Reader’s guide · First edition · September 2026 · Revised September 23, 2026
Tesamorelin
A guide to the only approved growth hormone releaser: what the label says, what the trials measured, and why the prescription is legal when the vial usually is not
Tesamorelin is the one growth hormone-releasing peptide with an FDA approval, two Phase 3 trials, and a label. It was approved in 2010 to reduce excess abdominal fat in people with HIV whose antiretroviral therapy had redistributed it, and in that population it reliably shrinks visceral fat by about a sixth while it is taken. Clinics now prescribe it off-label for belly fat, body composition, liver fat, and cognition, and research vendors sell it by the vial. This guide separates the approved use from the off-label claims, gives the label's own warnings, and explains which routes to the drug are lawful.
Who this is for
Written for adults who are using, or being offered, tesamorelin for abdominal fat, body composition, liver fat, or cognition. It summarizes the prescribing information, the published trials, and the regulatory position as of the edition date. It is not medical advice.
Tesamorelin is a synthetic copy of the full 44-amino-acid growth hormone-releasing hormone (GHRH) with one added group at the front that protects it from being broken down. It acts on the pituitary the way the natural hormone does, prompting a pulse of growth hormone that in turn raises IGF-1, the messenger that carries most of growth hormone's effects. It is the stabilized, approved version of the same idea behind sermorelin and CJC-1295.
- Class
- Growth hormone-releasing hormone analog; a prescription peptide drug
- Brand
- Egrifta (2010, 1 mg vials, 2 mg daily); Egrifta SV (2019, 2 mg vial, 1.4 mg daily); Egrifta WR (approved March 2025, available September 2025: an 11.6 mg vial reconstituted once a week, 1.28 mg daily). Made by Theratechnologies.
- Approved for
- Reduction of excess abdominal fat in adults with HIV and lipodystrophy. Nothing else.
- Forms in use
- Brand kits by prescription; compounded copies in limited circumstances; research-chemical 10 mg vials, which are unapproved drugs
- Anti-doping
- Prohibited by WADA at all times under section S2, growth hormone-releasing factors
Approved does not mean approved for you
The approval, the trials, and the label all describe one condition: fat that antiretroviral drugs pushed into the abdomen of people with HIV. Tesamorelin is legal to prescribe for anything, as any approved drug is, but the evidence a buyer is shown comes from a population most buyers are not in.
Two Phase 3 trials enrolled about 800 adults with HIV and excess abdominal fat, assigned two to one to tesamorelin 2 mg daily or placebo for 26 weeks, then re-randomized the tesamorelin group to continue or switch to placebo for another 26 weeks. Visceral fat was measured by CT scan.
Visceral fat at 26 weeks on tesamorelin, versus about +2% on placebo
At 52 weeks in those who continued; those switched to placebo regained toward baseline
Change in subcutaneous fat or body weight: the loss was visceral and the scale barely moved
Share of patients whose HbA1c rose to the diabetic range by week 26, tesamorelin versus placebo
| Question | Answer from the prescribing information |
|---|---|
| Does it reduce belly fat? | Yes, visceral fat, in the approved population, for as long as it is taken |
| Does it cause weight loss? | No. The label states it is not indicated for weight management and had a minimal effect on weight |
| Does the fat stay off? | No. Visceral fat returned toward baseline within six months of stopping in the trials |
| Does it reduce heart disease? | Unknown. The label states that whether the fat reduction improves cardiovascular outcomes has not been studied |
| Does it improve blood lipids? | Triglycerides fell modestly in the trials; cholesterol changes were small |
This is a genuinely positive result, and it is narrower than the marketing. The drug moves one fat compartment, in one disease, while it is taken, with a measurable cost in blood sugar.
