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Etravirine - Janssen R&D Ireland

Drug Profile

Etravirine - Janssen R&D Ireland

Alternative Names: Intelence; R165335; TMC-125

Latest Information Update: 24 Oct 2021

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At a glance

  • Originator Tibotec Pharmaceuticals
  • Developer Janssen R&D Ireland; Janssen-Cilag; Xian-Janssen
  • Class Antiretrovirals; Pyridazines; Small molecules
  • Mechanism of Action Non-nucleoside reverse transcriptase inhibitors
  • Orphan Drug Status

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

    Yes - HIV-1 infections
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed HIV-1 infections

Most Recent Events

  • 01 Apr 2018 French National Institute for Health and Medical Research completes a phase II trial for HIV-1 infections (Combination therapy, Treatment-experienced) in France, and Spain (NCT02212379)
  • 10 Mar 2015 No recent reports on development identified - Phase-II for HIV-1 infections (Combination therapy, Treatment-naive) in USA, Australia, Austria, Belgium, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Romania, Russia, Spain, Switzerland and United Kingdom (PO)
  • 16 Nov 2012 Committee for Medicinal Products for Human Use recommends approval of Etravirine for HIV-1 infections (combination therapy, in children, in adolescents, treatment-experienced patients) in EU
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