Tesamorelin: The Only GHRH Analogue Still Approved — and the Cancer Study That Stopped Halfway

Tesamorelin is an FDA-approved drug that removes visceral fat, and its label carries active malignancy as a contraindication. To monitor that risk, FDA required a 10-year post-marketing cohort study tracking time to development of malignancies against an unexposed control group. That study, NCT01579695, enrolled 391 patients, ran from February 2013 to August 2018, and is listed as terminated — roughly five and a half years into ten, with no reason given in the record.

The efficacy is real: 15.2% visceral fat reduction against a 5.0% gain on placebo in 412 patients. So is what happens when you stop — visceral fat came back at +22% and +16% in the two extension studies.

For dose calculations from the current 11.6 mg multi-dose vial, use the tesamorelin calculator — the reconstitution math changed in 2025 and most online guidance still describes the old presentation.

What is tesamorelin, and how does it differ from sermorelin and CJC-1295?

Tesamorelin is a 44-amino-acid analogue of human growth hormone-releasing hormone (MW 5,136 Da, CAS 218949-48-5), modified by a trans-3-hexenoyl group on the N-terminal tyrosine and amidated at the C-terminus. That single acylation is what protects it from dipeptidyl peptidase-4 degradation. Its plasma half-life is 11 minutes in healthy subjects. It was approved on 10 November 2010 under BLA 022505, sponsored by Theratechnologies, and developed under the code TH9507.

The sequence is YADAIFTNSYRKVLGQLSARKLLQDIMSRQQGESNQERGARARL — the full GHRH(1-44), not a fragment. PubChem indexes it under CID 16137828 and, revealingly, under the systematic synonym "(3E)-hex-3-enoylsomatoliberin."

That full-length structure is the practical difference from the other GHRH products sold in this market, and the three get conflated constantly.

A 1,778 dalton gap separates tesamorelin from sermorelin. That is not a subtle analytical problem — any mass spectrometry run distinguishes them instantly, and no HPLC purity figure does. A vial sold as tesamorelin that measures around 3,400 Da is sermorelin.

One database caution: PubChem's CJC-1295 record has had both "CJC1295 With DAC" and "CJC1295 Without DAC" listed as synonyms and subsequently removed them. Treat that record as the DAC form only. See mass spectrometry for peptides and our growth hormone peptide category.

What is tesamorelin actually approved for?

Tesamorelin is approved for one indication in one population: FDA's wording is that it is "a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." That is the entire approved scope, unchanged since November 2010. It is not approved for obesity, not for general body recomposition, and not for anti-aging — and the label says so directly rather than leaving it to inference.

The Limitations of Use section is unusually explicit, and worth reading verbatim:

"Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV."

Note the precise claim: weight neutral. Tesamorelin redistributes fat away from the visceral compartment; it does not reduce body weight. Anyone buying it expecting a number on a scale to move is buying it for something the manufacturer's own label rules out.

One application, three presentations. EGRIFTA, EGRIFTA SV and EGRIFTA WR are not separate approvals — all three are BLA 022505, and all three labels read "Initial U.S. Approval: 2010." The changes came through supplements: SUPPL-10 (formulation, March 2019), SUPPL-12 (renamed EGRIFTA SV, July 2019) and SUPPL-20 (renamed EGRIFTA WR, 25 March 2025).

The 2025 change did two things at once: it moved to a seven-dose vial reconstituted weekly, and it lowered the daily dose from 1.4 mg to 1.28 mg. Most dosing guidance in circulation still describes the 2 mg or 1.4 mg presentations. If you are working from the current product, the tesamorelin calculator handles the 8 mg/mL concentration; see also reconstituting peptides step by step.

How much visceral fat does tesamorelin actually remove?

Tesamorelin reduced visceral adipose tissue by 15.2% against a 5.0% increase on placebo over 26 weeks in a 412-patient randomised trial, measured by CT at the L4-L5 level (P<0.001). A pooled analysis of 806 patients across both pivotal trials found a treatment effect of −15.4%, with visceral fat falling 24 ± 41 cm² on tesamorelin and rising 2 ± 35 cm² on placebo. IGF-1 rose 81% in the first trial. These are human randomised controlled trial data — the strongest evidence tier on this platform.

