title: Plecanatide: First Global Approval.
abstract: Plecanatide (TrulanceTM) is an oral guanylate cyclase-C agonist that is being developed by Synergy Pharmaceuticals for the treatment of gastrointestinal disorders, such as chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It is a synthetic analogue of human uroguanylin, a 16 amino acid peptide that regulates ion and fluid transport in the gastrointestinal tract. In January 2017, plecanatide received its first global approval in the USA for the treatment of adult patients with CIC. Plecanatide is undergoing phase III investigation in IBS-C. This article summarizes the milestones in the development of plecanatide leading to this first approval in CIC.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.
authors.forename: Zaina T
authors.initials: ZT
authors.lastname: Al-Salama
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
authors.forename: Yahiya Y
authors.initials: YY
authors.lastname: Syed
mesh_terms: D000328:Adult; D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D003248:Constipation / Q000188:drug therapy*; D017277:Drug Approval; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D015394:Molecular Structure; D045265:Natriuretic Peptides / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D014481:United States
chemical_list: D005765:Gastrointestinal Agents; D045265:Natriuretic Peptides; C084362:uroguanylin; C584575:plecanatide