{"slug":"exenatide","seoKey":"exenatide","inn":"exenatide","displayName":"Exenatide","codes":["AC2993","A10BJ01"],"synonyms":["exendin-4","Exendin 4 (Heloderma suspectum)","exenatide synthetic","exenatidum","exenatida","Exenatid"],"legalClass":"rx","identifiers":{"cas":"141758-74-9","pubchemCid":45588096,"unii":"9P1872D4OL","inchikey":"HTQBXNHDCUEHJF-XWLPCZSASA-N","drugbankId":"DB01276","chemblId":"CHEMBL414357","wikidataQid":"Q417762","formula":"C184H282N50O60S","molecularWeight":4186.6},"approvals":[{"market":"US","status":"approved_rx","date":"2005-04-28","note":"Approved and prescription-only; the first glucagon-like peptide-1 receptor agonist approved anywhere. The original new drug application of 2005 covers the twice-daily form, two later applications the once-weekly depot form. All three originator applications are listed as discontinued, but the substance itself remains approved: a generic version was approved on 19 November 2024 through the ordinary generic pathway rather than a biosimilar one, and has been marketed since 22 November 2024. Only the labelling of the depot form carries a boxed warning on thyroid C-cell tumours; the labelling of the twice-daily form does not.","source":"https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA021773%22"},{"market":"EU","status":"approved_rx","date":"2006-11-20","note":"Authorised centrally and prescription-only, with a second authorisation from 17 June 2011 covering the once-weekly depot form. Both authorisations were listed as authorised on 10 September 2026, with no withdrawal or expiry recorded. The indication is type 2 diabetes only, in adults for the twice-daily form and from ten years of age for the depot form; no market has ever authorised this substance for weight reduction. The European product information carries no boxed warning, and hypersensitivity is the only contraindication listed.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/byetta"},{"market":"DE","status":"approved_rx","date":"2006-11-20","note":"Authorised through the centralised EU procedure and prescription-only: the substance is named in annex 1 of the German prescription regulation, so the requirement applies regardless of indication, brand or dosage form. Whether the products were still actually supplied in Germany on 10 September 2026 was not established; the authorisation continuing in law and a product remaining on the market are two separate questions.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"not_approved","date":"2026-09-10","note":"No current entry found. The full-text search of the national product compendium returned no result on 10 September 2026, while the control query for a comparable substance of the same class returned entries with working filters. HONEST CAVEAT: an authorisation existed historically through the European procedure, and the regulator's own product database could not be evaluated from this environment because it renders only in a browser. Whether the British authorisation has lapsed, is suspended, or merely no longer marketed, therefore remains open.","source":"https://www.medicines.org.uk/emc/search?q=exenatide"},{"market":"AU","status":"approved_rx","date":"2026-05-28","note":"Listed in the Poisons Standard as Schedule 4, prescription only, without any exemption. The date given is the registration of the June 2026 instrument, not a first approval. The register of therapeutic goods could not be queried from this environment on 10 September 2026, so registration numbers, sponsors and registration dates are deliberately absent; the scheduling status is verified from the local full text.","source":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/scheduling-basics/poisons-standard-susmp"},{"market":"CA","status":"approved_rx","date":"2011-06-01","note":"Authorised and classified as prescription, but NO LONGER MARKETED: all four drug identification numbers were cancelled in 2022, three post market between 6 January and 1 April 2022 and one pre market on 30 May 2022 without ever entering the market. The last delivered batches expired between July 2022 and January 2023. The database status does not distinguish a safety withdrawal from a commercial decision, and no reason for the cancellations is documented in any source checked.","source":"https://health-products.canada.ca/api/drug/drugproduct/?lang=en&type=json&id=84685"},{"market":"CH","status":"not_approved","date":"2026-09-10","note":"Not approved; the substance appears in none of the published lists of authorised human medicine packs. The full text of those lists was searched on 10 September 2026 with working control queries that return matches for comparable substances of the same class in the same file. Whether an authorisation never existed or has lapsed cannot be determined from these lists, which carry only currently authorised packs.","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":"NCT01144338","name":"EXSCEL (cardiovascular outcomes in type 2 diabetes; superiority not met)","phase":"Phase 3","n":14752,"status":"COMPLETED"},{"nct":"NCT00308139","name":"DURATION-1 (once-weekly depot form versus twice-daily form)","phase":"Phase 3","n":303,"status":"COMPLETED"},{"nct":"NCT01029886","name":"DURATION-6 (head-to-head comparison with liraglutide; non-inferiority not met)","phase":"Phase 3","n":912,"status":"COMPLETED"},{"nct":"NCT02229396","name":"DURATION-8 (combination with a sodium-glucose cotransporter-2 inhibitor)","phase":"Phase 3","n":695,"status":"COMPLETED"},{"nct":"NCT00518882","name":"LEAD-6 (head-to-head comparison with liraglutide, twice-daily form)","phase":"Phase 3","n":467,"status":"COMPLETED"},{"nct":"NCT01885208","name":"SUSTAIN 3 (head-to-head comparison with semaglutide; sponsored by the comparator's manufacturer)","phase":"Phase 3","n":813,"status":"COMPLETED"},{"nct":"NCT04232969","name":"Exenatide-PD3 (Parkinson's disease over 96 weeks; primary endpoint not met)","phase":"Phase 3","n":194,"status":"COMPLETED"},{"nct":"NCT01971242","name":"Exenatide-PD (Parkinson's disease, single centre; signal not confirmed later)","phase":"Phase 2","n":60,"status":"COMPLETED"},{"nct":"NCT01104701","name":"Once-monthly depot suspension (no authorisation followed)","phase":"Phase 2","n":121,"status":"COMPLETED"},{"nct":"NCT01785771","name":"Implantable osmotic pump delivery (terminated)","n":100,"status":"TERMINATED"},{"nct":"NCT01455922","name":"Implantable osmotic pump delivery (withdrawn before enrolment)","n":0,"status":"WITHDRAWN"}],"sameAs":["https://www.wikidata.org/wiki/Q417762","https://pubchem.ncbi.nlm.nih.gov/compound/45588096","https://go.drugbank.com/drugs/DB01276","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL414357/"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Exenatide: what the trials show, status and safety","summary":"Exenatide is a lab-made copy of a peptide found in the venom of the Gila monster, a lizard of the American south-west. It has been a prescription-only medicine since 2005, and it was the first of the GLP-1 family to reach the market. In its largest trial, 14,752 adults with type 2 diabetes were followed for about three years. Serious heart events were slightly less common, but the difference was too small to rule out chance (p = 0.06). Newer relatives beat it in every head-to-head trial on this page, and a trial of 194 people found no effect on Parkinson's disease.","updated":"2026-09-10","url":"https://mypep.app/peptides/exenatide"}