U.S. FDA Accepts Gilead’s Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) 300-mg tablet as a potential once-weekly (QW) oral formulation for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027.

“This filing reflects Gilead’s continued commitment to advancing new HIV prevention options,” said Dietmar Berger, Chief Medical Officer, Gilead Sciences. “Nearly one year after the approval of twice-yearly Yeztugo, we are building on the established clinical profile of lenacapavir to potentially extend the impact of our long‑acting innovation into new formulations to meaningfully broaden how HIV prevention is delivered as PrEP. HIV prevention is not one-size-fits-all, and if approved, once-weekly oral Yeztugo would provide more choice for people who need or want PrEP.”

The submission is supported by the robust and established clinical profile of lenacapavir for PrEP, based on results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated high efficacy across diverse global populations, including cisgender women, cisgender men and gender-diverse people. Lenacapavir oral tablets are already approved for use within the Yeztugo regimen as an initial loading dose and as a bridge therapy when administration of the every-six-month injections are delayed. If approved, once-weekly oral Yeztugo could become the first long-acting oral PrEP option.

Once-weekly oral lenacapavir for PrEP is investigational and not approved anywhere globally. There is currently no cure for HIV or AIDS.

Please see below for the U.S. Indication and Important Safety Information for Yeztugo, including Boxed Warning.

About Lenacapavir

Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

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