Varenicline

Drug Profile

Varenicline

Alternative Names: Champix; Chantix; CP-526,555; CP-526555-18; Varenicline tartrate

Latest Information Update: 11 Jan 2017

Price : $50

At a glance

  • Originator Pfizer
  • Class 3-ring heterocyclic compounds; Azabicyclo compounds; Benzazepines; Bridged-ring heterocyclic compounds; Quinoxalines; Small molecules; Smoking cessation therapies
  • Mechanism of Action Alpha4 beta2 nicotinic receptor agonists
  • 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

  • Marketed Smoking withdrawal
  • Discontinued Alzheimer's disease

Most Recent Events

  • 01 Jan 2017 Pfizer completes a phase III trial in Smoking withdrawal in Pakistan (PO) (ISRCTN94103375)
  • 16 Dec 2016 US FDA approves removal of boxed warning regarding serious neuropsychiatric events from varenicline label
  • 14 Sep 2016 The US FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee recommend removal of the boxed warning for Smoking withdrawal
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