{"id":"tesamorelin","name":"Tesamorelin","aliases":["Egrifta","GHRH analogue","TH9507"],"url":"https://lyoresearch.com/compounds/tesamorelin","class":{"id":"ghrh-analogues","name":"GHRH analogues","url":"https://lyoresearch.com/classes/ghrh-analogues"},"summary":"Tesamorelin is a synthetic analogue of growth-hormone-releasing hormone, approved in the United States to reduce excess abdominal fat in people with HIV-associated lipodystrophy. In that population it cuts visceral fat by about 15% over six months, and the fat returns when treatment stops. Its use for general fat loss, muscle or anti-ageing rests on extrapolation from that specific group; there are no trials in healthy adults. It is not authorised in the EU.","overall_grade":"B","overall_grade_meaning":"probable, not settled","human_trials":"Several RCTs","regulatory_status":"Approved (Rx, US)","molecule":{"formula":"C221H366N72O67S","molecular_weight":"5136","cas":"218949-48-5","pubchem_cid":16137828,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection, once daily","half_life":"About 8 minutes","licensed_regimen":"1.4 mg (0.35 mL reconstituted) subcutaneously once daily","product":"Egrifta SV","source":{"title":"Egrifta SV prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224"}},"outcomes":[{"outcome":"Visceral fat (HIV lipodystrophy)","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"2 phase 3 RCTs (n=816)","evidence":"Pooled phase 3: visceral adipose tissue −15.2% at 26 weeks vs +5% on placebo; effect lost within 26 weeks of stopping.","references":[{"citation":"Falutz J, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: pooled analysis of two phase 3 trials.","where":"J Acquir Immune Defic Syndr, 2010;53:311–322","url":"https://pubmed.ncbi.nlm.nih.gov/20554713/"}],"verbatim":{"text":"At wk 26, VAT decreased significantly in tesamorelin-treated patients (-24 ± 41 vs. 2 ± 35 cm(2), tesamorelin vs. placebo, P < 0.001; treatment effect, -15.4%).","citation":"Falutz J, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: pooled analysis of two phase 3 trials.","url":"https://pubmed.ncbi.nlm.nih.gov/20554713/"}},{"outcome":"Liver fat (HIV with NAFLD)","grade":"B","grade_meaning":"probable, not settled","effect_size":"moderate","adverse":false,"human_studies":"1 RCT (n=61)","evidence":"Hepatic fat fraction fell by about a third over 12 months vs placebo; a specific population, one trial.","references":[{"citation":"Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, placebo-controlled trial.","where":"Lancet HIV, 2019","url":"https://pubmed.ncbi.nlm.nih.gov/31611038/"}],"verbatim":{"text":"Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of -4·1% (95% CI -7·6 to -0·7, p=0·018), corresponding to a -37% (95% CI -67 to -7, p=0·016) relative reduction from baseline.","citation":"Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, placebo-controlled trial.","url":"https://pubmed.ncbi.nlm.nih.gov/31611038/"}},{"outcome":"Cognition in older adults","grade":"C","grade_meaning":"weak human evidence","effect_size":"small","adverse":false,"human_studies":"1 RCT (n=152)","evidence":"20 weeks of tesamorelin improved some executive-function measures in healthy older adults and those with mild cognitive impairment. Single trial, never replicated or developed further.","references":[{"citation":"Baker LD, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults.","where":"Arch Neurol, 2012;69:1420–1429","url":"https://pubmed.ncbi.nlm.nih.gov/22869065/"}],"verbatim":{"text":"The intent-to-treat analysis indicated a favorable effect of GHRH on cognition (P=.03), which was comparable in adults with MCI and healthy older adults.","citation":"Baker LD, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults.","url":"https://pubmed.ncbi.nlm.nih.gov/22869065/"}},{"outcome":"Fat loss in healthy adults","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"None","evidence":"Not studied. The approved population is not a proxy for the general public.","references":[]},{"outcome":"IGF-1 elevation and glucose effects","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":true,"human_studies":"Phase 3 programme","evidence":"Raises IGF-1 as intended; small rises in blood glucose and injection-site reactions are documented. Long-term cancer risk at elevated IGF-1 is the reason for the narrow label.","references":[{"citation":"Falutz J, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: pooled analysis of two phase 3 trials.","where":"J Acquir Immune Defic Syndr, 2010;53:311–322","url":"https://pubmed.ncbi.nlm.nih.gov/20554713/"}],"verbatim":{"text":"Mean IGF-I increased 108 ± 112 vs. -7 ± 64 ng/ml (P < 0.001 vs. placebo).","citation":"Falutz J, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: pooled analysis of two phase 3 trials.","url":"https://pubmed.ncbi.nlm.nih.gov/20554713/"}}],"regions":[{"region":"European Union","status":"Not authorised","note":"The Egrifta marketing authorisation application was withdrawn on 26 June 2012 after the CHMP could not conclude a positive benefit–risk balance."},{"region":"United States","status":"Approved (Egrifta), prescription-only","note":"Approved for excess abdominal fat in HIV-associated lipodystrophy. Prescribing outside that indication is a clinical decision; selling vials for 'research' is not a lawful supply route."},{"region":"United Kingdom","status":"Not licensed","note":"No MHRA licence. Unlicensed medicine when supplied for human use."},{"region":"Australia","status":"Not registered","note":"Not on the ARTG; prescription-only if obtained at all."},{"region":"Canada","status":"Authorised (Egrifta), prescription-only","note":"Authorised in Canada for HIV-associated abdominal fat. Vials sold online were nonetheless among the products Health Canada seized in August 2025."},{"region":"Sport (WADA)","status":"Prohibited at all times","note":"GHRH analogue: S2.2.4, growth hormone releasing factors."}],"faq":[{"q":"Does tesamorelin burn belly fat?","a":"In people with HIV-associated lipodystrophy, yes — about 15% less visceral fat after six months in two phase 3 trials. In anyone else it has not been tested, and the fat returns when treatment stops."},{"q":"Is tesamorelin the same as growth hormone?","a":"No. It prompts the body to release its own growth hormone rather than supplying it. The downstream effects overlap, including higher IGF-1."},{"q":"Is tesamorelin legal?","a":"It is a prescription medicine in the United States for one indication. It is not authorised in the EU or UK, and it is banned in sport."}],"references":[{"cite":"Falutz J, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: pooled analysis of two phase 3 trials.","where":"J Acquir Immune Defic Syndr, 2010;53:311–322","url":"https://pubmed.ncbi.nlm.nih.gov/20554713/","note":"816 participants; the approval basis."},{"cite":"Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, placebo-controlled trial.","where":"Lancet HIV, 2019","url":"https://pubmed.ncbi.nlm.nih.gov/31611038/","note":"61 participants, 12 months."},{"cite":"Baker LD, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults.","where":"Arch Neurol, 2012;69:1420–1429","url":"https://pubmed.ncbi.nlm.nih.gov/22869065/","note":"152 adults, 20 weeks; not replicated."}],"last_reviewed":"2026-09-02","literature_searched_to":"2026-09-02","changelog":[{"date":"2026-09-02","note":"Full page. Added liver-fat, cognition and IGF-1 rows; regional status; FAQ."},{"date":"2026-09-01","note":"Initial publication."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}