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Lenacapavir · Sunlenca, Yeztugo

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

Approved FDA, Dec 2022

GILD Developer

4 Registered trials

What is Lenacapavir?

Lenacapavir is an HIV-1 capsid inhibitor that binds the viral capsid protein and interferes with its function during the viral life cycle. It is studied in HIV-1 infection and in pre-exposure prophylaxis to reduce the risk of HIV-1 acquisition.

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

At a glance

Also known as: Sunlenca, Yeztugo, LEN, GS-6207, GS-714207
Drug type: Small molecule
Targets: HIV-1 capsid protein
Mechanism: Inhibitor of HIV-1 capsid protein
Therapy area: Infectious disease
Developer: Gilead Sciences Inc (GILD)
FDA status: Approved as Sunlenca, Yeztugo (December 22, 2022), NDA215973 · FDA label
UNII: A9A0O6FB4H

✅ FDA-approved uses

HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 (Sunlenca)
Oral loading as a component of the initiation regimen for BIXLENVO (bictegravir/lenacapavir) (Sunlenca)
Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 (Yeztugo)

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
NCT07708727	Phase 2/3	HIV-1-infection	Recruiting	GILD
NCT06532656	Phase 2/3	HIV-1-infection	Active not recruiting	GILD
NCT04925752	Phase 3	Pre-Exposure Prophylaxis of HIV Infection	Active not recruiting	GILD
NCT04150068	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-infectionPre-Exposure Prophylaxis of HIV Infection

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Sources

Updated Oct 11, 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