Educational tesamorelin (Egrifta) guide: what it is, its FDA-approved use and off-label context, the trial record, half-life and side effects. Research/educational use only, not medical advice.
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Educational use only — not medical advice. This guide summarizes information reported in published research and community practice for educational purposes. It is not medical advice and not a recommendation to use any compound. Any doses, schedules, or combinations shown are examples of what has been reported, not instructions for you. Many peptides described here are research compounds that are not FDA-approved for the uses discussed and may be investigational or restricted. Effects, risks, and legal status vary; individual needs and results vary. Consult a qualified, licensed healthcare professional before making any decision. Do not use this content to diagnose, treat, or dose yourself.
Tesamorelin at a glance
What it is
Tesamorelin (Egrifta) — a stabilized synthetic analog of growth-hormone-releasing hormone, hexenoyl-GHRH(1-44) amide.
Identity
PubChem CID 16137828 · C221H366N72O67S · MW 5136 · CAS 218949-48-5 · development code TH9507.
Approved for
Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Nothing else.
Approved dose
Egrifta SV 1.4 mg (0.35 mL) or Egrifta WR 1.28 mg (0.16 mL), subcutaneously once daily into the abdomen, rotating sites — from the current labels.
Human record
Two Phase 3 trials by Theratechnologies: NCT00123253 (n=412) and its extension NCT00608023 (n=263).
Measured effect
Visceral adipose tissue down 15–20% over 6–12 months; responders pre-defined as ≥8% VAT reduction (PMID 22495074).
Plasma half-life
8 minutes (Egrifta SV) / 11 minutes (Egrifta WR) in healthy subjects, per the labels.
Label diluent
Sterile Water for Injection, supplied with the product — not bacteriostatic water. This matters and is explained below.
Regulatory status
FDA-approved for HIV-lipodystrophy only; every other use is off-label; WADA-prohibited.
Educational reference. This page does not publish dose ranges or reconstitution arithmetic.
What it is / mechanism
Tesamorelin is a stabilized analog of the first 44 amino acids of human growth-hormone-releasing hormone, modified at the N-terminus with a trans-3-hexenoyl group to resist DPP-4 breakdown. It agonises the GHRH receptor on the pituitary, prompting the body's own pulsatile release of growth hormone, which raises IGF-1 and drives lipolysis of visceral rather than subcutaneous fat. Because it stimulates endogenous GH instead of supplying GH directly, the release pattern stays pulsatile. One precision worth keeping: it is a GHRH(1-44) analog, not a modified GHRH(1-29) — that is what separates it from CJC-1295 and sermorelin, which are built on the shorter fragment, and it is why the three are not interchangeable even though all three are described as GHRH analogs.
Researched effects
The Phase 3 program is the reason this compound is worth reading about carefully. Two randomized, double-blind studies assigned men and women with HIV-associated abdominal fat accumulation 2:1 to tesamorelin or placebo for 26 weeks; at week 26 those on tesamorelin were re-randomized to continue or switch to placebo for another 26 weeks. Visceral adipose tissue fell by 15–20% over 6 to 12 months. The statistical analysis plan defined responders in advance as those with a VAT reduction of at least 8%, and the published per-protocol analysis of 402 initially randomized subjects found responders had greater reductions in triglycerides and attenuated changes in fasting glucose compared with non-responders (Stanley et al., Clin Infect Dis 2012;54(11):1642-51, PMID 22495074). Two things follow. The effect is real, measured against placebo, in a defined population. And it reverses — visceral fat re-accumulates after stopping, which is why the label frames continuation as a risk/benefit decision rather than a course with an end date.
Evidence & regulatory status
The label is the primary source, and it is current. EGRIFTA WR's prescribing information carries a Dosage and Administration revision dated 03/2025 and states the indication as reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy, with explicit limitations of use: long-term cardiovascular safety has not been established, it is not indicated for weight-loss management as it is weight-neutral, and there are no data supporting improved antiretroviral compliance.
The approved doses are specific and formulation-dependent. EGRIFTA SV: 1.4 mg, which is 0.35 mL of the reconstituted solution, subcutaneously once daily into the abdomen with site rotation. EGRIFTA WR: 1.28 mg, 0.16 mL, subcutaneously once daily. The SV label states plainly that its recommendations apply only to the 2 mg-per-vial formulation and that the formulations differ in dosage, number of vials per dose, reconstitution instructions and storage — so a figure quoted without its formulation is close to meaningless.
