Cobicistat/darunavir/emtricitabine/tenofovir alafenamide

Drug Profile

Cobicistat/darunavir/emtricitabine/tenofovir alafenamide

Alternative Names: Cobicistat/darunavir/emtricitabine/GS 7340; Cobicistat/darunavir/emtricitabine/GS 7340 fixed-dose combination - Gilead/Tibotec; Darunavir/cobicistat/emtricitabine/GS-7340; Darunavir/emtricitabine/GS 7340/cobicistat; Emtricitabine/GS 7340/cobicistat/darunavir; GS 7340/cobicistat/darunavir/emtricitabine; SYMTUZA; Tenofovir alafenamide/cobicistat/darunavir/emtricitabine

Latest Information Update: 27 Jul 2017

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At a glance

  • Originator Gilead Sciences; Tibotec Pharmaceuticals
  • Developer Gilead Sciences; Janssen R&D Ireland
  • Class Antiretrovirals; Deoxyribonucleosides; Purines; Pyrimidine nucleosides; Small molecules; Sulfonamides
  • Mechanism of Action Cytochrome P 450 enzyme system inhibitors; HIV protease inhibitors; Nucleoside reverse transcriptase inhibitors; Nucleotide reverse transcriptase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration HIV-1 infections

Most Recent Events

  • 26 Jul 2017 Janssen plans a phase III trial for HIV-1 infections (Treatment-naive) in USA (NCT03227861)
  • 25 Jul 2017 Interim efficacy adverse events data from a phase III EMERALD trial in HIV-1 infections released by Janssen-Cilag International
  • 21 Jul 2017 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of cobicistat/darunavir/emtricitabine/tenofovir alafenamide for HIV-1 infections in European Union
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