Off-label prescribing rests on four smaller randomized trials, three of them in people with HIV and one in adults selected for low growth hormone output. None studied a healthy adult with ordinary belly fat, and none ran longer than a year.
| Year | Population | Result | What it supports |
|---|---|---|---|
| 2012 | 60 abdominally obese adults without HIV, selected for reduced growth hormone secretion, 2 mg daily for 12 months | Visceral fat fell about 16 cm² versus a rise of about 19 cm² on placebo | Visceral fat loss in people with low growth hormone output; not tested in people with normal output |
| 2012 | 137 older adults, 76 healthy and 61 with mild cognitive impairment, 1 mg nightly for 20 weeks | Better executive function and, to a lesser degree, verbal memory | A single cognition trial, never replicated or extended |
| 2014 | 48 adults with HIV and excess visceral and liver fat, 6 months | Liver fat fell about 2% versus a 1% rise on placebo; visceral fat fell | Liver fat in HIV |
| 2019 | 61 adults with HIV and fatty liver, 12 months | Liver fat fell 4.1 percentage points versus a 0.9 rise on placebo; less fibrosis progression on biopsy | Fatty liver in HIV; the best off-label evidence, in a population most buyers are not in |
Body composition in healthy adults, muscle gain, recovery, sleep, and anti-aging have no trial at all. Those claims are borrowed from growth hormone itself, and the trial record for growth hormone in healthy older adults shows small lean-mass gains, no gain in strength or function, and more swelling, joint pain, and glucose problems.
What would count as evidence for the way it is sold
A randomized trial of tesamorelin against placebo in adults without HIV and without low growth hormone, measuring visceral fat, glucose, and a clinical outcome over a year or more. None exists, and as of this edition none is registered.
The label is unusually specific, which makes the drift in clinic protocols easy to see. On the label, tesamorelin is a daily injection into the abdomen at a fixed dose, with IGF-1 checked and the drug stopped if it does not help. In clinics it becomes a five-night-a-week bedtime injection at a dose chosen by cost, often for months without a scan.
| Form | Instruction | What is known |
|---|---|---|
| Egrifta WR (label) | 1.28 mg (0.16 mL) once daily, subcutaneous, abdomen; one 11.6 mg vial reconstituted per week | The approved regimen; equivalent to the original 2 mg dose of the older formulation |
| Egrifta SV (label) | 1.4 mg (0.35 mL) once daily from a 2 mg vial reconstituted each day | Approved 2019; still dispensed |
| Clinic, off-label | 1 to 2 mg at bedtime, five nights on and two off, for 12 weeks or longer | Bedtime timing and rest days are custom, not label; the 1 mg dose comes from the cognition trial |
| Research vial | 10 mg lyophilized powder, reconstituted by the buyer, dosed as above | An unapproved drug; identity and strength unverified |
What the next table is, and is not
It expresses the common clinic protocol for the 10 mg vial as sold, so the arithmetic can be checked against the label doses. The brand kits come with their own diluent and instructions, which override this. A research-chemical vial's identity and strength are unverified.
- Vial
- 10 mg, as sold by research vendors; identity and quantity unverified unless a pharmacy dispensed it
- Water added
- 2 mL bacteriostatic water. Most 10 mg vials are 3 mL glass and hold it.
- Concentration
- 5,000 mcg/mL (5 mg/mL). One concentration for the whole course.
- Syringe
- 0.5 mL or 1 mL insulin syringe. The 2 mg draw is 40 units, beyond a 0.3 mL syringe.
| Weeks | Nightly dose | Draw | Units | Used per 4 weeks |
|---|---|---|---|---|
| 1–2 | 1 mg | 0.2 mL | 20 | 20 mg (2 vials) |
| 3–12 | 2 mg | 0.4 mL | 40 | 40 mg (4 vials) |
| Label, for comparison | 2 mg every day (1.28 mg of the WR formulation) | 0.4 mL | 40 | 56 mg (about 6 vials) |
| After 12 | Measure, and stop if nothing measurable changed |
The label has no ramp; the two-week 1 mg start is clinic custom. Fat returns within about six months of stopping, so a course is a commitment to continuing or to losing the result.
What each draw looks like · 0.5 mL (50-unit) U-100 insulin syringe
The plunger tip sits on the line for the dose. Units are marks on a U-100 syringe: 100 units is 1 mL. The picture assumes the concentration in the table above; a different amount of water changes every line.
- The label's own stopping rule is worth keeping: reassess, and discontinue if there is no reduction in abdominal fat. Without a scan or at least a waist measurement, nobody can tell.
- IGF-1 is the monitoring test on the label. A clinic protocol without a baseline and follow-up IGF-1 is skipping the one safety check the trials used.
