FOSTER CITY, Calif., June 16, 2026
Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for a once-weekly oral formulation of Yeztugo® (lenacapavir) for HIV pre-exposure prophylaxis (PrEP), marking a significant step toward expanding prevention options for individuals at risk of HIV infection. If approved, the therapy could become the first long-acting once-weekly oral pill for HIV prevention, offering a new alternative to daily oral regimens and injectable preventive therapies. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027, initiating the regulatory review process for the investigational formulation.
FDA Acceptance Advances Long-Acting HIV Prevention Strategy
The regulatory submission builds on the established clinical profile of lenacapavir, a multi-stage HIV capsid inhibitor that has already gained recognition as one of the most important advances in HIV prevention and treatment. According to Gilead, the filing reflects the company’s ongoing commitment to expanding prevention choices and addressing diverse patient needs through innovative long-acting therapies. The proposed once-weekly oral formulation is designed to provide greater flexibility for individuals who may prefer a long-acting pill over injectable or daily oral options.
The application is supported by findings from the landmark PURPOSE 1 and PURPOSE 2 clinical trials, which demonstrated high efficacy in preventing HIV infection across diverse populations, including cisgender women, cisgender men, and gender-diverse individuals. These results helped establish lenacapavir as a leading candidate in the next generation of HIV prevention strategies and reinforced its potential role in helping reduce new HIV infections globally.
Lenacapavir Clinical Profile Supports Expanded PrEP Access
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Lenacapavir possesses a unique mechanism of action that differentiates it from currently available antiviral therapies. Unlike traditional HIV medicines that target a single stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle, providing durable antiviral activity and a strong resistance profile. The molecule is already approved in several countries as part of HIV treatment and prevention programs and serves as the foundation of Gilead’s long-acting HIV portfolio.
The company noted that oral lenacapavir tablets are currently approved within the existing Yeztugo regimen as an initial loading dose and as bridge therapy when scheduled injections are delayed. If the once-weekly formulation receives approval, it would represent a major expansion of patient choice within the HIV prevention landscape. Importantly, the investigational regimen remains under regulatory review and has not yet been approved for HIV prevention anywhere in the world.
Potential First Long-Acting Weekly Pill for HIV Prevention
The FDA acceptance highlights growing momentum behind long-acting HIV prevention technologies, which are increasingly viewed as critical tools in reducing barriers to adherence and expanding access to PrEP. Gilead continues to advance lenacapavir across multiple prevention and treatment programs, including studies evaluating various dosing schedules and formulations. The company believes offering both long-acting injectable and oral options could help meet the diverse preferences of people and communities affected by HIV worldwide.
Industry observers note that successful approval of once-weekly oral Yeztugo could reshape the HIV prevention market by introducing a convenient long-acting oral alternative capable of improving adherence while maintaining strong efficacy. As regulatory review progresses toward the February 2027 decision date, the HIV community will closely watch whether lenacapavir becomes the first approved weekly oral PrEP option and further strengthens efforts aimed at ending the global HIV epidemic.
Source: Gilead Sciences press release
