FDA accepts Gilead's sNDA for once-weekly oral Yeztugo for HIV PrEP

Sponsor

Gilead Sciences $GILD

Drug

Yeztugo · lenacapavir

Indication

HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents

FDA accepted Gilead Sciences's supplemental New Drug Application for Yeztugo (lenacapavir) 300 mg tablet as a once-weekly oral formulation for HIV pre-exposure prophylaxis (PrEP). PDUFA target action date is February 2, 2027. If approved, once-weekly oral Yeztugo would be the first long-acting oral PrEP option — filling the middle ground between the current daily-oral standard-of-care (F/TDF, F/TAF) and Gilead's own twice-yearly subcutaneous lenacapavir (Yeztugo injection, approved 2025). The submission is supported by the established clinical profile of lenacapavir in PrEP from the PURPOSE 1 and PURPOSE 2 Phase 3 trials.