Two Phase 3 registry records exist, both sponsored by Theratechnologies under the development code TH9507: NCT00123253, 'TH9507 in Patients With HIV-Associated Lipodystrophy' (n=412), and NCT00608023, the extension study (n=263). Both are completed.
The label specifies Sterile Water for Injection as the diluent, supplied with the product. That is a single-use diluent with no preservative, which fits a product reconstituted and injected the same day under a prescription. It is not bacteriostatic water, and this guide does not suggest the approved product may be reconstituted with anything other than what its label specifies.
Regulatory: FDA-approved as Egrifta (2 mg), Egrifta SV (1.4 mg) and Egrifta WR (1.28 mg), all from Theratechnologies, strictly for excess visceral abdominal fat in HIV-associated lipodystrophy. Not approved for HIV-negative individuals, general obesity, or anti-ageing. WADA-prohibited in competitive sport.
Research-grade (non-pharmacy) material is sold for research and educational use only, and is not the approved product.
Research timeline
Dated milestones taken from the primary records: the molecule's discovery, its first registered human study, the trials that shaped the evidence and the regulatory decisions. Each entry links to the record it comes from.
The first placebo-controlled study in people (61 HIV-infected adults with central fat gain, 12 weeks) reports raised IGF-1, less trunk fat at the higher dose and no change in glucose; the drop in visceral fat was not significant against placebo. PMID 16052083
The first phase 3 trial (412 HIV-infected patients, 26 weeks) is published in the New England Journal of Medicine: visceral fat fell 15.2% with tesamorelin and rose 5.0% with placebo; adverse events did not differ overall, but more patients on tesamorelin withdrew because of one. PMID 18057338
The second phase 3 trial (404 HIV-infected patients, 12 months) reports visceral fat down 10.9% at six months against 0.6% with placebo; patients switched from tesamorelin to placebo lost the gain quickly. PMID 20101189
FDA approves Egrifta (tesamorelin, Theratechnologies) as a new molecular entity, to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. FDA · Drugs@FDA 022505
Ferrer withdraws its EU marketing application for Egrifta. EMA's committee had provisionally judged that it could not be approved, partly because excess abdominal fat from lipodystrophy is hard to tell apart from other abdominal fat in practice. EMA · Egrifta, application withdrawn
A 20-week placebo-controlled trial in 152 adults aged 55 to 87, with or without mild cognitive impairment, reports a favourable effect on cognition, mainly executive function; mild adverse events were reported by 68% on tesamorelin and 36% on placebo. PMID 22869065
A six-month trial in 50 HIV-infected patients, published in JAMA, finds that tesamorelin reduced both visceral fat and liver fat against placebo; fasting glucose rose at two weeks, but not over the six months as a whole. PMID 25038357
A 12-month trial in 61 people with HIV and fatty liver, published in The Lancet HIV, reports a 37% relative drop in liver fat with tesamorelin compared with placebo. PMID 31611038
Records checked Oct 3, 2026
Claims at a glance
The claims most often made about this compound, each with the strongest kind of evidence we found for it. The grade says what was studied, not whether the claim is true; the line beside it says what that study showed.
Reduces belly (visceral) fatHuman, randomised trial. In people with HIV and abdominal fat build-up, visceral fat fell 10.9% against 0.6% on placebo at six months, and the gain was lost quickly after switching to placebo. PMID 20101189
Causes weight lossHuman, randomised trial. Contradicted: FDA's label says it is not indicated for weight loss because its effect on body weight is neutral. FDA label · Egrifta (application 022505)
Clears fat from the liverHuman, randomised trial. In 61 people with HIV and fatty liver, liver fat fell by 37% relative to placebo over a year; an effect on fibrosis was not established. PMID 31611038
Builds lean massHuman, randomised trial. FDA's label reports a mean gain in lean body mass of about one kilogram in each pivotal trial; strength and function were not the endpoints. FDA label · Egrifta (application 022505)
Is safe for long-term useNo study found. No cardiovascular outcome trial exists, and FDA's label notes that lifetime cancer studies in rodents were not done. FDA label · Egrifta (application 022505)
The reasoning behind each grade, study by study, is in this guide's Benefit & Outcome Review.
