Tesamorelin

Status Approved in the US for one indicationBest evidence E1Sources checked 2026-09-17

Tesamorelin is an approved prescription drug, and its label covers one thing: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The label states it is not indicated for weight loss management. Its European application was withdrawn after the regulator provisionally found no demonstrated clinical benefit despite the measured fat reduction.

Identity

Sequence: trans-3-hexenoyl-hGHRH(1-44)-NH2, the 44 amino acid GHRH sequence with a hexenoyl moiety on the N-terminal tyrosine
PubChem CID: 16137828

What it is

Tesamorelin is a synthetic analogue of human growth hormone releasing hormone, the full 44 amino acid sequence with a hexenoyl group attached to the first residue. That modification is there to slow degradation. It is a prescription biologic, marketed as Egrifta, and it is the only compound on this site so far with an approved label.

FDA approved it on 10 November 2010. The application has since been converted from a new drug application to a biologics licence, and the formulation has changed twice, from the original Egrifta to Egrifta SV in 2019 and Egrifta WR in 2025.

What was approved, and for whom

The indication, verbatim from the current label: a growth hormone releasing factor analogue indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

That is the whole of it. The label carries three limitations of use, also verbatim. Long-term cardiovascular safety has not been established. Not indicated for weight loss management. There are no data to support improved compliance with antiretroviral therapies. The original 2010 label was blunter on the second point, reading not indicated for weight loss management, with a parenthetical noting a weight neutral effect.

So the label does not claim weight loss, does not claim general body-composition improvement, does not claim anything about ageing, and does not claim cardiovascular benefit. There is no approved indication in any population without HIV. The population wording has narrowed over time rather than broadened: the word adult was added after 2013.

The approved dose is 1.28 mg subcutaneously once daily on the current formulation, having been 1.4 mg on the previous one and 2 mg on the original.

There is no boxed warning. The contraindications are disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity, and pregnancy. The warnings section is headed, in order, by increased risk of neoplasms, elevated IGF-1 levels, fluid retention, glucose intolerance or diabetes, hypersensitivity, injection site reactions, and increased mortality in patients with acute critical illness.

The evidence behind the approval

Two phase 3 trials, 806 patients pooled, both randomised double-blind placebo-controlled in a 2 to 1 ratio, 26 weeks with a 26 week extension, tesamorelin 2 mg subcutaneously daily. The primary endpoint was percent change in visceral adipose tissue measured by CT at the fourth and fifth lumbar vertebrae.

Study one gave a treatment difference of minus 31 square centimetres with a 95 percent confidence interval of minus 39 to minus 24, a 20 percent difference against placebo. Study two gave minus 21 square centimetres, confidence interval minus 29 to minus 12, a 12 percent difference. Waist circumference fell by about 2 centimetres more than placebo in the first and 1 centimetre in the second. Triglycerides fell 50 milligrams per decilitre against a rise of 9 on placebo. IGF-1 rose 81 percent against a 5 percent fall.

Two features of that result matter for how the compound is used off-label. Subcutaneous fat did not change, with a pooled treatment effect of minus 0.6 percent at p equals 0.08, so the drug moved visceral fat specifically and not fat generally. And the 52 week extension showed the visceral effect sustained at minus 18 percent while treatment continued.

The dose was set by a phase 2 trial in 61 patients comparing 1 mg against 2 mg against placebo. At 2 mg, trunk fat fell 9.2 percent and reached significance. At 1 mg it fell 4.6 percent and did not. Visceral fat did not reach significance against placebo in either arm of that smaller study. That is why the pivotal programme used 2 mg, and it matters for the section below.

Safety, from the label and the trials

Over the first 26 weeks, injection site reactions occurred in 25 percent of treated patients against 14 percent on placebo. Arthralgia 13 against 11 percent, myalgia 6 against 2, peripheral oedema 6 against 2. Serious treatment-emergent events in under 4 percent.

