Darunavir

Drug Profile

Darunavir

Alternative Names: Prezista; TMC-114; Virem

Latest Information Update: 18 Nov 2016

Price : $50

At a glance

  • Originator Tibotec Pharmaceuticals
  • Developer Janssen R&D Ireland
  • Class Antiretrovirals; Sulfonamides
  • Mechanism of Action HIV protease inhibitors
  • Orphan Drug Status

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

    Yes - HIV infections
  • 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
  • Available For Licensing Yes - HIV infections; HIV-1 infections

Highest Development Phases

  • Marketed HIV-1 infections

Most Recent Events

  • 18 Jul 2016 The US FDA approves use of darunavir in pregnant women with HIV-1 infections
  • 18 Jul 2016 Adverse events data from a phase III trial in HIV-1 infections released by Janssen Therapeutics
  • 19 Mar 2015 Darunavir is still in phase III trials for HIV-1 infections (pharmacokinetics study in pregnant women) in Costa Rica
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