Tesamorelin
Tesamorelin is a lab-made analogue of growth hormone-releasing factor[1]. It is the active ingredient in the US-approved Egrifta products[1]. For tesamorelin dosage per day, the current WR label reports 1.28 mg[1]. The SV label reports 1.4 mg[8]. The pivotal trials used 2 mg[2]. At 26 weeks, pooled phase 3 trials in 806 adults found a 15.4% visceral-fat treatment effect[2]. The label lists injection-site reactions, joint pain, and other adverse effects[1]. It says long-term cardiovascular safety has not been established[1]. No head-to-head clinical trial with ipamorelin appeared in the exact search below[9].
What is Tesamorelin?
The label says tesamorelin binds human GRF receptors[1]. It stimulates growth hormone release[1]. The label also reports increased IGF-1 and IGFBP-3[1].
What has been published in humans?
Human trials exist. The key studies used CT scans to track deep belly fat in adults with HIV. That fat sits around the organs. It is not the same as fat under the skin. A later trial paid for with public funds looked at liver fat in adults with HIV.
| Source | People and design | What the study found | Limit and funding | Checked |
|---|---|---|---|---|
| Study 1, PMID 18057338[3] | The trial randomized 412 adults for 26 weeks. | Mean visceral fat changed by -15.2% with tesamorelin and +5.0% with placebo. | The result applies to adults with HIV and treatment-associated abdominal fat. The abstract names no funder. NCT00123253 names Theratechnologies as lead sponsor[17]. | 2026-09-02 |
| Study 2, PMID 20101189[4] | The trial randomized 404 adults and followed its extension to 12 months. | Mean visceral fat changed by -10.9% with tesamorelin and -0.6% with placebo at 6 months. | The abstract names no funder. The pivotal programme records name Theratechnologies as lead sponsor[18]. | 2026-09-02 |
| Pooled phase 3 analysis, PMID 20554713[2] | The analysis pooled 806 adults from the two trials. | The visceral-fat treatment effect was -15.4% at 26 weeks. | The abstract names no funder. The programme registry records name Theratechnologies as lead sponsor[17]. | 2026-09-02 |
| HIV and fatty-liver trial, PMID 31611038[5] | The trial enrolled 61 adults. Thirty received tesamorelin and 30 received placebo for 12 months. | The relative liver-fat reduction versus placebo was 37% (95% CI 7% to 67%). | The study population had HIV and at least 5% liver fat. The NIH and NIAID funded the study. | 2026-09-02 |
The current US label gives its own view of the key results[1]. In Study 1, deep belly fat fell 18% with the drug and rose 2% with placebo. The gap was -20% (95% CI -24% to -15%). In Study 2, deep belly fat fell 14% with the drug and 2% with placebo. The gap was -12% (95% CI -16% to -7%). The label and papers use two ways to sum up the same trials. Their values stay in their own source frames.
The pooled paper also found changes in blood fats and body-image scores at week 26. Each result stays in the table with its test and time point.
| PMID 20554713 outcome[2] | Tesamorelin | Placebo | Reported comparison | Checked |
|---|---|---|---|---|
| Visceral-fat area | -24 ± 41 cm² | +2 ± 35 cm² | Treatment effect -15.4%; p<0.001 | 2026-09-02 |
| Triglycerides | -37 ± 139 mg/dL | +6 ± 112 mg/dL | Treatment effect -12.3%; p<0.001 | 2026-09-02 |
| Total-cholesterol-to-HDL ratio | -0.18 ± 1.00 | +0.18 ± 0.94 | Treatment effect -7.2%; p<0.001 | 2026-09-02 |
| Belly-appearance distress | Improved | Comparator | p=0.002 | 2026-09-02 |
| Patient-rated belly profile | Improved | Comparator | p=0.003 | 2026-09-02 |
| Physician-rated belly profile | Improved | Comparator | p<0.001 | 2026-09-02 |
| Glucose measures | No clinically meaningful group difference | No clinically meaningful group difference | Weeks 26 and 52 | 2026-09-02 |
The pooled follow-up kept the deep-fat loss through week 52[2]. The mean change for those who stayed on the drug was -17.5% ± 23.3%. The Study 2 paper called the kept change about -18%[4]. Deep belly fat came back when people switched to placebo[4].
