, Volume 72, Issue 16, pp 2167–2175


First Global Approval


  • Vanessa McWilliams
    • Springer HealthcareAdis R&D Insight
    • Springer HealthcareAdis R&D Insight
  • Kate McKeage
    • Adis
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


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.

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© Springer International Publishing AG 2012