Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo as a potential once-weekly oral formulation for HIV prevention. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027, to review the application for the 300-mg tablet used as pre-exposure prophylaxis (PrEP).
The submission is supported by the clinical profile of lenacapavir, the active ingredient in Yeztugo. Data from the PURPOSE 1 and PURPOSE 2 trials demonstrated high efficacy in HIV prevention across diverse populations, including cisgender women, cisgender men, and gender-diverse people. If approved, this once-weekly oral option could become the first long-acting oral PrEP available.
Dietmar Berger, Chief Medical Officer at Gilead Sciences, stated that the filing reflects the company's commitment to advancing new HIV prevention options. He noted that nearly one year after the approval of twice-yearly Yeztugo, the company aims to extend the impact of its long-acting innovation into new formulations to broaden how HIV prevention is delivered.
Currently, lenacapavir oral tablets are approved within the Yeztugo regimen as an initial loading dose and as bridge therapy when administration of the every-six-month injections is delayed. The once-weekly oral formulation for PrEP remains investigational and is not approved anywhere globally.
About Lenacapavir
Lenacapavir is approved in multiple countries as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents at risk of acquisition. It is also approved for the treatment of multi-drug-resistant HIV in adults in combination with other antiretrovirals. The drug features a multi-stage mechanism of action designed to inhibit HIV at multiple stages of its lifecycle, with no known cross-resistance to other existing drug classes in vitro.
| Feature |
Description |
| Current Approval |
PrEP and treatment of multi-drug-resistant HIV |
| Mechanism |
Multi-stage inhibition of HIV lifecycle |
| Investigational Use |
Once-weekly oral PrEP |