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Approved peptide medicine

Tesamorelin

Sold as Egrifta (Egrifta SV, Egrifta WR). Also called TH9507, GHRH(1-44) with N-terminal hexenoyl group, N-trans-3-hexenoyl-GHRH(1-44) amide, Growth hormone-releasing factor analogue.

Tesamorelin is a lab-made copy of a natural brain hormone that tells the pituitary gland to release growth hormone. It is approved in the US for one narrow use: reducing extra belly fat in adults with HIV who have a fat-distribution problem called lipodystrophy. It is not approved for general weight loss.

How strong is the evidence?

AnecdoteAnimalsHuman trialsApproved
Approved. Approved by a major regulator after large trials.Approved by the US FDA (2010) on the basis of two randomised, double-blind, placebo-controlled 26-week phase 3 trials in HIV-infected adults with excess abdominal fat, each followed by a 26-week safety extension (806 patients pooled). Evidence is specific to HIV-associated abdominal fat; long-term cardiovascular outcomes have not been shown. Small randomised trials in HIV-associated fatty liver disease exist but are exploratory, and that use is unapproved.

Last verified 2026-09-29 · how we verify

Rendering of PDB 7CZ5: GHRH(1-44) (native hormone) bound to the Growth hormone-releasing hormone receptor. Experimental structure · cryo-EM 2.6 Å · PDB 7CZ5 (2020).
Related structure

Experimental structure · cryo-EM 2.6 Å · PDB 7CZ5 (2020)RCSB entry ↗

Not Tesamorelin itself. No structure of Tesamorelin bound to its receptor has been published, so a related structure is shown for context.

The body's own growth hormone-releasing hormone (GHRH, 44 residues) at its receptor. No tesamorelin- or sermorelin-bound structure was found in the PDB (RCSB search, 2026-09-29); shown for context only. Palmitic acid, cholesterol and nanobody Nb35 (chain N) omitted. Structure from Zhou et al., Nat Commun 2020. Colours are ours, not the molecule's.

Acts on
Growth hormone-releasing hormone (GHRH) receptor on pituitary somatotroph cells
Taken as
Subcutaneous injection once daily, into the abdomen, in the approved HIV-lipodystrophy use (US label). It is a prescription product for use under medical supervision; it is not taken by mouth.
Half-life
About 11 minutes for Egrifta WR in healthy subjects (26 minutes in healthy subjects and 38 minutes in HIV-infected patients for the original 2010 formulation)[src]
US approval
FDA approved Egrifta (tesamorelin for injection) on 10 November 2010 for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy (NDA 022505).[src]
Egrifta WR
The FDA approved Egrifta WR, a newer once-daily formulation, on 25 March 2025 for the same indication in adults with HIV and lipodystrophy.[src]
Original US label
Initial U.S. approval 2010; label revised 11/2010; not indicated for weight loss management (weight neutral effect)[src]

Inside the body

What Tesamorelin does, step by step

Watch the 3D journey →
  1. 01Skin

    Injected under the skin

    The medicine is a short chain of amino acids that is injected just under the skin of the belly. From there it seeps into tiny blood vessels. Only a small share of it makes it into the blood.

    For experts

    Given by subcutaneous injection, tesamorelin has an absolute bioavailability of under 4% in healthy adults (measured with the original formulation). Median Tmax is 0.15 h, and the mean volume of distribution after a single subcutaneous dose of Egrifta WR was 4.8 +/- 1.9 L/kg in healthy subjects. With the original formulation, AUC was 34% higher in HIV-infected patients without lipodystrophy than in healthy subjects, with similar Cmax.[src]

  2. 02Bloodstream

    Gone from the blood within minutes

    Once in the blood, the peptide does not last long. Half of it is gone in about 11 minutes. Even so, that short burst is enough to give the pituitary gland a nudge.

    For experts

    Mean elimination half-life is 11 minutes after a single subcutaneous dose of Egrifta WR in healthy subjects (26 and 38 minutes in healthy subjects and HIV-infected patients respectively for the original formulation). No formal metabolism studies have been performed in humans. Pharmacokinetics in renal or hepatic impairment, children and elderly patients have not been established.[src][src]

  3. 03Brain

    Switches on the GHRH receptor in the pituitary

    At the base of the brain, the pituitary gland makes growth hormone. It has a docking site for a natural signal called GHRH. Tesamorelin is a copy of that signal, so it fits the same site and switches it on.

