Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-15. ← Back to Evidence Library
Tesamorelin: what the evidence says
At a glance
What it is: a lab-made copy of GHRH, the brain's growth-hormone "on" signal. It is an FDA-approved prescription drug (EGRIFTA SV and EGRIFTA WR) for reducing excess belly fat in adults with HIV and lipodystrophy (abnormal fat distribution). It is also sold on the gray market and used off-label for fat loss. Caution [UNVERIFIED: no cited source for extent of off-label use] R1, R7
What the evidence says: strong for its approved use; untested for general fat loss in people without HIV. R2
Biggest risks: raised blood sugar, fluid retention, and possible growth of existing cancers, per the FDA label. Gray-market vials have none of the label's quality guarantees. R4, R7
| Rating | |
|---|---|
| Human Human evidence (HIV belly fat) | Strong: two phase 3 RCTs (806 people pooled) plus further RCTs R2 |
| Human Human evidence (other uses) | Limited: one RCT in HIV-related fatty liver (61 people); Unknown no human data in people without HIV (nothing at all) |
| Animal Animal evidence | Unknown Not reviewed for this page (human RCT data take precedence) |
| Regulatory | FDA-approved (HIV lipodystrophy only) · WADA-banned R7, R8 |
| Established human dose | Only for the approved use, under prescription: see the FDA labels in R7. Unknown No established dose for any other use |
Evidence verdict: HIV belly fat: Strong · Other uses: Limited (HIV-related fatty liver); no human data in people without HIV · Animal: not reviewed Card verdict: Strong (HIV belly fat, FDA-approved as Egrifta) · HIV fatty liver: Limited · General fat loss or anti-aging without HIV: No human data Card note: Varies by use, see page
This page reports what studies and the approved label used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
What is it?
Tesamorelin is a 44-amino-acid copy of GHRH, the brain's growth-hormone "on" signal. It makes the pituitary (a gland at the base of the brain) release more of the body's own growth hormone. The FDA approved it for adults with HIV who have excess abdominal fat from lipodystrophy (abnormal fat distribution). R1, R7
Does it work?
Human In people with HIV: in two large trials, belly (visceral) fat dropped about 15% more than placebo (a dummy treatment) at 26 weeks. Triglycerides (a blood fat) were also lower. Fat under the skin didn't change much. In a smaller trial in people with HIV and fatty liver, liver fat dropped more than on placebo. R2
Unknown In people without HIV: we found no published trial for weight or fat loss. The label says it is "not indicated for weight loss management." R7
Is it safe?
- Human In the 404-person phase 3 trial, no change in glucose parameters was seen over the 6-month main phase. R2
- Caution The FDA label warns about: growth of existing cancers (people with active cancer must not use it), raised IGF-1 (a growth factor) with unknown long-term effects, fluid retention (swelling, joint pain, carpal tunnel), glucose intolerance or diabetes, allergic reactions, and increased death risk in people with acute critical illness. It must not be used in pregnancy (contraindicated). Long-term heart safety is not established. R4, R7
What we don't know
- Unknown Whether it helps, or is safe, in people without HIV
- Unknown Long-term cardiovascular safety (per the label)
- Unknown Effects of long-term raised IGF-1 (per the label)
Is it legal?
FDA-approved as a prescription drug for HIV-associated lipodystrophy, in two formulations (EGRIFTA SV and EGRIFTA WR) that are not interchangeable. WADA's (World Anti-Doping Agency) 2026 list bans it at all times under S2.2.4 (GHRH analogues). As of Oct 15, 2026. R7, R8
What's in the vial?
Pharmacy-dispensed Egrifta is made under FDA oversight. Gray-market "tesamorelin" (sold outside regulated channels) is not. It could hold the wrong compound or amount. It could also contain impurities, bacterial toxins or heavy metals. We test retail vials blind under the Open Peptide Standard. See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe. R10
What do users report?
Self-report, not evidence.
Unknown TBD. We'll only list this once we can cite a public source.
Study details
R2 Human Human studies
Most trials were sponsor-funded (Theratechnologies). UNVERIFIED sponsor details not checked against full texts.
| Study | People | Route | Dose used | Follow-up | Reported | Limitations | Citation |
|---|---|---|---|---|---|---|---|
| Falutz 2010 (JAIDS), HIV + abdominal fat | 404, randomized 2:1 | Subcutaneous | 2 mg daily (original 1 mg/vial formulation) | 12 mo (6 + 6 extension) | VAT −10.9% vs −0.6% at 6 mo; no change in glucose parameters; "well tolerated" (abstract; AE and dropout counts not in abstract) | HIV population only | PMID 20101189 |
| Falutz 2010 (JCEM), pooled phase 3 | 806, randomized 2:1 | Subcutaneous | 2 mg daily | 26 + 26 wk | VAT treatment effect −15.4%; triglycerides down; IGF-1 up; "generally well tolerated", no meaningful glucose change (AE and dropout counts not in abstract) | HIV only | PMID 20554713 |
| Stanley 2019, HIV + fatty liver | 61 enrolled, 60 treated (30 vs 30), randomized 1:1 | Subcutaneous | 2 mg daily | 12 mo + 6 mo open | Liver fat −37% relative vs placebo; more injection-site complaints than placebo, none serious; no difference in glucose or HbA1c | Small; funded by NIH/NIAID | PMID 31611038 |
R4, R7, R8 Label and regulatory (as of Oct 15, 2026)
- R7 FDA labels (approved indication only, quoted for transparency, not as advice): both labels: "indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy"; "not indicated for weight loss management as it has a weight neutral effect"; "Long-term cardiovascular safety... has not been established."
- Dosing: approved dosing is set by the prescribing labels; see the labels: EGRIFTA SV, EGRIFTA WR (DailyMed). The labels say EGRIFTA WR and EGRIFTA SV "are not substitutable."
- The trials used the original EGRIFTA formulation (study arms in the study table); doses differ by formulation.
- R4 EGRIFTA SV label, Warnings 5.1–5.5 and 5.7 (neoplasms, elevated IGF-1, fluid retention, glucose intolerance/diabetes, hypersensitivity, increased mortality in acute critical illness) and Contraindications (active malignancy, pregnancy, hypothalamic-pituitary disruption, hypersensitivity).
- R8 WADA: 2026 list S2.2.4 names "tesamorelin". WADA 2026 list
- R1 "GHRH(1-44)" per Falutz 2010 (PMID 20101189).
- R10 Open Peptide Standard panel as on other pages. Unknown Results pending the first batch.
Full reference list (all verified on PubMed, Oct 15, 2026)
- Falutz J, et al. J Acquir Immune Defic Syndr. 2010;53(3):311-22. doi:10.1097/QAI.0b013e3181cbdaff. PMID 20101189
- Falutz J, et al. J Clin Endocrinol Metab. 2010;95(9):4291-304. doi:10.1210/jc.2010-0490. PMID 20554713
- Stanley TL, et al. Lancet HIV. 2019;6(12):e821-e830. doi:10.1016/S2352-3018(19)30338-8. PMID 31611038
Disclaimer
This page is for education and harm reduction. It is not medical advice and not a recommendation to use tesamorelin outside a prescription. Its safety is established only for its approved use, under medical supervision. Please talk to a clinician you trust, especially if you have or have had cancer, have diabetes, are pregnant, or are a tested athlete. Seek care right away for a serious reaction, and report it to FDA MedWatch (https://www.fda.gov/safety/medwatch).