Naldemedine

Drug Profile

Naldemedine

Alternative Names: S-297995

Latest Information Update: 22 Dec 2016

Price : $50

At a glance

  • Originator Shionogi
  • Class Small molecules
  • Mechanism of Action Opioid mu receptor antagonists
  • Orphan Drug Status

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

    No
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Constipation

Most Recent Events

  • 19 Dec 2016 Shionogi and Purdue Pharma establish alliance for joint commercialisation of naldemedine in USA
  • 15 Oct 2016 Updated pooled efficacy and safety data from two phase III trial in Constipation presented at the 24th United European Gastroenterology Week (EGW-2016)
  • 07 Oct 2016 Efficacy and safety data from the phase III COMPOSE IV trial in Constipation presented at the 41st European Society for Medical Oncology Congress (ESMO - 2016)
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