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peptide

Tesamorelin

A lab-made copy of the brain signal that triggers growth hormone release; FDA approved as Egrifta to cut belly fat in HIV.

A growth hormone-releasing hormone analogue, FDA approved since 2010 as Egrifta to reduce excess abdominal fat in HIV-associated lipodystrophy, and regulated as a biologic since 2020.

Data refreshed 2026-11-01 · Based on 9 published references

At a glance

FDA approved
Yes: Egrifta, Egrifta SV, Egrifta WR
Potential results
  • Less deep belly fat in adults with HIV (FDA approved use)
  • Belly fat came back after stopping (large trial)
  • Less liver fat in HIV fatty liver (trial vs placebo)
  • No better blood sugar in type 2 diabetes (trial vs placebo)
  • Better thinking skills in older adults (trial vs placebo)

Unverified, online reports only: a flatter stomach or smaller waist, reducing visceral fat around the organs, and raising IGF-1.

Dose
Label dosing
Converter: mg, mL and syringe units
Storage
Egrifta SV and Egrifta WR vials are labeled for storage at 20–25 °C (68–77 °F), protected from light.
Side effects and warnings
  • Most common side effects: joint pain, redness and itching where the shot goes in, pain in arms or legs, swelling, and muscle pain.
  • It can raise blood sugar and the risk of diabetes (HbA1c 6.5% or higher in 5% vs 1% on a dummy treatment by week 26). Labels advise checking blood sugar.
  • It can cause fluid build-up, including carpal tunnel syndrome (numb or tingling hands). Allergic reactions such as rash and hives can happen.

A summary of the sources on this page, not medical advice.

What else trials studied for a diagnosed condition: see the research quiz.

Names

Generic: tesamorelin

Brands: Egrifta, Egrifta SV, Egrifta WR

Also called: TH9507, tesa

Regulatory (US)

FDA approval: approved

503A compounding: restricted
Compounding is limited to the circumstances described under Regulatory picture; not a general permission.

Egrifta — Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy (US, 2010)

Egrifta SV — Same indication, higher-concentration formulation (US, 2018)

Egrifta WR — Same indication, once-weekly reconstitution formulation (US, 2025)

Molecule

Formula: C221H366N72O67S

MW: 5135.9 g/mol

CAS: 218949-48-5

PubChem entry

Sequence: trans-3-hexenoyl-Y-A-D-A-I-F-T-N-S-Y-R-K-V-L-G-Q-L-S-A-R-K-L-L-Q-D-I-M-S-R-Q-Q-G-E-S-N-Q-E-R-G-A-R-A-R-L-NH2

Origin

Discovered by: Theratechnologies, Montreal

Developer: Theratechnologies

What it is

Tesamorelin is a short chain of amino acids (a peptide). It is a man-made copy of a natural brain signal called growth hormone-releasing hormone (GHRH). This signal tells the pituitary gland to release growth hormone. The body breaks down natural GHRH within minutes. Tesamorelin has a small chemical cap on one end. The cap slows that breakdown. So a daily shot keeps boosting the body’s own bursts of growth hormone.

The FDA has approved it under the brand name Egrifta for one narrow use. It reduces deep belly fat that builds up in some people with HIV. These people have taken HIV medicines (antiretroviral therapy) for a long time. It is the only drug of its kind sold in the United States today. An earlier one, sermorelin (Geref), was approved in 1990. It was later taken off the market.

Tesamorelin is human GHRH(1-44) amide with a trans-3-hexenoyl group on the N-terminal tyrosine, which sterically blocks DPP-4 cleavage at the Ala2-Asp3 bond. It binds the GHRH receptor on somatotrophs and augments pulsatile GH secretion while preserving negative feedback through IGF-1 and somatostatin, which distinguishes it from exogenous GH. Downstream effects include increased lipolysis in visceral adipose tissue and a rise in serum IGF-1 of roughly 100 µg/L at the 2 mg dose in the pivotal trials. Current labels give an elimination half-life of about 8–11 minutes in healthy subjects, but the biological effect on GH pulsatility persists across the dosing interval.

Who made it and when

A Montreal company called Theratechnologies developed tesamorelin in the early 2000s. Its code name was TH9507. The FDA approved it in November 2010. A more concentrated version, Egrifta SV, came out in November 2018. Egrifta WR was approved in March 2025. It only needs mixing once a week. Since March 2020, the FDA has treated it as a biologic, not a standard drug. A biologic is a medicine made from larger, more complex molecules.