- Bedtime dosing is borrowed from the secretagogue market to ride the natural nocturnal pulse. The trials dosed once daily without specifying time.
Because tesamorelin is an approved drug, its regulatory position is the clearest of any peptide in this series, and it cuts against the way most of it is sold. The brand, by prescription, for any use a doctor chooses: lawful. A compounded copy for convenience or price: generally not. A research vendor's vial: an unapproved drug, and FDA has said so in writing.
| Route | Legal position | What the buyer gets |
|---|---|---|
| Brand (Egrifta WR or SV) by prescription | Approved. Off-label prescribing is lawful and common | A verified product with a label, at a price set for a rare indication and rarely covered by insurance off-label |
| Compounded tesamorelin from a 503A pharmacy | Restricted. A pharmacy may not regularly compound what is essentially a copy of an available approved drug unless the change meets a documented patient-specific need | Usually a cheaper copy justified by a dose or ingredient change; FDA has issued warning letters over exactly this practice |
| Research-chemical vial | An unapproved new drug. FDA's August 2026 warning letter to a peptide seller names tesamorelin among products sold as "research use only" with a dosing guide and bacteriostatic water | Unverified identity and strength, no pharmacy, no prescriber |
The approval belongs to the brand, not to the powder
Sellers cite "FDA-approved" for a vial FDA has never seen. The approval covers Theratechnologies' product, made under its manufacturing controls, dispensed on a prescription. A vial from a chemical supplier is no more approved than BPC-157 is, and unlike BPC-157 it competes with a drug the law protects.
- Tesamorelin is not on the 503A bulk-substances lists at all: as a component of an approved drug it does not need to be, which is why the Category 2 fights over CJC-1295 and ipamorelin do not touch it.
- Telehealth prescribers who dispense compounded tesamorelin typically document a patient-specific reason for the copy. Ask what yours is.
- Substitution is a known problem in the research market: sermorelin, a shorter and cheaper peptide, has been sold as tesamorelin. A certificate of analysis should show identity by mass spectrometry, not purity alone.
Reading a vial: the milligram arithmetic3
Tesamorelin doses are in milligrams, not micrograms, which makes it one of the easier peptides to draw and one of the easier to confuse with the others. A protocol written for ipamorelin in micrograms, applied to a tesamorelin vial, is off by a thousand.
units = (dose mg ÷ concentration mg/mL) × 100
A 10 mg vial reconstituted with 2 mL of bacteriostatic water is 5 mg/mL. A 2 mg dose is 0.4 mL, which is 40 units on a U-100 insulin syringe; a 1 mg dose is 20 units.
| Water added | Concentration | 1 mg | 2 mg |
|---|---|---|---|
| 1 mL | 10 mg/mL | 10 units (0.1 mL) | 20 units (0.2 mL) |
| 2 mL | 5 mg/mL | 20 units (0.2 mL) | 40 units (0.4 mL) |
| 3 mL | 3.3 mg/mL | 30 units (0.3 mL) | 60 units (0.6 mL) |
Reconstituted tesamorelin is less stable than most peptides; the older brand kit was reconstituted daily for that reason, and the 2025 formulation was engineered to last a week. A research vial in the refrigerator should be assumed to degrade within days to weeks.
Tesamorelin has a real safety record, about 800 patients over up to a year, which is more than any other growth hormone releaser can claim. It is also a record from one population, for one year, and the label is explicit that the long-term effects of raised IGF-1 are unknown.
- Common (over 5%)
- Joint pain, injection-site redness and itching, pain in the limbs, swelling of the legs and hands, muscle pain. Headache and joint pain were the usual reasons people stopped.
- Blood sugar
- Glucose intolerance is a labeled warning. Five percent of treated patients crossed into the diabetic HbA1c range by week 26, against one percent on placebo.
- Fluid retention
- Swelling, joint discomfort, and carpal tunnel syndrome, attributed to growth hormone; transient or resolving on stopping.
- IGF-1
- Rises on treatment. The label requires monitoring and says the effects of prolonged elevation are unknown. IGF-1 is a growth signal, and the label's malignancy warning follows from it.
- Do not use
- In pregnancy; with an active cancer, which should be inactive and its treatment complete first; with a disrupted pituitary axis from surgery, tumor, radiation, or head injury; with a known hypersensitivity.
