Tesamorelin: what it is, what the studies show and where it stands
Tesamorelin is a synthetic analog of human growth hormone-releasing factor: the full 44 amino acid sequence with a hexenoyl group attached to the first amino acid. It makes the pituitary release growth hormone.
At a glance
US Approved for one use
Canada No longer sold
Group Growth hormone
Sources 14
Checked 10 Oct 2026What is Tesamorelin?
Tesamorelin is a synthetic analog of human growth hormone-releasing factor: the full 44 amino acid sequence with a hexenoyl group attached to the first amino acid. It makes the pituitary release growth hormone. [1]
Other names: TH9507, tesamorelin acetate, Egrifta, Egrifta SV, Egrifta WR.
How it has been given to people: injection under the skin of the abdomen, once daily.
Looking for doses? Tesamorelin dosage chart and vial math
Is Tesamorelin approved in the US and Canada?
United States: FDA approved (BLA 022505, first approved November 10, 2010) for one use only: reducing excess abdominal fat in HIV-infected adults with lipodystrophy. [1]
Canada: Not currently marketed in Canada: Egrifta DIN 02438712 (1 mg/vial) is Cancelled Post Market as of 2022-09-30 and DIN 02423677 (2 mg/vial) is Cancelled Pre Market as of 2023-07-13. [5]
Both were checked on 10 Oct 2026 against the regulators' own product databases.
Which approved products contain Tesamorelin?
| Product | Country | Approved for | Label |
|---|---|---|---|
| Egrifta SV | US | reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy | Label |
| Egrifta WR | US | reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy | Label |
| Egrifta (original 1 mg/vial formulation) | US | reduction of excess abdominal fat in HIV-infected patients with lipodystrophy | Label |
| Egrifta | Canada | not read: the Canadian product monograph was not fetched | Label |
What human studies of Tesamorelin exist?
The 13 findings listed here: 10 from randomized human trials and 3 from smaller or observational human studies.
In the first Phase 3 trial, visceral fat on CT fell 15.2% over 26 weeks on 2 mg daily and rose 5.0% on placebo. [6]
IGF-I rose 81% on tesamorelin in that trial and fell 5% on placebo. [6]
In the second Phase 3 trial, visceral fat fell 10.9% over 6 months on 2 mg daily against 0.6% on placebo. [7]
The fat came back when treatment stopped: patients switched to placebo after 6 months quickly lost the improvement. [7]
In the 12-week dose-ranging trial, 2 mg lowered trunk fat against placebo; the fall in visceral fat on 2 mg (15.7%) was not statistically significant against placebo in that small trial, and on 1 mg the fall (3.6%) was smaller than on placebo (5.4%). [8]
In HIV-infected patients with abdominal fat accumulation, 6 months of 2 mg daily reduced visceral fat and modestly reduced liver fat. [9]
In people with HIV and fatty liver, 35% of those on tesamorelin and 4% of those on placebo had liver fat below 5% after 12 months. [10]
In patients with type 2 diabetes, 12 weeks of 1 mg or 2 mg did not change insulin response or blood sugar control. [11]
In adults aged 55 to 87 without HIV, 20 weeks of 1 mg nightly had a favourable effect on cognitive test scores against placebo. This is not an approved use. [12]
The label states that tesamorelin does not change body weight and is not a weight loss treatment. [1]
Less than 4% of a dose injected under the skin reaches the bloodstream. [1]
The three US products use different doses because the formulations differ, not because the intended exposure differs: 1.4 mg of Egrifta SV gives blood levels similar to 2 mg of the original Egrifta. [1]
Likewise 1.28 mg of Egrifta WR gives blood levels similar to 2 mg of the original Egrifta. [2]
What are the side effects of Tesamorelin?
