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Bictegravir · Biktarvy, Bixlenvo

Small molecule · Inhibitor of HIV-1 integrase · developed by Gilead Sciences

Approved FDA

GILD Developer

1 Registered trials

What is Bictegravir?

Bictegravir is an HIV-1 integrase strand transfer inhibitor (INSTI) that inhibits the strand transfer activity of HIV-1 integrase, preventing integration of viral DNA into host genomic DNA.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Biktarvy, Bixlenvo, GS-9883, GS-9883-01
Drug type: Small molecule
Targets: HIV-1 integrase
Mechanism: Inhibitor of HIV-1 integrase
Pathways: viral replication
Therapy area: Infectious disease
Developer: Gilead Sciences, Inc. (GILD)
FDA status: Approved as Biktarvy, Bixlenvo, NDA221104 · FDA label
UNII: 8GB79LOJ07

✅ FDA-approved uses

HIV-1 infection (Bixlenvo)
HIV-1 infection (Biktarvy)

From the indications section of the FDA label (version of Aug 27, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06532656	Phase 2/3	HIV-1-infection	Active not recruiting	GILD

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

HIV-1-infection

More from Gilead Sciences

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the GILD page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z