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Bictegravir/lenacapavir - Gilead Sciences

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Drug Profile

Bictegravir/lenacapavir - Gilead Sciences

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

Latest Information Update: 31 Aug 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

  • Registered HIV-1 infections

Most Recent Events

  • 27 Aug 2026 Registered for HIV-1 infections (Treatment-experienced) in USA (PO)
  • 29 Apr 2026 FDA assigns PDUFA action date of (27/08/2026) for Bictegravir/lenacapavir for HIV-1 infections
  • 29 Apr 2026 Preregistration for HIV-1 infections (Treatment-experienced) in USA (PO) prior to April 2026

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