Drug Profile


Alternative Names: GCRA; Guanilib; SP-304

Latest Information Update: 15 Dec 2016

Price : $50

At a glance

  • Originator Callisto Pharmaceuticals
  • Developer Synergy Pharmaceuticals Inc
  • Class Anti-inflammatories; Peptides
  • Mechanism of Action Guanylate cyclase C agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Constipation
  • Phase III Irritable bowel syndrome
  • Discontinued Inflammatory bowel diseases; Ulcerative colitis

Most Recent Events

  • 09 Dec 2016 Efficacy and adverse events data from two phase III trials in Irritable bowel syndrome (characterised by constipation) released by Synergy Pharmaceuticals
  • 09 Nov 2016 Updated adverse events data from a phase III trial in Constipation released by Synergy Pharmaceuticals
  • 17 Oct 2016 Adverse events data from a phase III extension trial in Constipation released by Synergy Pharmaceuticals
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