Linaclotide: first global approval.
Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.
Adis RD Insight, Springer Healthcare, Auckland, New Zealand.
Vanessa
V
McWilliams
Glenn
G
Whiteside
Kate
K
McKeage
D003248:Constipation / Q000188:drug therapy*; D017277:Drug Approval; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D005772:Gastrointestinal Transit / Q000187:drug effects; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D050705:Receptors, Guanylate Cyclase-Coupled / Q000819:agonists* / Q000627:therapeutic use; D018000:Receptors, Peptide / Q000819:agonists* / Q000627:therapeutic use; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D010455:Peptides; D018000:Receptors, Peptide; D050705:Receptors, Guanylate Cyclase-Coupled; C523483:linaclotide