Theratechnologies advanced TH9507 through two pivotal Phase 3 trials in HIV-associated lipodystrophy (2005–2008). FDA approved Egrifta (application 022505) on 2010-11-10 after an advisory committee voted in favour. Egrifta SV (a more concentrated 2 mg-vial formulation) was approved in November 2018, and Egrifta WR (the F8 formulation, 1.28 mg daily from a vial reconstituted weekly) on 2025-03-25 as a supplemental BLA. Because tesamorelin is a 44-residue peptide, it met the statutory definition of a protein, and its NDA was deemed a biologics license application on 2020-03-23. Composition and use patents are held by Theratechnologies; check current expiry status before relying on them.

What the data say

Two large trials looked at people with HIV. Daily shots cut deep belly fat by about 11–15% over six months. People on a dummy treatment (placebo) had little or no change. The fat came back after people stopped. A smaller study looked at people with HIV and fatty liver disease. Tesamorelin also lowered their liver fat. It has no approved use for weight loss or body shape in people without HIV. No completed trials have tested that use.

A pooled analysis of the two Phase 3 trials (n=806) reported a treatment effect of −15.4% on VAT vs placebo at 26 weeks, with triglyceride reduction and no significant change in abdominal subcutaneous fat; IGF-1 rose by a mean 108 ng/mL. VAT reduction was maintained to 52 weeks with continued treatment and was rapidly lost in those switched to placebo. The NAFLD study (n=61) reported an absolute reduction in hepatic fat fraction of 4.1% vs placebo (a 37% relative reduction) and less fibrosis progression over 12 months, without differences in fasting glucose or HbA1c. Labels report HbA1c of 6.5% or higher by week 26 in 5% of tesamorelin vs 1% of placebo participants. No outcome data exist for cardiovascular events.

Regulatory picture

Egrifta is fully FDA approved for its HIV use. That approval does not cover any other use. Since 2020, tesamorelin has been treated as a biologic. The FDA says biologics cannot be compounded (made to order by pharmacies). So pharmacies have no legal way to make copies of it. Products sold online as “research tesamorelin” are not Egrifta.

Tesamorelin acetate is the active ingredient of Egrifta SV and Egrifta WR, licensed under BLA 022505 since the 2020-03-23 transition of protein products from NDAs to BLAs. FDA’s compounding guidance states that biologics cannot be compounded and that federal law provides no pathway for biologics prepared outside an approved BLA, so the drug-shortage exceptions available to 503A and 503B compounders for conventional drugs do not apply. The approved indication is limited to reduction of excess abdominal fat in HIV-infected adults with lipodystrophy; no supplemental indication has been approved. Off-label prescribing of the approved product is a matter of medical practice, not of this site.

Dose

Doses reported in trials and studies

How dosing worked in the studies

In the first large trial (Phase 3 trial 1), 412 adults with HIV and belly fat build-up were assigned by chance to one of two groups. One group got 2 mg under the skin once a day. The other got a dummy treatment (placebo). Both went on for 26 weeks. The second large trial (Phase 3 trial 2) did the same with 404 adults with HIV on HIV medicines. People who went on to a 26-week extension were then assigned by chance again to tesamorelin or placebo. A trial in HIV and fatty liver included 61 adults with HIV and liver fat. They were assigned by chance to 2 mg a day or placebo for 12 months. Smaller placebo studies used 1 mg or 2 mg once a day for 12 weeks to 12 months. One study gave 2 mg once a day for 2 weeks to 13 healthy men, with no comparison group.

Label dosing (FDA-approved products)

  • The Egrifta WR label states that "The recommended dosage of EGRIFTA WR is 1.28 mg subcutaneously once daily," injected into the abdomen, with injection sites rotated to different areas of the abdomen. It adds that Egrifta WR and Egrifta SV "are not substitutable" because the two formulations differ in dosage. (EGRIFTA WR (tesamorelin) for injection, prescribing information (DailyMed, revised 03/2025))
  • The Egrifta SV label states that the dose is 1.4 mg injected subcutaneously once daily into the abdomen, and that systemic exposure at this dose is similar to the 2 mg dose of the original Egrifta (1 mg/vial) formulation, whose clinical trials the SV label relies on for safety and effectiveness. It also advises considering stopping treatment when IGF-1 stays persistently high (e.g., >3 SDS), "particularly if the efficacy response is not robust." (EGRIFTA SV (tesamorelin) for injection, prescribing information (FDA label, revised 02/2024))

Study doses are not personal dosing instructions. Reading doses safely: how concentration and syringe markings work.

