Gilead expands lenacapavir licensing to 120 nations

On 16 September 2026, Gilead Sciences announced that it expanded six royalty-free voluntary licensing agreements to include its investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP). The agreements cover 120 high-incidence countries, primarily low- and lower-middle-income nations, to prepare manufacturing, technology transfer, and supply planning during Phase 3 trials.

The Phase 3 PURPOSE 365 study is currently testing the safety, tolerability, and pharmacokinetics of an intramuscular dose designed to maintain protective drug concentrations over a 52-week interval. The formulation remains investigational and has not received regulatory approval.

The expanded agreements were signed with six generic manufacturing partners: Dr. Reddy's Laboratories, Emcure Pharmaceuticals, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan Laboratories, a subsidiary of Viatris. Gilead noted that an estimated 1.2 million people contracted HIV globally in 2025, while UNAIDS reported fewer than 4 million people used PrEP in 2024 against a target of more than 21 million.

Gilead also increased the planned reach of its no-profit supply program with PEPFAR and the Global Fund by 50%, moving from 2 million to up to 3 million people through 2028. Its twice-yearly lenacapavir is already available in 10 countries across sub-Saharan Africa, and the company recently signed an agreement with the Pan American Health Organization to expand regional access in Latin America and the Caribbean.