How does Tesamorelin compare with Ipamorelin?
No published trial in the exact PubMed search compared the pair. The search used both names and trial-only filters. It returned zero records on 2 September 2026[9]. An exact search of trial records also returned no study rows[10].
The two sets of tests asked unlike questions. The phase 3 work on this drug tracked deep belly fat in adults with HIV[2]. The human ipamorelin paper tracked drug levels and growth-hormone release in healthy men[11]. It did not track deep belly fat. Studies run on their own cannot show that one drug is better. They also cannot show that the pair works better.
An open forum thread has first-hand posts about the pair. Those posts appear below as user reports. They are not a head-to-head test.
What side effects and safety findings were recorded?
The current Egrifta label joins the first 26 weeks of both key studies[1]. Its table lists events seen in at least 1% of the drug group and more often than with placebo. The groups had 543 people on the drug and 263 on placebo. These rates show what took place in the trial groups. They do not predict what one person will feel.
| BLA022505 label event[1] | Tesamorelin | Placebo | Checked |
|---|---|---|---|
| Injection-site reaction | 17% | 6% | 2026-09-02 |
| Joint pain | 13% | 11% | 2026-09-02 |
| Pain in an extremity | 6% | 5% | 2026-09-02 |
| Muscle pain | 6% | 2% | 2026-09-02 |
| Peripheral edema | 6% | 2% | 2026-09-02 |
| Tingling sensation | 5% | 2% | 2026-09-02 |
| Reduced skin sensation | 4% | 2% | 2026-09-02 |
| Rash | 4% | 2% | 2026-09-02 |
| Indigestion | 2% | 1% | 2026-09-02 |
| Musculoskeletal pain | 2% | 1% | 2026-09-02 |
| Pain | 2% | 1% | 2026-09-02 |
| Itching | 2% | 1% | 2026-09-02 |
| Vomiting | 3% | 0% | 2026-09-02 |
| Musculoskeletal stiffness | 2% | 0% | 2026-09-02 |
| Increased blood creatine phosphokinase | 1% | 0% | 2026-09-02 |
| Carpal tunnel syndrome | 1% | 0% | 2026-09-02 |
| Joint swelling | 1% | 0% | 2026-09-02 |
| Muscle strain | 1% | 0% | 2026-09-02 |
| Night sweats | 1% | 0% | 2026-09-02 |
| Palpitations | 1% | 0% | 2026-09-02 |
The same label gives more test results and known gaps.
| BLA022505 label finding[1] | Result | Checked |
|---|---|---|
| Injection-site reactions in the broader warning section | Tesamorelin 25%; placebo 14% | 2026-09-02 |
| Hypersensitivity reactions | 4% with tesamorelin | 2026-09-02 |
| IGF-1 above two standard-deviation scores | 47% at week 26; 34% at week 52 | 2026-09-02 |
| IGF-1 above three standard-deviation scores | 36% at week 26; 23% at week 52 | 2026-09-02 |
| Newly elevated HbA1c | Tesamorelin 5%; placebo 1%; hazard odds ratio 3.3 (CI 1.4 to 9.6) | 2026-09-02 |
| Anti-tesamorelin IgG antibodies | 50% at week 26; 47% at week 52 | 2026-09-02 |
| Cross-reactivity with endogenous GHRH among antibody-positive participants | About 60% | 2026-09-02 |
| In-vitro neutralizing antibodies at week 52 | Tesamorelin 10%; human GHRH 5% | 2026-09-02 |
| Effect of prolonged IGF-1 elevation | Unknown in the label | 2026-09-02 |
| Other label warnings or limits | Fluid retention; active malignancy; pregnancy; long-term cardiovascular safety not established | 2026-09-02 |
The public-fund liver trial found more local site complaints with the drug[5]. None was judged serious. At 12 months, the two groups did not differ in fasted blood sugar or HbA1c.
What dosage information do sources report for Tesamorelin?