The IGF-1 numbers are the reason the label requires monitoring. Among patients treated for 26 weeks, 47 percent had IGF-1 more than two standard deviation scores above normal and 36 percent more than three, with the effect appearing as early as thirteen weeks. The label instructs prescribers to monitor IGF-1 and to consider discontinuing in patients with persistent elevations above three standard deviation scores, particularly where the response is not robust. It states directly that the effects of prolonged elevations in IGF-1 are unknown.

On glucose, elevated HbA1c at or above 6.5 percent occurred in 5 percent of treated patients against 1 percent on placebo, and the label reports an intent-to-treat hazard odds ratio for developing diabetes of 3.3 with a confidence interval of 1.4 to 9.6.

The European decision, which is the sharpest external check

An application for European marketing authorisation was withdrawn on 21 June 2012, after the committee had raised questions and received answers but with unresolved issues remaining. Per the agency withdrawal document, the committee provisional view was that the benefits of the product did not outweigh its risks.

The stated grounds are worth reading in full because they go to the heart of how tesamorelin is marketed elsewhere. Difficulty distinguishing lipodystrophy-related fat from ordinary obesity clinically. Insufficient evidence supporting the proposed patient restrictions. No demonstrated clinical health benefit despite the measured reduction in abdominal fat. Concern about raised IGF-1 as a safety issue. And absence of long-term safety data for a treatment expected to be taken long term.

Tesamorelin has no European marketing authorisation. The third of those grounds, a measured fat reduction that did not translate into demonstrated clinical benefit, is the single most useful sentence in this entry.

Regulatory status

Approved in the United States for the one indication above, under a biologics licence. Withdrawn from European consideration in the face of a negative provisional benefit-risk view. Prohibited in sport at all times, named directly in WADA section S2.2.4 among GHRH analogues alongside CJC-1293, CJC-1295 and sermorelin. And named in FDA warning letters issued on 24 August 2026 to peptide vendors, cited as an unapproved new drug introduced into interstate commerce without an approved application.

All four of those are true at once, and any account that gives only one of them is misleading.

Tesamorelin does not appear on the 503A bulk drug substances list in any category, which is not a permission. As the active ingredient of an approved drug it sits in a different statutory position from the unapproved peptides, and it is separately constrained by rules about compounding copies of commercially available drugs. No FDA document stating its 503A eligibility either way was located. Its usual blend partner, ipamorelin acetate, is in Category 2.

What is not known

What happens beyond the trial durations. The pivotal programme ran 26 weeks with a 26 week extension, and the European regulator named absence of long-term safety data for a long-term treatment as one of its concerns.

What prolonged IGF-1 elevation does. The label says directly that the effects are unknown, which is why it requires monitoring and sets a discontinuation threshold.

Whether the measured fat reduction produces a clinical health benefit. That was the European committee central objection and the US label states that long-term cardiovascular safety has not been established.

Whether it does anything in people without HIV-associated lipodystrophy. There is no approved indication in any other population.

Whether the effect persists after stopping. The extension data show it sustained while treatment continued.

How much tesamorelin is in a blend vial per injection. Blends are sold by combined peptide weight, so the per-dose amount is not determinable from the label, which makes the label-mandated IGF-1-guided dosing structurally impossible.

Doses used in published research

Amounts administered under a trial protocol. Not dosing, not a recommendation.
Trial	Population	Dose arms	Duration	What it measured
Falutz 2005 phase 2	61 adults with HIV and central fat accumulation	1 mg or 2 mg daily, subcutaneous, against placebo	12 weeks	Change in trunk fat and in visceral adipose tissue, with IGF-1 alongside
NCT00123253	412 adults with HIV-associated abdominal fat accumulation, 273 on tesamorelin and 137 on placebo	2 mg once daily, subcutaneous, against placebo, randomised 2:1	26 weeks plus a 26 week extension	Percent change in visceral adipose tissue at L4-L5 by CT at week 26
NCT00435136	404 adults with HIV-associated abdominal fat accumulation, 270 on tesamorelin and 126 on placebo	2 mg once daily, subcutaneous, against placebo, randomised 2:1	26 weeks plus a 26 week extension	Percent change in visceral adipose tissue at L4-L5 by CT at week 26

Tesamorelin has an approved dose, which makes it the only compound on this site where that sentence is true. It has changed with the formulation.

