R&D Insight Profile

Drugs

, Volume 72, Issue 16, pp 2167-2175

Linaclotide

First Global Approval
  • Vanessa McWilliamsAffiliated withSpringer Healthcare, Adis R&D Insight
  • , Glenn WhitesideAffiliated withSpringer Healthcare, Adis R&D Insight Email author 
  • , Kate McKeageAffiliated withAdis

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Abstract

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.