Plecanatide

Drug Profile

Plecanatide

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

Latest Information Update: 08 Jun 2017

$50 / €47 *
* $ price applies to USA, Canada and Latin America. € price applies to the rest of the world. Final gross prices may vary according to local VAT.

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
  • 09 May 2017 Safety and efficacy data from a pooled analysis of the phase III SP304203-05 and SP304203-04 studies in Irritable bowel syndrome (characterised by constipation) released by Synergy Pharmaceuticals
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