Doses reported in studies, exactly as the cited trial reported them. They are not personal dosing instructions. Population, route and schedule matter more than the number.

TrialPhaseStatusPopulationDoseResult
Phase 3 trial 1
NCT00123253
3Completed412 HIV-infected adults with abdominal fat accumulation2 mg subcutaneous once daily, 26 weeksVisceral adipose tissue −15.2% vs +5.0% placebo (Falutz et al., NEJM 2007)
Phase 3 trial 2
NCT00608023
3Completed404 HIV-infected adults with excess abdominal fat on antiretroviral therapy; this registry record (TH9507-CTR-1012) covers the 263 who entered the 26-week extension2 mg subcutaneous once daily for 26 weeks, then re-randomisation to tesamorelin or placebo for a 26-week extensionVisceral adipose tissue −10.9% vs −0.6% placebo at 26 weeks; the reduction was lost after switching to placebo (Falutz et al., JAIDS 2010)
Tesamorelin in HIV-associated NAFLD
NCT02196831
N/ACompleted61 HIV-infected adults with hepatic steatosis2 mg subcutaneous once daily, 12 monthsLiver fat fraction reduced by an absolute 4.1% vs placebo; fewer participants progressed in fibrosis (Stanley et al., Lancet HIV 2019)
Tesamorelin plus exercise (Phase 2)
NCT06554717
2Recruiting (record updated May 2026; primary completion expected June 2028)100 adults, planned; Massachusetts General Hospital1.28 mg subcutaneous once daily alongside an exercise programmeNo results posted.

Doses in other published studies

Published studies not listed in the trials table above: smaller or unregistered human studies first, then animal and cell studies. Doses are shown exactly as each study reported them. Animal studies report weight-based doses, absolute amounts or concentrations; none translates directly to people, and none is converted here.

SubjectsDesignDoseFindingSource
Humans: five randomised, placebo-controlled trials in adults with HIV-associated lipodystrophy, pooledSystematic review and random-effects meta-analysis of randomised controlled trials, searched to July 2025Tesamorelin as given in the included trials (2 mg subcutaneous once daily in the pivotal studies)Versus placebo: visceral adipose tissue −27.7 cm² (95% CI −38.4 to −17.1), trunk fat −1.18 kg, liver fat −4.28 percentage points, waist −1.61 cm and lean body mass +1.42 kg; no significant change in subcutaneous fat or BMI; adverse events included joint and muscle pain, paraesthesia and injection-site redness, with no glucose disturbance reported.Badran AS et al., Obes Res Clin Pract, 2026
Humans: 13 healthy men (mean age 45, mean BMI 27.3)Single-group study: baseline, 2 weeks on treatment, then 2 weeks after withdrawal (registered as NCT00850564)Tesamorelin 2 mg subcutaneously once daily for 2 weeksMean overnight GH, GH peak area and basal GH secretion rose and IGF-I increased by 181 ± 22 µg/L, while fasting glucose and insulin-stimulated glucose uptake did not change significantly.Stanley TL et al., J Clin Endocrinol Metab, 2011
Humans: 53 adults with type 2 diabetesRandomised, placebo-controlled, three-arm trial sponsored by the manufacturer (NCT01264497)Tesamorelin 1 mg or 2 mg by subcutaneous injection once daily for 12 weeksRelative insulin response, fasting glucose and HbA1c did not differ significantly between groups over 12 weeks; total and non-HDL cholesterol fell in the 2 mg group (p<0.05 vs placebo).Clemmons DR et al., PLoS One, 2017
Humans: 60 abdominally obese adults with reduced GH secretionRandomised, double-blind, placebo-controlled trial (NCT00675506)Tesamorelin 2 mg once daily for 12 months (the abstract gives no route; the linked registry record NCT00675506 lists subcutaneous injection)Visceral fat fell compared with placebo (treatment effect −35 cm²), as did triglycerides, C-reactive protein and carotid intima-media thickness, with no significant effect on abdominal subcutaneous fat; IGF-I rose; fasting glucose, 2-h glucose and HbA1c did not change.Makimura H et al., J Clin Endocrinol Metab, 2012
Humans: 61 HIV-infected adults with abdominal fat accumulationRandomised, double-blind, placebo-controlled dose-ranging trialTH9507 (tesamorelin) 1 mg or 2 mg subcutaneously once daily for 12 weeksIGF-I rose 48% (1 mg) and 65% (2 mg) versus placebo; trunk fat fell significantly only in the 2 mg group; the fall in visceral fat (−15.7% at 2 mg) was not significant versus placebo, and subcutaneous fat did not change.Falutz J et al., AIDS, 2005
Humans: 152 adults aged 55–87, 66 of them with mild cognitive impairmentRandomised, double-blind, placebo-controlled trial with assessment after a 10-week washout (NCT00257712)Tesamorelin 1 mg/day, self-administered by subcutaneous injection 30 minutes before bedtime, for 20 weeksCognition improved compared with placebo in the intent-to-treat analysis (P=.03), with a positive effect on executive function (P=.005) and a non-significant trend in verbal memory; IGF-1 rose 117% and percent body fat fell 7.4%; mild adverse events were reported by 68% of treated participants vs 36% on placebo.Baker LD et al., Arch Neurol, 2012
Animals: pigs, rats and dogs; subchronic toxicity in rats and dogsManufacturer's non-clinical pharmacology and repeat-dose toxicity studiesDaily repeat intravenous or subcutaneous injections at doses up to 600 µg/kg; subchronic toxicity studies with treatment for up to 4 monthsPlasma GH and IGF-1 rose markedly; after repeat daily subcutaneous injections dogs showed a more pronounced anabolic effect and reversible liver and kidney findings, anaemia, clinical chemistry changes and organ-weight effects, which the authors attributed to prolonged supraphysiological GH and/or IGF-1.Ferdinandi ES et al., Basic Clin Pharmacol Toxicol, 2007