Grades checked Oct 5, 2026
A printable reference sheet with the compound's key facts, storage guidance and a vial record comes with All-Access Lifetime.
Half-life & pharmacokinetics
Tesamorelin clears in minutes, and the exact figure depends on which formulation is being described — a distinction most summaries flatten. The current labels report a mean elimination half-life of 8 minutes for Egrifta SV after a 1.4 mg subcutaneous dose and 11 minutes for Egrifta WR at 1.28 mg, both in healthy subjects; longer figures of roughly 26–38 minutes circulate for the original Egrifta formulation. The apparent paradox — a molecule gone within the hour, dosed once a day, producing a body-composition change measured over six months — is the whole point of a secretagogue. What persists is not the peptide but the growth-hormone pulse it triggers and the IGF-1 response downstream of that, and the visceral-fat effect accumulates across months of daily pulses.
Reported side effects & toxicology
The most commonly reported effects in trials were arthralgia (joint pain, roughly 6–13%), injection-site reactions (roughly 8–13%), extremity pain, peripheral edema, and myalgia. Trials reported modest rises in fasting glucose, and the label's warnings name diabetes and pre-diabetes. Because IGF-1 increases substantially — on the order of 80% — the label mandates IGF-1 monitoring and discontinuation above a threshold. Label contraindications include pregnancy, active malignancy, disruption of the pituitary or hypothalamic-pituitary-adrenal axis (hypophysectomy, pituitary tumour, surgery, radiation or trauma), and known hypersensitivity. The labels also state explicitly that long-term cardiovascular safety has not been established. That is an unusually well-characterised safety picture by the standards of this library, and it is characterised because the trials were run — which is exactly what most compounds sold alongside it lack.
Storage & handling
Pharmacy Egrifta/SV/WR: store per the package insert — the labels state that the formulations differ in storage requirements, so do not carry one product's instructions across to another.
Research lyophilized (unmixed): store cold and dark; long-term typically frozen.
Reconstituted: refrigerate (~2–8°C); use within days to about two weeks; protect from light; swirl gently and do not shake or freeze.
References
Primary sources cited on this page: the FDA-approved prescribing information for EGRIFTA SV and EGRIFTA WR (Theratechnologies Inc., accessed via DailyMed; WR Dosage and Administration revised 03/2025); Stanley TL, Falutz J, Marsolais C et al., 'Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin', Clin Infect Dis 2012;54(11):1642-51 (PMID 22495074); ClinicalTrials.gov NCT00123253 and NCT00608023 (Theratechnologies); PubChem CID 16137828; the WADA Prohibited List. Verify current product labeling and regulatory status against the label itself.
Evidence File
Tesamorelin Evidence File: One Registry Record, Two Pivotal Trials, and a Mock Study
Tesamorelin has one of the deepest registry footprints of any peptide sold for research use: two pivotal Phase 3 trials, a 52-week extension that posts an outcome table, a dozen investigator-initiated randomized studies, and a set of terminated and withdrawn records almost nobody reads. This file works through the registered studies by NCT number, states which post results and which do not, traces the most-quoted tesamorelin figures back to the specific analysis each came from, and separates what the registry supports from what circulates as protocol. Every absence is stated with the searches and the registry fields behind it.
A recruiting Phase 2 liver-fat trial in the registry is titled a mock study
The 15-18 percent visceral fat figure mixes 26-week and 52-week results
Both registered tesamorelin sleep studies were withdrawn with zero enrolled
The 10-year malignancy cohort was terminated and posts no outcome data
One registry record serves two pivotal trials
A recruiting trial that is labelled a mock study, and the two that are real
The 15 to 18 percent visceral fat figure is four numbers from four analyses
The withdrawal question has a posted outcome table, and it is stronger than the usual claim
Sponsor trials outside the approved indication, and exactly what each one posts
The investigator-initiated randomized trials, including the two without HIV
Cognition: three randomized datasets that do not agree
What the registry does not contain
8 more sections in the Evidence File for Tesamorelin
Unlock the Evidence File, Sourcing File and Benefit & Outcome Review for Tesamorelin for $14 — or every compound in the library, plus the printable reference sheets, for $99.
