Paliperidone

Drug Profile

Paliperidone

Alternative Names: 9-hydroxyrisperidone; Invega; JNS-007ER; Paliperidone ER; Paliperidone ER OROS; Paliperidone extended-release; R0-76477; RO-76477

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Johnson & Johnson
  • Developer Janssen Pharmaceutical KK; Johnson & Johnson
  • Class 2 ring heterocyclic compounds; Antipsychotics; Fluorobenzenes; Isoxazoles; Piperidines; Pyrimidinones; Small molecules
  • Mechanism of Action Dopamine D2 receptor antagonists; Serotonin 2 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 No

Highest Development Phases

  • Marketed Aggression; Agitation; Schizoaffective disorder; Schizophrenia
  • Discontinued Bipolar disorders; Insomnia; Manic episodes

Most Recent Events

  • 17 Apr 2016 Biomarkers information updated
  • 05 Mar 2015 No recent reports on development identified - Phase-III for Schizophrenia (In adolescents) in India, Russia, South Korea and Ukraine (PO)
  • 24 Oct 2014 Committee for Medicinal Products for Human Use (CHMP) of EMA recommends approval of paliperidone XR (25mg, 50mg, 100mg, 150mg and 150/100mg) for Schizophrenia in European Union, based on an informed consent application
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