Mixing examples reported by protocol websites

Examples for the freeze-dried powder, as reported by protocol websites, not taken from studies. The water amount only sets the concentration (how much is in each mL); it does not change how much of the compound is in the vial. Each concentration assumes the vial really holds its labelled amount and the final liquid volume equals the water added.

VialWater addedConcentration
2 mg0.5 mL4,000 mcg/mL
5 mg1.0 mL5,000 mcg/mL
10 mg2.0 mL5,000 mcg/mL
  1. Clean the rubber tops of both vials with an alcohol swab.
  2. Add the water slowly, letting it run down the inside wall of the vial rather than onto the powder.
  3. Swirl or roll gently until the powder dissolves; protocol sites advise against shaking.
  4. The liquid should be clear. If it is cloudy or has specks in it, do not use it. Clear liquid does not show that the product is pure, the right strength or sterile.
  5. Write the date and the concentration on the vial, and keep it in the fridge (2–8 °C). No safe storage time after mixing has been established for these products.

Products sold as "research peptides" have not gone through FDA review for safety, effectiveness or quality. Bacteriostatic water does not sterilize a contaminated powder. It contains benzyl alcohol, and its label says it is not for use in newborns. To work out a volume from your own numbers, use the converter.

Doses described in clinical or compounding practice

From FDA labels and documents, other regulators, published reviews and professional references, as each source states them. Unless a source says otherwise, these describe practice or proposals, not results tested in trials. Reading doses safely: how concentration and syringe markings work.

Doses reported in online communities (untested)

Unverified, and not a recommendation. These are amounts people describe in online forums such as Reddit, collected so researchers can see how practice differs from the evidence. These forum accounts are not clinical evidence, even where they overlap studied doses. Products sold online as "research peptides" are not FDA approved, and their identity, purity and strength are not verified; they can be mislabeled, contaminated or wrongly dosed.

What people report

In the threads reviewed, posters described subcutaneous amounts of about 0.3 mg to 2 mg per injection, usually once a day, and several combined it with ipamorelin, retatrutide or other peptides. Posters disagreed about whether breaks are needed and how long results take to appear. Reported side effects included water retention and bloating, numb or tingling hands, joint pain, and fatigue or grogginess. Several posters described generalised itching, hives or allergic reactions for which they called an ambulance or went to an emergency department.

How this compares with the studies

The studies gave 1 mg or 2 mg subcutaneously once daily for 2 weeks to 12 months, and the Egrifta WR label gives 1.28 mg once daily for its formulation. The threads describe unverified products and frequent use alongside other drugs, so exposure, safety or efficacy cannot be compared. Separately, the label records hypersensitivity reactions in 4% of trial patients.

