FOSTER CITY, Calif. — September 17, 2026
Gilead Sciences, Inc. announced that it has expanded six royalty-free voluntary licensing agreements for lenacapavir to include its investigational once-yearly formulation for HIV prevention as pre-exposure prophylaxis (PrEP). The agreements cover 120 high-incidence countries, primarily low- and lower-middle-income markets, and are designed to support manufacturing readiness, technology transfer and future supply planning while the Phase 3 PURPOSE 365 study remains ongoing. The expanded licensing strategy represents an early access-planning effort intended to prepare generic manufacturing capacity ahead of potential regulatory approvals. Gilead is extending its established access model for twice-yearly lenacapavir to a potential once-yearly option, with the objective of shortening the pathway between regulatory approval and availability in regions with substantial HIV prevention needs.
PURPOSE 365 Evaluates Annual Lenacapavir PrEP
PURPOSE 365 is evaluating whether a single annual intramuscular dose of lenacapavir can maintain drug concentrations associated with HIV prevention throughout a 52-week dosing interval. The open-label Phase 3 study is assessing pharmacokinetics, safety and tolerability of the investigational regimen and is intended to determine whether reducing dosing frequency could provide another long-acting prevention option. Once-yearly lenacapapvir remains investigational and has not been approved by any regulatory authority, so its safety and efficacy for this use have not yet been established. The program builds on findings from the PURPOSE 1 and PURPOSE 2 Phase 3 studies, in which twice-yearly lenacapavir demonstrated high efficacy for HIV prevention across diverse populations. If successfully developed and approved, an annual administration schedule could expand PrEP choice for people who face challenges associated with more frequent medication schedules or healthcare visits.
Six Manufacturers Prepare for Potential Global Supply
Gilead’s six voluntary licensing partners are Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma, Ferozsons Laboratories, Hetero and Mylan Laboratories, a subsidiary of Viatris. The companies were selected based on their experience manufacturing complex sterile injectable medicines and their existing relationships with Gilead through voluntary licensing programs. Under the expanded agreements, the manufacturers can begin preparations that may include technology transfer and manufacturing readiness for once-yearly lenacapavir, providing additional time to develop future supply capabilities if the product receives regulatory approval. Gilead is also expanding its broader global access strategy for twice-yearly lenacapavir, including planned no-profit supply for up to 3 million people through 2028 through commitments involving PEPFAR and the Global Fund. The company said lenacapavir is already available in 10 sub-Saharan African countries, while additional regional access initiatives are being developed.
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Gilead Builds Long-Term HIV Prevention Access Strategy
The once-yearly licensing expansion forms part of Gilead’s broader strategy to combine long-acting HIV prevention innovation with sustainable global access planning. The company recently announced a partnership with the Pan American Health Organization to accelerate access to twice-yearly lenacapavir across PAHO Member States in Latin America and the Caribbean through the organization’s Regional Revolving Funds. Gilead said broader prevention choice is important because stigma, healthcare access and dosing frequency can affect PrEP uptake and persistence. Lenacapavir is already approved in multiple countries as twice-yearly PrEP for adults and adolescents at risk of sexually acquired HIV and is also approved in multiple countries for treatment of multidrug-resistant HIV in combination with other antiretrovirals. With PURPOSE 365 continuing to evaluate an annual formulation, early voluntary licensing and manufacturing preparation could establish an access pathway ahead of potential regulatory decisions, reinforcing Gilead’s long-term approach to expanding the reach of long-acting HIV prevention.
Source:Gilead Sciences, press release