A discrepancy worth naming, because both numbers are legitimate. FDA's label reports the same two trials as −18% versus +2% (treatment difference −20%) and −14% versus −2% (difference −12%). The published abstracts report −15.2% and −10.9%. These are different analysis populations of the same data, not contradictory findings. Cite one source per figure and say which — mixing them produces numbers that appear nowhere.

The lead investigator on the pivotal programme was Julian Falutz of McGill University Health Centre, working alongside Steven Grinspoon at Massachusetts General Hospital, whose group produced most of the subsequent non-HIV work.

What happens when you stop?

Visceral fat returns. In the extension phases of both pivotal trials, patients switched from tesamorelin to placebo regained 25 cm² (+22%) and 24 cm² (+16%) of visceral adipose tissue — recovering most of what the first 26 weeks removed. The JAIDS authors put it plainly: the benefit was "rapidly lost in those switching from tesamorelin to placebo." No maintenance effect, no durable remodelling, no residual benefit after discontinuation has been demonstrated in any published trial.

That single finding reframes what tesamorelin is. It is not a course of treatment that resolves a problem. It is indefinite therapy — the fat comes back when the daily injections stop, and the label's own instruction to "consider risk/benefit of continuation of treatment" only makes sense in that context.

For a compound whose warnings include neoplasm risk and elevated IGF-1, indefinite is a meaningful word. The safety questions in the next section are not questions about a 26-week exposure.

What the label warns about, and the safety study that was terminated

Tesamorelin's label carries four contraindications and seven warnings, and the most consequential is that active malignancy is an absolute contraindication — not a caution. Warning 5.1 covers increased risk of neoplasms and instructs prescribers to "discontinue EGRIFTA WR if there is any evidence of recurrent malignancy." Warning 5.2 requires IGF-1 monitoring throughout therapy. Warning 5.4 reports an intent-to-treat hazard odds ratio of 3.3 (95% CI 1.4, 9.6) for developing diabetes.

Contraindications: disruption of the hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumour or surgery, head irradiation, head trauma); active malignancy; known hypersensitivity; and pregnancy — where the label's reasoning is that "modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm."

What the trials recorded, across 543 tesamorelin and 263 placebo patients over 26 weeks:

Nearly half of patients exceeded two standard deviations of normal IGF-1 by six months, and more than a third exceeded three. Those figures fall to 34% and 23% by 52 weeks, but they are the reason IGF-1 monitoring is a labelled requirement rather than a suggestion — and the reason a compound with a neoplasm warning is dosed under supervision.

Now the part that is not in any competitor's coverage.

NCT01579695 was a Phase 4, observational, multicentre, 10-year prospective cohort safety study. Its primary outcome, in the registry's own words: "Time to development of malignancies … exposed to EGRIFTA® vs. concurrent, comparable control group not exposed."

It enrolled 391 patients. It ran from February 2013 to August 2018 — approximately five and a half years of a planned ten. Its status is terminated. No reason for termination appears in the record.

Two other post-marketing studies also stopped early: NCT01591902, a Phase 4 study of diabetic retinopathy in patients treated with EGRIFTA (n=129, terminated), and NCT01388920, a Phase 2 study in COPD muscle wasting (n=3, terminated).

We are not asserting why the malignancy study ended. Post-marketing commitments terminate for many reasons — enrolment, funding, sponsor changes, or a decision that the question had been answered. What is verifiable is that the long-term cancer surveillance study for a drug with an active-malignancy contraindication did not run to term, that no published result replaced it, and that the label still states long-term cardiovascular safety "has not been established" sixteen years after approval.

Does tesamorelin work outside HIV?

Yes, in small trials — and the strongest non-HIV result has never been published. In 60 non-HIV adults with obesity and reduced growth hormone secretion, tesamorelin 2 mg daily for 12 months reduced visceral fat by 35 cm² relative to placebo (95% CI −58 to −12, P=0.003) and reduced carotid intima-media thickness by 0.04 mm (P=0.02). That is a randomised, double-blind, placebo-controlled trial in exactly the population that buys tesamorelin off-label, and it is roughly one-seventh the size of the HIV programme.