Reported in human studies or on a label:
- Most common adverse reactions on the label (more than 5% of patients): joint pain, injection site redness and itching, pain in an arm or leg, swelling of the limbs, and muscle pain. [1]
- Injection site reactions occurred in 25% of treated patients and 14% of placebo patients in the first 26 weeks of the trials. [1]
- Hypersensitivity reactions (itching, redness, flushing, hives, rash) occurred in 4% of treated patients. [1]
- IGF-1 rose above the normal range in many patients: after 26 weeks 47% were more than 2 standard deviation scores above the mean and 36% more than 3. [1]
- More patients developed diabetes-range HbA1c on tesamorelin than on placebo: 5% against 1%, hazard ratio 3.3. [1]
- Fluid retention can occur, showing up as swelling, joint pain or carpal tunnel syndrome. [1]
- In the first Phase 3 trial, overall adverse event rates were similar to placebo, but more patients on tesamorelin dropped out because of an adverse event. [6]
- In the 20-week trial in older adults, mild adverse events were reported by 68% on tesamorelin and 36% on placebo. [12]
Warnings on the label
- Do not use in patients whose hypothalamic-pituitary axis is disrupted, for example by pituitary removal, hypopituitarism, pituitary tumour or surgery, head irradiation or head trauma. [1]
- Do not use in patients with active cancer; any earlier cancer should be inactive and its treatment finished first. [1]
- Do not use in pregnancy. [1]
- Do not use in patients with known hypersensitivity to tesamorelin or the other ingredients. [1]
- Increased risk of neoplasms: stop treatment if there is any sign of a cancer returning. [1]
- Raised IGF-1: the long-term effects are unknown, and IGF-1 should be monitored during treatment. [1]
- Glucose intolerance or diabetes may develop; glucose should be checked before and during treatment. [1]
- Acute critical illness: growth hormone in pharmacologic amounts has been linked to increased mortality in critically ill patients, so stopping should be considered. [1]
- Not for children: in children whose growth plates are open it may cause excessive growth. [1]
- Long-term cardiovascular safety has not been established. [1]
- Drugs cleared by cytochrome P450 liver enzymes (for example corticosteroids, sex steroids, anticonvulsants, cyclosporine): growth hormone may change their clearance, so patients should be monitored. [1]
- Glucocorticoid replacement: patients on it for diagnosed hypoadrenalism may need a higher maintenance or stress dose after starting. [1]
- Egrifta WR and Egrifta SV cannot be swapped for each other dose for dose. [2]
What is the half-life of Tesamorelin?
About 8 minutes in healthy adults after one 1.4 mg dose of Egrifta SV under the skin. Other labels give other figures for other formulations and conditions (see also). [1]
How does Tesamorelin compare with others in its group?
These are the peptides filed under growth hormone. The last column says whether a randomized human trial is on record for each.
| Peptide | US | Canada | Half-life | Randomized human trial |
|---|---|---|---|---|
| Ipamorelin | Not approved | Not authorized | Terminal half-life of about 2 hours after a 15-minute intravenous infusion in healthy men. No human figure after injection under the skin was found. | Yes |
| CJC-1295 without DAC | Not approved | Not authorized | Not found | No |
| CJC-1295 with DAC | Not approved | Not authorized | Estimated at 5.8 to 8.1 days in healthy adults after injection under the skin. | Yes |
| Sermorelin | No longer sold | Not authorized | Disappearance half-time of about 4.3 minutes after a 90-minute intravenous infusion in 10 healthy men. No human half-life after injection under the skin was found in the abstracts read. | Yes |
| Tesamorelin | Approved for one use | No longer sold | About 8 minutes in healthy adults after one 1.4 mg dose of Egrifta SV under the skin. Other labels give other figures for other formulations and conditions (see also). | Yes |
| IGF-1 LR3 | Not approved | Not authorized | Not found | No |
| GHRP-2 | Not approved | Not authorized | About 0.55 hours (33 minutes) for the slower phase after a single dose into a vein in 10 children. No human half-life after injection under the skin was found in the abstracts read. | Yes |
| GHRP-6 | Not approved | Not authorized | After a single dose into a vein in nine healthy men: distribution half-life about 7.6 minutes, elimination half-life about 2.5 hours. No human half-life after injection under the skin was found. | No |
| HGH | Approved, prescription | Authorized, prescription | About 3.8 hours after an injection under the skin in healthy subjects. The label says this long figure reflects slow absorption from the injection site. | Yes |
What could not be found
These were searched for and did not turn up. They are listed so a missing number is not mistaken for a hidden one.
