As reported on Business Wire, Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application for a 300‑mg oral formulation of lenacapavir (Yeztugo) as a once-weekly option for HIV pre-exposure prophylaxis (PrEP). The regulatory agency has assigned a target decision date of February 2, 2027 under the Prescription Drug User Fee Act.
If approved, the investigational therapy could represent the first long-acting oral PrEP regimen administered weekly, expanding the current range of HIV prevention strategies. Existing PrEP options typically include daily oral medications or, more recently, long-acting injectable agents administered every few months.
Clinical Evidence Supports Potential Use
The application is grounded in data from the PURPOSE 1 and PURPOSE 2 clinical trials, which evaluated lenacapavir for HIV prevention. Across these studies, the agent demonstrated strong efficacy in reducing HIV risk among diverse populations, including cisgender women, cisgender men, and gender-diverse individuals. These findings have contributed to growing interest in lenacapavir as a flexible prevention tool.
Lenacapavir already has an established role within its currently approved regimen. Oral tablets are used as part of a lead-in dosing strategy and as a temporary measure if scheduled injections are delayed. The proposed once-weekly version would build on this clinical foundation to offer a standalone preventive option.
Expanding the PrEP Landscape
According to Gilead leadership, the submission reflects ongoing efforts to diversify HIV prevention approaches. A weekly oral formulation could appeal to individuals who prefer not to adhere to a daily pill or who may not have access to injectable therapies. Broader choice in dosing schedules may help address adherence challenges and improve uptake of PrEP in different populations.
Long-acting HIV prevention has been a growing area of innovation, with the aim of reducing barriers associated with daily medication use. A once-weekly pill could occupy a middle ground between daily oral regimens and infrequent injections, potentially increasing convenience while maintaining sustained drug activity.
Ongoing Development and Considerations
It is important to note that the once-weekly oral formulation remains investigational and has not been approved in any country. While the clinical results to date are promising, regulatory review will determine whether the therapy meets safety and efficacy standards for widespread use.
Despite advances in prevention and treatment, HIV remains a significant public health concern worldwide, and there is still no cure. Continued development of diverse prevention modalities—including long-acting options—remains a key priority in global health efforts.
The FDA’s upcoming review of lenacapavir’s weekly oral formulation will be closely watched as stakeholders assess its potential role in future HIV prevention strategies.