Liver fat is where the more interesting signal sits.

Stanley et al., Lancet HIV 2019 (PMID 31611038) randomised 61 people with HIV and NAFLD to tesamorelin 2 mg daily or placebo for 12 months. Hepatic fat fraction fell by an absolute 4.1 percentage points (95% CI −7.6 to −0.7, p=0.018) — a relative reduction of 37% (95% CI −67 to −7, p=0.016). An earlier JAMA 2014 trial (PMID 25038357) in 50 patients found visceral fat down 34 cm² (95% CI −53 to −15) and liver fat down a median 2.0 percentage points versus a 0.9-point rise on placebo (P=.003).

And there is a completed non-HIV trial that exists only as registry data. NCT03375788, run at Massachusetts General Hospital as a Phase 2 study of "Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk," enrolled 51 participants with NAFLD and obesity — HIV status neither an inclusion nor an exclusion criterion. It completed in January 2025. Its posted results: tesamorelin (n=18) median hepatic fat fraction change −5.3% versus placebo (n=16) +3.6%. No publication is linked to the record.

That is a real result in the population that matters most for the MASLD question, sitting unpublished in a registry — and it should be cited as registry-posted data, not as a paper. Compare survodutide, whose phase 2 MASH trial produced histological endpoints in 293 patients.

Two other non-HIV strands, both worth knowing:

Cognition. Baker et al., Archives of Neurology 2012 (PMID 22869065) randomised 152 adults with mild cognitive impairment or healthy ageing to 1 mg daily for 20 weeks plus a 10-week washout, and reported a favourable effect on cognition (intent-to-treat P=.03, completer analysis P=.002, executive function P=.005). The paper describes the agent as "growth hormone-releasing hormone" throughout — the tesamorelin identification comes from the trial registry, NCT00257712. Cite it that way rather than silently substituting the drug name.

Glycaemic safety. A PLoS One 2017 trial (PMID 28617838) in 53 patients with type 2 diabetes found that 12 weeks of tesamorelin "did not alter insulin response or glycemic control," with total cholesterol and non-HDL each down 0.3 mmol/L at the 2 mg dose (p<0.05). Reassuring at 12 weeks; not a statement about the 5%-versus-1% diabetes incidence seen over 26 weeks in the pivotal programme.

How do you verify tesamorelin you did not get from a pharmacy?

Tesamorelin is verifiable by mass spectrometry more cleanly than most peptides on this platform, because at 5,136 Da it sits 1,778 daltons above sermorelin and 1,489 above CJC-1295 with DAC. Those gaps are unmissable on a mass spectrum and invisible on an HPLC purity certificate. The Purity Index records tesamorelin at 99.41% average HPLC purity across 497 independent tests from Bioviridian, Kovera, ILS and Freedom Diagnostics, across 227 verified vendors (verified August 2026).

Peptigrity's platform currently tracks 530 shops and 11,852 independent lab tests across 118 peptides, with 1,283 community reviews (verified 11 August 2026). Trust scores weight community reviews and independently verified HPLC purity equally, at 50% each, with no financial relationships influencing the ranking — the methodology is documented at how we calculate trust scores.

Two flags in the tesamorelin data. One vendor's sample tested 23.6% above labelled quantity, and endotoxin results are absent from most entries. On a compound titrated to 1.28 mg daily, a 23.6% overage is a real dosing error.

Tesamorelin price data shows 60 shops in stock, median $7.00/mg, lowest $3.50/mg on a 20 mg vial, across 73 comparable offers ranging to $22.00/mg (verified 8 August 2026). Vial size drives most of that: 2–5 mg vials run a median $10.00/mg against $7.00/mg for 10–20 mg. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing.

On the compounding question: tesamorelin appears on neither of FDA's bulk substances tables — not the 14-substance active Category 2 list, and not the 17-substance "nominated but withdrawn" table (page current 22 April 2026). Because tesamorelin is a component of a currently marketed FDA-approved drug, it satisfies one of the three statutory routes under 21 U.S.C. § 353a(b)(1)(A), which is a legal pathway for a licensed pharmacy compounding for a named patient — not an endorsement, and not applicable to a research vial. See compounding pharmacy versus research peptide and where to buy tesamorelin: purity and identity checks.

