Gilead expands royalty-free lenacapavir licenses across 120 countries to support potential once-yearly HIV PrEP manufacturing and supply.
Written By: Khushi Patel, PharmD
Reviewed By: Pharmacally Editorial Team
Gilead Sciences has expanded its existing royalty-free voluntary licensing agreements for lenacapavir to include an investigational once-yearly formulation for HIV pre-exposure prophylaxis (PrEP). The expanded agreements cover 120 high-incidence, resource-limited countries, primarily low- and lower-middle-income nations, giving six generic manufacturing partners additional time to prepare production, technology transfer and supply systems while the Phase 3 PURPOSE 365 trial (NCT07047716) continues.
Lenacapavir Targets Multiple Stages of HIV Replication
Lenacapavir is an HIV-1 capsid inhibitor that interferes with multiple stages of the viral lifecycle. Its mechanism differs from existing antiretroviral classes, and it has shown no known cross-resistance in vitro with other established drug classes.
The expanded access strategy addresses persistent gaps in global PrEP uptake. UNAIDS reported fewer than 4 million people using PrEP globally in 2024, compared with a global target of more than 21 million.
A once-yearly injection could reduce adherence and healthcare-visit barriers associated with daily oral PrEP or more frequent dosing. It could also provide a discreet, extended-duration prevention option for people who face challenges maintaining regular medication schedules or accessing healthcare services.
Drug Attribute | Details |
Drug Class | HIV-1 capsid inhibitor |
Mechanism | Inhibition of multiple stages of the HIV viral lifecycle |
Dosing Schedule | Investigational once-yearly intramuscular injection |
Indication | HIV pre-exposure prophylaxis (PrEP) |
Development Status | Phase 3, investigational |
PURPOSE 365 Evaluates a 52-Week Dosing Interval
The licensing expansion builds on the Phase 3 PURPOSE 1 and PURPOSE 2 trials, in which twice-yearly lenacapavir demonstrated high efficacy in preventing HIV acquisition and showed superiority to daily oral PrEP comparators in the respective trial settings.
However, those findings do not establish the efficacy of the once-yearly regimen.
The ongoing PURPOSE 365 study is a Phase 3, open-label trial evaluating the pharmacokinetics, safety and tolerability of once-yearly intramuscular lenacapavir. The study is assessing whether a single annual dose can maintain drug concentrations associated with HIV prevention throughout a 52-week dosing interval.
The results will determine whether the once-yearly approach can provide sustained drug exposure while maintaining an acceptable safety and tolerability profile.
Six Generic Manufacturers Expand Global Access Planning
Gilead extended the agreements with six partners already involved in manufacturing twice-yearly lenacapavir for HIV prevention:
- Dr. Reddy’s Laboratories Limited
- Emcure Pharmaceuticals Limited
- Eva Pharma for Pharmaceutical Industries S.A.E.
- Ferozsons Laboratories Limited
- Hetero
- Mylan Laboratories Limited, a subsidiary of Viatris
The partners have experience producing complex sterile injectable medicines. The expanded licenses allow them to begin preparing for potential manufacturing and supply requirements before the once-yearly formulation reaches any regulatory review.
The company has also expanded its no-profit supply commitment with PEPFAR and the Global Fund from 2 million to up to 3 million people through 2028. Lenacapavir is currently available in 10 countries across sub-Saharan Africa.
Gilead and the Pan American Health Organization established a coordinated regional pathway to expand access to twice-yearly lenacapavir for HIV prevention across PAHO Member States in Latin America and the Caribbean through the organization’s Regional Revolving Funds.
Regulatory Decisions Will Depend on PURPOSE 365
Johanna Mercier, Gilead’s Chief Commercial & Corporate Affairs Officer, said establishing voluntary licenses during Phase 3 development could provide more time for manufacturing readiness, healthcare-system preparation and community engagement if the once-yearly regimen is ultimately approved.
The expanded agreements therefore represent an early access-planning measure rather than evidence of regulatory approval. Once-yearly lenacapavir remains investigational, and no regulatory authority has approved the formulation for HIV prevention.
The next major milestone is the PURPOSE 365 clinical readout. If the study provides supportive pharmacokinetic, safety and tolerability data, those findings could inform subsequent regulatory submissions and potential development of a once-yearly HIV PrEP option across the licensed markets.
Reference
Gilead Accelerates Global Access Planning for Investigational Once-Yearly Lenacapavir for HIV Prevention, Gilead, 16 September 2026
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) (PURPOSE 365), ClinicalTrials.gov ID NCT07047716
About the Writer
Khushi Patel is a Pharm.D (Linkedin) professional with a strong foundation in clinical pharmacy, patient-centered care, regulatory affairs, and pharmacovigilance, with published work on Brugada syndrome.
Her interests include regulatory affairs, pharmacovigilance, guideline integration, multimodal therapy, pharmacogenomics, and antibiogram utilization, with a focus on evidence-based clinical decision-making and medication safety.
As a Pharmacally healthcare writer, she translates clinical and scientific evidence into clear, accurate, and clinically relevant healthcare content, while continuously developing her expertise in evolving pharmacy practice.