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FEB 2 2027
UPCOMING · 126 DAYS TO PDUFA

Gilead Sciences — Yeztugo (lenacapavir) $GILD

for HIV-1 pre-exposure prophylaxis (PrEP) — once-weekly oral formulation

sNDA · Standard Review

Accepted JUN 15 2026.

About

HIV pre-exposure prophylaxis (PrEP) is a highly effective strategy to prevent HIV infection, but current daily pills require strict adherence and long-acting injections need clinic visits. Yeztugo (lenacapavir) is a weekly oral pill that works by blocking the HIV capsid, a critical shell that protects the virus's genetic material. This once-weekly option could offer a more convenient prevention method, potentially helping people who struggle with daily pill routines.

Pivotal trial

PURPOSE 365 Phase 3 active not recruiting NCT07047716

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrE...

Source: ClinicalTrials.gov

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