Drugs

, Volume 72, Issue 16, pp 2167–2175

Linaclotide

First Global Approval
  • Vanessa McWilliams
  • Glenn Whiteside
  • Kate McKeage
R&D Insight Profile

DOI: 10.2165/11470590-000000000-00000

Cite this article as:
McWilliams, V., Whiteside, G. & McKeage, K. Drugs (2012) 72: 2167. doi:10.2165/11470590-000000000-00000

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.

Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  • Vanessa McWilliams
    • 1
  • Glenn Whiteside
    • 1
  • Kate McKeage
    • 2
  1. 1.Springer HealthcareAdis R&D InsightAucklandNew Zealand
  2. 2.AdisAucklandNew Zealand
  3. 3.Adis R&D InsightMairangi Bay, North Shore 0754, AucklandNew Zealand