    For experts

    In vitro, tesamorelin binds and stimulates human GHRH receptors with potency similar to endogenous GHRH. The receptor is a class B GPCR that couples to Gs. A cryo-EM structure of GHRH(1-44) bound to the human receptor and Gs (PDB 7CZ5) shows the natural ligand's binding mode; a tesamorelin complex was not found in the sources reviewed, so its pose is inferred from the natural hormone.[src][src]

  4. 04Brain

    Pituitary releases growth hormone

    When the docking site is switched on, the pituitary releases growth hormone into the blood. Levels of other pituitary hormones stayed about the same in the trials.

    For experts

    GHRH acts on somatotrophs to stimulate synthesis and pulsatile release of endogenous GH. In trials tesamorelin raised GH secretion and thereby IGF-1 and IGFBP-3, with no clinically significant changes in TSH, LH, ACTH or prolactin (label clinical pharmacology). IGF-1 rose 81.0% versus a 5.0% fall on placebo in the first phase 3 trial. This is shown in humans.[src][src]

  5. 05Liver

    The liver makes more IGF-1

    Growth hormone tells the liver and other tissues to make a helper hormone called IGF-1. In the trials, IGF-1 went up a lot. Doctors check IGF-1 levels because nobody knows what long-term high levels do.

    For experts

    Some, but not all, GH effects are mediated by IGF-1 produced in the liver and peripheral tissues. In the two 26-week phase 3 trials, mean IGF-1 rose by 107 and 108 ng/mL with tesamorelin (mean treatment differences versus placebo 122 and 105 ng/mL); 47% of tesamorelin-treated patients exceeded 2 SDS and 36% exceeded 3 SDS at 26 weeks. The label calls for IGF-1 monitoring, and the effects of prolonged elevation are unknown.[src][src]

  6. 06Fat tissue

    Belly fat around the organs shrinks

    Growth hormone helps the body break down fat, especially the deep fat packed around the organs in the belly. In trials with people who have HIV, that deep fat went down by about 15% compared with placebo. Fat just under the skin stayed about the same.

    For experts

    GH is lipolytic, and tesamorelin selectively reduced visceral adipose tissue (VAT) on CT: a treatment effect of -15.4% at week 26 in the pooled phase 3 analysis (-24 vs +2 cm2), with no significant change in abdominal subcutaneous fat (-0.6%). The reduction was maintained to week 52 with continued treatment. Triglycerides and the total cholesterol to HDL ratio also improved. These effects are shown in HIV-infected adults with abdominal fat accumulation only.[src][src][src]

  7. 07Liver

    Possible effect on fat in the liver (unapproved, small trials)

    Two small studies in people with HIV found that tesamorelin also lowered fat stored in the liver. These studies are early, and using the medicine for liver fat is not approved anywhere we checked.

    For experts

    In a 50-patient randomised trial, liver fat fell by a net 2.9 percentage points (lipid-to-water) over 6 months versus placebo (JAMA 2014). In a 61-patient randomised trial in people with HIV and NAFLD, hepatic fat fraction fell by an absolute 4.1% versus placebo at 12 months, and 35% versus 4% reached HFF below 5% (Lancet HIV 2019). These are small, exploratory human trials in HIV only; this indication is unapproved.[src][src]

For experts

The detail

Tesamorelin is a 44-residue synthetic analogue of human growth hormone-releasing hormone, GHRH(1-44) amide, carrying a trans-3-hexenoyl group on the N-terminal tyrosine (C221H366N72O67S; 5135.9 Da as free base). The 44 residues match the endogenous sequence; the hexenoyl group is the engineered modification. It binds and activates the GHRH receptor (a class B G protein-coupled receptor) on pituitary somatotrophs with potency similar to endogenous GHRH, stimulating pulsatile growth hormone (GH) release and raising IGF-1 and IGFBP-3, with no clinically significant changes in TSH, LH, ACTH or prolactin in trials. After subcutaneous injection, absolute bioavailability is under 4%, median Tmax is 0.15 h and the elimination half-life is about 11 minutes for the current Egrifta WR formulation (26 to 38 minutes reported for the original formulation). The FDA approved Egrifta on 10 November 2010 for reducing excess abdominal fat in HIV-infected patients with lipodystrophy; Egrifta SV and, in March 2025, Egrifta WR are newer formulations. In two pooled phase 3 trials (806 patients, 26 weeks) visceral adipose tissue fell by a treatment effect of 15.4%, with triglyceride improvement and an IGF-1 rise. The label warns of neoplasm risk, IGF-1 elevation, fluid retention, glucose intolerance and hypersensitivity. The EU application was withdrawn in 2012; Health Canada approved it in 2014, but its Drug Product Database has listed the marketed Egrifta product as cancelled since September 2022. Approval status at PMDA, NMPA, TGA and MHRA was not verified. Other uses (for example fatty liver in HIV) are unapproved and investigational.

