Once-weekly HIV prevention push, Gilead’s Yeztugo tablet moves toward FDA review

Gilead Sciences is advancing a 300 mg once-weekly Yeztugo (lenacapavir) tablet as a potential long-acting oral HIV pre-exposure prophylaxis option, after the FDA accepted a supplemental application and set a 2027 decision date.

Edited by ad hoc news New Releases & Launches Desk. Reviewed before publication on 06/16/2026 at 12:32 PM ET. Details in the imprint.

Gilead Sciences is moving its HIV prevention franchise into new territory with a proposed once-weekly oral version of Yeztugo, a 300 mg lenacapavir tablet intended for pre-exposure prophylaxis in people at risk of sexually acquired HIV-1. The U.S. Food and Drug Administration has accepted a supplemental new drug application for the investigational regimen and set a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027, giving the program a clear regulatory timetable. According to recent coverage summarizing Gilead's announcement, the company is positioning the weekly pill as a long-acting oral alternative for people who need or prefer HIV prevention options beyond daily pills or injectable products.

What Gilead’s once-weekly Yeztugo tablet aims to offer

Yeztugo is already authorized in the U.S. in an injectable form as a long-acting pre-exposure prophylaxis (PrEP) product, given twice yearly to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk of acquisition. The new tablet formulation uses the same antiviral backbone, lenacapavir, but is designed for once-weekly oral dosing to extend protection between doses while avoiding the need for injections and clinic visits that can limit adherence for some users. Gilead’s clinical program is evaluating the 300 mg tablet as a long-acting oral PrEP option, but once-weekly oral lenacapavir for HIV prevention remains investigational and is not approved anywhere globally. Gilead's own briefing on the filing describes the tablet as a potential first long-acting oral PrEP option, complementing rather than replacing existing daily pills and injectables.

The strategic rationale is clear: daily PrEP tablets such as tenofovir-based combinations have delivered strong efficacy in trials but can be undermined by inconsistent adherence, while long-acting injectables reduce dosing frequency at the cost of requiring injections and scheduled visits. Gilead is targeting a middle ground with the Yeztugo tablet, trading daily intake for a once-weekly schedule that might fit more easily into some users' routines. If approved, the weekly pill could broaden the appeal of PrEP among people who are reluctant to start daily therapy or hesitant about injections, potentially expanding the addressable patient population for Gilead’s HIV prevention portfolio. Outside of prevention, lenacapavir is already used as a twice-yearly subcutaneous injection for heavily treatment-experienced people with multi-drug-resistant HIV-1 infection, so the molecule itself is proven, but its use as a weekly oral prophylaxis remains under regulatory review.

Gilead’s once-weekly PrEP project sits within a competitive and fast-evolving HIV prevention landscape. ViiV Healthcare markets the long-acting injectable cabotegravir for PrEP, while generic versions of daily oral PrEP regimens are available in many markets. Gilead’s own injectable Yeztugo has launched with a branded "One2PrEP" campaign highlighting the twice-yearly dosing, underscoring how the company is leaning on adherence and convenience as key differentiators. Industry coverage of current PrEP marketing notes Yeztugo’s positioning as a twice-yearly injectable option, suggesting that a weekly tablet formulation would extend the same adherence-focused message to patients who prefer oral regimens. From a portfolio standpoint, a successful launch could give prescribers a broader menu of dosing preferences under a single brand family, potentially improving persistence on prevention.

For Gilead, HIV prevention and treatment continue to be central to the company’s revenue base, even as it invests in oncology and other therapeutic areas for long-term growth. The once-weekly Yeztugo tablet, if approved, would not be a near-term driver given the 2027 PDUFA date, but it represents an attempt to defend and expand the company’s PrEP franchise by addressing adherence barriers documented in real-world use of daily pills. In regulatory terms the product is still early: the FDA’s acceptance of the supplemental application confirms that the filing is sufficiently complete for review, but it does not pre-judge the outcome on safety and efficacy, and the company will have to navigate advisory committee scrutiny and label negotiations before any commercial rollout in the U.S. can begin. Shares of Gilead Sciences (ISIN US3755581036) traded on NASDAQ at $154.82 on 06/14/2026, according to recent market data compiled by MarketBeat.

Yeztugo once-weekly tablet in brief: the essentials

• Product: Yeztugo (lenacapavir) 300 mg once-weekly oral tablet for PrEP (investigational)
• Manufacturer: Gilead Sciences, Inc.
• Category: New Release/Launch - HIV prevention therapy
• Launch date: Under FDA review; PDUFA action date February 2, 2027
• MSRP / Price: Not yet set; product not approved or marketed in tablet PrEP form
• Availability: Investigational; no commercial availability for once-weekly oral PrEP at this time
• Target audience: Adults and adolescents at risk of sexually acquired HIV-1 who need or prefer long-acting oral PrEP instead of daily pills or injectables
• Key differentiator / USP: Proposed once-weekly oral dosing using long-acting lenacapavir for HIV pre-exposure prophylaxis

This article was a.i.-assisted and editorially reviewed. Product information without warranty; prices and availability may change at short notice. Not investment advice and not a buy or sell recommendation. Trading involves risk up to and including the total loss of invested capital.