{"slug":"semaglutide","seoKey":"semaglutide","inn":"semaglutide","displayName":"Semaglutide","codes":["NN9535","NNC 0113-0217"],"synonyms":["semaglutidum","semaglutida","Semaglutid","oral semaglutide","GLP-1 receptor agonist (substance class, not a trade name)"],"legalClass":"rx","identifiers":{"cas":"910463-68-2","pubchemCid":56843331,"unii":"53AXN4NNHX","inchikey":"DLSWIYLPEUIQAV-CCUURXOWSA-N","drugbankId":"DB13928","chemblId":"CHEMBL3616752","wikidataQid":"Q27261089","formula":"C187H291N45O59","molecularWeight":4113.58},"approvals":[{"market":"US","status":"approved_rx","date":"2017-12-05","note":"Approved and prescription-only. Three marketing applications cover type 2 diabetes, cardiovascular risk reduction, chronic kidney disease, weight management and metabolic dysfunction-associated steatohepatitis, in an injectable and an oral dosage form.","source":"https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA209637%22"},{"market":"EU","status":"approved_rx","date":"2018-02-08","note":"Authorised centrally and prescription-only. Three authorisations cover type 2 diabetes and weight management; unlike the US label, cardiovascular risk reduction is not a separate indication.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic"},{"market":"DE","status":"approved_rx","date":"2018-02-08","note":"Authorised through the centralised EU procedure and prescription-only under the German Medicines Act. For weight management, statutory health insurance does not cover it under section 34(1) sentence 7 of the German Social Code, Book V.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy"},{"market":"UK","status":"approved_rx","note":"Authorised and prescription-only. Indications were extended between 2024 and 2026 to cardiovascular risk reduction, an oral dosage form and, conditionally, metabolic dysfunction-associated steatohepatitis.","source":"https://www.medicines.org.uk/emc/search?q=semaglutide"},{"market":"AU","status":"approved_rx","note":"Registered in the Australian Register of Therapeutic Goods and listed in the Poisons Standard as Schedule 4, prescription only.","source":"https://www.tga.gov.au/resources/artg/446290"},{"market":"CA","status":"approved_rx","note":"Authorised with drug identification numbers; classified as prescription and, as a biologic drug, additionally under Schedule D.","source":"https://health-products.canada.ca/api/drug/status/?lang=en&type=json&id=96058"},{"market":"CH","status":"approved_rx","date":"2018-07-02","note":"Authorised and prescription-only (dispensing category B). The Swiss indication text names cardiovascular risk reduction and metabolic dysfunction-associated steatohepatitis explicitly.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT01720446","name":"SUSTAIN-6 (cardiovascular outcomes in type 2 diabetes)","phase":"Phase 3","n":3297,"status":"COMPLETED"},{"nct":"NCT03548935","name":"STEP 1 (weight reduction without diabetes)","phase":"Phase 3","n":1961,"status":"COMPLETED"},{"nct":"NCT03552757","name":"STEP 2 (weight reduction with type 2 diabetes)","phase":"Phase 3","n":1210,"status":"COMPLETED"},{"nct":"NCT03548987","name":"STEP 4 (withdrawal design)","phase":"Phase 3","n":902,"status":"COMPLETED"},{"nct":"NCT03693430","name":"STEP 5 (104 weeks)","phase":"Phase 3","n":304,"status":"COMPLETED"},{"nct":"NCT04102189","name":"STEP TEENS (adolescents from 12 years)","phase":"Phase 3","n":201,"status":"COMPLETED"},{"nct":"NCT03574597","name":"SELECT (cardiovascular outcomes without diabetes)","phase":"Phase 3","n":17604,"status":"COMPLETED"},{"nct":"NCT03819153","name":"FLOW (chronic kidney disease)","phase":"Phase 3","n":3533,"status":"COMPLETED"},{"nct":"NCT04788511","name":"STEP-HFpEF (heart failure with preserved ejection fraction)","phase":"Phase 3","n":529,"status":"COMPLETED"},{"nct":"NCT04916470","name":"STEP-HFpEF DM (same population with type 2 diabetes)","phase":"Phase 3","n":617,"status":"COMPLETED"},{"nct":"NCT04822181","name":"ESSENCE (metabolic dysfunction-associated steatohepatitis)","phase":"Phase 3","n":1205,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT02692716","name":"PIONEER 6 (cardiovascular outcomes, oral dosage form)","phase":"Phase 3","n":3183,"status":"COMPLETED"},{"nct":"NCT03914326","name":"SOUL (cardiovascular outcomes, oral dosage form)","phase":"Phase 3","n":9651,"status":"COMPLETED"},{"nct":"NCT05035095","name":"OASIS 1 (oral dosage form in obesity)","phase":"Phase 3","n":667,"status":"COMPLETED"},{"nct":"NCT05646706","name":"STEP UP","phase":"Phase 3b","n":1407,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q27261089","https://pubchem.ncbi.nlm.nih.gov/compound/56843331","https://go.drugbank.com/drugs/DB13928","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3616752/"],"lastVerified":"2026-09-06","version":"1.0","published":true,"locale":"en","title":"Semaglutide: what the trials show, status and safety","summary":"Semaglutide is a lab-made peptide that copies a natural gut hormone and switches on its docking point, the GLP-1 receptor. It is an approved medicine, available on prescription in eight markets, first licensed in December 2017. In its largest trial in people with obesity, body weight fell by an average of 14.9 percent over 68 weeks. In people with obesity but no diabetes it also cut serious heart problems by about a fifth, and in Alzheimer's disease it failed on the question it was built to answer.","updated":"2026-09-06","url":"https://mypep.app/peptides/semaglutide"}