Gilead Sciences (Nasdaq: GILD) announced that the US FDA has accepted its sNDA for Yeztugo (lenacapavir) 300-mg tablets as a once-weekly oral formulation for HIV prevention as PrEP in adults and adolescents at risk of sexually acquired HIV-1. If approved, the regimen would become the first once-weekly oral PrEP option, offering an alternative to daily oral prevention while expanding access beyond the currently approved twice-yearly injectable formulation.
The FDA has assigned a PDUFA action date to the filing of February 2, 2027. The sNDA is a supplemental application for a drug already approved in its injectable form; Yeztugo injection received US approval for PrEP in 2025. The oral tablet formulation is currently investigational and not approved anywhere globally, though lenacapavir tablets are already permitted as part of the existing Yeztugo injection regimen for loading doses and bridging therapy when injections are delayed.
The sNDA is supported by efficacy and safety data from the PURPOSE 1 and PURPOSE 2 Phase III trials, which evaluated twice-yearly subcutaneous lenacapavir for PrEP across diverse global populations including cisgender women, cisgender men, and gender-diverse individuals. Both trials demonstrated high efficacy in reducing sexually acquired HIV-1 infection. Lenacapavir oral tablets are already included in the approved Yeztugo regimen as an initiation loading dose and as bridge therapy when the six-monthly injection is delayed by more than two weeks, at a dosage of 300 mg once every seven days. The proposed once-weekly oral regimen would use the same 300-mg tablet dose.