Growth

Tesamorelin

A medicine for excess belly fat in HIV lipodystrophy

FDA-approved · by prescription

Tesamorelin (Egrifta, Egrifta SV and Egrifta WR) is FDA-approved to reduce excess abdominal visceral fat in adults with HIV who have lipodystrophy; it is not approved for general weight loss.

Consultations are opening state by state.

Important safety information. Tesamorelin is not for people with a disrupted hypothalamic-pituitary axis (for example, a pituitary tumor, surgery or radiation), active cancer or pregnancy; it can raise blood sugar and diabetes risk and cause fluid retention, joint pain and allergic or injection-site reactions. See safety

Stylised model of the real sequence

Overview.

Tesamorelin is an FDA-approved synthetic GHRH analog marketed as Egrifta to reduce excess abdominal (visceral) fat in adults with HIV-associated lipodystrophy. It is not approved for general weight loss or anti-aging use. A new, more concentrated formulation (Egrifta WR) was approved in 2025.

Also known as TH9507 · Egrifta · Egrifta SV · Egrifta WR

The molecule, decoded.

Sequence

N-[(3E)-hex-3-enoyl]-YADAIFTNSYRKVLGQLSARKLLQDIMSRQQGESNQERGARARL-NH2 (human GHRH 1-44; UniProt P01286)

Length
44 residues
Molecular weight
5,136 g/mol
Formula
C221H366N72O67S
CAS number
218949-48-5
Half-life
~8 minutes (after a subcutaneous dose)
Routes studied
subcutaneous injection
Modifications
N-terminal (3E)-hex-3-enoyl acylation of human GHRH(1-44) for DPP-4 protease resistance

How it works.

An N-terminal trans-3-hexenoyl modification of human GHRH(1-44) resists DPP-4 enzymatic degradation, stabilizing the peptide. It binds the pituitary GHRH receptor to stimulate endogenous pulsatile GH release, raising IGF-1 and preferentially reducing visceral (rather than subcutaneous) adipose tissue.

Evidence · FDA-approved · regulatory-grade trials

What the research shows

approval trial2010

Two multicenter, randomized, double-blind, placebo-controlled Phase 3 trials in 816 HIV-infected adults with lipodystrophy (Study 1, n=412; Study 2, n=404) found 26-week VAT changes of -18% vs +2% with placebo (Study 1) and -14% vs -2% (Study 2) with tesamorelin 2 mg daily.

816 HIV-infected adults with lipodystrophy-associated excess abdominal fat

approval trial2010

FDA approved Egrifta (tesamorelin for injection) on November 10, 2010, as the first treatment for reduction of excess abdominal visceral fat in HIV-associated lipodystrophy.

HIV-infected adults with lipodystrophy

approval trial2010

Tesamorelin treatment was associated with an increased risk of new-onset diabetes (HbA1c >=6.5%) relative to placebo (hazard/odds ratio ~3.3) in the pivotal trial program.

HIV-infected adults with lipodystrophy

approval trial2025

FDA approved a more concentrated F8 formulation (EGRIFTA WR) on March 25, 2025, requiring only weekly reconstitution and less than half the injection volume of the prior EGRIFTA SV (F4) formulation.

HIV-infected adults with lipodystrophy

approval trial2010

Egrifta labeling requires monitoring for recurrence of malignancy and periodic IGF-1 monitoring given the drug's mechanism of raising growth-hormone-axis activity, and states that the effects of prolonged IGF-1 elevation are unknown.

HIV-infected adults with lipodystrophy

What to know first.

Based on: the FDA-approved label and its Phase 3 trials.

Reported side effects

  • arthralgia
  • injection-site erythema and pruritus
  • pain in extremity
  • peripheral edema
  • myalgia
  • hypersensitivity reactions (rash, urticaria)
  • hyperglycemia / increased new-onset diabetes risk

Cautions

  • contraindicated with disruption of the hypothalamic-pituitary axis (e.g., pituitary tumor/surgery/radiation)
  • contraindicated in pregnancy and with active malignancy; discontinue if malignancy recurs
  • not indicated for general weight loss or anti-aging use -- label is specific to HIV-associated lipodystrophy
  • label warnings also cover fluid retention (edema, arthralgia, carpal tunnel syndrome), glucose intolerance/diabetes, hypersensitivity and injection-site reactions, and increased mortality in patients with acute critical illness (consider discontinuing)

Checked 2026-09

Where it stands.

FDA-approved, by prescription.

Approved use. Tesamorelin (Egrifta, Egrifta SV and Egrifta WR) is FDA-approved to reduce excess abdominal visceral fat in adults with HIV who have lipodystrophy; it is not approved for general weight loss.

When consultations open, a licensed clinician in your state will review your health history and prescribe Tesamorelin only if it’s appropriate for you. A licensed U.S. pharmacy will dispense it.

Read the FDA prescribing information

Join the waitlist
FDA
approved (Egrifta, tesamorelin for injection, November 10, 2010, for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy); reformulated as the single-vial F4 formulation sold as Egrifta SV (FDA approval announced November 5, 2018) and the F8 formulation Egrifta WR (supplemental BLA approval announced March 25, 2025; intended to replace Egrifta SV). Tesamorelin has been regulated as a biological product (BLA) since March 23, 2020.
Approved products
  • Egrifta (FDA, 2010): reduction of excess abdominal visceral fat in HIV-infected patients with lipodystrophy Label
  • Egrifta SV (FDA, 2018): same indication, F4 (lower-volume) formulation Label
  • Egrifta WR (FDA, 2025): same indication, F8 formulation, weekly reconstitution
Compounding
Not eligible for compounding under section 503A or 503B: tesamorelin (44 amino acids) has been regulated as a biological product since March 23, 2020 (Egrifta WR was approved through a supplemental BLA), and biological products cannot be compounded under 503A/503B. The compounding trade group APC states the 2020 reclassification made tesamorelin ineligible for compounding. Compounded or 'research' tesamorelin sold for human use is therefore not lawfully compounded, not a gray zone.
Sport (WADA)
Prohibited at all times under S2 (GHRH and its analogues) of the WADA Prohibited List, naming tesamorelin explicitly.
Enforcement
  • 24 Aug 2026: FDA warning letters to research-use-only peptide sellers Peptide Partners, Royal Peptides and Peak Performance Peptides listed tesamorelin among the unapproved products they sold.
References (1)
  1. DailyMed · FDA label

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