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Darunavir - Janssen R&D Ireland

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Drug Profile

Darunavir - Janssen R&D Ireland

Alternative Names: Prezista; TMC-114; Virem

Latest Information Update: 29 Jan 2026

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At a glance

  • Originator Tibotec Pharmaceuticals
  • Developer Gilead Sciences; Janssen R&D Ireland
  • Class Antiretrovirals; Carbamates; Furans; 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

  • 29 Jan 2026 No development reported - Phase-III for HIV-1 infections (In adolescents, In children, Treatment-experienced) in Guatemala, Thailand, Malaysia, Panama, Costa Rica (PO)
  • 29 Mar 2023 Phase-II/III clinical trials in HIV-1 infections (In adolescents, In children, In infants, Treatment-experienced) in Zimbabwe (PO) before March 2023 (NCT02016924)
  • 19 Feb 2023 Efficacy, adverse events and pharmacokinetic data from the phase II/III trial were presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI-2023)

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