title: Lixisenatide: first global approval.
abstract: The selective once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Lyxumia(®)) is under development with Sanofi for the treatment of type 2 diabetes mellitus. Lixisenatide belongs to a class of GLP-1 compounds designed to mimic the endogenous hormone GLP-1. Native GLP-1 stimulates insulin secretion in a glucose-dependent manner, as well as suppressing glucagon production and slowing gastric emptying. A once-daily subcutaneous formulation of lixisenatide has been approved in the EU, Iceland, Liechtenstein, Norway and Mexico for the treatment of type 2 diabetes, and is under regulatory review in the USA, Switzerland, Brazil, Canada, Ukraine, South Africa, Japan and Australia. This article summarizes the milestones in the development of lixisenatide, leading to this first approval for use in adults with type 2 diabetes.
authors.affiliation: Adis R&D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand. DRU@adis.com
authors.forename: Shelley
authors.initials: S
authors.lastname: Elkinson
authors.forename: Gillian M
authors.initials: GM
authors.lastname: Keating
mesh_terms: D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D017277:Drug Approval; D000067757:Glucagon-Like Peptide-1 Receptor; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D010455:Peptides / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D018027:Receptors, Glucagon / Q000819:agonists*; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D000067757:Glucagon-Like Peptide-1 Receptor; D007004:Hypoglycemic Agents; D010455:Peptides; D018027:Receptors, Glucagon; C000593833:GLP1R protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
references.citation: Diabetes Obes Metab. 2012 Oct;14(10):910-7
references.pmid: 22564709
references.citation: Diabet Med. 2010 Sep;27(9):1024-32
references.pmid: 20722676
references.citation: Diabetes Care. 2012 Jun;35(6):1225-31
references.pmid: 22432104
references.citation: IDrugs. 2009 Aug;12(8):503-13
references.pmid: 19629885
references.citation: Regul Pept. 2010 Sep 24;164(2-3):58-64
references.pmid: 20570597
references.citation: J Pharmacol Exp Ther. 2003 Nov;307(2):490-6
references.pmid: 12975499
references.citation: Adv Ther. 2013 Feb;30(2):81-101
references.pmid: 23423907
references.citation: Diabetes Obes Metab. 2013 Jul;15(7):642-9
references.pmid: 23368510
references.citation: Drugs. 2011 Sep 10;71(13):1675-88
references.pmid: 21902291