- Liver
- Not a cause of liver injury in trials; liver enzymes tended to fall, consistent with the liver-fat results.
- Unknown
- Use beyond one year, use in people without HIV over the long term, use with other growth hormone releasers, and effects in adolescents.
- Athletes
- A positive test at any time; detection methods for GHRH analogs are in routine use.
- Is this the brand, a compounded copy, or a research vial? If compounded, what is the documented patient-specific reason for the copy?
- What was my baseline IGF-1 and HbA1c, and when will they be rechecked?
- What is being measured to decide whether it works: a CT or DEXA scan, a waist measurement, or nothing?
- Do I have a cancer history, diabetes or prediabetes, or a pituitary condition?
- Am I pregnant or planning to be?
- For a research vial: does the certificate of analysis confirm identity by mass spectrometry, or only purity?
- Am I subject to anti-doping rules, at work or in sport?
- The fat returns within months of stopping. What is the plan: indefinite use, or a defined course with an endpoint?
What does have evidence for visceral fat in adults without HIV
Caloric deficit with resistance training, which reduces visceral fat preferentially; and for people with obesity, the GLP-1 medicines, which reduce visceral fat and body weight with cardiovascular outcome trials behind them. Tesamorelin's own trials were run because those patients could not lose the fat any other way.
Latest
Developments since this edition, newest first. Items here are dated and sourced; they update the guide without re-editing it.
FDA enforcement now reaches sellers of 'research' tesamorelin vials
A law-firm review of the August 24 warning letters lists tesamorelin among cited products alongside GLP-1 drugs, SS-31, and PT-141, and reads the letters as FDA calibrating enforcement to each market segment rather than to weight-loss peptides alone.
Warning letters name tesamorelin vials at two online vendors
Letters to Peptide Partners and Peak Performance Peptides cite tesamorelin products as unapproved new drugs; both vendors were also cited for selling bacteriostatic water for reconstitution.
Egrifta's maker taken private by Future Pak
Theratechnologies received final court approval for its acquisition by a Future Pak affiliate at US$3.01 a share plus a contingent payment, about $254 million. Egrifta WR continues under the new owner.
References
- 1.Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2359-2370. https://www.nejm.org/doi/full/10.1056/NEJMoa072375
- 2.Falutz J, et al. Effects of tesamorelin in HIV-infected patients with excess abdominal fat: pooled analysis of two phase 3 trials. J Clin Endocrinol Metab. 2010;95(9):4291-4304. https://pubmed.ncbi.nlm.nih.gov/20554713/
- 3.EGRIFTA WR (tesamorelin for injection) prescribing information. Theratechnologies, 2025; and EGRIFTA SV prescribing information, 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- 4.Theratechnologies. FDA approval of EGRIFTA WR (tesamorelin F8), March 25, 2025; availability, September 5, 2025. https://www.globenewswire.com/news-release/2025/03/25/3049233/0/en/Theratechnologies-Receives-FDA-Approval-for-EGRIFTA-WR-Tesamorelin-F8-to-Treat-Excess-Visceral-Abdominal-Fat-in-Adults-with-HIV-and-Lipodystrophy.html
- 5.Makimura H, et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab. 2012;97(12):4769-4779.
- 6.Baker LD, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults. Arch Neurol. 2012;69(11):1420-1429.
- 7.Stanley TL, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312(4):380-389. https://pubmed.ncbi.nlm.nih.gov/25038357/
- 8.Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised trial. Lancet HIV. 2019;6(12):e821-e830. https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/abstract
- 9.U.S. Food and Drug Administration. Warning letter to Royal Peptides LLC, August 24, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026
- 10.U.S. Food and Drug Administration. Compounded drug products that are essentially copies of a commercially available drug product under section 503A. Guidance for industry, 2018.
- 11.World Anti-Doping Agency. The Prohibited List 2026: S2, growth hormone-releasing factors, including tesamorelin. https://www.wada-ama.org/en/prohibited-list
- 12.Liu H, et al. Systematic review: the safety and efficacy of growth hormone in the healthy elderly. Ann Intern Med. 2007;146(2):104-115. https://pubmed.ncbi.nlm.nih.gov/17227934/