{"slug":"tesamorelin","seoKey":"tesamorelin","inn":"tesamorelin","displayName":"Tesamorelin","codes":["TH9507","TH-9507","H01AC06"],"synonyms":["tesamorelin acetate","trans-3-hexenoyl-GRF(1-44)amide","tesamorelina","tesamoreline","tesamorelinum","GHRH(1-44) analogue","(3E)-hex-3-enoylsomatoliberin"],"legalClass":"rx","identifiers":{"cas":"218949-48-5","pubchemCid":16137828,"unii":"MQG94M5EEO","inchikey":"QBEPNUQJQWDYKU-BMGKTWPMSA-N","drugbankId":"DB08869","chemblId":"CHEMBL1237026","wikidataQid":"Q7705415","formula":"C221H366N72O67S","molecularWeight":5135.9},"approvals":[{"market":"US","status":"approved_rx","date":"2010-11-10","note":"Approved and prescription-only, held as a biologics licence since the former new drug application was deemed to be one on 2020-03-23. The single indication is the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. The labelling states express limitations of use: long-term cardiovascular safety is not established, the product is not indicated for weight reduction because its effect is weight-neutral, and no data support improved adherence to antiretroviral therapy.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tesamorelin%22"},{"market":"EU","status":"not_approved","date":"2012-06-21","note":"Not approved. A marketing application was filed and withdrawn by the applicant on 2012-06-21, after the committee found the submitted data insufficient to establish a positive benefit-risk balance. No authorisation has existed since.","source":"https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/egrifta"},{"market":"DE","status":"not_approved","note":"Not approved: there is neither a centralised EU authorisation nor a national one, so no marketable finished medicinal product exists. The substance is not named in the prescription-only annex, but it is named in the annex to the anti-doping act, in the section on growth hormone releasing factors.","source":"https://www.gesetze-im-internet.de/antidopg/anlage.html"},{"market":"UK","status":"not_approved","note":"Not approved; the regulator's full-text product index returned no entry on 2026-09-07, verified against working control queries that return hundreds of hits for comparable substances. Supply would only be conceivable as an unlicensed medicine against a prescription.","source":"https://products.mhra.gov.uk/search/?search=tesamorelin"},{"market":"AU","status":"not_approved","note":"No registration identified. IMPORTANT CAVEAT: this is not a primary-verified negative finding. Both the register of therapeutic goods and the full text of the Poisons Standard were unreachable from the working environment on 2026-09-07, so no register extract exists and it could not be checked whether the substance is captured by name or as a class.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"approved_rx","note":"Authorised and prescription-only, but NO LONGER MARKETED: both drug identification numbers have been cancelled, one post market since 2022-09-30 and one pre market since 2023-07-13, and the last delivered batch expired on 2023-01-31. The indication covers excess visceral adipose tissue in treatment-experienced adults with HIV-associated lipodystrophy. The exact date of the notice of compliance could not be retrieved; the product monograph is dated 2015-03-26 and first marketing was 2015-06-23.","source":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92311"},{"market":"CH","status":"not_approved","note":"Not approved; the substance appears in none of the published lists of authorised human medicines. The full workbook text was searched on 2026-09-07 with working control queries that return matches for comparable substances in the same file.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"prohibited","section":"S2.2.4","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00123253","name":"Registration trial 1 (visceral adipose tissue at 26 weeks)","phase":"Phase 3","n":412,"status":"COMPLETED"},{"nct":"NCT00608023","name":"Extension of the registration trials to 52 weeks","phase":"Phase 3","n":263,"status":"COMPLETED"},{"nct":"NCT01591902","name":"Diabetic retinopathy under treatment (terminated)","phase":"Phase 4","n":129,"status":"TERMINATED"},{"nct":"NCT00257712","name":"Cognition in older adults with and without mild cognitive impairment","phase":"Phase 2","n":152,"status":"COMPLETED"},{"nct":"NCT06554717","name":"Adjunct to exercise training in people with HIV and frailty","phase":"Phase 2","n":100,"status":"RECRUITING"},{"nct":"NCT02572323","name":"Cognition in ageing people with HIV (open label, no placebo arm)","phase":"Phase 2","n":73,"status":"COMPLETED"},{"nct":"NCT02196831","name":"Hepatic fat fraction and liver histology over 12 months","n":61,"status":"COMPLETED"},{"nct":"NCT00675506","name":"Abdominal fat in obesity without HIV","phase":"Phase 2","n":60,"status":"COMPLETED"},{"nct":"NCT01264497","name":"Safety in type 2 diabetes (insulin response over 12 weeks)","phase":"Phase 2","n":55,"status":"COMPLETED"},{"nct":"NCT01263717","name":"Visceral fat and liver fat at 6 months","n":54,"status":"COMPLETED"},{"nct":"NCT03375788","name":"Fatty liver disease and cardiovascular risk markers","phase":"Phase 2","n":51,"status":"COMPLETED"},{"nct":"NCT03150511","name":"Functional outcome after peripheral nerve injury","phase":"Phase 2","n":36,"status":"RECRUITING"},{"nct":"NCT01579695","name":"Long-term observational safety study under market conditions (terminated)","n":391,"status":"TERMINATED"},{"nct":"NCT01388920","name":"Chronic obstructive pulmonary disease with muscle wasting (terminated after three participants)","phase":"Phase 2","n":3,"status":"TERMINATED"}],"sameAs":["https://www.wikidata.org/wiki/Q7705415","https://pubchem.ncbi.nlm.nih.gov/compound/16137828","https://go.drugbank.com/drugs/DB08869","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1237026/"],"lastVerified":"2026-09-07","version":"1.0","published":true,"locale":"en","title":"Tesamorelin: what the trials show, status and safety","summary":"Tesamorelin is a laboratory-made copy of the hormone that tells the pituitary gland to release growth hormone. It is a prescription-only medicine in the United States and nowhere else, approved in November 2010 for one purpose: reducing excess belly fat in adults who have HIV and lipodystrophy. In the main trial the deep belly fat fell by 15.2 per cent, while it rose by 5.0 per cent on placebo. Body weight did not change, and the label states plainly that the drug is not for weight loss. The European application was withdrawn in 2012, the Canadian product has been taken off the market, and the substance is banned in sport at all times.","updated":"2026-09-07","url":"https://mypep.app/peptides/tesamorelin"}