Egrifta, from 2010: 2 mg injected subcutaneously once a day. Egrifta SV, from 2019: 1.4 mg, which is 0.35 mL of the reconstituted solution, once daily. Egrifta WR, from 2025: 1.28 mg, which is 0.16 mL, once daily into the abdomen with sites rotated.

The pivotal phase 3 programme used 2 mg daily for 26 weeks with a 26 week extension. The phase 2 dose-ranging trial that set that dose compared 1 mg against 2 mg: only the 2 mg arm reached significance on trunk fat.

The label attaches monitoring to the dose. Glucose status is assessed before starting and periodically after, and IGF-1 is monitored with discontinuation considered above three standard deviation scores. A dose without that monitoring is not the approved regimen.

Compiled from: Falutz 2005, AIDS; EGRIFTA prescribing information

An approved dose exists for the labelled indication above. No dose has been established as safe or effective for any use outside that label.

Amounts above record what a named source reported administering in a study. They are not a recommendation, not a protocol, and not instructions.

Converting a vial and a syringe into a draw volume is a separate, mechanical question from what amount to use. The reconstitution calculator does that arithmetic for peptide, HCG, and HGH vials.

What circulates E5

Figures reported online. Not dosing, not verified, not endorsed.
Reported use	Route	Amount reported	Frequency	Reported length
Body composition, off-label	Subcutaneous	1 mg	Once daily, evening	Not specified
With ipamorelin, as a blend	Subcutaneous	Not determinable from the vial	Once daily	Not specified

Tesamorelin circulates as lyophilised powder in vials commonly labelled 2, 5 and 10 mg under research use framing. The route is subcutaneous, the frequency is once daily, the timing is evening on a stated rationale about nocturnal growth hormone, and the dominant single-agent figure is 1 mg a day.

That figure is below every dose ever approved. It is 50 percent of the original 2 mg, about 71 percent of the 1.4 mg formulation and about 78 percent of the current 1.28 mg. For most compounds on this site the circulating figure exceeds anything studied. Here it is lower, and that is not reassuring, because 1 mg is specifically the dose that failed to separate from placebo on visceral and trunk fat in the phase 2 trial that selected 2 mg for the pivotal programme. It is a real dose from the record, attached to the wrong endpoint.

Circulating material states no cycle length, no total duration, no stopping rule and no monitoring interval. That absence is itself the finding, because the approved product requires glucose assessment before starting and IGF-1 monitoring with a discontinuation threshold.

Blends make the monitoring impossible rather than merely absent. Tesamorelin is most often mixed with ipamorelin and sold by combined total peptide weight, commonly around 9, 13 or 15 mg, at ratios in the region of 2 to 1 up to 4 to 1. Because the vial is labelled by combined weight, how much tesamorelin a single injection delivers cannot be worked out from the vial at all, so the dose cannot be compared to the approved one and cannot be adjusted against an IGF-1 result.

On citation, the answer is nothing. Across the material surveyed there is no reference to the label, no NCT number, no journal reference, and no mention of the HIV-lipodystrophy-only indication, the not-indicated-for-weight-loss limitation, the active-malignancy contraindication, the IGF-1 monitoring requirement or the diabetes hazard odds ratio of 3.3. Meanwhile the framing centres weight loss, abdominal spot reduction, muscle gain and anti-ageing, which is close to an inversion of what the label says.

Recorded as an observation about what is published elsewhere. No figure here is a dose, a protocol, or a recommendation, and nothing in this section is evidence that any amount is safe or effective.