Plecanatide- Synergy Pharmaceuticals

Drug Profile

Plecanatide- Synergy Pharmaceuticals

Alternative Names: GCRA; Guanilib; SP-304; TRULANCE

Latest Information Update: 17 Oct 2017

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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.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 08 Jun 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Irritable bowel syndrome in USA (PO) is 2018-01-24
  • 07 Jun 2017 The US FDA accepts sNDA for Plecanatide for Irritable bowel syndrome with constipation for review
  • 01 Jun 2017 Synergy Pharmaceuticals completes a phase III long-term safety trial for Irritable bowel syndrome (characterised by constipation) in USA (PO) (NCT02706483)
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