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Linaclotide

First Global Approval

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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.

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Authors and Affiliations

  1. Springer Healthcare, Adis R&D Insight, Auckland, New Zealand

    Vanessa McWilliams & Glenn Whiteside

  2. Adis, Auckland, New Zealand

    Kate McKeage

Authors
  1. Vanessa McWilliams
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  2. Glenn Whiteside
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  3. Kate McKeage
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Correspondence to Glenn Whiteside.

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McWilliams, V., Whiteside, G. & McKeage, K. Linaclotide. Drugs 72, 2167–2175 (2012). https://doi.org/10.2165/11470590-000000000-00000

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  • DOI: https://doi.org/10.2165/11470590-000000000-00000

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