Gilead Sciences announced that the US Food and Drug Administration (FDA) has 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.

Dietmar Berger, Chief Medical Officer (CMO), Gilead Sciences, said, “This filing reflects Gilead’s continued commitment to advancing new HIV prevention options. Nearly 1 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-6-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.