Evidence: Approved by the US FDA (2010) on the basis of two randomised, double-blind, placebo-controlled 26-week phase 3 trials in HIV-infected adults with excess abdominal fat, each followed by a 26-week safety extension (806 patients pooled). Evidence is specific to HIV-associated abdominal fat; long-term cardiovascular outcomes have not been shown. Small randomised trials in HIV-associated fatty liver disease exist but are exploratory, and that use is unapproved.[src][src][src][src][src]

Known safety signals

  • Contraindicated in disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity and pregnancy. Because it induces release of growth hormone, a known growth factor, it must not be used with active cancer; the label also asks for careful consideration before starting, given the higher background cancer risk in people with HIV.[src]
  • It raises IGF-1. In the trials 47% of treated patients had IGF-1 above 2 SDS and 36% above 3 SDS at 26 weeks; the label calls for IGF-1 monitoring and says the effects of prolonged elevation are unknown.[src]
  • Most common adverse reactions (over 5%) were arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema and myalgia. Fluid retention, including carpal tunnel syndrome, can occur.[src]
  • Glucose intolerance and diabetes can develop: HbA1c of 6.5% or more occurred in 5% of tesamorelin patients versus 1% on placebo up to week 26 (hazard ratio 3.3).[src]
  • Hypersensitivity reactions occurred in clinical trials, and anti-tesamorelin antibodies were found in 50% of patients treated for 26 weeks with the original formulation. The label also notes increased mortality in acute critical illness.[src]
  • Limitations of use on the label: long-term cardiovascular safety has not been established, it is not indicated for weight loss, and there are no data showing improved adherence to antiretroviral therapy.[src]

Around the world

Is Tesamorelin legal where you live?

CountryStatusWhat it meansVerified
AustraliaNot approvedNot on the ARTG. The Poisons Standard lists growth hormone releasing hormones as a prescription-only class with a possession control.Details →source2026-09-29
BrazilNot approvedNo Anvisa registration for tesamorelin; a medical council lists it among unregistered injectable peptidesDetails →source2026-09-29
CanadaProhibitedNot authorised since Egrifta was cancelled in 2022; Health Canada has seized unauthorised tesamorelin (2025 notices)Details →source2026-09-29
ChinaNot approvedNo NMPA approval found for tesamorelin; it cannot lawfully be sold as a medicine in China.Details →source2026-09-29
European UnionNot approvedNot authorised in the EU: the Egrifta application was withdrawn in 2012Details →source2026-09-29
IndiaNot approvedNot approved in India: no CDSCO marketing permission found for tesamorelinDetails →source2026-09-29
JapanNot approvedNo marketing approval in Japan; tesamorelin is not in PMDA's approved-drug lists, and WADA prohibits it in sportDetails →source2026-09-29
MexicoUnverifiedCOFEPRIS registered Egrifta (tesamorelin) in 2015; whether the registration is still valid could not be confirmedsource2026-09-29
New ZealandNot approvedNo tesamorelin product is approved by Medsafe; it is classed as a prescription medicineDetails →source2026-09-29
United Arab EmiratesUnverifiedCould not confirm whether tesamorelin (Egrifta) is registered by the EDE; no UAE-specific record was foundsource2026-09-29
United KingdomNot approvedNo UK licence for tesamorelin; the EU application was withdrawn in 2012Details →source2026-09-29
United StatesApproved, restrictedFDA-approved since 2010 as Egrifta only for extra belly fat in adults with HIV and lipodystrophy; not for weight lossDetails →source2026-09-29

Who makes it

Related molecules

SermorelinCJC-1295Ipamorelin

Sources (52)

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