Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has expanded the scope of its six royalty-free voluntary licensing agreements for lenacapavir to include investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP). The agreements cover 120 high-incidence countries (which are primarily low- and lower-middle-income) and will support manufacturing readiness, technology transfer and future supply planning while the Phase 3 PURPOSE 365 trial is ongoing.
Key Highlights
- If approved, once-yearly lenacapavir could provide a full year of HIV prevention with a single annual dose, expanding prevention choice and helping address barriers that can limit PrEP uptake and persistence.
- PURPOSE 365 is an ongoing Phase 3 study evaluating the pharmacokinetics, safety and tolerability of investigational once-yearly intramuscular lenacapavir for HIV prevention.
- Across the Phase 3 PURPOSE 1 and PURPOSE 2 trials, twice-yearly lenacapavir demonstrated unprecedented efficacy for HIV prevention, delivering protection against HIV acquisition across diverse populations while showing superiority to a daily oral PrEP comparator.
- Gilead is extending its global access model for twice-yearly lenacapavir for HIV prevention to enable broad, sustainable access to multiple generic long-acting HIV prevention options.
- The expanded agreements represent one of the earliest HIV PrEP access planning efforts undertaken during Phase 3 development and build on Gilead’s two decades of experience developing global access pathways for HIV medicines, including unprecedented work for twice-yearly lenacapavir.
“Investigational once-yearly lenacapavir for HIV prevention has the potential to add a discreet, extended-duration prevention option that, if approved, could be especially important in high-incidence, resource-limited settings, where people often face significant barriers to accessing and staying on PrEP,” said Johanna Mercier, Chief Commercial & Corporate Affairs Officer, Gilead Sciences. “By establishing voluntary licensing agreements this early in our development process, we are hoping to provide additional time to support manufacturing readiness, healthcare system preparation and community engagement. This supports our goal of helping to ensure that, if approved, the path from innovation to impact has the potential to be shorter, broader and more equitable.”
The expanded agreements have been signed between Gilead and the six voluntary licensing partners who are manufacturing twice-yearly lenacapavir for HIV prevention as PrEP: Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Eva Pharma for Pharmaceutical Industries S.A.E., Ferozsons Laboratories Limited, Hetero and Mylan Laboratories Limited, a subsidiary of Viatris. These manufacturers were selected based on their demonstrated capabilities in producing complex, sterile injectable medicines and their long-standing experience as voluntary licensing partners with Gilead.
Expanding Choice in HIV Prevention
Despite significant progress in HIV PrEP, substantial gaps in access and uptake remain around the world. An estimated 1.2 million people acquired HIV globally in 2025, underscoring the continued need for additional prevention options that can reach more people who are vulnerable to HIV acquisition. Use of PrEP remains well below global targets: UNAIDS has reported that fewer than 4 million people were using PrEP globally in 2024, far short of the global goal of reaching more than 21 million people.
Expanding choice is critical to helping close the gap in HIV PrEP. People have different needs, preferences, and life circumstances, and barriers such as stigma, healthcare access, and the demands of more frequent dosing or healthcare visits can affect PrEP use. Offering a broader range of options can help more people find an approach that fits their lives, supports discretion, and empowers them to work with their healthcare provider to choose the tool that works best for them.
Once-yearly lenacapavir for PrEP is investigational and has not been approved by any regulatory authority. Its safety and efficacy have not been established. There is no cure for HIV or AIDS.
Building Toward Broad, Sustainable Access to Lenacapavir for HIV Prevention as PrEP
Gilead continues to make progress on its strategy to expand access to twice-yearly lenacapavir for HIV prevention as PrEP. The company recently expanded its partnership commitments with the U.S. State Department through PEPFAR and the Global Fund, increasing the planned reach of its no-profit supply program by 50% – from 2 million people to up to 3 million people through 2028. Lenacapavir is now available in 10 countries across sub-Saharan Africa.
At the same time, licensed manufacturers, governments and implementation partners are actively preparing for upcoming generic availability, reflecting continued momentum toward making twice-yearly HIV prevention medicine, if approved, available to more people in the regions with the greatest unmet need.
Earlier this week, Gilead announced a new agreement with the Pan American Health Organization (PAHO) to accelerate access to twice-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP) across all PAHO Member States in Latin America and the Caribbean. Through PAHO’s Regional Revolving Funds, the agreement establishes a coordinated regional pathway to expand access to long-acting HIV prevention and support country-led efforts toward adoption and implementation, as part of the broader efforts to end the epidemic across the region.
About PURPOSE 365
PURPOSE 365 is an ongoing Phase 3, open-label study evaluating the pharmacokinetics, safety and tolerability of investigational once-yearly intramuscular lenacapavir for HIV prevention as PrEP. The study is designed to assess whether a single annual dose of lenacapavir can maintain drug concentrations associated with HIV prevention throughout a 52-week dosing interval, while also evaluating the safety and tolerability of the investigational regimen.
PURPOSE 365 builds on the broader PURPOSE clinical development program, which is evaluating lenacapavir across multiple populations and settings with the goal of expanding prevention choice through long-acting HIV prevention options. The study represents the next phase of Gilead’s long-acting HIV prevention research program and is exploring whether reducing dosing frequency to once yearly may help address barriers that can limit uptake and persistence with existing prevention approaches.
By evaluating a once-yearly formulation, PURPOSE 365 aims to generate data that could inform a future HIV prevention option requiring only a single healthcare visit for administration each year. If successful, such an approach could further expand prevention choice and support efforts to reach people who may face challenges with more frequent healthcare interactions or medication schedules.
About Lenacapavir
Twice-yearly lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.
The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program, including a once-yearly injection for HIV prevention. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 14 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.
Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 365); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage, execute and realized the anticipated benefits from the access strategy relating to lenacapavir, including voluntary licensing arrangements and external partnerships relating to lenacapavir; difficulties or unanticipated expenses in connection with such strategy. arrangements and partnerships; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
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For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs.
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