral edema, and changes in glucose tolerance in some individuals. Because it modulates GH and IGF-1, there is ongoing interest in long-term safety, particularly in populations with existing metabolic or cardiovascular risk.

Clinician oversight, appropriate patient selection, and regular monitoring are essential parts of safe use.

Pharmacology and dosing considerations

Tesamorelin is a GHRH analog with a specific clinical approval for visceral fat reduction in HIV-associated lipodystrophy.

Common administration patterns

Route: Subcutaneous injection (typically abdomen).

Protocol structure and dosage:
  • Clinical dose: 1.4 mg once daily (EGRIFTA SV) or 1.28 mg once daily (EGRIFTA WR). The 2 mg figure often quoted comes from the original phase 3 trials and the discontinued first-generation product.
  • Timing: Administered in the morning.
  • Reconstitution: Requires careful reconstitution of lyophilized cake immediately before use.

This information is based on the FDA-approved labeling for Egrifta.

Formulations and combinations

Two approved presentations exist and they are not interchangeable. EGRIFTA SV supplies a 2 mg vial reconstituted with 0.5 mL of sterile water for a single 1.4 mg daily dose; EGRIFTA WR supplies an 11.6 mg vial reconstituted weekly with 1.3 mL of bacteriostatic water to provide seven 1.28 mg daily doses. The labeling states explicitly that the two products differ in dose, vials per dose, reconstitution, and storage, and are not substitutable.

No combination product containing tesamorelin is approved. It is sometimes discussed alongside ghrelin-receptor peptides such as ipamorelin on the rationale that GHRH and ghrelin pathways are complementary, but that pairing has no trial evidence behind it and none of the data on this page describes it.

Research and evidence snapshot

Clinical trials of tesamorelin in HIV-associated lipodystrophy have examined endpoints such as visceral fat volume, metabolic markers, and quality of life. Additional research explores broader metabolic effects and durability of response.

As evidence accumulates, questions remain about long-term outcomes, optimal patient selection, and how tesamorelin compares with other interventions. High-level educational summaries should be paired with direct review of primary data when making clinical decisions.

Frequently asked questions

Is tesamorelin FDA-approved? Yes, for one indication: reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Two products are currently marketed — EGRIFTA SV and EGRIFTA WR — and the label states they are not substitutable (EGRIFTA SV prescribing information, DailyMed).

How much visceral fat does it actually remove? In the pooled phase 3 analysis of 806 adults on 2 mg daily, visceral adipose tissue fell 24 ± 41 cm² versus a 2 ± 35 cm² increase on placebo at week 26 — a −15.4% treatment effect — reaching −17.5% by week 52 (J Clin Endocrinol Metab 2010; PMID 20554713).

Does the fat come back if you stop? Yes. In the 404-patient trial, participants switched from tesamorelin to placebo rapidly lost the VAT improvement they had gained over six months (J Acquir Immune Defic Syndr 2010; PMID 20101189). It is an ongoing therapy, not a course with a lasting result.

Is the dose 2 mg per day? Not any more. The 2 mg figure comes from the original trials and the discontinued first-generation product. The currently approved doses are 1.4 mg daily for EGRIFTA SV and 1.28 mg daily for EGRIFTA WR, with different vial strengths and reconstitution instructions for each.

Does it affect blood sugar? The label carries a glucose intolerance warning: 5% of treated patients developed an HbA1c of 6.5% or higher versus 1% on placebo, with a hazard ratio of 3.3 for developing diabetes. Growth hormone opposes insulin, so this is inherent to the mechanism rather than incidental.

How does it compare with sermorelin or CJC-1295? All three act on the GHRH receptor, but only tesamorelin has a randomised phase 3 programme, an FDA label, and published data on what happens after discontinuation. The difference is evidence, not concept.

Compounds related to Tesamorelin

Grouped by catalog family, category and shared research themes. For the wider picture, read the GH / growth factors class overview or browse the full peptide catalog.

Side-by-side comparisons

Tesamorelin is covered in the following head-to-head reference pages, each contrasting mechanism, evidence quality and safety themes.

Prefer the index? See all peptide comparisons.

Key studies

Curated primary literature for Tesamorelin. Links open the publisher or PubMed record in a new tab.

  1. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension dataPubMed
  2. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extensionPubMed
  3. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trialPubMed
  4. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelinPubMed

Search the literature

PubMed · ClinicalTrials.gov · Google Scholar

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