US FDA accepts Gilead’s application for investigational once-weekly oral Yeztugo, potentially the first long-acting pill for HIV prevention

Gilead Sciences has announced that the US Food and Drug Administration has accepted its supplemental New Drug Application for Yeztugo (lenacapavir) as a 300mg tablet in a potential once-weekly oral formulation for HIV prevention as pre-exposure prophylaxis. The FDA has assigned a Prescription Drug User Fee Act action date of February 2nd 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 application is grounded in the well-established clinical profile of lenacapavir for pre-exposure prophylaxis, drawing on findings from the PURPOSE 1 and PURPOSE 2 trials, which confirmed high efficacy across a wide range of global populations including cisgender women, cisgender men, and gender-diverse individuals. Lenacapavir oral tablets already hold approval within the Yeztugo regimen, serving as both an initial loading dose and a bridge therapy when the every-six-month injection schedule is interrupted. Should the submission succeed, once-weekly oral Yeztugo could become the first long-acting oral pre-exposure prophylaxis option available anywhere in the world.

Once-weekly oral lenacapavir for pre-exposure prophylaxis remains investigational and has not yet received approval in any market globally. No cure currently exists for HIV or AIDS.

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Related Topics and Keywords

gilead, HIV, Yeztugo