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Darunavir - Janssen R&D Ireland

Drug Profile

Darunavir - Janssen R&D Ireland

Alternative Names: Prezista; TMC-114; Virem

Latest Information Update: 08 Jul 2019

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At a glance

  • Originator Tibotec Pharmaceuticals
  • Developer Gilead Sciences; 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
  • New Molecular Entity Yes
  • Available For Licensing Yes - HIV infections; HIV-1 infections

Highest Development Phases

  • Marketed HIV-1 infections

Most Recent Events

  • 08 Jul 2019 Launched for HIV-1 infections (Combination therapy) in USA prior July 2019 (PO)
  • 24 Jun 2018 Biomarkers information updated
  • 23 Nov 2017 Janssen R&D Ireland completes a continued access phase II trial in HIV-1 infections (Combination therapy, In Children In adolescents, In adults, In the elderly) in Argentina, Brazil, France, India, South Africa, Spain, Ukraine, United Kingdom and Italy (PO) (NCT01138605) (EudraCT2009-017013-29)
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