{"slug":"dulaglutide","seoKey":"dulaglutide","inn":"dulaglutide","displayName":"Dulaglutide","codes":["LY2189265","A10BJ05"],"synonyms":["Dulaglutidum [INN-Latin]","dulaglutidum","Dulaglutid","dulaglutida","Dulaglutide (genetical recombination)","GLP-1 receptor agonist (substance class, not a trade name)"],"legalClass":"rx","identifiers":{"cas":"923950-08-7","unii":"WTT295HSY5","drugbankId":"DB09045","chemblId":"CHEMBL2108027","wikidataQid":"Q21011228"},"approvals":[{"market":"US","status":"approved_rx","date":"2014-09-18","note":"Licensed as a biological product under a Biologics License Application (BLA 125469) and prescription-only; the original approval was classified as a new molecular entity. The indication covers type 2 diabetes from ten years of age and, since a supplement approved on 21 February 2020, the reduction of major adverse cardiovascular events in adults with type 2 diabetes — both in established cardiovascular disease and in the presence of multiple cardiovascular risk factors, which reaches further than the comparable indications of other agents in this class. There is no approval for weight management. Neither a generic nor a biosimilar has been approved.","source":"https://api.fda.gov/drug/drugsfda.json?search=application_number:%22BLA125469%22"},{"market":"EU","status":"approved_rx","date":"2014-11-21","note":"Authorised centrally (procedure EMEA/H/C/002825, authorisation numbers EU/1/14/956/001 to 016) and prescription-only; the authorisation was last renewed on 23 August 2019. The indication covers insufficiently controlled type 2 diabetes from ten years of age, as monotherapy where the standard first-line medicine is unsuitable or in addition to other diabetes medicines. Unlike the US label, the European product information does not carry cardiovascular risk reduction as a separate indication, and there is no approval for weight management.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/trulicity"},{"market":"DE","status":"approved_rx","date":"2014-11-21","note":"Authorised through the centralised EU procedure with the same indication, and prescription-only under the German Medicines Act, dispensed only against a prescription. As an antidiabetic medicine it is not caught by the exclusion for lifestyle medicines in section 34(1) sentence 7 of the German Social Code, Book V, which bars medicines for slimming, appetite suppression and body-weight regulation from statutory health insurance; the question of self-payment for weight management does not arise here, because no such indication is approved anywhere.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/trulicity"},{"market":"UK","status":"approved_rx","date":"2014-11-21","note":"Authorised under four Great Britain marketing authorisations (PLGB 14895/0259 to 0262), carried over from the earlier European authorisation, and classified as a prescription only medicine. The summary of product characteristics was last revised on 25 February 2026.","source":"https://www.medicines.org.uk/emc/search?q=dulaglutide"},{"market":"AU","status":"approved_rx","date":"2026-05-28","note":"Listed in the Poisons Standard as Schedule 4, prescription only, without any exemption; the substance entry stands in the Schedule 4 list alongside the other agents of this class. Date given is the registration of the Poisons Standard instrument (F2026L00633), not a first approval; the Australian Register of Therapeutic Goods could not be queried on 10 September 2026, so registration numbers and sponsor are deliberately absent.","source":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/scheduling-basics/poisons-standard-susmp"},{"market":"CA","status":"approved_rx","note":"Authorised with six drug identification numbers and marketed; classified as prescription and, as a biologic drug, additionally under Schedule D. One of the products has been cancelled pre market since 22 July 2021. No date is given because the date of the first notice of compliance could not be retrieved — that endpoint answered with HTTP 404 on 10 September 2026; the earliest verified market date is the start of marketing of one presentation on 8 January 2016.","source":"https://health-products.canada.ca/api/drug/drugproduct/?lang=en&type=json&id=93430"},{"market":"CH","status":"approved_rx","date":"2015-05-06","note":"Authorised under authorisation number 65236 as a principal authorisation and prescription-only (dispensing category B), classified as a biotechnological medicine; the authorisation runs without a time limit. The two lower strengths carry the 2015 authorisation date, the two higher ones 18 October 2021. The register lists the field of use as an antidiabetic medicine with prevention of cardiovascular events.","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":"NCT01394952","name":"REWIND (cardiovascular outcomes in type 2 diabetes)","phase":"Phase 3","n":9901,"status":"COMPLETED"},{"nct":"NCT03495102","name":"AWARD-11 (higher strengths versus the highest approved strength)","phase":"Phase 3","n":1842,"status":"COMPLETED"},{"nct":"NCT02963766","name":"AWARD-PEDS (type 2 diabetes from 10 to under 18 years)","phase":"Phase 3","n":154,"status":"COMPLETED"},{"nct":"NCT01064687","name":"AWARD-1 (add-on to metformin and pioglitazone)","phase":"Phase 3","n":978,"status":"COMPLETED"},{"nct":"NCT01075282","name":"AWARD-2 (comparison with a sulfonylurea regimen)","phase":"Phase 3","n":810,"status":"COMPLETED"},{"nct":"NCT01126580","name":"AWARD-3 (monotherapy comparison with metformin)","phase":"Phase 3","n":807,"status":"COMPLETED"},{"nct":"NCT01191268","name":"AWARD-4 (add-on to mealtime insulin)","phase":"Phase 3","n":884,"status":"COMPLETED"},{"nct":"NCT00734474","name":"AWARD-5 (dose finding and confirmation on metformin)","phase":"Phase 2/3","n":1202,"status":"COMPLETED"},{"nct":"NCT01624259","name":"AWARD-6 (head-to-head comparison with liraglutide)","phase":"Phase 3","n":599,"status":"COMPLETED"},{"nct":"NCT01621178","name":"AWARD-7 (type 2 diabetes with moderate to severe chronic kidney disease)","phase":"Phase 3","n":577,"status":"COMPLETED"},{"nct":"NCT02152371","name":"AWARD-9 (add-on to basal insulin)","phase":"Phase 3","n":300,"status":"COMPLETED"},{"nct":"NCT02597049","name":"AWARD-10 (add-on to an SGLT2 inhibitor)","phase":"Phase 3b","n":424,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q21011228","https://go.drugbank.com/drugs/DB09045","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108027/"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Dulaglutide: what the trials show, status and safety","summary":"Dulaglutide is a laboratory-made protein that copies a natural gut hormone and switches on the same docking point. It has been an approved, prescription-only medicine since 2014, licensed for type 2 diabetes and, in America, for lowering heart risk. In a trial of 9,901 adults followed for a median of 5.4 years, serious heart events were about 12 percent less common. It is licensed nowhere for weight loss, and in the one trial that placed it beside semaglutide it came off worse on both blood sugar and weight.","updated":"2026-09-10","url":"https://mypep.app/peptides/dulaglutide"}