The sources do not all use the same amount. Each row says who gave the amount and why. A vial size is not the same as the amount used each day. This table reports source facts. It does not pick a dose for the reader.
| Source | Reported amount | Source type and meaning | Checked |
|---|---|---|---|
| Egrifta WR label, BLA022505[1] | The label reports 1.28 mg once daily for its 11.6 mg-per-vial formulation. | Current approved-product label. It applies to Egrifta WR. | 2026-09-02 |
| Egrifta SV label, BLA022505[8] | The label reports 1.4 mg once daily for its 2 mg-per-vial formulation. | Current approved-product label. It applies to Egrifta SV. | 2026-09-02 |
| Pooled phase 3 trials, PMID 20554713[2] | The trials used 2 mg once daily for 26 weeks. | Research method in adults with HIV and excess abdominal fat. | 2026-09-02 |
| Fatty-liver trial, PMID 31611038[5] | The trial used 2 mg once daily for 12 months. | Research method in adults with HIV and at least 5% liver fat. | 2026-09-02 |
The current WR label says Egrifta WR and Egrifta SV cannot be swapped[1]. The table keeps their amounts apart. It does not turn either label into a plan for a product from some other source.
What do animal and laboratory studies add?
| Source | Finding | Limit and funding note | Checked |
|---|---|---|---|
| Egrifta WR label, BLA022505[1] | In vitro, tesamorelin bound and stimulated human GRF receptors with potency similar to endogenous GRF. | This is a receptor result. A US product label has no trial-funder disclosure for this assay. | 2026-09-02 |
| Egrifta WR label, BLA022505[1] | A test battery found no mutagenic potential in bacteria, mammalian cells, or mouse bone-marrow cells. | The label reports laboratory and animal tests, not a human outcome. | 2026-09-02 |
| Egrifta WR label, BLA022505[1] | Tesamorelin acetate did not affect rat fertility at up to 0.6 mg/kg. | The label describes approximately clinical exposure. Males were studied for 28 days and females for 14 days. | 2026-09-02 |
| Egrifta WR label, BLA022505[1] | Lifetime rodent carcinogenicity studies have not been conducted. | This is an explicit evidence absence in the current label. | 2026-09-02 |
The human trials give the best direct answer on deep belly fat. The lab and rat work answer much more narrow points. They show how the drug can act and what the product record did not test.
What has direct vial or product testing found?
A vial test can check a name, an amount, or a purity score. Each result has a small scope. It does not tell us what is in a vial that was not tested. It also cannot show that a vial was sterile when no such test was run.
| Source | What was measured | What was not measured | Funder note | Checked |
|---|---|---|---|---|
| Mendias and Awan preprint[12] | The authors reported 11 identity failures among reports labelled tesamorelin. The paper reports a 3.6% identity-failure rate. | The text does not print the full tesamorelin identity denominator beside the count. | No external funding; no declared conflicts. | 2026-09-02 |
| Mendias and Awan preprint[12] | Figure 5 labels the tesamorelin amount-and-purity panel N=111. | That panel label is not the denominator for the 11 identity failures. | No external funding; no declared conflicts. | 2026-09-02 |
| Mendias and Awan preprint[12] | The full analytic cohort had 6,285 amount-and-purity reports. The endotoxin subset had 243 reports. | The text gives no tesamorelin-only endotoxin result. The submissions were voluntary and self-selected. | No external funding; no declared conflicts. | 2026-09-02 |
These vial results do not cover approved Egrifta goods. The vial-testing guide keeps the name, amount, purity, endotoxin, and sterile-use tests apart. The sterility guide shows what a purity score cannot prove.
What do user reports add?
User posts tell us what one person saw and felt. They are self-reported and self-picked. The open Reddit thread names no sponsor or pay. It shows no lab report for the named goods. The full thread stays linked, so the posts can be read in their own frame.
Knicco described body and waist changes while also saying that tesamorelin was not used alone[13]:
Noticed fat loss overall bf(%). But not directly on top of abs only. Like another poster mentioned, I noticed the biggest difference in waistline. I went from almost a size 32 to 29. I assumed the decrease in visceral fat overall caused my “insides” to be less bulky, therefore my overall midsection reduced. Not sure if the theory is true or not. But the 32 to 29 waistline is definitely real and not exaggerated. O.. and I did not run tesa alone. I stacked it.
Ipa in the morning, tesa at night 5/2 for 6 weeks.