The sections above this one stay free to read without an account.
Sourcing File
Tesamorelin Sourcing File: Three Correct Masses, a 96 Dalton Test, and a Label That Disagrees With Itself
Tesamorelin is a 44-residue peptide carrying two modifications that a routine certificate of analysis will not mention and a mass check will not always catch. This file assembles the identity record from PubChem, the FDA substance registry and both current prescribing information documents, shows the salt and charge-state arithmetic in full rather than asserting it, works through a certificate line by line, and sets out the substitution modes that a single mass measurement can and cannot resolve. It also documents where the published record runs out, and marks those points as unverified rather than filling them in.
Tesamorelin acetate is about 92 percent peptide, so 10 mg gross is 9.24 mg
Two FDA labels state one acetate ratio and imply two different acetate contents
A vial reading 3358 or 3647 Da is sermorelin or CJC-1295, not tesamorelin
Egrifta SV is reconstituted with sterile water, not bacteriostatic water
Three masses that are all correct, and the one that is not
The two modifications that make it tesamorelin rather than GHRH
What an ESI-MS of a 44-mer actually looks like, and how the compound is detected
Salt arithmetic, and a discrepancy inside the FDA labels themselves
Substitution and mislabelling modes, each as a detectable signature
A certificate of analysis read line by line
Formulation facts that change the arithmetic, and one half-life that could not be sourced
7 more sections in the Sourcing File for Tesamorelin
Unlock the Evidence File, Sourcing File and Benefit & Outcome Review for Tesamorelin for $14 — or every compound in the library, plus the printable reference sheets, for $99.
The sections above this one stay free to read without an account.
Benefit & Outcome Review
Tesamorelin Benefit and Outcome Review: What Held Up, What Was Over-Extended, What the Label Denies
Tesamorelin is unusual among research peptides in having approval-grade evidence for one specific claim and much weaker evidence for everything the market attaches to it. This review takes the claims one at a time, states what was measured, in whom, against what comparator and for how long, and grades each on that basis rather than on how often it is repeated. It separates imaging endpoints from histology, within-group changes from between-group differences, and target engagement from clinical effect, and it works through the safety table the compound's own prescribing information publishes.
The label states it is not indicated for weight loss and is weight neutral
Arthralgia was 13 percent on drug and 11 percent on placebo in the label table
Anti-tesamorelin antibodies appeared in about half of patients by 26 weeks
No human trial of tesamorelin combined with any GHRP has been registered
How these claims are graded, and the one that survives every test
The selectivity claim, and how to state a null result without overstating it
Liver fat moved; liver histology did not
Weight loss: a claim the manufacturer's own label denies
Non-responders, and who carries the glycaemic cost
The safety table, corrected against the label
Cardiovascular risk: one surrogate, and no outcome trial
Claims with no completed human trial behind them
8 more sections in the Benefit & Outcome Review for Tesamorelin
Unlock the Evidence File, Sourcing File and Benefit & Outcome Review for Tesamorelin for $14 — or every compound in the library, plus the printable reference sheets, for $99.
Quick answers about guide scope, access, and educational use context.
Is tesamorelin FDA-approved?
Yes — and it is one of the few compounds in this library that is. It is approved to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. Every other use, including general weight loss and anti-ageing, is off-label. The label also states it is not indicated for weight-loss management because it is weight-neutral.
What is the approved tesamorelin dose?
It depends on the product, and the labels are explicit that the formulations are not interchangeable. Egrifta SV is 1.4 mg (0.35 mL of reconstituted solution) subcutaneously once daily into the abdomen; Egrifta WR is 1.28 mg (0.16 mL) once daily. The original Egrifta formulation was 2 mg.
What does the label say to reconstitute it with?
Sterile Water for Injection, supplied with the product — not bacteriostatic water. That is a single-use, preservative-free diluent, which suits a prescription product mixed and injected the same day. Research-grade material is a different situation and is commonly reconstituted with bacteriostatic water, but the approved product should be prepared exactly as its own label directs.
How much visceral fat did the trials actually remove?
