Gilead Expands Licensing for Investigational Once-Yearly HIV Prevention Injection to 120 Countries

Gilead Sciences, the company behind lenacapavir, the HIV prevention injection that the journal Science named its 2024 Breakthrough of the Year, has expanded six royalty-free licensing agreements to include an investigational once-yearly version.

Gilead said the option, if approved, could be especially important in high-incidence, resource-limited settings.

Announced on 16 September 2026, the agreements are intended to help six generic drug manufacturers prepare to produce the annual injection, transfer the technology needed to manufacture it and plan future supplies while clinical trials continue.

Gilead has not named the individual countries covered by the expanded agreements or stated how many are in Africa.

The six licensing partners are Dr. Reddy’s Laboratories, based in Hyderabad, India; Emcure Pharmaceuticals, headquartered in Pune, India; EVA Pharma, based in Cairo, Egypt; Ferozsons Laboratories, headquartered in Lahore, Pakistan; Hetero, based in Hyderabad, India; and Mylan Laboratories Limited, a subsidiary of Viatris with a registered office in Hyderabad, India.

All six companies already manufacture the twice-yearly formulation of lenacapavir for HIV prevention.

Gilead said it selected them for their experience producing complex sterile injectable medicines and their existing relationships as licensing partners.

The agreements allow the manufacturers to prepare for potential production and supply in the 120 covered countries.

They do not mean the once-yearly injection is already available there, or that every country will receive it as soon as it is approved.

Gilead’s chief commercial and corporate affairs officer, Johanna Mercier, said establishing the agreements during clinical development could give manufacturers, healthcare systems and communities more time to prepare for potential introduction of the medicine.

What researchers are testing

The once-yearly injection is being studied in PURPOSE 365, an ongoing Phase 3 clinical trial designed to assess whether a single injection of lenacapavir can maintain drug concentrations associated with HIV prevention for 52 weeks.

Researchers are also evaluating its safety and tolerability.

The study is testing whether people could eventually receive HIV prevention through one injection a year instead of needing more frequent medication or injections.

If the formulation proves safe and effective and receives regulatory approval, it could provide another option for people who find regular medication schedules or frequent healthcare visits difficult.

The annual formulation remains investigational.

No regulatory authority has approved it, and its safety and efficacy have not been established.

Earlier research into the twice-yearly formulation included PURPOSE 1 and PURPOSE 2, two Phase 3 trials that compared lenacapavir with existing prevention approaches in different populations.

Those studies found that the twice-yearly injection was superior to a daily oral pre-exposure prophylaxis (PrEP) comparator.

Their results do not establish that the investigational once-yearly formulation is equally effective.

PrEP is medication taken by people who do not have HIV to reduce their risk of acquiring the virus.

Why another prevention option matters

An estimated 1.2 million people acquired HIV worldwide in 2025, according to figures cited by Gilead from UNAIDS.

PrEP use also remains below global targets: fewer than 4 million people were using PrEP worldwide in 2024, compared with a previous target of reaching more than 21 million people by 2025.

PrEP can prevent HIV acquisition, but its impact depends partly on whether people can access it and use it consistently.

Stigma, barriers to healthcare and the demands of taking medication or attending appointments can affect whether people start or continue prevention.

A once-yearly injection could reduce the number of visits needed for prevention if it is approved and made accessible.

However, its actual benefits will depend on trial results, regulatory decisions, cost and how health systems deliver it.

Existing access to twice-yearly lenacapavir

Gilead said its twice-yearly lenacapavir injection for HIV prevention is now available in 10 countries across sub-Saharan Africa: Eswatini, Kenya, Lesotho, Malawi, Mozambique, Nigeria, South Africa, Uganda, Zambia and Zimbabwe.

This is the existing twice-yearly formulation, not the investigational annual injection.

The company has also expanded a no-profit supply programme involving the U.S. State Department, the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund.

The programme’s planned reach has increased from 2 million people to up to 3 million through 2028. This is a supply commitment, not confirmation that 3 million people have already received the medicine.

Separately, on 15 September 2026, Gilead and the Pan American Health Organization announced an agreement to create a route for access to twice-yearly lenacapavir through PAHO’s regional purchasing system.

The arrangement covers 14 countries in Latin America and the Caribbean and is separate from the expanded licensing agreements for the investigational once-yearly formulation.

The new licensing agreements are intended to prepare manufacturers and health systems for potential future supply before the annual injection completes clinical development.

Whether it becomes available, and when, will depend on the results of the trial and regulatory approval.