In a later reply, the same user separated personal observations from certainty:
Anecdotally, I noticed benefits of a reduced waistline, lower blood pressure, better sleep and recovery scores, vascularity increased, and reduction in body fat % overall. From blood test results, cholesterol came down several points. I wish I had more hard data to share.
space_wiener reported a different experience in the same thread:
I used it for about 10 weeks before stopping for a surgery. It made me waaaay hungrier. I was pr’ing a lot in the gym, diet and exercise routine did change. By the end I was up about 4-5 points. Visually I didn’t lose any weight at all.
These are two people's accounts. They are not a count of what most people feel. The pair, other life changes, and unknown vial contents make cause hard to pin down.
What is the current evidence status, and what is the regulatory status?
A trial result, a drug approval, and a vial test are not the same fact. The table keeps each one in its own row.
| Question | Current answer | Source and limit | Checked |
|---|---|---|---|
| Evidence tier | Tier A | Egrifta has a named US approval[7]. Two phase 3 trials report human visceral-fat outcomes[2]. | 2026-09-02 |
| US status | Approved prescription product | Drugs@FDA records BLA022505, Egrifta, Theratechnologies, and original approval on 10 November 2010[7]. | 2026-09-02 |
| US indication | Reduction of excess abdominal fat in adults with HIV and lipodystrophy | The label says Egrifta is not indicated for weight-loss management[1]. | 2026-09-02 |
| Central EU status | unclear | The EMA records that the Egrifta application was withdrawn in June 2012[14]. A withdrawn central application does not answer every national route. | 2026-09-02 |
| Germany register flag | doping_classified | The DmMV 2023 annex names Tesamorelin under growth hormone-releasing factors[15]. This is separate from approval and evidence tier. | 2026-09-02 |
| Sweden register flag | unclear | The product file dated 1 September 2026 had 38,414 rows and no Tesamorelin or Egrifta row[16]. Positive controls were semaglutide 44, tirzepatide 18, somatropin 132, afamelanotide 1, and mecasermin 1. This file result does not classify another represented product. | 2026-09-02 |
| Pivotal registry records | Completed | NCT00123253 lists 412 participants and Theratechnologies as lead sponsor[17]. NCT00608023 lists 263 participants and the same sponsor[18]. | 2026-09-02 |
| Registry discrepancy | Unresolved identifier alias | The current ClinicalTrials.gov API resolves NCT00435136 to NCT00123253, which lists 412 participants[17]. The US label and PMID 20101189 report 404 participants for Study 2[4]. This page keeps 404 for that published result. | 2026-09-02 |
| Controlled comparison with ipamorelin | No direct human trial found | Exact PubMed and ClinicalTrials.gov searches returned zero matching clinical-trial records[9]. | 2026-09-02 |
| Direct vial evidence | A preprint reports tesamorelin identity failures[12]. | The reports were voluntary submissions. The manuscript has not been peer reviewed. | 2026-09-02 |
The register stores first_observed: 2010-11. That month comes from the US drug approval[7]. It does not say when grey-market use began.
FAQ
Is Tesamorelin a steroid?
No. It is a 44-amino-acid growth hormone-releasing factor analogue[1]. It helps the body release growth hormone. It is not a steroid.
How long is Tesamorelin's half-life?
The Egrifta WR label gives a mean half-life of 11 minutes after one 1.28 mg dose in healthy adults[1]. That drug-level fact does not say how long a change in body fat will last.
Is an Egrifta pen the approved product?
Current DailyMed records show Egrifta WR and Egrifta SV as drug kits with vials[1]. The cited labels do not show an approved pen.
See also
- Ipamorelin register record - the separate human GH-release evidence discussed in the comparison section.
- CJC-1295 register record - evidence for another GHRH-related compound without treating it as interchangeable.
- Vial-testing guide - separate identity, amount, purity, endotoxin, and sterility findings.
- Sterility guide - the sterile-use question that chemical purity does not answer.
- All compounds in the register - the evidence and regulatory fields for every listed compound.
References
- ↑ a b c d e f g h i j k l m n o p q r s t u v w x Theratechnologies Inc. Egrifta WR prescribing information. DailyMed, revised 2025. BLA022505. Used for identity, indication, mechanism, pivotal results, safety, product amount, pharmacokinetics, nonhuman findings, and explicit unknowns; checked 2026-09-02.
- ↑ a b c d e f g h i Falutz J et al. Pooled analysis of two phase 3 trials. J Clin Endocrinol Metab, 2010. PMID 20554713. DOI 10.1210/jc.2010-0490. Used for population, design, amount, visceral-fat, lipid, body-image, glucose, and extension findings. The PubMed abstract names no funder; programme records name Theratechnologies as sponsor. Checked 2026-09-02.