Visceral adipose tissue fell 15–20% over 6 to 12 months in the Phase 3 program, with responders defined in advance as those achieving at least an 8% reduction (Stanley et al., Clin Infect Dis 2012, PMID 22495074). The trials were NCT00123253 (n=412) and its extension NCT00608023 (n=263).
Does the visceral fat stay off after stopping?
No. It re-accumulates after treatment stops, which is why the label frames continuation as an ongoing risk/benefit judgement rather than a course with a finish line.
What is the tesamorelin half-life?
8 minutes for Egrifta SV and 11 minutes for Egrifta WR in healthy subjects, per the current labels; around 26–38 minutes is cited for the original formulation. Once-daily dosing works because what lasts is the growth-hormone and IGF-1 response, not the peptide.
Is tesamorelin the same as CJC-1295 or sermorelin?
No, and the difference is structural rather than cosmetic. Tesamorelin is a hexenoyl-modified GHRH(1-44); CJC-1295 and sermorelin are built on the shorter GHRH(1-29) fragment. All three are GHRH analogs, so stacking them together is redundant — but they are not the same molecule, and only tesamorelin has approval-grade visceral-fat data.
Does tesamorelin require monitoring?
The label requires IGF-1 monitoring, because IGF-1 rises substantially on treatment and the label directs discontinuation above a threshold. It also flags caution in diabetes and pre-diabetes given the modest fasting-glucose rises seen in trials.
Is tesamorelin banned in sport?
Yes — it is WADA-prohibited in competitive sport.
What are tesamorelin's identity numbers?
PubChem CID 16137828, molecular formula C221H366N72O67S, molecular weight 5136, CAS 218949-48-5, development code TH9507. At roughly 5,136 daltons it is far larger than the GHRH(1-29) analogs it is often grouped with — a certificate of analysis reporting a mass near 3,300 is not describing tesamorelin.
Compliance and trust notes
Educational content only; no personalized health or outcome claims.
No personalized use recommendation outputs.
Use this material for general learning and research-context literacy.
A certificate of analysis (COA) is a laboratory’s report on one sample of one batch. The single most useful thing to know about it is that purity and identity are two separate results that fail in different ways. A high purity figure says the sample was mostly one substance; it does not say that substance was Tesamorelin. Identity — normally a mass-spectrometry result matching the expected molecular weight — is what establishes what the material actually is, and a certificate reporting purity alone has not answered that question.
Two further limits are worth holding onto. Mass per vial is its own test: a vial can be 99% pure and still contain less material than the label claims. And sterility, endotoxin, heavy metals and residual solvent screening are separately commissioned tests, usually priced individually — so a “third-party tested” badge asserts none of them unless the certificate names them. Check that the batch or lot number on the document matches the vial in front of you; an unmatched certificate describes someone else’s material.
Medibact does not test, endorse or resell peptides, and publishes no rating of any laboratory. How to read a peptide certificate of analysis walks through the document section by section, and what each COA field establishes covers the field-by-field detail and the laboratories that publish their methods.
You’ll need bacteriostatic water
The diluent for reconstituting Tesamorelin
Reconstitution is volume arithmetic — it assumes a lyophilized vial is dissolved in bacteriostatic water, which is sterile water preserved with 0.9% benzyl alcohol. The preservative is what allows a vial to be entered more than once; plain sterile water carries none and is single-entry by design. Medibact supplies USP-grade Bacteriostatic Water for Injection in a 30 mL multi-dose vial, produced in an FDA-registered U.S. facility and shipped from the United States, for research use only. One 30 mL vial covers 30 reconstitutions at 1 mL each, 15 at 2 mL, or 10 at 3 mL — division only, not a dosing recommendation.
Educational use only — not medical advice. This guide summarizes information reported in published research and community practice for educational purposes. It is not medical advice and not a recommendation to use any compound. Any doses, schedules, or combinations shown are examples of what has been reported, not instructions for you. Many peptides described here are research compounds that are not FDA-approved for the uses discussed and may be investigational or restricted. Effects, risks, and legal status vary; individual needs and results vary. Consult a qualified, licensed healthcare professional before making any decision. Do not use this content to diagnose, treat, or dose yourself.
