Ranolazine extended-release

Drug Profile

Ranolazine extended-release

Alternative Names: CVT 303; CVT 3041; KEG 1295; RAN D; Ran4; Ranexa; Ranolazine hydrochloride; RS 43285; RS 43285-003; RS 43285-193

Latest Information Update: 14 Feb 2017

Price : $50

At a glance

  • Originator Syntex Pharmaceuticals International
  • Developer CV Therapeutics; Gilead Sciences; Kissei Pharmaceutical; Menarini; North Shore-Long Island Jewish Health System; University of Rochester
  • Class Acetanilides; Anti-ischaemics; Ischaemic heart disorder therapies; Piperazines; Small molecules
  • Mechanism of Action Partial fatty acid oxidation inhibitors; Pyruvate dehydrogenase stimulants
  • 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 Angina pectoris
  • Phase III Acute coronary syndromes; Atrial fibrillation; Type 2 diabetes mellitus
  • Phase II Aortic valve stenosis; Heart failure; Left ventricular hypertrophy; Long QT syndrome; Myocardial ischaemia
  • Discontinued Intermittent claudication; Ventricular arrhythmias

Most Recent Events

  • 15 Mar 2016 Biomarkers information updated
  • 01 Mar 2016 Menarini initiates a phase I trial in Healthy volunteers in South Korea (PO) (NCT02817932)
  • 01 Aug 2015 North Florida Foundation for Research and Education and Gilead initiate a phase II trial for Angina pectoris in USA (PO) (NCT02147834)
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