- ↑ Falutz J et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med, 2007. PMID 18057338. DOI 10.1056/NEJMoa072375. Used for Study 1 population, duration, visceral-fat, and lipid results. The PubMed abstract names no funder; NCT00123253 names Theratechnologies as sponsor. Checked 2026-09-02.
- ↑ a b c d Falutz J et al. Tesamorelin in adults with HIV and abdominal fat accumulation. J Acquir Immune Defic Syndr, 2010;53(3):311-322. PMID 20101189. DOI 10.1097/QAI.0b013e3181cbdaff. Used for Study 2 population, six-month result, extension result, and registry discrepancy. The PubMed abstract names no funder; programme records name Theratechnologies as sponsor. Checked 2026-09-05.
- ↑ a b c Stanley TL et al. Tesamorelin in HIV-associated fatty liver disease. Lancet HIV, 2019. PMID 31611038. NCT02196831. Used for population, trial amount, liver-fat result, glucose result, injection-site findings, and limits. Funded by NIH and NIAID. Checked 2026-09-02.
- ↑ a b c d e NCATS GSRS. Tesamorelin substance record. GSRS. UNII MQG94M5EEO. Used for display name, aliases, development codes, sequence, CAS, and UNII. Checked 2026-09-02.
- ↑ a b c d e f United States FDA. Egrifta application record. Drugs@FDA via openFDA. BLA022505. Used for sponsor, brand, active ingredient, prescription status, and original approval date. Checked 2026-09-02.
- ↑ a b Theratechnologies Inc. Egrifta SV prescribing information. DailyMed, revised 2024. BLA022505. Used for the source-reported Egrifta SV amount and formulation. Checked 2026-09-02.
- ↑ a b c National Library of Medicine. Exact PubMed clinical-trial search for tesamorelin and ipamorelin. PubMed. Used for the zero-result head-to-head clinical-trial search. Checked 2026-09-02.
- ↑ National Library of Medicine. Exact ClinicalTrials.gov intervention search. ClinicalTrials.gov API. Used for the empty study-list result from the registered-combination search. Checked 2026-09-02.
- ↑ Gobburu JV et al. Ipamorelin pharmacokinetic and pharmacodynamic study. Pharm Res, 1999. PMID 10496658. DOI 10.1023/a:1018955126402. Used only to describe the separate human ipamorelin study question. The PubMed record names no funder. Checked 2026-09-02.
- ↑ a b c d Mendias CL, Awan TM. Research-grade peptide testing preprint. Preprints.org, 2026. DOI 10.20944/preprints202604.1748.v1. Used for tesamorelin identity failures, panel size, full-cohort counts, endotoxin scope, selection, review status, funding, and conflicts. No external funding; no declared conflicts. Checked 2026-09-02.
- ↑ Knicco, space_wiener, and other Reddit users. Tesamorelin for belly fat loss or redistribution?. r/Peptides, 2024. Used for opened self-reports about waist, body-fat, sleep, recovery, appetite, combination use, and uncertainty. No payment is disclosed. No laboratory report is shown. Checked 2026-09-02.
- ↑ European Medicines Agency. Egrifta application withdrawal. EMA, 2012. Used for the withdrawn central marketing-authorisation application and its scope. Checked 2026-09-02.
- ↑ German Federal Ministry of Justice. DmMV 2023 annex. Gesetze im Internet, 2023. Used only for the separate German register flag and named growth hormone-releasing-factor category. Checked 2026-09-02.
- ↑ Swedish Medical Products Agency. Medicinal-products workbook. Läkemedelsverket, extracted 2026-09-01. Used for the bounded Swedish product-register search and positive controls. Checked 2026-09-02.
- ↑ a b c d Theratechnologies. Study TH9507/III/LIPO/010. ClinicalTrials.gov. NCT00123253. Used for lead sponsor, actual enrolment, status, and current identifier alias. Checked 2026-09-02.
- ↑ a b Theratechnologies. Study TH9507-CTR-1012. ClinicalTrials.gov. NCT00608023. Used for programme sponsor and actual enrolment. Checked 2026-09-02.