Open questions a study would need to answer

Threads consulted, checked 2026-09-26: Anyone else not find tesamorelin effective? · Tesamorelin dose and IGF1 respond for 43 Male Research Subject · Sharing my tesamoralin experience that ended with me in hospital · Has anyone experienced this with Tesamorelin? Pretty scary reaction. · Feeling like tingling on hands when I'm laying down and holding my phone could it be tesaMorelin? · Exhausted on Tesamorelin · Tesamorelin (running longer than 12 weeks) · Anyone care to share experience with tesamorelin?

Enforcement history

Side effects and warnings

Full lists are in the .

Reported side effects

Interactions

Contraindications

Storage

Unopened: Egrifta SV and Egrifta WR vials are labeled for storage at 20–25 °C (68–77 °F), protected from light. Original Egrifta vials required refrigeration.

Reconstituted / in use: Egrifta SV is labeled for immediate use after reconstitution. A reconstituted Egrifta WR vial is labeled for storage at 20–25 °C and provides daily doses for 7 days, after which unused solution is discarded.

Research-grade lyophilized powder is typically stored frozen; supplier stability claims are not label data.

Product characteristics

Form: Lyophilized powder for reconstitution and subcutaneous injection

Appearance: White to off-white lyophilized powder; clear, colorless solution after reconstitution

Solubility: Soluble in sterile water for injection

Stability: N-terminal hexenoyl group protects against DPP-4 cleavage; label half-life is about 8 minutes (Egrifta SV) to 11 minutes (Egrifta WR) in healthy subjects, and 26–38 minutes was reported for the original formulation, but pulsatile GH release persists

Compound information

Synthetic 44-residue GHRH(1-44) analogue with a trans-3-hexenoic acid modification at the N-terminus and a C-terminal amide. Handle as a bioactive peptide.

Molecule, patents, enforcement history, full trial tables and compound details are in the .

Common questions

What is Tesamorelin?

Tesamorelin is a short chain of amino acids (a peptide). It is a man-made copy of a natural brain signal called growth hormone-releasing hormone (GHRH). This signal tells the pituitary gland to release growth hormone. The body breaks down natural GHRH within minutes. Tesamorelin has a small chemical cap on one end. The cap slows that breakdown. So a daily shot keeps boosting the body's own bursts of growth hormone.

Is Tesamorelin FDA approved?

FDA approved as Egrifta, for reducing excess belly fat in adults with HIV-related lipodystrophy.

What have studies found?

How was it dosed in studies?

In the first large trial (Phase 3 trial 1), 412 adults with HIV and belly fat build-up were assigned by chance to one of two groups. One group got 2 mg under the skin once a day. The other got a dummy treatment (placebo). Both went on for 26 weeks. The second large trial (Phase 3 trial 2) did the same with 404 adults with HIV on HIV medicines. People who went on to a 26-week extension were then assigned by chance again to tesamorelin or placebo. A trial in HIV and fatty liver included 61 adults with HIV and liver fat. They were assigned by chance to 2 mg a day or placebo for 12 months. Smaller placebo studies used 1 mg or 2 mg once a day for 12 weeks to 12 months. One study gave 2 mg once a day for 2 weeks to 13 healthy men, with no comparison group.

What are the side effects and warnings?

References

This page summarises the published sources below. PeptideBasics101 does no original research. Trial doses and results are reported as the cited study or label reported them. Sources can themselves be wrong or superseded; if you find a statement here that does not match its source, please tell us through our corrections process. Sources were last checked on 2026-11-01.

Based on 9 published references
  1. Egrifta WR prescribing information (FDA label, rev. 03/2025) (accessdata.fda.gov)
  2. Egrifta SV prescribing information (FDA label, rev. 02/2024) (accessdata.fda.gov)
  3. Badran AS et al. Body composition, hepatic fat, metabolic and safety outcomes of tesamorelin in HIV-associated lipodystrophy: a meta-analysis of randomised controlled trials. Obes Res Clin Pract 2026;20:2-12 (pubmed.ncbi.nlm.nih.gov)
  4. Falutz J et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. NEJM 2007 (nejm.org)
  5. Falutz J et al. Effects of tesamorelin in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. JAIDS 2010 (doi.org)
  6. Stanley TL et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV. Lancet HIV 2019 (doi.org)
  7. Drugs@FDA: Egrifta (BLA 022505, formerly NDA) (accessdata.fda.gov)
  8. FDA: Compounding and the FDA, questions and answers (biologics cannot be compounded) (fda.gov)
  9. PubChem: tesamorelin (pubchem.ncbi.nlm.nih.gov)

Clinical trial entries in the table above link to their ClinicalTrials.gov registry records. Spotted an error? See corrections.

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