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Tesamorelin: FDA Status, Research and Uses

By Living+. Updated October 25, 2026.

Key takeaway

Tesamorelin is a lab-made analog of growth hormone-releasing factor built on 44 amino acids. FDA approved it in 2010, and it is sold as Egrifta SV and Egrifta WR to reduce excess belly fat in adults with HIV and lipodystrophy. It has also been studied for liver fat in people with HIV [1, 3, 7].

At a glance

Where it stands

Checked

  • FDA approvedYesAs Egrifta WR, Egrifta SV
  • Pharmacy compounding (503A)Not eligibleActive ingredient of FDA-approved Egrifta. The application was deemed a BLA on March 23, 2020; FDA says biological products that transitioned that day are not eligible for the 503A compounding exemptions.
  • Outsourcing facilities (503B)Not eligibleDeemed a BLA on March 23, 2020; FDA says transitioned biological products are not eligible for the 503B exemptions. Not in any 503B category (list updated March 21, 2025).
  • WADA (sport)ProhibitedS2.2.4 Growth hormone releasing factors (GHRH analog)
Same data as the Status Tracker. Checked against 7 sources

Key facts

Class
Growth hormone-releasing factor (GHRF) analog [1]
Length
44 amino acids plus a hexenoyl group at the N-terminal tyrosine [1]
Half-life
About 8 to 11 minutes after a subcutaneous dose (label, healthy adults) [1, 2]
Route in studies
Subcutaneous injection [1]
First studied
Phase 3 results published in 2007; FDA approval on November 10, 2010 [4, 3]

How it works

The brain releases a hormone called growth hormone-releasing factor, also known as GHRH. It signals the pituitary gland to make growth hormone. Tesamorelin is a lab-made copy of the full 44 amino acid sequence of human GHRH. It has a small fatty acid group, called a hexenoyl group, added to the first amino acid [1].

Tesamorelin acts on the pituitary and causes it to release the body's own growth hormone. This raises IGF-1, a growth factor. The label says IGF-1 rises during treatment and should be monitored [1]. Because it needs a working pituitary, the label says it must not be used by people whose hypothalamic-pituitary axis has been disrupted, for example by pituitary surgery or head radiation [1].

In people with HIV and extra belly fat, daily tesamorelin lowered fat deep inside the abdomen, called visceral fat, compared with placebo. Fat under the skin of the belly did not change much [5]. Later trials also studied its effect on liver fat [6, 7].

The drug leaves the blood fast. The label lists a mean half-life of 8 minutes for Egrifta SV and 11 minutes for Egrifta WR in healthy adults [2, 1].

What the research shows

4 human trials

  1. 2019Human trial

    Stanley et al., fatty liver in HIV (Lancet HIV)

    Studied for fatty liver

    61 adults with HIV and fatty liver Randomized, double-blind, placebo-controlled, multicenter, 12 months

    Liver fat fraction fell 4.1 points more than placebo. 35% on tesamorelin vs 4% on placebo reached under 5% liver fat [7]

    Read the study
  2. 2014Human trial

    Stanley et al., visceral and liver fat (JAMA)

    50 adults with HIV and abdominal fat buildup Randomized, double-blind, placebo-controlled, 6 months

    Visceral fat and liver fat both fell compared with placebo. Net liver fat effect was -2.9% lipid to water [6]

    Read the study
  3. 2010Human trial

    Falutz et al., pooled phase 3 analysis

    806 adults with HIV on antiretroviral therapy and excess abdominal fat Pooled analysis of two double-blind, placebo-controlled trials, 26 weeks plus a 26-week extension

    Visceral fat treatment effect was -15.4% at week 26. The drop was maintained to week 52 in people who stayed on drug [5]

    Read the study
  4. 2007Human trial

    Falutz et al., phase 3 (NEJM)

    412 adults with HIV and abdominal fat buildup Randomized, placebo-controlled, 26 weeks

    Visceral fat fell 15.2% on tesamorelin 2 mg daily and rose 5.0% on placebo. IGF-1 rose 81% [4]

    Read the study

Doses used in studies

The FDA label dose for Egrifta SV is 1.4 mg given subcutaneously once daily [2]. The label dose for Egrifta WR is 1.28 mg given subcutaneously once daily. The label says the two products have different doses and are not substitutable [1].

The phase 3 trials and the liver fat trials used 2 mg of tesamorelin once daily [4, 5, 6, 7].

Dosing is set by a licensed provider.

Side effects and safety

The label lists no boxed warning. It is contraindicated in people with a disrupted hypothalamic-pituitary axis, active cancer, known allergy to tesamorelin or its ingredients, and in pregnancy [1].

Warnings include a possible higher risk of new or returning cancers, raised IGF-1, fluid retention (swelling, joint pain, carpal tunnel syndrome), glucose intolerance or diabetes, allergic reactions, injection site reactions, and higher death rates seen with growth hormone in acutely critically ill patients [1].

In trials, allergic reactions occurred in 4% of patients. Injection site reactions occurred in 25% on drug vs 14% on placebo over 26 weeks. Side effects seen in more than 5% of patients were joint pain, injection site redness and itching, pain in the arms or legs, swelling of the legs, and muscle pain [1].

Common questions

Is tesamorelin FDA approved?

Yes. FDA first approved it in 2010. It is sold as Egrifta SV and Egrifta WR to reduce excess abdominal fat in adults with HIV and lipodystrophy [3, 1, 2].

Is tesamorelin approved for weight loss?

No. The label says it is not indicated for weight loss management because it has a weight neutral effect [1].

What is the difference between Egrifta SV and Egrifta WR?

They are two formulations with different label doses: 1.4 mg daily for Egrifta SV and 1.28 mg daily for Egrifta WR. The label says they are not substitutable [2, 1].

Can tesamorelin be compounded?

Egrifta has been regulated as a biologic since March 23, 2020. FDA says biological products that transitioned on that date are not eligible for the 503A and 503B compounding exemptions [3, 9].

Does tesamorelin reduce liver fat?

It was studied for this. In a 12-month trial in 61 adults with HIV and fatty liver, liver fat fell more on tesamorelin than on placebo [7]. Fatty liver is not an approved use.

Does tesamorelin raise blood sugar?

It can. The label warns about glucose intolerance and diabetes and says to check glucose before and during treatment [1].

Is tesamorelin banned in sports?

Yes. The WADA 2026 Prohibited List names tesamorelin under S2.2.4, banned in and out of competition [8].

How long does tesamorelin last in the body?

Not long. The label lists a mean half-life of 8 to 11 minutes in healthy adults, depending on the product [2, 1].

Sources

  1. DailyMed: Egrifta WR (tesamorelin) label
  2. DailyMed: Egrifta SV (tesamorelin) label
  3. Drugs@FDA: BLA 022505 (Egrifta)
  4. Falutz et al. 2007, N Engl J Med (PubMed)
  5. Falutz et al. 2010, J Clin Endocrinol Metab (PubMed)
  6. Stanley et al. 2014, JAMA (PubMed)
  7. Stanley et al. 2019, Lancet HIV (PubMed)
  8. WADA: 2026 Prohibited List
  9. FDA: Notice to Compounders, changes as of March 23, 2020
  10. FDA: Egrifta WR supplement approval letter, March 25, 2025
  11. FDA: Egrifta and Egrifta SV supplement approval letter (S-012, S-013), July 2019

Updated October 25, 2026. Educational information, not medical advice.