On sport: WADA's 2026 Prohibited List names tesamorelin explicitly at S2.2.4 — "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)." Prohibited at all times, non-specified.

The trial that would settle this

Frequently Asked Questions

What is tesamorelin approved for?

One indication only: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy, under BLA 022505, approved 10 November 2010. The label's Limitations of Use state explicitly that it "is not indicated for weight loss management as it has a weight neutral effect."

How much visceral fat does it remove?

In the pivotal 412-patient trial, 15.2% reduction versus a 5.0% increase on placebo over 26 weeks. A pooled analysis of 806 patients found a treatment effect of −15.4%. FDA's own label reports the same trials as −18% and −14% using different analysis populations — both figures are legitimate, and they should not be mixed.

Does the fat come back if I stop?

Yes. In the extension phases of both pivotal trials, patients switched to placebo regained 25 cm² (+22%) and 24 cm² (+16%) of visceral fat. The published description is that the benefit was "rapidly lost." Tesamorelin functions as indefinite therapy, not a course of treatment.

What are the main safety concerns?

Active malignancy is a contraindication, not a caution, and the label carries a neoplasm warning. IGF-1 exceeded two standard deviations of normal in 47% of patients at 26 weeks. The diabetes hazard odds ratio was 3.3 (95% CI 1.4, 9.6), with HbA1c ≥6.5% in 5% versus 1% on placebo. Injection site reactions occurred in 25%.

Does tesamorelin work for people without HIV?

The evidence is small but real. A 60-person randomised trial in non-HIV obesity with reduced GH secretion found visceral fat down 35 cm² relative to placebo (P=0.003) and carotid intima-media thickness down 0.04 mm (P=0.02) over 12 months. A completed 51-person MASLD trial at Massachusetts General Hospital reported a median hepatic fat fraction change of −5.3% versus +3.6% on placebo, but that result exists only as registry-posted data with no publication.

What changed with EGRIFTA WR?

Two things, in March 2025. The presentation moved to an 11.6 mg multi-dose vial reconstituted with 1.3 mL of bacteriostatic water and discarded after seven days, and the daily dose dropped from 1.4 mg to 1.28 mg. Most dosing guidance still describes the older 2 mg or 1.4 mg presentations.

Where this sits

Tesamorelin is the strongest compound in the growth hormone category, and the honest reading of its file is narrower than either its supporters or its critics tend to allow. It works: 806 patients in randomised trials, a consistent 15% visceral fat reduction, an FDA approval that has held since 2010. What travels less often is that the fat returns at +22% on withdrawal, that IGF-1 exceeds two standard deviations in 47% of patients, and that the ten-year malignancy study stopped at year five.

It works. Eight hundred and six patients in randomised trials, a consistent 15% visceral fat reduction, an FDA approval that has held for sixteen years and a product still on pharmacy shelves — that is a real drug with real data, and nothing else in this category comes close.

What the file also contains is a set of facts that rarely travel with it. The fat comes back at +22% when you stop, so this is indefinite therapy. Half of patients push IGF-1 past two standard deviations. The diabetes hazard ratio is 3.3. Active cancer is a hard contraindication. The ten-year study designed to watch for malignancy over exactly the timeframe indefinite therapy implies stopped at year five and a half. And the label still says long-term cardiovascular safety has not been established.

None of that makes tesamorelin a bad drug for the patients it was approved for, who have a specific condition and a prescriber watching their IGF-1. It makes it a poorly characterised long-term exposure for everyone else — which is most of the sixty shops selling it at seven dollars a milligram.

Browse the growth hormone peptides category, or our complete peptide guide with 118 compounds (verified August 2026). For the 11.6 mg vial math, use the tesamorelin calculator alongside the reconstitution calculator. Compare shops through independent lab tests and community-verified shop reviews.

This article is for educational and informational purposes only and does not constitute medical advice. Peptides discussed may be investigational compounds not approved by the FDA (or equivalent regulators in your jurisdiction) for human use. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.