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Bictegravir/lenacapavir - Gilead Sciences

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Drug Profile

Bictegravir/lenacapavir - Gilead Sciences

Alternative Names: GS-6207/GS-9883; GS-9883/GS-6207; Lenacapavir/bictegravir - Gilead Sciences; Lenacapavir/bictegravir oral combination - Gilead Sciences

Latest Information Update: 05 Mar 2026

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At a glance

  • Originator Gilead Sciences
  • Class Acetamides; Alkynes; Antiretrovirals; Antivirals; Chlorobenzenes; Fluorinated hydrocarbons; Oxazepines; Pyrazines; Pyrazoles; Pyridines; Pyridones; Sulfonamides; Sulfones
  • Mechanism of Action Capsid protein inhibitors; HIV integrase 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 Yes

Highest Development Phases

  • Phase III HIV-1 infections

Most Recent Events

  • 25 Feb 2026 Efficacy and adverse events data from the phase III ARTISTRY-2 and phase II/III ARTISTRY-1 trial in HIV-1 infections released by Gilead Sciences
  • 12 Jan 2026 Phase-II/III clinical trials in HIV-1 infections (Treatment-experienced, In children, In adolescents) in Argentina, Italy, South Africa, Spain (PO) (NCT06532656)
  • 15 Dec 2025 Gilead Sciences announces intention to submit regulatory application for HIV-1 infections

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