- The Canadian product monograph (Canadian indication and dose): not fetched. Only the Drug Product Database status records were read.
- Why the two Canadian DINs were cancelled: the database gives no reason.
- A current US label for the original 1 mg/vial Egrifta: not on DailyMed or openFDA. The 2 mg dose row for it is taken from the November 2010 approval label.
- Approval dates of the Egrifta SV and Egrifta WR formulations: not recorded here. Drugs@FDA shows them as supplements to BLA 022505 and the supplement history was not read in full.
- Missed-dose instructions: not looked up in the patient leaflet sections.
- The registry record of the second approval trial: ClinicalTrials.gov now redirects NCT00435136 to NCT00123253 (the first trial), so no separate record was read. Trial phases given here are from ClinicalTrials.gov records NCT00123253, NCT01264497 and NCT00257712.
- Any trial in healthy people measuring muscle gain, strength or athletic performance.
Tesamorelin questions
Is Tesamorelin approved in the US?
FDA approved (BLA 022505, first approved November 10, 2010) for one use only: reducing excess abdominal fat in HIV-infected adults with lipodystrophy.
Is Tesamorelin authorized in Canada?
Not currently marketed in Canada: Egrifta DIN 02438712 (1 mg/vial) is Cancelled Post Market as of 2022-09-30 and DIN 02423677 (2 mg/vial) is Cancelled Pre Market as of 2023-07-13.
What is the half-life of Tesamorelin?
About 8 minutes in healthy adults after one 1.4 mg dose of Egrifta SV under the skin. Other labels give other figures for other formulations and conditions (see also).
Has Tesamorelin been tested in a randomized human trial?
Yes. At least one randomized human trial is listed on this page.
Sources
Each one was opened on 10 Oct 2026 and matched to the line it supports.
- EGRIFTA SV (tesamorelin) for injection: US prescribing information Theratechnologies Inc., via openFDA and DailyMed 2026-07-29. api.fda.gov.
- EGRIFTA WR (tesamorelin) for injection: US prescribing information Theratechnologies Inc., via openFDA and DailyMed 2026-07-29. api.fda.gov.
- EGRIFTA (tesamorelin for injection): original US approval label, BLA 022505 US Food and Drug Administration, Drugs@FDA 2010-11. accessdata.fda.gov.
- Drugs@FDA application record for EGRIFTA, BLA 022505 (via openFDA) US Food and Drug Administration. api.fda.gov.
- Health Canada Drug Product Database: EGRIFTA product and status records (DIN 02438712, DIN 02423677) Health Canada. health-products.canada.ca.
- Falutz J et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med 2007. PubMed 18057338. Trial NCT00123253.
- Falutz J et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr 2010. PubMed 20101189. Trial NCT00435136.
- Falutz J et al. A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with abdominal fat accumulation. AIDS 2005. PubMed 16052083.
- 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. PubMed 25038357. Trial NCT01263717.
- Stanley TL et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV 2019. PubMed 31611038. Trial NCT02196831.
- Clemmons DR et al. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One 2017. PubMed 28617838. Trial NCT01264497.
- Baker LD et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol 2012. PubMed 22869065. Trial NCT00257712.
- Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks Health Canada 2025-08-01. recalls-rappels.canada.ca.
- The Prohibited List (2026 list as shown on the WADA website) World Anti-Doping Agency. wada-ama.org.
Next
Tesamorelin dosage2 mg vial5 mg vial10 mg vialGrowth hormoneStatus in Canada
DosageFacts is an information site. It is not medical advice. Talk to a licensed professional before using any medication.